Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania
Conditions: Penile Infection, Penile Haematoma, Penile Bleeding, Deformity
Sponsor: IntraHealth International

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
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PROTOCOL 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male 
Circumcision in Shinyanga, Tanzania 
October 22, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
The study protocol was approved by the Ethics Committees of the Tanzanian National Institute for 
Medical Research (Ref: NIMR/HQ/R.8a/Vol. IX/2995), US Centers for Disease Control and Prevention, 
Center for Global Health (CGH HSR Tracking #2019-519), and Johns Hopkins School of Public Health 
Institutional Review Board Office (FWA #00000287). 
Evaluating Partner: Gissenge J. I. Lija, MD, National AIDS Control Programme, Tanzanian Ministry of 
Health & Social Welfare, Community Development, Elderly and Children (MoHCDGEC) 
Centers for Disease Control and Prevention 
 
Boniface Nguhuni, MD, MsC, Division of Health, Social Welfare & Nutrition Services, President’s Office 
– Regional Administration and Local Government (PORALG) 
 
Co-Evaluating Partners:  
Angela A. Ramadhani, MD, MoHCDGEC 
Susan Mmbando, MD, MoHCDGEC 
Jerry Mushi, MoHCDGEC 
James Juma McOlog, MoHCDGEC 
 
Collaborators: 
Lucy Mphuru, IntraHealth International, Dar-es-Salaam 
Pastory Sekule, IntraHealth International, Dar-es-Salaam 
Kija Nyalali, IntraHealth International, Dar-es-Salaam 
Paul Mwakipesile, IntraHealth International, Dar-es-Salaam 
Daniel Kija, IntraHealth International, Dar-es-Salaam 
Dr. Johnson Joachim, IntraHealth International, Dar-es-Salaam 
Jennifer Wesson, IntraHealth International, Chapel Hill 
Carolina Mejia, IntraHealth International, Chapel Hill 
Catherine Brokenshire-Scott, IntraHealth International, Chapel Hill 
Julia Brasileiro, IntraHealth International, Chapel Hill 
 
Catharine Laube, Jhpiego, Washington, DC 
Alice Christensen, Jhpiego, Dar-es-Salaam 
 
Koku Kazaura, CDC Tanzania 
Daimon Simbeye, CDC Tanzania 
Mbaraka Amuri, CDC Tanzania 
 
Stephanie Davis, CDC Atlanta 
Melissa Habel, CDC Atlanta 
Jonas Hines, CDC Atlanta 
Lawrence Hinkle, CDC Atlanta 
Carlos Toledo, CDC Atlanta 
 
 

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Table of Contents 
List of Acronyms .......................................................................................................................................................6 
Investigators, Institutional Affiliations and Roles and Responsibilities ...............................................................6 
Section A: Funding Source ..................................................................................................................................... 10 
Section B: Executive Summary ............................................................................................................................. 10 
Section C: Protocol ................................................................................................................................................. 11 
Introduction ....................................................................................................................................................... 11 
Voluntary Male Medical Circumcision (VMMC), VMMC Devices and ShangRing ..................................... 11 
ShangRing and HIV+ Men .............................................................................................................................. 12 
HIV in Tanzania .............................................................................................................................................. 13 
Male Circumcision in Tanzania ..................................................................................................................... 13 
Introducing a New Circumcision Device ...................................................................................................... 13 
Justification for Evaluation ............................................................................................................................ 13 
Evaluation Design and Methods ....................................................................................................................... 14 
Evaluation Goal .............................................................................................................................................. 14 
Evaluation Objectives .................................................................................................................................... 14 
Primary Endpoint .......................................................................................................................................... 14 
Secondary Endpoints ..................................................................................................................................... 15 
Evaluation Design .............................................................................................................................................. 16 
Overall Design ................................................................................................................................................ 16 
Description of Evaluation Populations and Catchment Areas .................................................................... 16 
Client Inclusion Criteria ................................................................................................................................. 16 
Client Exclusion Criteria ................................................................................................................................ 17 
Client Withdrawal Criteria ............................................................................................................................ 18 
Procedure for Handling Clients Lost-to-Follow-Up .................................................................................... 18 
Provider Participant Inclusion Criteria ........................................................................................................ 19 
Provider Participant Exclusion Criteria ....................................................................................................... 19 
Minimum Site Requirements for ShangRing Pilot Service Delivery .......................................................... 19 
Sample Size, Data Collection and Analysis Timeline ................................................................................... 20 
Supplies and Logistics ................................................................................................................................... 20 
Evaluation Phases .............................................................................................................................................. 21 
Training Phase ............................................................................................................................................... 21 
Implementation Phase ................................................................................................................................... 21 

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Table 2: Implementation Pilot: Training and Implementation Phases...................................................... 23 
Evaluation Procedures and Logistics ............................................................................................................... 24 
Evaluation Offices .......................................................................................................................................... 24 
Clinic Space and Circumcision Area ............................................................................................................. 24 
Staff Training .................................................................................................................................................. 24 
Recruitment and Enrollment of Clients ........................................................................................................... 25 
Recruitment .................................................................................................................................................... 25 
Written Informed Consent ............................................................................................................................ 26 
Eligibility Screening ....................................................................................................................................... 26 
HIV Testing Procedures ................................................................................................................................. 27 
Evaluation Identification Code...................................................................................................................... 27 
Male Circumcision Using ShangRing Device .................................................................................................... 27 
Key Post-Placement Procedure Counseling following ShangRing Circumcision ...................................... 28 
Key Post-Device Removal Counseling following ShangRing Circumcision ............................................... 29 
Key Post-Device Removal Counseling during AE Assessment Call ............................................................ 29 
Follow-Up Visits ............................................................................................................................................. 29 
Post Day 49 Healing Assessment Visits ........................................................................................................ 31 
Unscheduled Visits ......................................................................................................................................... 31 
In-Person Qualitative Interviews.................................................................................................................. 31 
Quality Control and Quality Assurance ........................................................................................................ 32 
Photography ................................................................................................................................................... 32 
Data Management and Analysis ........................................................................................................................ 33 
Data Collection ............................................................................................................................................... 33 
Adverse Events Management ........................................................................................................................ 34 
Adverse Event (AE) and Other Device-Related Incident Documentation ................................................. 35 
ShangRing and Tetanus ................................................................................................................................. 36 
Data Entry ....................................................................................................................................................... 36 
Data Management .......................................................................................................................................... 36 
Analysis Overview ......................................................................................................................................... 37 
Long-Term Data Storage ............................................................................................................................... 38 
Ethical Considerations ....................................................................................................................................... 38 
Potential Harm and Measures to Mitigate Harm ......................................................................................... 38 

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Potential Benefits ........................................................................................................................................... 40 
Social Harm Events ........................................................................................................................................ 40 
Approvals and Consultations ........................................................................................................................ 41 
Data Security and Confidentiality ................................................................................................................. 41 
Potential Risks ................................................................................................................................................ 41 
HIV Notification Policy .................................................................................................................................. 41 
Sponsor Monitoring ....................................................................................................................................... 41 
Conflicts of Interest ........................................................................................................................................ 42 
Reimbursements ............................................................................................................................................ 42 
Projected Timeline ............................................................................................................................................. 42 
Dissemination of Findings ............................................................................................................................. 43 
Table 3: ShangRing Implementation Pilot Timeline – Preparatory Phase ................................................ 44 
Table 4: ShangRing Implementation Pilot Evaluation Timeline – Implementation Phase ...................... 45 
Appendices ............................................................................................................................................................. 46 
Appendix I - Pathways for Introduction of VMMC Devices ............................................................................ 47 
Appendix II – Consent form for Male Circumcision by ShangRing ................................................................ 48 
Appendix III – Additional Informed Consent Form for Photography ............................................................ 53 
Appendix IV – Additional Informed Consent Form for Qualitative Interview .............................................. 55 
Appendix V - Assent Form for Male Circumcision by ShangRing (For Ages 13-17) ..................................... 57 
Appendix VI – Informed Consent Form for Photography (For Ages 13-17) ................................................. 62 
Appendix VII – Case Report Form (CRF) – Screening ..................................................................................... 64 
Appendix VIII – Tanzania MoHCDGEC Male Circumcision Client Form ........................................................ 70 
Appendix IX – Case Report Form (CRF) – ShangRing Device ......................................................................... 75 
Appendix X – ShangRing Post-Placement Survey ........................................................................................... 81 
Appendix XI – ShangRing Post-Removal Survey ............................................................................................. 83 
Appendix XII – ShangRing Case Report Form: Client Follow-Up Form ......................................................... 86 
Appendix XIII – Introductory script for contacting ShangRing clients by phone ......................................... 92 
Appendix XIV – ShangRing Adverse Event Day 3 Post-Removal AE Check-in Call Form ............................. 93 
Appendix XV – ShangRing Active Surveillance: Device Placement and Follow-up Log ............................... 96 
Appendix XVI: ShangRing Evaluation Pilot: Log of Client ShangRing Eligibility and Acceptance ............... 98 
Appendix XVII – ShangRing Post-Operative Care Instructions .................................................................... 100 
Appendix XVIII – Adverse Event Reporting Form ......................................................................................... 103 

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Appendix XIX: Adverse Event Classifications and Definitions: During Device Placement or Wearing and 
During or After Device Removal* ................................................................................................................... 107 
Appendix XX - ShangRing Evaluation Pilot: Application Time Form ........................................................... 111 
Appendix XXI - ShangRing Evaluation Pilot: Removal Time Form .............................................................. 113 
Appendix XXII – Client Qualitative Interview Guide ..................................................................................... 115 
Appendix XXIII – Consent form for Provider Interviews and Surveys ........................................................ 117 
Appendix XXIV – Phase 1 Provider Interview Guide..................................................................................... 120 
Appendix XXV – Phase 2 Provider Interview Guide ...................................................................................... 121 
Appendix XXVI – ShangRing Evaluation Provider Survey ............................................................................ 123 
Appendix XXVII: Employee Confidentiality Agreement ................................................................................ 126 
Appendix XXVIII – ShangRing Evaluation Client Withdrawal Log ............................................................... 127 
Appendix XXIX – WHO ShangRing Prequalification ...................................................................................... 128 
Appendix XXX – Data Use Agreement ............................................................................................................ 130 
Appendix XXXI – Investigator Qualifications ................................................................................................. 134 
References ............................................................................................................................................................ 135 
 
List of Acronyms 
 
AE 
 
Adverse event 
CDC 
 
U.S. Centers for Disease Control and Prevention  
CRF 
 
Case Report Form 
DGHT  
Division of Global HIV & TB 
HIV 
 
Human Immunodeficiency Virus 
IHI 
 
IntraHealth International 
MC 
 
Medical Circumcision 
MoHCDGEC 
Tanzanian Ministry of Health, Community Development, Gender, Elderly and Children 
PEPFAR  
U.S. President’s Emergency Plan for AIDS Relief 
PII 
 
Personally Identifiable Information 
STI 
 
Sexually Transmitted Infection 
TOT 
 
Trainer of Trainers 
VMMC  
Voluntary Medical Male Circumcision 
UNAIDS 
Joint United Nations Programme on HIV/AIDS 
WHO 
 
World Health Organization 
 
Investigators, Institutional Affiliations and Roles and 
Responsibilities 
 
Tanzanian Ministry of Health & Social Welfare, Community Development, Gender, Elderly and Children 
(MoHCDGEC): MoHCDGEC serves as a technical expert on health care and is committed to the provision of basic 

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health services that are of good, quality, accessible, affordable, and sustainable and gender sensitive to the 
people of Tanzania. Staff from MoHCDGEC will assist with all aspects of planning to ensure that the evaluation 
responds to the priorities and information needs of the Government of Tanzania. Staff will be responsible for 
assisting with oversight of all aspects of the evaluation planning and implementation including protocol 
development, procedures, results dissemination, and publications. 
 
 
MoHCDGEC Principal Investigator: Dr. Gisenge J.I. Lija, MD, MMed: Head of the prevention Unit, 
MOHCDGEC/National AIDS Control Program; Phone + 255 784 284148; email: j.lija@hotmail.com  
MoHCDGEC Co-Investigator: Dr. Angela A. Ramadhani MD, MPH: Program Manager; National AIDS 
Control Program (NACP); home +255 754 266233; e-mail: arshayo@yahoo.com. Provides programmatic 
guidance in matters pertaining to HIV/AIDS programming 
MoHCDGEC Co-Investigator: Dr. Susan Mmbando, AMO, MPH: Program Officer, Biomedical Prevention, 
National AIDS Control Program (NACP); Mob +255 754 276503, email: mmbandosusan@yahoo.com . 
Provide technical guidance on clinical VMMC 
MoHCDGEC Co-Investigator: Mr. Jerry Mushi, Monitoring and evaluation NACP, email: 
jerryflm@yahoo.com, mobile: +255 717 406670. 
MoHCDGEC Co-Investigator: Mr. James Juma McOlog, Mphil, Epidemiologist, Monitoring and Evaluation 
Officer; The National AIDS Control Program (NACP); Mob. +255 784 556337; email: jj162us@gmail.com. 
Provide technical guidance for the VMMC program evaluation activities. 
 
The Tanzania Presidents Office Regional Administration and Local Government (PORALG) authorities: PORALG 
serves as a technical expert on health care and is committed to the provision of basic health services that are of 
good, quality, accessible, affordable, and sustainable and gender sensitive to the people of Tanzania. Staff from 
PORALG will assist with all aspects of planning to ensure that the evaluation responds to the priorities and 
information needs of the Government of Tanzania. Staff will be responsible for assisting with oversight of all 
aspects of evaluation planning and implementation including protocol development, procedures, results 
dissemination, and publications. 
 
PORALG Co-Investigator: Boniface Nguhuni, MD, MSc  Division of Health, Social Welfare & Nutrition 
Services, President's Office - Regional Administration and Local Government (PORALG),   
Mobile: +255 754 669 512 E-mail: bonellias@gmail.com 
PORALG: Mr. Mathew Emmanuel Mganga (Pharmacist) matayosemunyu@gmail.com     Mobile: 
0767228290 or 0713228290 
 
WHO Tanzania Co-Investigator: Bhavin Jan, Tanzania- WHO office +255 713 528 827 +255 787 635 657 
bhavinium@gmail.com  
 
The Centers for Disease Control and Prevention, Voluntary Medical Male Circumcision (VMMC) Team in 
Atlanta (CDC Atlanta): CDC Atlanta Staff will provide financial support through JHPEIGO for the evaluation. CDC 
will provide technical support for the evaluation, data management and manipulation, analysis and report 
writing, and dissemination activities. CDC provides technical assistance which includes protocol and methods 
development; liaising between key partners and agencies, both locally and internationally; support for preparing 
and submitting the ethical protocol for local and CDC IRB approval; provides technical assistance for the 
evaluation methodology and development of the abstracted database; provides support for trainings; provides 
technical assistance in the field; leads in the data analysis for the quantitative evaluation component and report 
writing. CDC Atlanta employees consequently will not interact with evaluation clients and they will not have 
access to individually identifiable information. CDC staff will not be collecting data directly from participants, will 
not directly engage evaluation participants or have access to patient level data containing personally identifiable 
information (PII), nor will CDC staff have access to data that is linked to individual clients. 

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CDC Atlanta Co-Investigator: Stephanie Davis, MD, MPH: LCDR, US Public Health Service Commissioned 
Corps; Medical Epidemiologist, Voluntary Medical Male Circumcision Team, HIV Prevention Branch, 
Division of Global HIV and TB, Center for Global Health, U.S. Centers for Disease Control and Prevention; 
1600 Clifton Road, Mail Stop E-04, Atlanta, Georgia 30333; Telephone: +1 404-718-4776. SEV #: 13563. 
 
CDC Atlanta Co-Investigator: Jonas Hines, MD: LCDR, US Public Health Service Commissioned Corps; 
Medical Epidemiologist, Voluntary Medical Male Circumcision Team, HIV Prevention Branch, Division of 
Global HIV and TB, Center for Global Health, U.S. Centers for Disease Control and Prevention; 1600 
Clifton Road, Mail Stop E-04, Atlanta, Georgia 30333; Telephone: +1 404-718-3278. SEV #: 6212. 
 
CDC Atlanta Co-Investigator: Melissa Habel, MPH: Epidemiologist, Voluntary Medical Male Circumcision 
Team, HIV Prevention Branch, Division of Global HIV and TB, U.S. Centers for Disease Control and 
Prevention; 1600 Clifton Road, Mail Stop E-04, Atlanta, Georgia 30333; Telephone: +1 404-639-6462. 
SEV #: 19100. 
 
CDC Atlanta Co-Investigator: Lawrence Hinkle, MSPH: PHI/CDC Global Health Fellow, Voluntary Medical 
Male Circumcision Team, HIV Prevention Branch, Division of Global HIV and TB, Center for Global Health, 
U.S. Centers for Disease Control and Prevention; 1600 Clifton Road, Mail Stop E-04, Atlanta, Georgia 
30333; Telephone: +1 404-718-5654. SEV # 8564. 
 
CDC Atlanta Co-Investigator: Carlos Toledo, PhD: Health Scientist, VMMC Team Lead, HIV Prevention 
Branch, Division of Global HIV and TB, Center for Global Health, U.S. Centers for Disease Control and 
Prevention; 1600 Clifton Road, Mail Stop E-04, Atlanta, Georgia 30333; Telephone: +1 404-639-8662. 
SEV #: 7362. 
 
 
The Centers for Disease Control and Prevention, DGHT in Tanzania (CDC-Tanzania): CDC-Tanzania staff will 
provide technical assistance and evaluation monitoring to the teams responsible for implementing the field 
evaluation in Shinyanga, Tanzania. CDC employees consequently will not interact with evaluation clients and 
they will not have access to individually identifiable information, nor will CDC employees have accessed to data 
linked to individual clients. 
 
CDC-Tanzania Principal Investigator: Daimon Simbeye, MPH: Public Health Specialist, CDC-Tanzania; 
Telephone: +255 22 221 98400. Responsible for assisting with oversight of all aspects of evaluation 
planning and implementation including protocol development, procedures, results, and publications 
distribution. SEV 6320. 
 
CDC-Tanzania Principal Investigator: Koku Kazaura, DDS, MPH: Prevention Team Lead, CDC-Tanzania; 
Telephone: +255 22 221 98400. Responsible for assisting with oversight of all aspects of evaluation 
planning and implementation including protocol development, procedures, results, and publications 
distribution. SEV 18317. 
 
CDC-Tanzania Principal Investigator: Mbaraka Amuri, MD, MPH: PHS Senior Evaluation & Research 
Specialist, Deputy Branch Chief for Science, CDC Tanzania; Telephone: +255 22 219 8400. Responsible 
for assisting with oversight of all aspects of evaluation and implementation including protocol 
development, procedures, results, reports and publications writing. SEV 2740. 
 

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JHPEIGO: Jhpiego will provide funding to IHI through its Project IQ mechanism. Jhpiego will also provide some 
administrative support, and will support dissemination of the final report. 
 
IntraHealth International (IHI): as the CDC implementing partner working in Shinyanga, Tanzania, IHI clinical 
staff will provide the training and clinical implementation of the ShangRing at VMMC sites. IHI will support data 
collection and data management. IHI will also review and provide input on all relevant evaluation documents, 
tools and reports; develop a data management plan and conduct data quality checks; supervise fieldwork; 
support data analysis and report writing; support in the dissemination of the final report. IHI will also provide 
experienced clinical staff for pilot implementation and support monitoring and evaluation activities.  
 
IntraHealth International Co-Investigator: Dr. Lucy Mphuru , MD, MBA: Project Director, CDC funded 
VMMC  follow-on project, P. O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 784 840633, 
Email: lmphuru@intrahealth.org 
 
IntraHealth International Co-Investigator: Dr. Pastory Sekule, MD, MPH: Director of Programs, CDC 
funded VMMC  follow-on project, P. O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 754 
305366, Email: psekule@intrahealth.org 
 
IntraHealth International Co-Investigator: Kija Nyalali, MPH:  Director of MER, CDC funded VMMC  
follow-on project, P. O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 655 304781, Email: 
knyalali@intrahealth.org 
 
IntraHealth International Co-Investigator: Paul Mwakipesile, MPH: VMMC Program Manager, CDC 
funded VMMC follow-on project, P. O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 685 
142930, Email: pmwakipesile@intrahealth.org 
 
IntraHealth International Co-Investigator: Daniel Kija, BSc with Computer Science: M&E Officer , CDC 
funded VMMC  follow-on project, P.O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 763 
593996, Email: dkija@intrahealth.org 
 
IntraHealth International Co-Investigator: Dr. Johnson Joachim, MD:  Quality Assurance Advisor, CDC 
funded VMMC follow-on project,  P. O. Box 12,007 Dar-es-Salaam, Tanzania, Mobile phone +255 788 
470349, Email: jjoachim@intrahealth.org 
 
IntraHealth International Co-Investigators: Jennifer Wesson, Director MER, IntraHealth International, 
6340 Quadrangle Drive, Suite 200, Chapel Hill, North Carolina 27517, United States. Phone: +1 (919) 
313-9100, Fax: +1 (919) 313-9108, Mobile phone +1 (919) 313-9185; Email: jwesson@intrahealth.org 
 
IntraHealth International Co-Investigators: Carolina Mejia, Senior MER Advisor, IntraHealth 
International, 6340 Quadrangle Drive, Suite 200, Chapel Hill, North Carolina 27517, United States. 
Phone: +1 (919) 313-9100, Fax: +1 (919) 313-9108, Mobile phone +1 (919) 313-9185; Email: 
cmejia@intrahealth.org 
 
IntraHealth International Co-Investigators: Catherine Brokenshire-Scott, Senior Technical Manager, 
IntraHealth International, 6340 Quadrangle Drive, Suite 200, Chapel Hill, North Carolina 27517, United 
States. Phone: +1 (919) 313-9100, Fax: +1 (919) 313-9108, Mobile phone +1 (919) 313-9162; Email: 
cbrokenshire-scott@intrahealth.org 
 

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IntraHealth International Co-Investigators: Julia Brasileiro, MPH: Program Officer, IntraHealth 
International , 6340 Quadrangle Drive, Suite 200 , Chapel Hill, North Carolina 27517, United States, 
Phone: +1 (919) 313-9100,  Fax: +1 (919) 313-9108, Mobile phone +1 (919) 313-9162, Mobile phone +1 
(919) 313-9131; Email: jbrasileiro@intrahealth.org 
Section A: Funding Source 
 
Funding for this evaluation is provided by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the 
Centers for Disease Control and Prevention (CDC) under Cooperative Agreement Number 1USGGH001469 with 
Jhpiego and its Project IQ mechanism. Jhpiego will sub-contract with IHI to perform the in-country work through 
its Project IQ mechanism. 
 
CDC will collaborate with the Tanzanian Ministry of Health and Social Welfare (MoHCDGEC) and the President’s 
Office – Regional Administration and Local Government (PORALG) who are the custodians of the health facilities 
in which catchment areas the evaluation will be conducted. 
  
Section B: Executive Summary 
 
Medical circumcision devices have the potential to accelerate delivery of male circumcision by making the 
procedure quicker and easier, while remaining as safe as surgical circumcision. In addition, devices may be more 
acceptable to clients than a surgical approach in some circumstances. Thus circumcision devices may facilitate 
expansion of adult male circumcision programs for HIV prevention and address some of the common capacity 
issues in PEPFAR priority countries for male circumcision. 
 
One promising device for adult male circumcision is ShangRing, which was prequalified by the WHO in 2015 for 
males aged 13 and older. ShangRing has been available for purchase in China since 2005. The ShangRing device 
has also received approval for use in the European Union and the United States. 
 
ShangRing studies from Kenya, Uganda, and Zambia have demonstrated that ShangRing can be implemented in 
southern and eastern Africa. 
 
However, because health systems and conditions vary between countries, WHO has created a framework for 
introducing circumcision devices in a country. This framework recommends countries take a methodical 
approach to introducing circumcision devices, evaluating acceptability and safety within its health system before 
making widespread adoption. 1   
 
Evaluation Goal: 
To evaluate the safety and acceptability of the ShangRing device for nonsurgical circumcision in routine clinical 
settings, as a part of a comprehensive HIV prevention program for males in VMMC programs. 
 
Evaluation Endpoints: 
Primary Endpoint: the proportion of males experiencing mild, moderate and severe adverse events (AEs) 
associated with ShangRing circumcision procedures, including both intra- and post-operative events, and all 
device-related malfunctions (e.g., early spontaneous detachment). 
 
 
 

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Secondary Endpoints: 
• 
Training needed for proficiency using the ShangRing device, including number of procedures to become 
fully proficient at applying and removing the ShangRing device. 
• 
Client and provider acceptability, client satisfaction, and duration of procedure. 
• 
The percentage of clients clinically healed 49-52 days post-placement of the ShangRing device, and the 
time at which point all clients are clinically healed. 
 
Evaluation Design 
Training Phase: this phase will be used to evaluate the training requirements for implementation by mid-level 
providers, to preliminarily assess acceptability to providers, and to monitor logistical needs. Each clinician will 
perform no fewer than 10 ShangRing device placements, and 5 ShangRing removals before start of the next 
phase (implementation pilot). 
 
Implementation Pilot: following the training period, 575 male clients will be recruited to undergo circumcision 
with the ShangRing device in the context of routine service delivery.  
 
Data will be collected at up to at least 5 points in time: at enrollment and device placement (day 0), at device 
removal (day 7), during a follow-up phone call (day 10), in-depth qualitative interviews for 50 purposefully 
selected clients (day 28), at an in-person follow-up visit to assess wound healing (day 49), and at subsequent 
weekly visits to assess healing for those not completely healed at day 49. 
 
Upon completion of the implementation pilot, the data will be analyzed and used to assist with policy decisions 
and recommendations on ShangRing use in adult male circumcision programs. 
 
Section C: Protocol 
 
Introduction 
Voluntary Male Medical Circumcision (VMMC), VMMC Devices and ShangRing 
 
Three randomized controlled trials have demonstrated that Voluntary Medical Male Circumcision (VMMC) 
reduces the risk of heterosexual HIV transmission from women to men by up to 60%.2,3,4 For this reason, in 2007 
the World Health Organization (WHO) and Joint United Nations Program on HIV & AIDS (UNAIDS) recommended 
VMMC as part of a comprehensive HIV prevention package in 14 priority countries in sub-Saharan Africa 
(including Tanzania), each with high HIV prevalence and low male circumcision (MC) coverage. Although each of 
the 14 priority countries has made progress in implementing and providing VMMC, most fell short of their target 
number of circumcisions to be performed by 2016. 
 
In August 2016, UNAIDS released the “Fast-Track Commitments to End AIDS By 2030.” These commitments 
included a number of ambitious targets that must be met by 2020 in order to achieve 90% reduction in HIV 
incidence. Among these targets was an additional 27 million circumcisions in the 14 PEPFAR priority countries.5  
 
Circumcision devices can help VMMC programs like Tanzania’s meet their ambitious targets in several ways. 
Depending on their mechanisms of action, devices may have the potential to address up to two major concerns 
noted by men that affect VMMC program uptake: pain and loss of time from work. As noted below, studies have 
shown lower pain levels associated with the use of devices, including ShangRing, and this could enable programs 
to overcome fear of pain as a barrier to circumcision uptake; and it may help convince men if they are able to 

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return to work sooner following the procedure.  Devices could lessen the burden placed on the healthcare 
system, the shorter procedure time implies that a given number of providers can attend to a larger number of 
clients. Additionally, the ease of use of devices allows lower cadres of provider to be able to perform 
circumcision procedures. These facts, in turn, can help decrease overall costs of human resources needed to 
operate a VMMC program.  
 
The WHO has approved of (“prequalified”) two circumcision devices for use. PrePex, which was adopted in 
several southern and eastern African countries, was discovered to pose increased risk of tetanus because non-
viable tissue was left in situ for 7 days after device application; as such, its use has declined in most countries 
that initially adopted it. With the ShangRing device, the foreskin is removed during placement and tetanus risk is 
felt to be at the background rate for a country.6 Multiple countries in southern and eastern Africa are now at 
various stages of incorporating ShangRing into VMMC programs. 
 
Several studies in China have demonstrated that the ShangRing is safe, easy to use, and enjoys high levels of 
patient satisfaction. One study of 1,200 ShangRing circumcisions in China found low complication rates; and 
these findings were corroborated by a second study of 328 Chinese men. 7,8 Both studies found that there were 
lower pain levels associated with use, and patient satisfaction rates were very high (over 98% in both studies).  
 
A review of ShangRing studies in Kenya, Uganda, and Zambia has demonstrated that ShangRing continues to 
maintain its low levels of complications and ease of use in African countries.9 These studies also found that 
ShangRing had comparable AE rates and pain scores to conventional techniques, that men preferred ShangRing 
to conventional circumcision, and that patient satisfaction scores were high.10,11,12,13,14 For these reasons, the 
authors of the review suggested that ShangRing could assist in expanding VMMC services to more men 
throughout sub-Saharan Africa. 
 
The procedure time of the ShangRing device across the different studies is faster than conventional 
circumcision. A study in Kenya found that the average placement time was approximately 5 minutes, and 
average removal time was approximately 4 minutes (though this study did not compare these times to 
conventional circumcision). 15 Another study in Kenya comparing ShangRing to conventional circumcision found 
the ShangRing procedure to take approximately 7 minutes, compared to 21 minutes for conventional 
circumcision; a similar study in Uganda found the ShangRing procedure to take approximately 6 minutes, 
compared to 18 minutes for conventional circumcision.16 The faster ShangRing procedure times have been 
attributed to the device eliminating the need for placing sutures.    
 
Currently, the WHO is reviewing data from ShangRing studies where the procedure was performed with topical 
anesthetic cream as opposed to injected anesthesia. If the data review shows that ShangRing circumcisions can 
be performed without injections this may remove another common barrier – fear of pain and needles – that 
affects uptake of circumcision among men. The WHO is also reviewing data on a new technique of performing 
ShangRing circumcisions called the no-flip technique. This technique is an easier procedure to perform, and if 
approved may allow the ShangRing to be performed by a wider assortment of lower-cadre providers. 
 
ShangRing and HIV+ Men 
A field study of ShangRing, which contained a small number of HIV+ male participants (N=84) found similar 
outcomes to HIV-negative men receiving ShangRing circumcisions. In the study, the moderate and severe AE 
rate was 1.2% among HIV+ men and 1.7% among HIV- men (Table 1).17 Acceptability was high in both groups, 
with 97.4% and 94.6% of HIV+ and HIV- participants being very satisfied with the appearance, respectively, and 
100% and 98.7% of HIV+ and HIV- participants willing to recommend ShangRing MC to a friend or family 

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member, respectively. Furthermore, time until wound healing was similar at 35-42 days between HIV+ and HIV- 
men (85.7% vs. 87.3%, respectively). 
 
Table 1. Adverse events by HIV status during field study in Kenya18 
 
HIV+ Men 
(N = 84)* 
HIV-men 
(N=1065)* 
Mild AEs, n (%) 
1 (1.2) 
0 (0.0)† 
Moderate AEs, n (%) 
0 (0.0) 
16 (1.5)‡ 
Severe AEs, n (%) 
0 (0.0) 
2 (0.2) 
Total AEs, n (%) 
1 (1.2) 
18 (1.7) 
*Data were available from the researchers on 101 HIV-positive men and 1086 HIV-negative men. 
Including these additional men increased the AE rate to 3.0% in HIV-positive men (n=3) and 2.6% in 
HIV-negative men (n=28). 
†19 (1.7%) males experienced cutaneous pinches, although these were not included in the AE case 
definition. 
‡The most common AE was wound dehiscence (n = 9). 
 
 
HIV in Tanzania 
Based on the 2016/2017 Tanzania HIV Impact Survey (THIS), there are an estimated 1.4 million people aged 15-
64 years living with HIV in Tanzania. The prevalence of HIV among adults aged 15-64 is 5% (6.5% for females, 
and 3.5% for males). The HIV prevalence varies geographically across Tanzania, with a high of 11.4% in Njombe 
to less than 1% in Lindi and Zanzibar. The Annual incidence of HIV among adults aged 15-64 years in Tanzania is 
0.29% (0.4% among females, 0.17% among males). This corresponds to approximately 81,000 new cases 
annually among adults aged 15-64.19  
 
Male Circumcision in Tanzania 
As part of its prevention approach, in 2010 Tanzania adopted a target of 80% VMMC coverage for males aged 
10-34, and estimated it needed to reach 2.8 million people by 2015 to meet this goal. As of 2013, 72% of males 
in Tanzania reported being circumcised, though circumcision coverage varies considerably by region.20 In regions 
where traditional male circumcision is practiced, MC prevalence rates are as high as 80% to 99%; in regions that 
do not practice traditional MC, the prevalence is as low as 26%.21 As of 2016, program data from PEPFAR 
indicates that Tanzania has performed 2,361,440 circumcisions since 2010.22 
 
Introducing a New Circumcision Device 
The pilot evaluation for ShangRing in Tanzania described in this protocol is designed to meet the standards set 
by the WHO’s Framework for Clinical Evaluation of Devices for Male Circumcision. 23 This framework provides the 
data necessary to assess the safety of device when used by providers in their normal settings. The WHO’s 
framework also provides data related to several other characteristics: client acceptability, provider acceptability, 
ease of use, cost, and regulatory and marketing.  
   
Justification for Evaluation 
ShangRing can address some of the financial and human resources challenges posed by conventional 
circumcision techniques. The data from this evaluation will be used to assist the Tanzanian MoHCDGEC with 
policy decisions and possible recommendations on the use of the device in adult male circumcision programs 
including provider training, implementation of device circumcision, and messages for male clients and their 
partners in pre-procedure counseling sessions.  

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Evaluation Design and Methods 
 
Evaluation Goal 
To evaluate the safety and acceptability of the ShangRing for device-based circumcision in routine clinical 
settings, as a part of a comprehensive HIV prevention program for males aged 13 and older in Tanzania. 
 
Evaluation Objectives 
The specific objectives of the proposed implementation pilot is to: 
• 
Describe/assess the safety of the ShangRing device by the occurrence of clinical adverse events 
(calculated as a rate), when circumcision is performed by trained mid-level providers; 
• 
Ascertain capacity and required clinical capabilities of clinical staff of various cadres to carry out 
ShangRing procedures; 
• 
Describe/assess male client and provider acceptability of the ShangRing device and process (e.g. need to 
return to the clinic for device removal, tolerance for leaving device in situ);  
• 
Assess the percentage of clients clinically healed 6 weeks (42 days) following the removal of the device; 
• 
Determine the time at which point all clients are physically healed following the removal of the device. 
 
Primary Endpoint 
The primary endpoint related to the goal and objectives of the evaluation is to: 
• 
Measure the incidence of mild, moderate and severe AEs associated with ShangRing procedures 
including both procedure and post-procedure events, and all device-related malfunctions such as early 
spontaneous displacement. The primary endpoint will be assessed at device placement, at device 
removal, 3-days post removal, at the day 49 post-placement healing assessment, and at any 
unscheduled visit in that time frame. Adverse events will be measured and described in the following 
ways:  
o Total numbers and types of known AEs occurring among clients, including all severities of AEs 
(mild, moderate, severe) and serious AEs (see below), including detailed information about all 
instances of device displacement/detachment/self-removal/malfunction, need for medical 
attention or intervention, and final outcomes in those experiencing AEs. 
o Total number of clients with known AEs (may be different from above if clients experience 
multiple AEs), including all severities of AEs and serious AEs. 
o A description of each adverse event by type, severity, time of detection (days post-application 
and/or post-removal) captured as date AE is diagnosed, clinical management, and resolution. 
The likelihood of relatedness to having undergone VMMC and relatedness specifically to the 
ShangRing device will be determined.  AEs will be defined using the definitions in the second 
edition of the VMMC Adverse Event Action Guide.24  These are specific to each AE type, but in 
general: 
▪ 
Mild: classification indicates minimal or no intervention is required beyond reassurance 
and observation; 
▪ 
Moderate: classification relates to those AEs that are neither mild nor severe, require 
intervention, and are usually managed on-site; 
▪ 
Severe: classification requires extensive intervention with referral or specialist input. 
▪ 
Note: a Serious Adverse Event (SAE) is a standard definition used across many types of 
interventions. In the context of VMMC, all AEs that meet criteria for severe should also 
be classified as SAEs. In addition, SAEs also include any event that: 
• 
Results in death 

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• 
Is life threatening 
• 
Requires intervention to prevent permanent disability or incapacitation 
(including deformity), or results in permanent disability or incapacitation 
(including deformity) 
• 
Requires hospitalization or referral to a specialist for higher level care or 
intervention. 
o (Note: device displacement is included as an AE both in the moderate and severe classifications 
– see Appendix XV). 
  
Secondary Endpoints 
• 
Determine the training needed for proficiency, including number of procedures required under 
supervision to become certified as fully proficient. This will involve analyzing AE rates stratified by 
during training and post-training in addition to overall.  
o Determining whether various cadres are trainable as safe providers. This would involve 
analyzing AE rates stratified by provider cadre.  
• 
Document client acceptability and satisfaction, to be measured by the following:  
o Time for client to return to normal activity, including work and routine tasks. 
o Clients’ opinions of convenience (having device applied, ‘wearing’ the device for a week, and 
returning for device removal), acceptability, cosmetic result, and whether they would 
recommend VMMC, and specifically the ShangRing VMMC option to others. 
o Total number of clients who fail to return to the circumcision site (or site indicated by service 
providers) for recommended follow-up (whether removal visit or AE follow-up). 
o Proportion of all men receiving VMMC services at the evaluation sites who choose ShangRing 
method instead of surgical circumcision. 
• 
Document provider acceptability of ShangRing, to be measured by the following: 
o Provider perceived ease of application, ease of removal, ease of clinical management of adverse 
events, and preferences in comparison to conventional circumcision methods. 
• 
Document duration of procedures, and problems encountered during procedures and post-procedure 
care, to be measured by the following: 
o  ShangRing application time will be measured, including the overall time the client is on the 
procedure table, and the time required for discreet application activities: client preparation 
time (including application of local anesthetic and sizing), marking and device application, and 
clean-up time. 
o ShangRing removal time will be measured, including the overall time the client is on the 
procedure table, the time required for discreet removal activities, and time for post removal 
instructions given to the client. 
• 
The percentage of clients determined by a clinician to be clinically healed 49-52 days post-placement of 
the ShangRing device (42 days post-removal), and the time at which point all clients are clinically 
healed.   
o Healing will be documented by evaluation staff, who will take photographs of the client’s 
genital area during the follow-up visits. 
o Healing will meet the definition of clinical healing after VMMC, defined as:  
▪ 
“Intact epithelium (unbroken skin) covering the wound as judged by the provider on 
visual inspection, meaning that none of the following are present: sutures, scabbing, 
drainage, moisture, gaps between epithelial edges or ulceration.”25 
 

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Evaluation Design 
 
Overall Design 
This implementation pilot is comprised of two phases: a training phase and the main implementation pilot. 
During the training phase clinicians at the participating sites will be trained in the use of the ShangRing device. 
Upon completion of the training phase, the main implementation pilot will begin. The implementation pilot is a 
single arm, open label, prospective cohort evaluation. 
 
Description of Evaluation Populations and Catchment Areas 
 
Shinyanga, Tanzania 
Shinyanga is 1 of 31 regions in Tanzania. Shinyanga covers a total of 18,555 square kilometers, which include 3 
districts, 6 Local Government Authorities, 15 divisions, 126 wards, and 511 villages.26Shinyanga is bordered by 
Mwanza to the north, Simiyu to the east, Geita to the west, and Tabora to the south. The capital of Shinyanga 
Region is the municipality of Shinyanga, located in Shinyanga District. As of the 2012 census, the population of 
the Shinyanga region was 1,534,808. The economy of the region is primarily driven by agriculture. As of 2011, 
the HIV prevalence of Shinyanga was 7.4%.27 
 
According to the Tanzania Demographic Health Survey and Malaria Indicator Survey, 54% of men in Shinyanga 
reported that they are circumcised.28 The Tanzania team has proposed the following VMMC static sites in 
Shinyanga for participation in the evaluation: 
• 
Kahama District Hospital, Shinyanga; this hospital is located in Kahama Town council and serves as 
referral hospital for three district councils; Ushetu, Msalala and Kahama Town council. It has the 
catchment population of 270,000 people and offers OPD, IPD, CTC, Reproductive and child health 
services, Labor and delivery and Laboratory services.  The hospital has the bed capacity of 102. VMMC 
services were integrated in September 2011, and Kahama VMMC static clinic is the busiest MC clinic in 
Shinyanga region. There are total of 29 VMMC providers and three VMMC National trainers based in this 
hospital. 
• 
Ushetu Health Centre, Shinyanga; this health center is located in Ushetu district council, about 75 km 
from Kahama town in Shinyanga region. The facility offers OPD, IPD, Reproductive and child health 
services, Labor and delivery and CTC services. The facility has a bed capacity of 40 and serves a 
catchment population of 17,274 people. VMMC static clinic was initiated and integrated in August 2013.  
There are total of 8 trained VMMC providers. 
 
These sites were selected based on determinations by IntraHealth, CDC-Tanzania, and the Tanzanian 
MoHCDGEC, that they could meet the inclusion criteria outlined below; and that there was sufficient intrinsic 
demand for VMMC services in their catchment areas, to offer a sample size large enough to meet the one 
needed by this evaluation.  
 
Client Inclusion Criteria 
Potential clients will receive a medical history screening and a genital examination conducted by the VMMC 
provider to determine that they are in overall good physical health. Additional inclusion criteria include the 
following: 
• 
Male aged 13 years and older 
• 
Uncircumcised following physical assessment 
• 
Seeking medical circumcision at one of the evaluation sites 

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• 
Consents to an HIV test. 
• 
Agrees to be circumcised using the ShangRing device 
o Those aged 13-17 years will also require parental/guardian approval in order to be included in 
addition to providing assent. Parents must also agree to be present at the facility during the 
circumcision (though not in the operating room unless requested by the client), for the 
discharge instructions, and for subsequent follow-up visits.  
• 
Penis fits into one of the 18 ShangRing ring sizes 
• 
Able to understand the evaluation procedures and requirements 
• 
Agrees to abstain from sexual intercourse and masturbation, for six (6) weeks post removal, seven (7) 
weeks total 
• 
Lives within 30 kilometers of the facility in Shinyanga, Tanzania 
• 
Willing to provide valid contact information (i.e. telephone number, address of residence, place of 
employment and other locator information) and willing to receive communications and/or follow-up 
visits, clients may also be asked for names of relatives or friends to be contacted in the event that the 
client cannot be reached 
• 
Has an activated cell/mobile phone or access to a cell/mobile phone 
• 
Agrees to return for a follow-up visit to assess healing day 49 post-placement (42 days post-removal). 
• 
If not healed at the day 49 post-placement visit, agrees to return for weekly follow up visits until healed. 
• 
Agrees to a 10 day post-placement (3 days post-removal) telephone call to assess and detect symptoms 
of AEs 
• 
Able to communicate in English and/or Swahili  
• 
Capable and willing to provide written informed consent (18 years and older), or written informed 
consent from a parent guardian (13-17 years) to participate for both HTS and VMMC services. 
 
Client Exclusion Criteria 
Clients who do not meet the inclusion criteria above and who have the following known medical conditions will 
be excluded from the evaluation: 
 
• 
Cognitive impairment that prevents the client from providing consent 
• 
Any health condition (reported or observed) that is a contraindication to surgical VMMC in the national 
program, or that ShangRing providers deem a contraindication. These may include diabetes, peripheral 
vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness. 
• 
Known uncontrolled diabetes, hypertension or tuberculosis (TB) 
o Note: if a client has controlled diabetes they may still be eligible for circumcision, but blood 
sugar should be checked first. If the check reveals blood sugar to be acutely elevated, defer 
circumcision until blood sugar is better controlled. 
• 
Acute illness, other than colds or other minor complaints 
• 
Active skin infection 
• 
Anatomical variations and anomalies of genitalia: 
o Hypospadias, epispadias, or other urethral anomaly; except for glanular hypospadias, which is 
not a contraindication if provider is experienced 
o Hydrocele or other scrotal swelling 
o Scrotal hernia 
o Phimosis or paraphimosis 
o Other genital anomaly or disease including infectious or traumatic ulcers, or scarring involving 
frenulum, foreskin or glans 
o Dermatitis of the penis or foreskin, filariasis or penile cancer 

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o Genital warts involving both foreskin and glans (note: genital warts involving only foreskin are 
not a contraindication if provider is experienced) 
o Urethral discharge 
o Balanitis or posthitis (clients with balanitis should be referred to a specialist, as circumcision is 
likely to be necessary but should be done by an experienced provider) 
• 
Current sexually transmitted infection (STI) other than HIV (clients with STIs can return for circumcision 
once STI is treated) 
• 
Other conditions, which in the opinion of the supervising circumcision coordinator, prevents the subject 
from undergoing a circumcision with the ShangRing device 
 
Clients who do not meet inclusion criteria will be offered standard surgical circumcision if not contraindicated. 
The number and reasons for such exclusions will be recorded and included in the final evaluation report.  
 
Medical Referral 
Males who present with exclusion criteria for one of the medical reasons listed above will be referred to the 
appropriate specialist for management of their conditions. Additionally, any men who have an anatomic 
contraindication but still want circumcision, can be referred to an urologist for further management. In keeping 
with standard national practice, clients presenting with specific disease conditions such as STIs or TB may be 
treated on-site or referred for care elsewhere if appropriate services are not available on site. Furthermore, 
males who are HIV+ will be assessed to determine if they are on antiretroviral therapy (ART). Those not on ART 
will be referred for ART. 
 
Client Withdrawal Criteria 
A client has the right to withdraw from the evaluation at any time, for any reason, without prejudice to his 
future medical care by the provider or the health facility (see Appendices V and VI for the client and minor client 
assent forms). If a client withdraws after consent, but prior to device placement, the client will be replaced until 
the desired sample size is reached and the data will be excluded from analysis. If a client withdraws after device 
placement, the client will not be replaced and the existing data will be included in the analysis, but no attempts 
will be made to collect further data other than that required for clinical documentation of the removal visit. The 
reason, timing and circumstances of the withdrawal will be documented and analyzed. The client will 
subsequently not be included among those selected for the day 28 in-person interview, nor will they be asked to 
return for the day 49 follow-up visit to assess healing. When the client withdraws, they will be informed that 
they may still return to the clinic for removal of the device as scheduled, and contact the clinic should they have 
further questions, suffer an AE, or experience other difficulties healing.   
 
A client will be informed in advance that if he wishes to withdraw from the evaluation after ShangRing 
placement but before scheduled removal, he must still return to the provider for device removal on day 7 for 
his own health. The client will also be advised that once applied, it is not safe to remove the device before day 
5. If the client requests removal on day 5 or 6, it will be removed as requested. The number and reasons for 
client withdrawals will be recorded and included in the final evaluation report (See Appendix XXII). 
 
Procedure for Handling Clients Lost-to-Follow-Up 
Clients who are lost to follow-up after device placement, and therefore do not return to have the device 
removed, will not be recorded as experiencing an AE, and also will not be included in calculations when 
measuring AEs.  
 
In the event that a client refuses to return for follow-up, ShangRing has been shown to detach on its own. 
Studies show that for those clients who do not come in to have the device removed, and wear it for more than 

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seven days, the ShangRing will eventually spontaneously detach on its own, and healing will progress normally. 
In one study, complete detachment of the device occurred in 66.7% of men who wore the device for more than 
seven days, and 14% of men requested removal of a partially detached device 8-14 days after placement. No 
severe or serious AEs were reported among this group.29  
 
A study of delayed removal of ShangRing in Kenya found that in 81.8% of men the ShangRing had completely 
detached on its own between 10-16 days after circumcision.30 By 21 days following the circumcision the ring had 
at least partially detached in 100% of men, and was completely detached in 93.7%. While the ShangRing has 
been found to be safe if left on, this is not the recommended standard of care for the purposes of this 
evaluation, and clients will be followed up with for device removal as described in this protocol. 
 
Provider Participant Inclusion Criteria 
Providers meeting the following criteria will be included in the evaluation: 
• 
Adult aged 18 or older 
• 
Employed as a medical doctor, Assistant Medical Officer, Clinical Officer, professional nurse, or enrolled 
nurse at the participating sites in Shinyanga, Tanzania 
• 
Experienced in providing conventional surgical circumcision 
• 
Trained and certified in ShangRing circumcision techniques for the current evaluation by a trainer who is 
trained in ShangRing application, and has performed a minimum of 10 placements and 5 removals. The 
evaluation team will bring in ShangRing master trainers from countries with prior ShangRing experience 
(i.e. Kenya, Zambia) to train providers based in Shinyanga who will then train mid-level providers to 
conduct ShangRing circumcision, or send physicians from Tanzania to these countries for training.  
o Trained and competent in identifying and managing complications related to ShangRing 
circumcision. 
o Trained and competent in screening clients to determine their eligibility for ShangRing 
circumcision.    
• 
Providers are able to demonstrate competence in ShangRing procedure upon completion of the course 
as described below. 
• 
Providers are trained and competent in screening clients to determine their eligibility for ShangRing 
circumcision. 
• 
Agrees to complete evaluation surveys and focus group discussions at midpoint of the evaluation, 
following at least 4 weeks of client enrollment.  
• 
Ability to communicate in English and/or Swahili.  
• 
Capable and willing to provide written informed consent to participate 
 
Provider Participant Exclusion Criteria 
Providers with the following criteria will be excluded from the evaluation: 
• 
Failure of ShangRing training, as determined by the instructors at the end of the training period 
• 
Failure to comply with universal precautions for infection prevention and control 
• 
Failure to provide written informed consent 
 
Minimum Site Requirements for ShangRing Pilot Service Delivery  
Sites in Shinyanga, Tanzania were selected upon their ability to provide safe male circumcision services and on 
the basis of meeting minimum readiness requirements necessary to provide ShangRing service delivery. These 
requirements are as follows: 
• 
Prior to the beginning of the evaluation, at least some providers are trained and competent in 
conventional surgical male circumcision. This is because there is a risk that ShangRing circumcision will 

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need to be converted to surgical intervention in the event of certain AEs (e.g., uncontrolled, bleeding), 
device malfunction or displacement. This criterion may change with further experience demonstrating 
whether this risk materializes. 
• 
Site is equipped for emergency clinical management of immediate and post-procedure complications. 
• 
Site has an agreed-upon referral plan to a district, sub-district or other facility where providers with skills 
to manage rare complications are available. 
• 
All supplies for ShangRing placement and removal are reliably available. 
• 
Site is capable of complying with relevant national policies on tetanus immunization for VMMC by both 
device-based and conventional surgical methods, as applicable. 
 
Sites should provide a brief orientation to other health centers in the catchment area. The purpose of this 
orientation is to provide these health centers with an overview of the pilot, to offer the health centers guidance 
on how to provide care for any pilot clients that may present to their clinic, and to request the health centers 
alert the pilot sites in the event that a client from the pilot seeks follow-up care from the center (i.e. in the case 
of the AE), and provide the health centers with contact information for implementation pilot staff in order to do 
so.  
 
Sample Size, Data Collection and Analysis Timeline 
The total sample size for this implementation pilot is 575 male clients at the selected sites in Shinyanga, 
Tanzania. Both HIV- and HIV+ men will be included in the sample. The sample size of 575 males is consistent 
with the framework for circumcision device introduction as proposed by the WHO (see appendix I below).  
Additionally, this sample size is powered to detect the occurrence of adverse events, which is estimated to be 
2%.  A minimum of 335 males are necessary for 95% confidence that the population proportion is within ±1.5% 
with an observed adverse event rate of 2%. An additional 240 males will be recruited for further confidence in 
the results, and to align with the WHO framework. The evaluation teams will enroll males until the 575 sample 
size figure is achieved. All 575 males to be considered for the data analysis will be enrolled upon completion of 
the training phase.  
 
All data collection will begin as soon as the first circumcision of an enrolled client occurs. Data will continue to 
be collected until the country has performed 575 circumcisions with the ShangRing device, and all post-
circumcision follow-up data collected from clients as detailed in this protocol is complete. After the 575 
circumcisions and all follow-up information is collected, the analysis of data as described per the primary and 
secondary endpoints will begin. If after the country has finished 575 circumcisions, and wishes to conduct the 
analysis necessary to inform national policy for the purposes of implementing the ShangRing device on a wider 
scale, that country may continue to enroll clients, and the first 1000 circumcisions performed should be 
monitored through active surveillance, as detailed in the WHO framework, and the country should perform its 
own data analysis as needed. 31  
 
Supplies and Logistics 
ShangRing devices and medical instruments for placement and removal will be supplied to each partner at the 
beginning of the evaluation pilot. Partners will be responsible for further distribution to their pilot sites. 
Depending on actual consumption, disbursed supplies may be recalled for redistribution to match supply with 
demand at each site. A total of 750 devices will be purchased in various sizes to allow for the 575 procedures to 
be performed, as well as those performed during the training phase.   
 
 
 

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Evaluation Phases 
 
Training Phase 
During the training phase, clinicians at participating sites will be trained in the use of the ShangRing device by 
“master trainer” clinicians who have previous experience with the ShangRing device. This training phase will be 
used to evaluate the training requirements for implementation by mid-level providers, and to preliminarily 
assess acceptability to providers and clients and monitor logistical needs. Each clinician will perform no fewer 
than 10 ShangRing device placements, and 5 ShangRing removals before the start of the implementation pilot. 
Between 8 and 12 providers will be trained, meaning the number of clients receiving ShangRing during this time 
will be approximately 80-120. The clinicians trained in the master trainers will then train midlevel providers at 
the participating sites (anticipated to be another 2-4 providers at each site).  Implementation pilot data will be 
collected from the clients receiving circumcisions with the ShangRing device during the training phase. 
 
Measures of ShangRing skills following training in the use of ShangRing application including: theoretical tests, 
practical test of hands-on-skills and clinical test of performing ShangRing on subjects.  Indirect measures will 
focus on the average procedure time of trainees undergoing ShangRing device training. Additional aspects of the 
training will be explored through qualitative in-depth interviews (See Appendices XIX-XX). Areas of exploration 
with qualitative data collection will focus on the strengths and weaknesses of the training, effectiveness of 
training package/materials, satisfaction with training, and suggestions for improvement of training and 
facilitation. Provider training and acceptability of the ShangRing device will also be assessed through 
quantitative measures including a Likert scale designed to measure the ease of the procedure, and how willing 
providers would be to continue performing ShangRing procedures following the conclusion of the 
implementation pilot (see Appendix XXI).  
 
Implementation Phase 
Following the training phase, a cohort of 575 male clients will be recruited to evaluate the safety of the device, 
training needs, acceptability and healing time of ShangRing in the context of routine use by clinicians.  Detailed 
CRFs will be maintained for all clients, including those circumcised during the training of mid-level providers. The 
CRFs and standardized forms will be used to evaluate the three components of the Implementation Phase: 
safety, acceptability, and healing (Appendices VII-X). 
 
Safety Component 
The primary aim of the safety component is to monitor clinical adverse events and device-specific adverse 
incidents according to type and experience of the provider.  Data on both general and device-specific adverse 
events will be monitored using detailed clinical records maintained for all clients and standardized forms 
completed at specific data collection points.  The records and forms will provide information on procedure and 
removal times and safety, technical difficulty and complications experienced during the procedure and removal 
process and pain experienced by the male client. 
 
Acceptability Component 
The primary focus of the acceptability component of the evaluation is to document attitudes towards and 
experiences with device circumcision (e.g., acceptability during the procedure and post-operatively during 
healing period while the device remains in situ), effects on activities of daily living, attitudes towards protection 
from HIV, effects on sexual satisfaction and/or penile sensation and behavior, pain, and satisfaction with 
cosmetic final result. Perceived acceptability of female partners will be assessed through male clients.  The 
evaluation team will also collect data on reasons for not accepting the device by administering a brief survey to 
males declining participation in the evaluation (see Appendix XII).  Provider acceptability will be assessed by 
exploring attitudes towards and experiences with device circumcision, impact of offering circumcisions on 

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clinical practice, barriers and facilitators of clinicians’ implementation of device circumcisions (consistency of the 
final result, simplicity or ease of use).   
 
All men (n=575) who are circumcised during the main implementation phase will be asked to answer a phone 
call to assess AEs three days post device removal (day 10). All men (n=575) will be asked to return for a follow-
up visit on day 49 post-placement to assess healing. All men who are not clinically healed on the day 49 post-
placement visit will be asked to return to the clinic at weekly intervals until healed. During the day 49 visit, and 
subsequent healing visits, men will also have their genital area photographed.  A selection of 50 male clients will 
be asked to participate in private face-to-face qualitative interviews 28 days post-procedure. All clients returning 
for the day 49 healing assessment, and subsequent healing visits (and for clients under 18 a parent/guardian 
accompanying them), will be compensated a small amount for their travel costs and time (estimated to be 
between 7-10 USD/16,000-22,000 Tanzanian Shillings per visit, but not to exceed 30 USD/68,000Tanzanian 
Shillings) total, as will clients selected for the face-to-face qualitative interviews (see Reimbursements section). 
As noted above, providers will be interviewed at the evaluations midpoint, at least after four weeks of client 
enrollment, and this interview will assess provider satisfaction with training, as well as provider acceptability.   
 
Healing Component 
The primary focus of the healing component is to determine the percentage of men that are clinically healed by 
day 49-52 following the placement of the ShangRing device (42-45 days post-removal), and to determine the 
time point post-placement at which all clients are clinically healed. All clients will be asked to return for a day-49 
healing assessment, where a provider will review the clients wound to determine healing. As noted above, the 
wound will be considered healed if it meets the clinical definition of healing after VMMC, and will be indicated 
as such on the CRF. All clients will also have a photograph of their genital area taken at this visit to document 
healing. If the client is not clinically healed at the day-49 healing assessment, the client will be asked to return 
for another assessment in one week’s time. Weekly healing assessments will continue until all clients are 
clinically healed. 
 
 

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Table 2: Implementation Pilot: Training and Implementation Phases 
Evaluation 
Component 
Sample Size 
Endpoints 
Methods and Data Collection 
Phase 1: Training 
Approximately 
80-120, 
depending 
upon # of 
providers 
trained (at 
least 10 clients 
per provider) 
Primary endpoints: 
- Provider training needs 
- Provider acceptability 
Secondary endpoints: 
- Procedure and removal times 
Training Needs Component 
Primary endpoints: 
- Provider proficiency with applying 
and removing the device 
Secondary endpoints: 
- Adverse events and device-related 
incidents 
- Procedure and removal times 
- Training satisfaction and needs of 
providers 
 
 
Administered knowledge and theory 
based tests 
Supervisor/doctor observation 
 
 
Standardized forms to collect data on 
adverse events and device-related 
adverse events 
Client records 
Qualitative interview with providers 
Photographs of the client’s genital 
area, to be taken post-device removal 
(day 7), and at the day 49 healing 
assessment visit and at subsequent 
weekly healing visits 
Phase 2: Implementation 
Cohort Evaluation 
455-495 
(Depending 
upon # 
performed 
during training 
phase) 
 
 
Safety Component 
Primary endpoints: 
- Adverse events and device-related 
incidents 
Secondary endpoints: 
- Safety of procedure/removal 
- Provider perception of technical 
difficulty and complications during 
procedure and removal process 
 
 
 
Provider Acceptability Component: 
- Provider acceptability 
- Practicality of device use 
- Procedure and removal times 
Client Acceptability Component: 
- Client satisfaction 
- Cosmetic results 
- Comfort: 
     - During procedure to place device 
     - During (nocturnal) erections 
     - During removal 
 
Healing Component 
- Percentage of men clinically healed 
49-52 days post placement (42 days 
post-removal) 
- Time at which point all men are 
clinically healed 
 
Standardized forms to collect data on 
adverse events and device-related 
adverse events 
Client records 
Brief surveys to collect data on 
reasons to decline participation in 
the evaluation as indirect measure of 
acceptability 
Brief surveys to collect data on client 
experience with the ShangRing as an 
indirect measure of acceptability 
 
Qualitative interview with providers 
 
Qualitative interviews with 50 male 
clients 
Qualitative interview with providers 
Brief surveys to collect data on 
reasons to decline participation in 
the evaluation as indirect measure of 
acceptability 
Client records – including those 
recording application and removal 
times 
Client records indicating healing per 
VMMC healing definition as 
completed by providers during day 49 
healing assessment visit and 
subsequent weekly healing visits for 
those not healed at day 49 
Photographs of the client’s genital 
area, to be taken post-device removal 
(day 7), and at the day 49 healing 
assessment visit and at subsequent 
weekly healing visits 
 
 
 

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Evaluation Procedures and Logistics 
 
Evaluation Offices 
Private spaces in the clinic sites will be used to privately administer interviews and counseling, and provide 
service referrals. Only evaluation staff, investigators and clients will be granted access to these spaces during the 
times the evaluation is being conducted. All documents and materials related to the evaluation will be stored in 
a locked cabinet in a locked office.  Electronic data and files will be maintained on password protected 
computers, used only by the evaluation team.  
 
Clinic Space and Circumcision Area 
The ShangRing procedures will be conducted in a sterile, surgical environment, at sites in Shinyanga, Tanzania. 
 
Staff Training 
 
Physician Training 
Physicians from Tanzania will be connected to physicians from countries with previous ShangRing experience 
(i.e. Kenya, Malawi, Uganda, Zambia) who have been trained and certified as Trainers of Trainers (TOT) at 
Ningbo Hospital, China, for training to be performed either in Tanzania, or the trainer’s home country. The 
training will follow the framework outlined by expert consultants from the Department of Urology at the Weill 
Cornell Medical College. Studies suggest that newly trained providers needed to perform a minimum of 7 
ShangRing procedures during training in order to be considered competent with the device.32 Therefore, each 
trainee physician will perform at least 10 placements of the ShangRing device, and five removals as part of their 
training. All ShangRing procedures in this group will be closely monitored and tutored by the TOTs. The trainee 
physicians will act as both operator (the physician applying the ShangRing device) and as assistant alternately. 
The trainee physicians will also be trained on device removal and AE management. All routine follow-up, 
including the resolution of any adverse events, will be adhered to based on standard practice. All client data 
collected during the training phase will be included in the final analysis. 
 
The ShangRing experienced physicians will use a checklist to document each trainee’s proficiency. The checklist 
will include the following proficiencies: 
• 
Determination of suitability for circumcision using ShangRing 
• 
Selection of the correct ShangRing size 
• 
The placement procedure and subsequent removal of the foreskin 
• 
Prevention and management of pain 
• 
Removal of the ShangRing device 
• 
Post-circumcision follow-up of clients, including assessment of wound healing and identification and 
management of adverse events 
 
When each physician's ShangRing skills are found acceptable by passing a training course and theoretical, 
practical and clinical tests, s/he will be certified by the training provider as competent.  The newly certified 
Tanzanian physicians will then assist in training mid-level providers (registered and enrolled nurses) in Tanzania.  
 
Mid-Level Provider Training  
An integrated team, led by the TOTs and assisted by the recently ShangRing trained Tanzanian physicians, will 
conduct the training for mid-level providers (defined as registered and enrolled nurses) in Tanzania. In this phase 
of evaluation activities, each trainee mid-level provider will also successfully perform 10 placements and 5 
removals before being deemed competent. All ShangRing procedures in this group will be closely supervised and 

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tutored by the integrated training team described above. When each trainee provider’s ShangRing skills are 
found acceptable by passing a training course and theoretical, practical and clinical tests, s/he will be certified by 
the integrated training team as competent and permitted to participate in the evaluation as a ShangRing 
evaluation provider. Additionally, by having the recently trained Tanzanian physicians assist in the training of 
mid-level providers, the Tanzanian physicians will be better able to conduct future trainings in the event of 
ShangRing scale-up.  All outcomes data during the training phase will be collected per the protocol as part of 
their training, but will not be included in the analysis. 
 
Additional Staff Training  
Additional implementation pilot staff will include site coordinators, counselors, and interviewers.  All staff will be 
trained on evaluation implementation including: the protocol, evaluation methods, data management and 
security, research ethics, safety, human subjects protection and confidentiality. The evaluation staff will also 
receive basic training on the ShangRing device and appropriate messages to share with clients about the device 
and circumcision in general. This will help to ensure that implementation pilot staff is able to conduct proper 
and effective discharge sessions for evaluation subjects after the devices have been placed. The circumcision 
counselors will participate in a mandatory refresher training on the national guidelines for HIV counseling, 
testing and referral services.  Interviewer training will entail a question by question discussion and consensus-
building process on how to ask each question in the surveys and interview guides based on intent and current 
terms in common usage.   
 
Recruitment and Enrollment of Clients 
 
Recruitment 
Phase 2 of the implementation pilot will recruit 455-495 male clients, aged 13 and up who are accessing 
conventional surgical circumcision services in two health facilities in Shinyanga in Tanzania. All male clients, 13 
years and older, who arrive at participating clinics seeking VMMC services will be asked if they would like to 
participate in the evaluation and to receive a ShangRing device-based circumcision. There will be no ShangRing 
specific recruitment to identify men, instead men recruited through standard programmatic activities, or 
seeking circumcision on their own initiative, arriving at the clinic will be asked if they would like to participate. 
Potential clients will be asked until enrollment goals are reached. Clients will be entered into the evaluation in 
the order in which they enrolled, and therefore will be entered into either phase 1 or 2 depending upon which is 
ongoing when they enroll. Only subjects who sign an informed consent form (adults), or who have a 
parent/guardian provide informed consent (those aged 13-17) and provide assent, and meet the eligibility 
criteria listed below will qualify for enrollment. 
 
Interested males will be informed about: (a) the evaluation requirements, (b) their potential role in the 
evaluation, (c) the ShangRing circumcision method, and (d) the evaluation procedures.  Those males interested 
in participation will continue with the enrollment process, which includes the following: 
• 
Administration of informed consent 
• 
Confirmation of eligibility through inclusion/exclusion criteria 
• 
Assignment of the client number 
• 
Administration of evaluation questionnaires and case report forms (CRFs) to collect needed information 
• 
Review of medical and medication history 
• 
Completion of a physical examination, including a genital exam, and photography 
• 
Collection of contact information from the client 
 
Males with contraindications for circumcision or device circumcision will not be permitted to participate and 
they will be referred for standard surgical circumcision, if appropriate. 

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If a man cannot be circumcised on the day of screening and enrollment, he will be asked to return to the site 
within seven days to complete the circumcision procedure.  Men who do not return within one week of 
screening will have to undergo re-screening to be enrolled.  
 
Recruitment for the implementation pilot will begin as soon as the providers participating in the ShangRing 
training are considered competent in its application as demonstrated by passing knowledge and theory based 
tests, have performed no fewer than 10 placements and 5 removals (approximately 80-120), and deemed ready 
by the training clinicians to perform ShangRing circumcisions. 
 
Written Informed Consent 
Written informed consent is required by the MoHCDGEC and the National Institute for Medical Research 
(NIMR).  Eligible clients for this evaluation will read and/or have read to them the written consent form in 
English or the local language. Men aged 13-17 will also have a parent/guardian present to read/have read to 
them the written consent form in English or the local language. Eligible clients also will have the opportunity to 
have any questions answered by an evaluation nurse. Informed consent will cover evaluation procedures, 
potential risks, benefits, and contact persons for reporting complaints or concerns. Procedures will also be put in 
place to protect confidentiality of the client, and these procedures will be explained to the client prior to their 
enrollment. Evaluation nurses will explain the procedure and follow-up visits in detail including the need to take 
confidential photographs of the healing wound at follow-up visits. Evaluation nurses will tell potential clients 
that the procedure will provide to them safe male circumcision and help the MoHCDGEC to understand the best 
way to scale-up male circumcision and make it more accessible as one of the prevention strategies for HIV 
infection. Evaluation nurses also will notify potential clients that they have the right to withdraw from the 
evaluation at any time; however, if they choose to withdraw after the ShangRing device has been placed, they 
will need to wait at least 5 days before the device can be safely removed by trained staff. Males who test 
positive for HIV during screening will still be offered the opportunity to receive a ShangRing circumcision, and 
these men will receive additional counseling and referral for HIV care and treatment services as described 
below.   
 
After the contents of the consent form are clearly understood by clients, they (and their parent/guardian, if 
applicable) will be asked to sign all or part of their name if they accept ShangRing circumcision and agree to 
follow-up visits.  Clients who are unable to sign their name will be allowed to make a digital impression (i.e., 
thumbprint).   
 
A copy of the signed consent form will be provided to clients and their parent/guardian if applicable (see 
Appendices III-VI for different consent forms).  Another copy of the consent form will be maintained in the site’s 
evaluation files in a locked file cabinet with access limited to evaluation staff.   
 
Eligibility Screening 
The potential client’s eligibility will be assessed through a medical history screening and a genital examination, 
which cover the inclusion criteria listed above and helps to ensure that the client is in overall good physical 
health. The screening and examination will be documented on evaluation forms (see Appendix VII).   
 
Potential clients who are not eligible to participate in the evaluation will be offered standard surgical 
circumcision, if their reason for ineligibility does not likewise disqualify them from receiving a standard 
circumcision. The number and reasons for ineligibility will be recorded and included in the final evaluation 
report (See Appendix XII). 
 

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HIV Testing Procedures 
Serological testing for HIV, which follows national standards established and approved by the Tanzanian 
MoHCDGEC, is a standard component of male circumcision services globally.  
 
HIV rapid testing will be conducted after receiving written informed consent, and completion of pre-test 
counseling by certified personnel. Per national guidelines, any person above the age of 18, or any mature minor 
less than 18 years of age may give informed consent to receive HTC services. A mature minor is defined as any 
person below 18 years of age who is married, sexually active, or otherwise believed to be at risk for HIV 
infection. A young person below 18 years of age who does not meet the definition of a mature minor may 
receive HTC services with the written consent of a parent or legal guardian. Tanzanian national HIV guidelines 
for HIV counseling, testing and referral services will be followed and pre-test counseling will include an 
explanation of HIV infection and transmission, the meaning of test results, and risks associated with sexual 
behaviors. Rapid testing will be conducted using the national algorithm in Tanzania. Clients will be tested using 
the standard national algorithm and tests. Clients will be informed of the result of their test verbally by a 
counselor upon its completion.  
 
All potential clients will receive post-test counseling, with specific messages tailored to their test result. Men 
with negative results will be counseled on strategies for behavioral risk reduction, maintenance of risk reduction 
and explanation of risk reduction methods (e.g., condom use) before they provide consent for ShangRing 
circumcision. Men with positive results will be given referral to HIV care services and further counseling and 
testing, and can receive ShangRing or surgical circumcision that day if still desired and they are otherwise 
eligible. The counselor will inform them of any additional health assessments required under MoHCDGEC policy 
for them to access ShangRing or surgical circumcision. If rapid test results are indeterminate, per national 
guidelines the provider will immediately repeat the test following testing instructions, or another HTC 
provider/lab technician will repeat the test. If the test is still indeterminate, the client will be retested in two 
weeks. 
 
All samples and specimens collected as part of routine HIV serological testing will be disposed of in accordance 
with Tanzanian MoHCDGEC VMMC program guidelines.  
 
Evaluation Identification Code 
This evaluation will use evaluation identification (ID) codes for the various documents related to the evaluation 
including the CRF, photographs and surveys. The use of evaluation codes will link evaluation documentation 
with consent forms, which contain client names and signatures. An evaluation ID code will be created for every 
client. The master list, linking the ID codes with actual clinic records and the client’s name, will be maintained by 
the site coordinator in a locked file cabinet in a locked office separate from all other evaluation files.  
 
The evaluation ID will be an alphanumeric code created by elements related to the evaluation.   
• 
Site location (Initials of site location) 
• 
Date of enrollment 
• 
Client number (consecutive) 
 
In this regard, the first client enrolled at Good Hope Health Center (fictitious example) on September 1 would 
have the following evaluation ID code: GH0109001. 
 
Male Circumcision Using ShangRing Device 
The ShangRing device contains the following items: two concentric plastic rings, the inner of which is lined by a 
silicone pad, a measuring tape, and bandages. These must be discarded after each use. The ShangRing device 

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also requires a removal cutter and removal key to remove the rings, which are sold separately but can be re-
used after being thoroughly cleaned and disinfected. The ShangRing device also requires the use of general 
hospital supplies, local anesthetic, povidone-iodine, and instruments (e.g. hemostatic clamps, surgical scissors). 
These are not included with the device. 
 
All circumcisions with the ShangRing device will be performed according to the ShangRing Instructions for Use. 
The current instructions are available online (here: 
http://www.who.int/hiv/topics/malecircumcision/prequal_mc_devices_2015.pdf ). The current IFU is under 
review by the WHO. If the WHO updates the IFU based upon its review, pilot providers will be advised to follow 
the new IFU. 
 
At the end of the application procedure, a photo will be taken of the client’s genital with the device in place. 
Ibuprofen 400 mg (or the equivalent of another non-narcotic analgesic) will be given to the client to use at home 
if needed. After the procedure the client will take part in a formal discharge and counseling session (as detailed 
below), where he will be instructed to return at set follow-up visits and to take painkillers in case of discomfort.  
 
On the seventh day following device application, the client returns to the clinic to have the ShangRing device 
removed. The provider will examine the client’s genitals and a photo of the genitals will be taken. After which 
the provider will clean the area, dress the wound with sterile gauze and secure the bandage with adhesive tape. 
The client will receive one dressing pad for home to change in case the dressing gets wet. The preparation and 
procedure time for the device removal will be measured and recorded. The client is instructed to return to the 
evaluation site in case of any unexpected event, to abstain from sex for six weeks or until the wound is clinically 
healed (whichever comes later) and to abstain from masturbation. The client will have another counseling 
session (detailed below) and instructed to return for the healing assessment six weeks later (day 49). Clients that 
are not clinically healed at day 49 will be asked to return to the clinic at weekly intervals to assess healing, until 
all clients are clinically healed. 
 
The ShangRing device is intended for single use only and is supplied in a sterile environment. All ShangRing 
devices removed from clients will be destroyed before disposal. Specifically, the elastic ring is destroyed by 
cutting it with a scalpel, and the inner ring is destroyed by breaking it with a cutter. Surgical tools used during 
the ShangRing removal will be sterilized between procedures using an autoclave in accordance with infection 
prevention and control policies at the clinics.  
 
Key Post-Placement Procedure Counseling following ShangRing Circumcision  
Following each circumcision with the ShangRing device, all clients will receive post-circumcision counseling. This 
counseling will occur on the day that the circumcision is performed and the ShangRing device is placed, and will 
stress the following messages: 
• 
When to return for the follow-up visit (day 7) for removal of the ShangRing. 
• 
The importance of abstaining from sex or masturbation for 7 weeks (49 days), following the placement 
of the ShangRing device, or until the penis is fully healed (whichever comes last). 
• 
The importance of good hygienic practices while the device is in place and the wound heals, and how to 
keep the penis and wound clean and free of potential infection, and strategies to mitigate the risk of 
tetanus. 
• 
The client will be instructed to return to the evaluation site in case of any unexpected event, for 
example if there is difficulty urinating, increasing swelling with discoloration of the penis, signs of 
infection (purulence), severe or increasing pain, the ring spontaneously detaches before day 7,  or any 
other significant concern that they may have. 
• 
The client will also be advised that painful erections may occur during the night. 

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• 
All clients will be provided with a phone number for the facility, and encouraged to call any time with 
any questions or concerns. 
• 
All clients will be provided with a pamphlet with the above information, as well as with contact 
information for additional counseling if so desired (see Appendix XIII). 
 
Key Post-Device Removal Counseling following ShangRing Circumcision 
Following the removal of the ShangRing during the day 7 follow-up visit, all clients will receive additional 
counseling. This counseling will stress the following messages: 
• 
A phone call to the client to take place in 3 days to assess symptoms of AEs. 
• 
When to return for the day 49 (42 days post-removal) visit to assess healing. And the importance of 
returning for that assessment.  
• 
The importance of good hygienic practices while the wound heals, and how to keep the penis and 
wound clean and free of potential infection, including the importance of tetanus mitigation strategies. 
• 
The client will be instructed to return to the evaluation site in case of any unexpected event, for 
example if there is severe discoloration of the penis, signs of infection (purulence), severe or increasing 
pain, or any other significant concern they may have. 
• 
The client will be advised that painful erections may occur during the night. 
• 
All clients will be provided with a phone number for the facility, and encouraged to call any time with 
any questions or concerns.  
• 
All sexually active clients will be offered a package of condoms to take home. 
• 
The importance of continued abstention from sex or masturbation for 6 weeks (42 days), following the 
removal of the ShangRing device, or until the penis is fully healed (whichever comes last). 
 
Key Post-Device Removal Counseling during AE Assessment Call 
Three days following the removal of the ShangRing, all clients will receive a phone call to assess for symptoms of 
AEs. If the client is determined to be exhibiting signs of an AE, they will be advised to immediately return to the 
site that performed the circumcision for treatment. During this call, implementation pilot staff will also remind 
clients of the following: 
• 
The importance of good hygienic practices while the wound heals, and how to keep the penis and 
wound clean and free of potential infection, including the importance of tetanus mitigation strategies. 
• 
The client will be reminded to return to the evaluation site in case of any unexpected event, for example 
if there is severe discoloration of the penis, signs of infection (purulence), severe or increasing pain, or 
any other significant concern they may have. 
• 
The client will be reminded that painful erections may occur during the night. 
• 
All clients will be reminded that they are encouraged to call any time with any questions or concerns.  
• 
The importance of continued abstention from sex or masturbation for 6 weeks (42 days), following the 
removal of the ShangRing device, or until the penis is fully healed (whichever comes last). 
• 
When to return for the day 49 (42 days post-removal) visit to assess healing. And the importance of 
returning for that assessment.  
 
Follow-Up Visits 
Active follow-up will be initiated for clients who fail to return on day 7 post-placement to have the device 
removed, or for other visits (e.g. AE follow-up) recommended by the ShangRing clinician. Each implementing site 
will assign staff to conduct follow-up telephone calls and home visits as needed. All active follow-up efforts will 
be documented on the appropriate forms designed for this purpose (Appendix XI). For clients who fail to return 
for device removal on day 7, active follow-up will start on day 8. Active follow-up will start with telephone calls 
to the contact number(s) provided by client and recorded on the locator information sheet at enrolment. An 

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introductory script for contacting clients by phone is attached as Appendix X. If a client is not reachable through 
direct voice calls, short text message reminders will be sent to his contact phone number. The reminder text 
message will include client name and specify the name and phone number of the clinic reaching out to him. The 
text message will not include the purpose of appointment visit for which the reminder is sent. Up to five calls 
will be made to reach the client; one per day starting on day 8, and continuing over the next 4 days through Day 
12 (5 days post-procedure). 
 
Once contact is made, the staff member will reinforce the importance of device removal and encourage the 
client to return to the circumcision site. If the client states that he is not able to return by day 9 post-placement, 
or the schedule day, or does not in fact return by day 9 or the schedule day, the staff member will attempt to 
verify the addresses provided to schedule an appointment at one of the address locations provided for device 
removal on day 9, or as soon as possible. If the client has not been successfully contacted by day 9 or the 
scheduled day, home tracing visits to the address he provided will begin. These will total up to 4 visit attempts 
on different days if necessary to reach the client. 
 
For clients not under follow-up for AEs who miss scheduled visits other than the day 7 visit, follow-up will be 
done through phone by text messages or voice calls only, except in exceptional circumstances where a clinician 
deems physical follow-up necessary.  
 
All clients in the evaluation will be followed up at three points in time following ShangRing circumcision, on day 
7 (device removal), on day 10 (three day post-removal AE assessment phone call), and day 49 (42 days/6 weeks 
following device removal). Ten percent of all clients will be brought in on day 28 (21 days/3 weeks following 
device removal) for in-depth qualitative interviews.  
 
At the day 49 visit, a clinician will assess healing, an evaluation staff will photograph the client’s genitals to 
document healing, and the client will receive counseling that will stress the following messages: 
• 
If the wound is considered to be healed, the client will be informed that they may resume sexual activity 
and masturbation, but counseled on the need to continue safe sexual practices. 
• 
If the wound is not considered healed, the clinician will offer ask the client to return in one weeks’ time 
to assess healing and ensure the wound is fully healed. The client will also be advised to continue 
abstention from sexual activity and masturbation. 
• 
If the client is not considered healed, and there is a clinically indicated reason to schedule further follow-
up to take place before the next weekly visit, the evaluation staff will schedule such follow-up visits at a 
medically appropriate time.  
• 
All sexually active clients will be offered a package of condoms to take home. 
 
One week preceding the day 49 healing assessment visit (day 42) the client will receive a short reminder text 
asking that the client contact the site to confirm the appointment. The reminder text message will include client 
name and specify the name and phone number of the clinic reaching out to him. The text message will not 
include the purpose of appointment visit for which the reminder is sent. The client will be asked to confirm the 
appointment by either calling the clinic, or by replying with a text. If the client does not confirm the 
appointment within 3 days, (day 45), the client will be sent a second text. If the client still has not confirmed the 
appointment by day (47), the client will receive one phone call per day from day 47-49 until they have confirmed 
the appointment or indicated their intent not to come. If the client does not come in on day 49 for the healing 
assessment visit, and has not indicated his desire to withdraw from the evaluation, then the client will be 
established as lost to follow up.  
 

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Post Day 49 Healing Assessment Visits 
Clients who are not considered healed at the Day 49 healing assessment will be asked to continue returning to 
the clinic at weekly intervals until they are clinically healed. At each weekly visit, a clinician will assess healing, an 
evaluation staff will photograph the client’s genitals to document healing, and the client will receive counseling 
that will stress the following messages: 
• 
If the wound is considered to be healed, the client will be informed that they may resume sexual activity 
and masturbation, but counseled on the need to continue safe sexual practices. 
• 
If the wound is not considered healed, the clinician will ask the client to return again in on weeks’ time 
to assess healing and ensure the wound is fully healed. The client will also be advised to continue 
abstention from sexual activity and masturbation. 
• 
If the client is not considered healed, and there is a clinically indicated reason to schedule further follow-
up to take place before the next weekly visit, the evaluation staff will schedule such follow-up visits at a 
medically appropriate time. 
• 
All sexually active clients will be offered a package of condoms to take home. 
 
Unscheduled Visits 
Additional visits may occur as needed for complications or adverse events, or for wound healing that is delayed 
beyond 49 days.  Men will be told they should come for an unscheduled visit if they experience medical events 
such as: any unexpected event, for example if there is severe discoloration of the penis, signs of infection 
(purulence), severe or increasing pain, or any other significant concern they may have.  During unscheduled 
visits, providers will: 
• 
Review genital health and sexual activity and/or sexual function if applicable 
• 
Examine penis and assess wound healing 
• 
Review device-related events and AE, if applicable 
• 
Review concomitant medications, if applicable 
• 
Take photographs of genital area, if applicable 
• 
Provide HIV risk reduction counseling and condoms (as needed) 
• 
Schedule additional follow-up visits, if necessary 
• 
Refer to a higher level of care, if necessary 
 
Telephone Calls Initiated By Clients due to AEs:   
The staff member will discuss the clinical course and AE with the client and encourage the client to return for 
review to the health facility where the circumcision procedure was performed, if deemed medically necessary. If 
the client does not return for follow-up visits deemed medically indicated, active tracing will be initiated. In 
situations where clients cannot be reached by telephone or located through physical tracing, after a total of 8 
calls and 4 visits on different days, the case will be directed to the attention of the site manager for disposition. 
In this case, these clients will be considered to have experienced a moderate AE by default, unless follow-up 
indicating otherwise is able to be completed. 
 
In-Person Qualitative Interviews 
The evaluation staff will select 50 individuals to participate in a more in depth in-person qualitative interview to 
be held 28 days post-circumcision. Fifty clients were chosen as the sample size, based on prior experience with 
evaluating acceptability of circumcision devices, which suggests that 50 is sufficient to obtain the necessary 
range of views and opinions. Only males aged 18 years or older will be eligible to be selected to participate in 
the qualitative interviews. All clients will be asked when they are enrolled if they are willing to participate in an 
interview. The first 50 clients, aged 18 years or older, to indicate willingness at enrollment to participate will be 
asked to interview. If after contacting these men for an interview, not all are able to participate, clinic staff will 

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continue to proceed down the list of clients in the order in which they enrolled and agreed to an interview, until 
50 clients are selected. These interviews will be used to assess client pain, discomfort, and satisfaction with the 
procedure. Males selected for the qualitative interviews may refuse to participate or withdraw at any time, the 
reason for their refusal/withdrawal will be recorded and reported. Clients will be offered a small amount to 
reimburse their travel and time spent for the interview (estimated to be between 20-25 USD/45,000-56,500 
Tanzanian Shillings but not to exceed 30 USD/67,900 Tanzanian Shillings).  
 
Interviewers will receive training on the administration of the surveys and questionnaire, question by question 
in English or Swahili (Tanzania). In order to ensure quality of the interviews training will be provided. Once data 
collection begins, the site supervisor will also review one out of every ten of the completed surveys conducted 
by each interviewer.  Following each review, the evaluation supervisor and interviewer will meet to discuss 
areas where the interviewer could improve. Draft interview guides are included in Appendix XVIII. 
 
Quality Control and Quality Assurance 
In order to assure quality of the clinical and surgical procedures, the following has or will be done: 
• 
Sites with previous MC experience and with MoHCDGEC endorsement for MC services will be used 
for this evaluation.  
• 
All circumcisions with ShangRing will be by adequately trained and certified providers. 
• 
Experienced VMMC providers, trained in surgical and ShangRing circumcision, will be present at 
each site to monitor and assess the quality of services being provided, including observing surgical 
procedures and identifying and addressing any quality assurance problems. 
• 
Relevant documentation will be obtained and maintained at evaluation sites. 
 
Photography 
Photographs of the client’s penis and genital area will be taken by a clinic staff member, after the ShangRing 
device is placed, after the ShangRing device is removed, at the day 49 healing assessment visit, and at 
subsequent healing visits for those clients not healed at day 49. Additional photographs may be taken at the 
request of the attending clinician as necessary in case of unscheduled medical visits, such as occurrence of AEs. 
The photographer will take four photographs, presenting a 360˚ view around the glans and showing the 
frenulum. The photographer will take photographs while a special photo frame is placed around the penis 
including the subject evaluation number, date of photo, and evaluation day. The photos will not include the 
client’s face. Clients will be asked for consent prior to any photograph, and reserve the right to refuse 
photographs at any point. Clients will not be removed from the study if they choose not to be photographed. 
 
At the end of each day, all photographs will be downloaded to a password-protected evaluation computer saved 
in a specific location and backed up on a removable hard drive. The removable hard drive will be kept separate 
from the computer for ensuring no loss of data. Photographs will not be erased from the camera digital memory 
card in order to create space on the card. In case the card is full, a new card will be used.  The evaluation staff 
will maintain the removable hard drive and digital memory cards in a secure locked cabinet in a locked office 
accessible only by evaluation staff. Photographs and digital files will not be kept for more than one year. Upon 
the conclusion of the evaluation, and the publication of the final report, the digital photographs will be disposed 
of per Tanzanian MoHCDGEC policies.     
 
The purpose of the photographs is to document complete healing, cosmetic results, complications and adverse 
events. The photographs collected will be used in part to chart and document healing over time, in order to 
better understand the healing timeframe. An analysis of healing times will be performed by clinic staff and 
project investigators in order to better inform the pre-procedure counseling messages clients receive with 
regard to healing – and when resumption of sexual activity can begin following the procedure. Photographs will 

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also be used to document and report AEs. When an AE is reported, the photos will be reviewed and verified by 
project investigators as part of a medical investigation. 
 
 
Data Management and Analysis 
 
Data Collection 
Data from the client’s surgical and male circumcision medical records will be recorded on CRFs included in the 
Appendices (see Appendices VII and IX) The CRFs will be used to transfer the information collected in the 
performance of this evaluation to the clinical database. The original CRF will be kept in the clinic files and a copy 
will be maintained with additional documentation specifically for this evaluation including photographs, 
interviewer administered surveys and brief questionnaires.  The hardcopy data will be entered into the 
evaluation database at each site. Corresponding forms, surveys and questionnaires will be completed 
immediately after each subject's visit. The site coordinator will review the CRFs for completeness and accuracy 
(signatures, dates, adverse events, serious adverse events, protocol departures) sign/date the forms where 
indicated.  The evaluation team will retain originals of all source documents, subject consent forms, photographs 
and evaluation data as a permanent record.  
 
The following data will be collected from clients receiving ShangRing circumcision: 
 
Clinic Visit #1: Enrollment and Circumcision (Day 0) 
• 
Documentation of general physical screening and medical examination on CRF 
• 
Documentation of medication history on CRF 
• 
Documentation of genital examination on CRF 
• 
Documentation of device-related events and AE on forms, as needed 
• 
Administration of evaluation survey after circumcision 
• 
Collection of contact information from the client 
 
Clinic Visit #2: Removal Visit (Day 7) 
• 
Photographs of genitals after device removal 
• 
Documentation of wound healing and genital examination on CRF 
• 
Documentation of device-related events, AE and treatment and resolution of AE, as needed, on forms 
• 
Documentation of changes to medical condition and medication on CRF 
• 
Administration of evaluation survey after device removal 
 
AE Assessment Phone Call (Day 10) 
• 
Administration of an interview to determine whether client is experiencing signs and symptoms of an AE 
 
Follow-Up In-Person Qualitative Interview (Day 28) 
• 
For 50 clients 
• 
Interview to determine client’s feelings about ShangRing circumcision experience 
 
Follow-Up In-Person Healing Assessment (Day 49) 
• 
Documentation of wound healing and genital examination on CRF 
• 
Photographs of genitals to document healing 
• 
Documentation of device-related events, AE and treatment and resolution of AE, as needed, on forms 
• 
Documentation of changes to medical condition and medication on CRF 
 

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Additional Wound Healing and Unscheduled Visits 
• 
Documentation of wound healing and genital examination on CRF 
• 
Documentation of device-related events, AE and treatment and resolution of AE, as needed, on forms 
• 
Documentation of changes to medical condition and medication on CRF 
• 
Photographs of genitals to document healing 
 
The following data will be collected from providers conducting ShangRing circumcision: results from theoretical 
tests, practical test of hands-on-skills and clinical test of performing ShangRing on subjects following 
participation in a formal training course; the rate of AE, the rate of device-related incidents and the average 
procedure time of trainees undergoing ShangRing device training; and strengths and weaknesses of the training, 
effectiveness of training package/materials, satisfaction with training, and suggestions for improvement of 
training and facilitation.  Providers and select staff working in the facilities where the evaluation is being 
conducted will also be interviewed about device acceptability. 
 
Source documents for this evaluation include, but are not limited to, staff notes, medical notes, client CRFs and 
files, screening and interviews and interviewer notes, enrollment logs, informed consent forms, client 
reimbursement logs, audiotapes and transcripts from qualitative interviews. 
 
Clinic-based data collection will rely on standard clinical forms with data abstracted onto evaluation specific CRF 
and AE forms. Evaluation providers will complete both standard surgical and evaluation specific forms.  The 
evaluation coordinator, or the site coordinator in the evaluation coordinator’s absence, will verify the 
completeness of forms. Surveys and interviews will be administered by evaluation-hired interviewers. Data 
collection for this evaluation will be completed using standardized forms for quantitative, clinical data.  
Providers and interviewers will complete the forms.  Once a form is completed, it will be copied and given to site 
coordinator for data entry. The original form will be retained in the client file at the evaluation site and the copy 
will be stored in the evaluation office in a locked file cabinet.   
 
Clients and clinic staff/providers interviews will have data collected with digital recordings and interviewer 
notes. Translations and transcriptions of the digital recordings will be made.  Original digital recordings will be 
destroyed once they have been translated and transcribed. Interviewer notes and transcriptions will be stored in 
in the evaluation office in a locked file cabinet.  
 
The original client file, normally maintained by the clinic, will contain all source documents. This source file will 
be maintained at the site and be available for review as needed by the evaluation team. The original CRF will be 
retained at the evaluation site in the client’s file. All subsequent changes to the CRF will be documented on the 
relevant CRF. 
 
No names or other identifying information will be collected on the various forms other than the clinical record, 
only client IDs.  Completed forms will be given to the site coordinator in an evaluation client folder. 
 
Adverse Events Management 
ShangRing clinicians will be trained on how to detect and manage the known complications of ShangRing 
circumcision. The responsibilities of the attending clinician in management of AEs will be as follows: 
• 
Manage the AE in a manner consistent with national guidance and the Adverse Event Action Guide for 
Voluntary Medical Male Circumcision by Device or Surgery, 2nd edition. This may include urgent surgery 
at the ShangRing facility. 
• 
In the event of a complication that requires client referral to a higher level of care or specialist attention, 
make sure that the referral is effected and that the client is transferred to the point of care. 

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• 
Document and report the event as described in the section below. Moderate, severe and serious AEs 
should be documented and reported even if they are not apparently related to the procedure. 
• 
Take photographs to document the progression of the AE. 
• 
Notify the lead ShangRing clinician at the site about the event to begin the reporting process describe 
below. 
 
Adverse Event (AE) and Other Device-Related Incident Documentation 
AE and other incidents that occur as a result of the ShangRing device will be recorded as part of this evaluation.  
All events and incidents – including mild, moderate and severe AE, expected side effects such as common post-
operative findings, occurrences resulting from clients’ failure to follow instructions, and device malfunctions – 
will be documented on the appropriate visit section and device-related events form of the CRF. Events classified 
according to the definitions provided as mild, moderate and severe based on the PEPFAR AE definitions below 
should also be recorded on the adverse events form of the CRF. The adverse events form will include a 
description of the onset, duration, relationship to the procedure, severity, seriousness, and final outcome of the 
AE. For additional information on severity criteria by type of AE see Appendix XV.  
 
For the purposes of this evaluation AEs that are related to the evaluation device will be graded using the 
following definitions as guides: 
• 
Definitely related: direct association with the procedure, i.e., follows a reasonable temporal sequence 
and is a recognized AE of the procedure.  Note that this does not imply any error on the part of the 
provider or client, only that the event would not have happened if the procedure had not been 
performed. 
• 
Likely/possibly related: more likely explained by the procedure, i.e., follows a reasonable temporal 
sequence from the procedure and is a plausible AE of the procedure, but could have another cause. 
• 
Likely unrelated: more likely explained by another cause. 
• 
Definitely unrelated: clearly explained by another cause. 
 
A physician will evaluate each AE for severity, seriousness, and relationship to the MC procedure, per the 
categories and criteria delineated in the AE Action Guide for Voluntary Medical Male Circumcision by Surgery or 
Device, 2nd Edition (see Appendix XV for table of AEs and severity). To ensure objectivity, the evaluating 
physician will be brought in from a site other than where the circumcision was performed. Any evaluating 
physician should be trained in male circumcision, and have experience evaluating adverse events. Methods to 
assess the severity, seriousness and relatedness of the AE are detailed in the evaluation SOP manual. Evaluation 
physicians will be trained to make these assessments in a manner as standardized as possible. The site 
coordinator will verify that this information will be captured during every evaluation subject visit. AEs will be 
managed medically as appropriate, and will be followed until resolution or until a clinically stable endpoint is 
achieved.  
 
The incidence and severity of all AEs related to the circumcision procedure will be documented and collected on 
the appropriate visit section and device-related events form of the CRF. This form will include a description of 
the onset, duration, relationship to the procedure, severity, seriousness, and final outcome of the AE. Severe 
and serious AEs, as well as AEs related to client self-removal of the ShangRing, will also be documented on the 
ShangRing Device Related Adverse Events form (see Appendix XIV), which must be completed for all AEs that 
result in hospitalization and all AEs classified as severe per the AE classification guidelines, as well as for those 
whose severity cannot be classified. The evaluation will compile and analyze mild, moderate and severe AE to 
determine the AE rate.  All other device-related events, including expected side effects and occurrences 
resulting from clients’ failure to follow instructions, will be compiled and summarized to inform program policy 
related to ShangRing use. 

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For the purposes of this evaluation, all severe AEs must be reported to the CDC within 24 hours of notification. 
Standard reporting procedures for all notifiable AEs must be followed per PEPFAR and national guidelines.  
 
ShangRing and Tetanus 
Because the foreskin is removed at the time of device application, ShangRing is not believed to pose increased 
risk of tetanus when compared to conventional surgical MC.  For the purposes of this evaluation, tetanus cases 
will be treated as a severe AE and must be reported to CDC within 24 hours of notification.33 As tetanus is also a 
notifiable AE, standard reporting procedures for tetanus must be followed per PEPFAR and national guidelines.  
 
Data Entry 
Once completed and verified, information contained on CRFs and AE forms in client evaluation folders will be 
forwarded to site coordinator. The coordinator at each site will be responsible for re-confirming the 
completeness of the forms before giving them to the data entry manager. For each question on the CRFs, the 
data entry screen will contain a variable name, description, type and code list, if appropriate. Ten percent of the 
CRFs and AE forms will be checked by the site coordinator for accuracy and quality control. Any inconsistencies 
will be resolved with the help of the data manager or site coordinator. The data manager or site coordinator will 
document the item with an apparent error, the original data stored in the data field, a description of the 
error/omission/inconsistency and revised data (if any). The data manager or site coordinator will note when the 
revision was made and the rationale for making the revision. The database will be backed up on a daily basis. 
 
Electronic files containing the transcripts from qualitative interviews will be transferred to a qualitative data 
analysis program such as Atlas.ti.   
 
Quantitative data will be entered using Microsoft Excel, or another standard statistical software. The local data 
warehouse that contains the electronic evaluation data will be located on a password-protected computer. 
 
Client folders, containing paper-based evaluation forms, will be maintained in a secure locked cabinet in the 
locked evaluation office.  Access to this information and the office will be limited to the circumcision 
coordinators, site supervisors and investigators. 
 
Data Management 
The electronic files from the local data warehouse will be uploaded by the site supervisor for inclusion in the 
central data warehouse at the end of each day. The site supervisor will also store a back-up copy of the files on a 
flash drive and CD-ROMs that will be kept in a locked cabinet.  The data manager will upload all local files to a 
central data warehouse located on a password-protected computer.  
 
The database will be encrypted and maintained by the data manager in a central data warehouse. 
The data manager will perform continuous quality assurance checks to ensure that the database is clean and 
that there are no illogical responses.  The data manager will communicate with site staff to resolve the identified 
issues, if necessary.  The data manager will document the item with an apparent error, the original data stored 
in the data field, a description of the error/omission/inconsistency, revised data (if any), noting who made the 
revision, when the revision was made, and the rationale for making the data change.   
 
All databases will be password protected and data will be encrypted before transmission over public networks. 
 
As noted above, all photographs will be downloaded to a password-protected evaluation computer saved in a 
specific location and backed up on a removable hard drive. The removable hard drive will be kept separate from 

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the computer for ensuring no loss of data. Photographs will not be erased from the camera digital memory card 
to create space on the card. In case the card is full, a new card will be used.  The evaluation staff will maintain 
the removable hard drive and digital memory cards in a secure locked cabinet in a locked office accessible only 
by evaluation staff. The digital files will be disposed of in accordance with Tanzanian country policies upon 
conclusion of the project and the completion of any final analyses and reports. 
  
 
Analysis Overview 
Quantitative and qualitative data collection will occur during the period comprising the start of evaluation 
recruitment and the end of the follow-up period of evaluation clients. Data analysis will be conducted in parallel 
with the recruitment and follow-up process of evaluation clients.  
 
Baseline demographics and client characteristics will be presented in tabular format using descriptive statistics. 
Binary data such as adverse events will be presented as counts and percentages and the upper limit of the 
estimate of the AE rate (percent of clients with one or more AE) will be based on a two-sided 95% confidence 
interval. Adverse event rates will be compared descriptively with the reported rates of similar treatments 
reported in Tanzania and elsewhere, including: comparison against AE rates found in other studies of ShangRing, 
comparison against AE rates found in studies of other circumcision devices, and comparison against reported 
rates of AEs in studies of surgical circumcision. No formal hypothesis tests will be done comparing AE rates in 
this evaluation to other AE rates. 
 
 Adverse event rates will be presented by seriousness, severity, relation to device and outcome by site and by 
cadre. Continuous data will be represented by a mean, standard deviation, median, minimum and maximum 
together with 95% confidence intervals for the means.  The number and percent of subjects who fail to 
complete the evaluation will be assessed. Time to withdrawal may also be assessed. The procedure time will be 
calculated. The first 15 procedures performed by each provider will be compared to the last 15 procedures by 
that provider with respect to procedure time, to evaluate whether procedure time is shortened with experience. 
All of the first and last 15 procedures evaluated will take place during the main implementation pilot phase. If a 
provider does not perform 30 total procedures following the training phase, then the first half of the total 
number of procedures performed will be compared against the last half. Adverse event rates from the training 
and post-training phases will also be reported, as well as an overall AE rate. Procedure times during the provider 
training phase will be tracked, but not used for comparisons. The differences in mean procedure times will be 
compared with a t-test or a non-parametric equivalent. 
 
Standard statistical software packages R, Stata or SAS will be used for the analysis.  No corrections for missing 
values will be imputed. The data will be analyzed and presented “as-is”. 
 
Client acceptability, time to return to normal activity, and clients’ satisfaction with the post-circumcision 
cosmetic results will be summarized from data recorded on the evaluation surveys and during qualitative 
interviews conducted with 10% of randomly selected clients. Similarly, provider acceptability will be summarized 
from data recorded during qualitative interviews conducted with providers.  Qualitative interviews will be 
digitally recorded and then transcribed by qualified staff. The recordings will transcribed according to the local 
language used and then to English. The recordings will not be marked with any identifying information but with 
a unique identifier. Transcriptions will be reviewed electronically, using a qualitative interview analysis software 
such as Atlas.ti or NVivo, and analyzed for themes. The analysis of the qualitative data will be done through an 
inductive process where categories are identified as they emerge.  Opinions generated by the 10% of clients 
included in the interviews will be used to tailor the messaging for future program implementation.  
 

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The percentage of men healed by day 49, and the time at which all clients are healed, will be reported from data 
recorded on the client CRFs. The proportion of men unsuitable for ShangRing MC will be extracted from an 
evaluation log maintained for the purpose of documenting the number of ineligibles and the reasons for their 
exclusion.  Similarly, the number of men who decline ShangRing or who withdrawal will be reported as a 
proportion. 
 
The photographs taken to document healing and adverse events will be used to supplement the analysis of both 
endpoints. Photographs will be reviewed only by evaluation project staff, and used to enhance the 
understanding of different adverse events and as evidence of the duration of the healing process. Photographs 
of all adverse events (if the client consents) will also accompany the AE reporting, to provide further clarity on 
these events. The photos will also be used by project staff to better educate ShangRing providers. 
 
Long-Term Data Storage 
Each evaluation site in Tanzania will keep the originally signed informed consent documents for each client, the 
original CRFs, and originals of all other evaluation documentation (e.g., photographs, surveys product-tracking 
tools and master logs). The data will be owned by the Tanzanian MoHCDGEC and IntraHealth. The data 
warehouse will be kept at a location agreed upon by IntraHealth and the Tanzanian MoHCDGEC. The software 
used for the data warehouse will also be agreed upon by IntraHealth and the Tanzanian MoHCDGEC. Following 
the completion of evaluation data collection, these documents will be transferred to the Tanzanian MoHCDGEC 
where it will be maintained for a minimum of five years and will be available for monitoring, audit or inspection 
as needed.  The evaluation database also will be maintained by the MoHCDGEC for a minimum of five years, 
CDC-Tanzania will keep a copy of the data, which will be stored on a password protected computer and with 
password protected evaluation files. A process will be established to share data with interested researchers 
after the publication of evaluation results.  
 
A data transfer agreement will be signed whenever data is taken out of the country. Data available for transfer 
will include aggregate data from client records data collected through the standardized ShangRing specific data 
collection forms (device placement and removal times, adverse event forms, etc.), photographs, written data 
and transcripts from the provider interviews and surveys, and written data and transcripts from the client 
qualitative interviews. All data will be reviewed to make sure that it is completely de-identified before sharing, 
and any party interested in obtaining the data must agree to make no effort to identify either clients or 
providers through their use of the data – and must alert the MoHCDGEC if they inadvertently do so.     
 
Ethical Considerations 
 
Potential Harm and Measures to Mitigate Harm 
Participation in this evaluation is believed to pose no more than minimal risks. Potential complications of the 
ShangRing device circumcision include excessive bleeding, hematoma, infection, pain, wound dehiscence, injury 
to the glans or urethra, excessive or insufficient skin removal, and poor cosmetic results. The use of the 
ShangRing device has yielded low rates of adverse events in different studies. In a proof of concept evaluation in 
Kenya, all 40 procedures were completed successfully.34 Only three mild adverse events, all cutaneous injuries of 
the skin of the penis, was reported among the 40 clients (7.5%) and mean pain scores were low. A second 
evaluation in Kenya enrolled 197 men, each of whom received successful ShangRing circumcisions, these were 
compared against 201 men who received conventional surgical circumcisions.35 The ShangRing group 
experienced AEs at a similar rate to the conventional surgical circumcision group, with 14 moderate and one 
severe AE in the ShangRing group (7.6%) and 10 moderate AEs in the conventional surgical circumcision group 
(5.0%). The severe AE was a case of pain that occurred in the ShangRing group during the circumcision. The 
other AEs included: wound dehiscence, post-procedure pain, and an anesthetic complication. All AEs were 

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treated and resolved without problems. The pain scores between the two groups were similar at most points of 
time, with the exception that the pain during an erection while the device is in place was significantly higher for 
the ShangRing group. A comparative evaluation in Uganda found that a majority of men chose ShangRing over 
the dorsal slit method when asked to choose a preferred procedure, 508 chose ShangRing compared to 113 
(though four men who chose ShangRing had to receive conventional circumcision when the ShangRing 
procedure failed, these failures occurred early in the evaluation and were attributed to provider inexperience).36 
There were no differences in the rate of moderate and severe AEs between the two groups – five total (1%) in 
the ShangRing group, and one (.9%) in the conventional surgical circumcision group. The AEs included post-
operative pain, bleeding, infection, wound dehiscence, and insufficient skin removal. Additional studies in Kenya 
and Zambia have found similar rates of AEs between ShangRing procedures and conventional circumcision.37       
 
Clients will be reminded during the device placement and removal visits to come into the clinic for follow-up 
care should any complications arise for example if there is severe discoloration of the penis, signs of infection 
(purulence), severe or increasing pain, or any other significant concern they may have. If clinical care is required 
after evaluation close-out, care will be provided at the evaluation site as part of their regular activities. If 
necessary, men may be referred to a hospital near the evaluation site for additional care. To assist in locating 
clients who do not return for scheduled follow-up, personal contact data such as addresses, cell phone numbers, 
and contact information of friends and family members will be collected. If clinical care is required after 
evaluation close-out, care will be provided at the evaluation site as part of their regular activities. 
 
Potential conventional surgical complications of male circumcision include excessive bleeding, hematoma 
formation, infection, pain, injury to the glans or urethra, excessive or insufficient skin removal, and poor 
cosmetic results. It is expected that at least some of these complications will be decreased with the ShangRing, 
or will at minimum occur with similar frequency as with conventional male circumcision. There are, however, 
AEs specific to the ShangRing method of circumcision, such as device displacement or malfunction.   
 
Research studies performed on this topic have found no association between circumcision status and increased 
risky sexual behaviors. One such study was performed in Kisumu, Kenya, between 2009-2013. In that time, the 
circumcision prevalence increased from 30% to 60%, but despite this increase there was no or minimal sexual 
risk compensation.38 A second research study performed in Nyanza Province, Kenya (where Kisumu is located), 
found similar results. This study followed 3299 males, aged 18-35, for two years. Half of this group was 
circumcised at enrollment in the study, the other half was not. The males in the study were surveyed on their 
sexual behaviors several times over the two years. The study found that not only was there no evidence of risk 
compensation among circumcised men but both circumcised and uncircumcised men significantly reduced their 
HIV risk behaviors.39 Recently, separate studies in Kenya, South Africa, and Zambia further corroborated these 
results. Each study found no evidence that circumcised men are more likely to engage in risky sexual behavior 
than uncircumcised men.40    
 
Although clients will be asked to sign a written consent to participate in this evaluation, several procedures will 
be taken to minimize the risks associated with participation. All clients will be provided with photocopies of their 
signed consent and assent forms. 
 
1. Counselors and interviewers will reiterate that participation in the evaluation and circumcision are 
voluntary.  They will conduct all counseling and interviews in a private area. 
2. All adverse events will be immediately treated and clients will be followed to resolution. AE will be 
clinically managed according to 2nd edition of the Adverse Event Action Guide. Clients will be entitled for 
continuation of clinical follow-up and treatment until their evaluation related clinical problem has been 
resolved, even beyond the six week follow-up period.  

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3. Consistent with standard clinic procedures and MoHCDGEC policy, surgical and male circumcision 
medical records and evaluation instruments (i.e., consent forms and paper-based surveys) will be stored 
in a secured, locked file cabinet in a locked office with access limited to select evaluation staff.   
4. All electronic files will be kept on an encrypted and password-protected computer with access limited to 
select evaluation staff. 
5. All evaluation staff interacting with clients will be required to sign an Employee Confidentiality 
Agreement (see Appendix XXIII for this form). 
6. Sites with previous MC experience and with MoHCDGEC endorsement for MC services will be used for 
this evaluation.  Relevant documentation will be obtained and maintained in the central evaluation files. 
7. All providers who will perform the ShangRing procedures will be trained by others experienced with the 
device.  Training certificates will be on file. 
 
Potential Benefits 
Regardless of the circumcision procedure performed, research studies have shown that circumcised men are at 
a reduced risk for acquiring urinary tract infections and sexually transmitted infections, including HIV. In 
addition, available data on ShangRing suggests that it is associated with shorter procedure times, similar pain 
scores, similar AE rates, and similar or higher client satisfaction scores than standard MC.41 
 
Additional potential individual benefits associated with participating in this evaluation include the following: 
• 
Enhanced counseling for HIV and other STIs 
• 
Condoms, health information, and referrals for HIV prevention services 
 
Social Harm Events 
Social harm events will be reported to the Tanzanian Bioethics Committees and all other ethical review boards 
including to the Bioethics Committee, and CDC ADS. Potential incidents may include protocol noncompliance, 
breach of confidentiality, loss of privacy, stigmatization, relationship difficulties, physical or verbal abuse, 
interference with gainful employment, and coercion. Social harms may be identified during interviews with the 
clients or by other evaluation staff. All social harm events (i.e., events potentially related to evaluation 
participation) should be brought to the attention of the site coordinator. Clients who report social harm events 
will be referred to speak with an evaluation staff person. The site coordinator or his/her designee will report 
the event on the device-related events form to the Principal Investigator within 24 hours of becoming aware 
of the event in the same way that severe AE are reported (above). Social harm events will then be reported to all 
ethical review boards.  The device-related events form for this evaluation is located in Appendix XIV. 
 
Protocol noncompliance may be identified by the evaluation staff or the investigators during the periodic and 
closeout monitoring visits as well as during in-house monitoring. The procedures for capturing, recording and 
reporting protocol noncompliance will be specified in the evaluation manual and data management plan. 
Non-emergency noncompliance from the protocol must be approved by the investigators. If these changes 
might affect the scientific soundness of the protocol or the rights, safety, or welfare of human subjects, IRB 
approval is also required prior to implementation. Deviations from the protocol by clients will not be considered 
protocol noncompliance (e.g., not following wound care instructions; missing a follow-up visit, etc.). Evaluation 
staff will provide continued counseling of and education for the clients who do not adhere to the prescribed 
evaluation procedures. 
 
An emergency departure from protocol that eliminates an apparent immediate hazard to a client and is deemed 
crucial for the safety and well-being of that client may be instituted for that client only by the site coordinator or 
his/her designee.  In those cases, the site investigator will notify the IRBs in writing as soon as possible, no later 

41 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
than five working days after the emergency occurred, and document on the Protocol Violation form reasons for 
non-compliance and ensuing events. 
 
Generally, non-emergency non-compliance is the result of simple human error by site staff.  In all such cases, the 
non-compliance event must be documented.  If protocol non-compliance events persist, refresher training in 
evaluation procedures will be undertaken. 
 
Approvals and Consultations 
This evaluation is being submitted for approval from the National Institute for Medical Research, and the 
Centers for Disease Control and Prevention Office of the Associate Director of Science (OADS). 
 
Data Security and Confidentiality 
Clients will be identified by name only on their client CRF, but not on any survey questionnaire, photograph, or 
any other documentation. All evaluation records will be kept in a locked file cabinet with access limited to 
evaluation staff only. Client identifiers, such as names and faces, will not be shown in or written on any 
photograph taken during this evaluation. Client identifiers will be entered on a master client log that links names 
and identification numbers; that log will be stored in the locked file cabinet with restricted access.  
 
Clients’ evaluation files at the site, including informed consent and CRF, will be kept in a locked file cabinet with 
access limited to evaluation staff. Clients’ information will be filed by client ID number, with names written in a 
discrete location (e.g., on the inside cover of the client’s file folder) in order to reduce the chance of an 
inadvertent breach of confidentiality. Clients will not be reported by name in any report or publication resulting 
from data collected in this evaluation.  
 
All computerized database records will identify clients by identification numbers only.  Electronic data files will 
be maintained on password-protected computers accessible only by site coordinators and investigators. 
 
 
Potential Risks 
While medical male circumcision is generally a safe procedure, clients are at risk for a number of adverse events 
including pain, injury to the penis, risk of excessive bleeding, and infection, among others. Some of these 
adverse events have resulted in death in the past. As noted above, the rate of adverse events in circumcision 
programs, and through previous ShangRing trials, is very low. All men will be counseled on the risk of adverse 
events when enrolling in the evaluation, and will have the option to withdraw from the procedure until the 
device is placed.  
 
HIV Notification Policy 
All men enrolling in this evaluation must consent and agree to receive an HIV test. Men not wishing to receive an 
HIV test will be offered conventional surgical circumcision. Men who do receive an HIV test, and test positive, 
will be notified of their status per Tanzanian Voluntary Medical Male Circumcision Program guidelines. 
Additionally, men who test positive will be actively linked to HIV care and treatment, also per program 
guidelines. 
  
Sponsor Monitoring 
As the evaluation sponsor, the Centers for Disease Control and Prevention (CDC) may conduct monitoring or 
auditing of evaluation activities to ensure the scientific integrity of the evaluation and to ensure the rights and 
protection of evaluation clients.  Monitoring and auditing activities may be conducted by: 

42 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
• 
CDC staff (“internal”) 
• 
authorized representatives of CDC (e.g. a contracted party considered to be “external”) 
• 
both internal and external parties 
 
Monitoring or auditing may be performed by means of on-site visits to the MMC clinic or through other 
communications such as telephone calls or written correspondence.  The visits will be scheduled at mutually 
agreeable times, and the frequency of visits will be at the discretion of CDC.  During the visit, any evaluation-
related materials may be reviewed and the Investigator along with evaluation staff should be available for 
discussion of findings. The evaluation may also be subject to inspection by regulatory authorities (national or 
foreign) as well as the IECs/IRBs to review compliance and regulatory requirements. 
 
Conflicts of Interest 
The project investigators and co-investigators report no conflicts of interest.  
Reimbursements 
Reimbursement for evaluation participation will be offered to compensate clients for the substantial 
commitment of time and effort required to complete surveys and interviews and to return to the clinic for 
follow-up visits (Day 7, Day 49, and subsequent follow-up healing visits). It is anticipated that clients will receive 
transportation and time reimbursement only for their follow-up clinic visits (not for the initial placement visit), 
transportation and time reimbursement for the qualitative interview, and a HIV prevention kit for participation 
in the evaluation. Based on an analysis of transportation costs in Shinyanga, and considering the length of times 
the clients are in the clinic for the VMMC procedure, the value of time and transportation reimbursement is 
estimated to be between 7-10 USD per visit (16,000-22,000 TZS). If the cost of transportation within Shinyanga, 
Tanzania increases, the reimbursement may increase to keep pace with the economic environment. However, 
the reimbursement value will not exceed 12 USD (27,000 TZS) per visit. Reimbursements will be paid to the 
client upon the conclusion of the visit. For clients under 18, the time and transportation reimbursement will be 
paid to the client’s guardian accompanying them to the clinic upon the conclusion of the visit. 
 
Some benefits offered for participating in this evaluation (e.g., the provision of condoms and educational 
materials) may be perceived as additional incentives. During the qualitative interviews conducted with all 
providers trained to use ShangRing and a random sample of clients, a snack valued at approximately 3 USD 
(6,500 Tanzanian Shillings) will be offered. 
 
Projected Timeline 
The estimated time needed to complete the evaluation, including ethical approvals and report dissemination, is 
12 months.   
 
During the preparatory phase, # mid-level providers will participate in a (length in days TBD) training course in 
good clinical practice.  All providers who successfully complete this course will receive formal training on 
ShangRing device application and removal. The training will be conducted by the trained doctors from countries 
with previous ShangRing experience (Kenya, Zambia, Uganda).  
 
The detailed timelines for both the preparatory and implementation phases of the evaluation are provided in 
Tables 2 and 3.  Additional details about interactions with clients, including the application and removal of the 
device and client follow-up, are provided in Table 4. 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Dissemination of Findings  
Throughout the course of the evaluation pilot key stakeholders in Tanzania will receive a monthly update on the 
status of the pilot. In Tanzania, key stakeholders include the following: MoHCDGEC, PORALG, RCHMT VMMC 
TWG, Tanzania PEPFAR TWGs, IntraHealth, and Jhpiego. A monthly update will be provided by IntraHealth. The 
purpose of these updates is to ensure that all parties that will ultimately assume responsibility for transitioning 
the pilot to active surveillance under the Ministry are involved. As enrollment approaches completion, 
discussions will include the transition from evaluation pilot to active surveillance oversight. 
 
Upon completion of primary data analysis and prior to finalizing a final report, findings will be shared with 
leadership at MOHCDGEC and the national VMMC TWG to ensure the involvement of key stakeholders in the 
report writing process. Feedback gathered will be used to complete the final evaluation report, which is 
intended to inform and shape MoHCDGEC policies regarding the use of devices for adult male circumcision in 
Tanzania. Other means of dissemination will include presentations at international meetings and workshops, 
and submission of manuscripts to peer reviewed journals. The primary manuscript of the main evaluation results 
(primary evaluation objectives) will be a project shared by MoHCDGEC, PORALG, CDC, Jhpiego, IHI, and other 
implementing partners. The final report will be produced in alignment with PEPFAR requirements, and will also 
be posted in English on a publically accessible website within 90 days of clearance, per PEPFAR regulations.  Any 
presentations/manuscripts on the main evaluation results will assign proper credit and acknowledgment to the 
contributions of all partners.  Presentations/manuscripts on secondary analyses of evaluation data may be 
undertaken by each partner who has the capability to utilize the data properly and professionally. Requests for 
data will be made to MoHCDGEC in writing and all collaborating partners will review all presentations or 
manuscripts for accuracy. No data collected in this evaluation may be published without prior written 
agreement of relevant staff.   

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. Version 4. October 22, 2018. 
Table 3: ShangRing Implementation Pilot Timeline – Preparatory Phase 
 
 
 
Activities 
Quarter 4 (July – September 2018) 
Quarter 1 (October – December 2018) 
Quarter 2 (January – March 2019) 
 
July 
August 
September 
October 
November 
December 
January 
February 
March 
Preparatory Phase 
 
 
 
 
 
 
 
 
 
 
Protocol Development 
X 
 
 
 
 
 
 
 
 
Human Subjects review and 
clearance 
X 
X 
 
 
 
 
 
 
 
 
Hire manager and interviewers 
 
X 
X 
 
 
 
 
 
 
Interviewer training 
 
X 
X 
 
 
 
 
 
 
Data collection: qualitative 
interviews with clinicians 
 
 
X 
X 
 
 
 
 
 
Training of clinicians in 
Tanzania  
 
 
X 
X 
 
 
 
 
 
Data collection: qualitative 
interviews with clinicians and 
surveys with ShangRing 
circumcised males 
 
 
 
X 
X 
 
 
 
 
Client follow-up and 
documentation of outcomes 
 
 
 
X 
X 
X 
 
 
 
 
Implementation Activities 
 
 
 
 
 
 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. Version 4. October 22, 2018. 
Table 4: ShangRing Implementation Pilot Evaluation Timeline – Implementation Phase  
Activities 
Quarter 4 (July – September 2018) 
Quarter 1 (October – December 2018) 
Quarter 2 (January – March 2019) 
Quarter 3 (April – June 2019) 
 
July 
August 
September 
October 
November 
December 
January 
February 
March 
April 
May 
June 
Implementation Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparatory Activities 
 
 
 
 
 
 
 
 
 
 
 
 
Mid-level provider training in 
Tanzania 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
Counseling and messaging 
training 
 
 
 
X 
 
 
 
 
 
 
 
 
Data collection: qualitative 
interviews with doctors and 
mid-level providers 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Site Preparation  
 
 
X 
X 
 
 
 
 
 
 
 
 
Client follow-up and 
documentation of outcomes 
from practice 
 
 
 
X 
X 
 
 
 
 
 
 
 
Recruitment of clients for 
evaluation and device 
placement 
 
 
 
X 
X 
 
 
 
 
 
 
 
Client follow-up and 
documentation of outcomes 
 
 
 
X 
X 
X 
 
 
 
 
 
 
Data collection: all men at 4 
points (immediately after 
circumcision, at device 
removal, 49 days post 
circumcision) 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
Data collection: 10% of men 
28 days after device 
placement 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
Data cleaning and merging 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 
Write preliminary report 
 
 
 
 
 
 
 
X 
X 
 
 
 
Discuss report and findings 
with key stakeholders 
 
 
 
 
 
 
 
 
X 
X 
X 
 
 
Present final report to TWG 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. Version 4. October 22, 2018. 
Appendices 
 

47 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. Version 4. October 22, 2018. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Regardless of pathway, preparation for introduction and implementation of a new technology should follow a participatory planning process that includes all key 
stakeholders. Beginning with the end in mind: planning pilot projects and other programmatic research for successful scaling up (WHO 2011) provides a framework on 
how to design pilot projects with scaling up in mind to increase the likelihood that they can be implemented on a large scale if proven successful. 
Appendix I - Pathways for Introduction of VMMC Devices 
 
This schematic shows three potential alternative pathways for introducing a new prequalified device into voluntary medical male circumcision programs, based on extent of previous experience with 
device introduction. All are consistent with the WHO Framework for Clinical Evaluation of Devices for Male Circumcision, 2012, designed to ensure appropriate safety monitoring in introduction.* 
 
                         Historic Pathway                                                                            Moderate Pathway                                                                       Rapid Pathway 
                          18 months; pathway historically used                                        7 months; may be appropriate for                                            6 months; appropriate for countries with experience 
                          for VMMC device introduction                                                    countries with limited VMMC device experience                   introducing and monitoring device of same class†  
 
Provider 
Training
•Can take place in or out of country
•2-4 Weeks
Impleme-
ntation 
Pilot
•1 to 2 phases with typically 500 (50 - 1200) clients
•6 months
PAUSE
•Review data and troubleshoot identified issues
•1 month
Provider 
Training
•Expand training to additional providers
•2-4 weeks
Active 
Surveilla-
nce
•Provide device services while monitoring outcomes
•1000 clients
•3 - 4 months
PAUSE
•Stop services for final data review.
Final Data 
Review
•Review data, make decision on implementation
•1 month
Scale Up
•Scale up device availability into routine VMMC 
services
•Train additional providers on rolling basis with scale 
up
•Conduct ongoing postmarketing surveillance
Provider 
Training
•Can take place in or out of country
•Train providers who will be involved in implementation 
pilot and active surveillance
•2-4 Weeks
Pilot & Active 
Surveillance
•Provide ongoing device services while monitoring 
outcomes
•1050 clients: 50-client implementation pilot, then 
transition to active surveillance for next 1000
•3 - 4 months
Final Data 
Review
•Review data, make decision on implementation
•Continue device services during review 
•1 month
Scale Up
•Scale up device availability into routine VMMC services
•Train additional providers on rolling basis with scale up
•Conduct ongoing postmarketing surveillance
Provider 
Training
•Can take place in or out of country
•2-4 Weeks
Impleme-
ntation 
Pilot
•1 phase with at least 50 clients
•Perform measurement and evaluation studies on 
implementation
•1 month
PAUSE
•Review data and troubleshoot identified issues
•1 month
Provider 
Training
•Expand training to additional providers
•2-4 weeks
Active 
Surveilla-
nce
•Provide device services while monitoring outcomes
•1000 clients
•3 - 4 months
Final Data 
Review
•Review data, make decision on implementation
•Continue device services during review
•1 month
Scale Up
•Scale up device availability into routine VMMC services
•Train additional providers on rolling basis with scale up
•Conduct ongoing postmarketing surveillance
* These pathways do not apply to bridging studies 
† Current classes are collar clamp and elastic collar 
compression. 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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Appendix II – Consent form for Male Circumcision by ShangRing 
 

49 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Consent Form for Male Circumcision by ShangRing 
 
 
What you should know about this program: 
• This consent form explains the requirements for circumcision by the ShangRing device.  
• Please read it carefully and take as much time as you need. Someone is available to read 
the material to you, if you are not able to read by yourself. 
• A device called ShangRing is now available as an alternative method of circumcising 
males 13 years and above who are HIV-negative. The ShangRing device has been used to 
perform large numbers of circumcisions in China and other countries and has been 
researched in Kenya, Uganda, and Zambia. You are being offered the opportunity to 
choose between being circumcised by the ShangRing device or through the conventional 
surgical method. 
 
Purpose of the implementation pilot 
You are being offered the opportunity to take part in a program being done by the Ministry of 
Health, Community Development, Gender, Elderly and Children (MoHCDGEC) and its 
partners to offer 575 circumcisions using the ShangRing device in selected health facilities. 
Although ShangRing has been successfully used in other countries, the purpose of this program 
is to learn more about using this method of circumcision for large numbers of males in Tanzania 
to decide whether to begin offering it all over the country. 
ShangRing circumcision differs from surgical circumcision because it is done without stitching, 
which makes the procedure much faster, but the device must stay on the penis for 7 days before 
removal. However, most men and boys who have been circumcised using the device are not 
bothered while wearing the device. 
 
Why you are being asked to participate 
You are being asked if you want to take part in this implementation pilot evaluation because you 
have come to the clinic for circumcision, you are 13 years or more, and have indicated that you are 
willing to take an HIV-test .If you choose to take part in this activity, you will be assessed to 
determine if you are eligible for circumcision using the ShangRing device.  This will include HIV 
testing. 
 
Procedures 
If you are eligible and agree to ShangRing circumcision, the health care team will give you 
anesthetic by [injection/topical cream] in your penis to prevent pain during the procedure.  The 
ShangRing will be placed on your foreskin, compressing it to prevent bleeding.  The rest of your 
penis is protected and will not be compressed.  Then your foreskin will be removed and the 
ShangRing will be left in place to protect the wound while it heals. 
 
You will be asked to return to the clinic on the seventh day to have the device removed. It is 
important not to try to remove the device yourself, as this can cause bleeding and infection, and 
to contact the clinic immediate if the device comes off or moves. 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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You will also be asked to return 6 weeks (42 days) after the device is removed in order to review 
healing. If you are not healed 6 weeks after the device is removed, you will be asked to return to 
the clinic once a week until you are completely healed. 
 
You will be asked to answer some questions by telephone three days after the device has been 
removed. During this call you will be asked questions to assess how well you are recovering from 
the procedure. You will also be asked if you are willing to participate in an interview three weeks 
(21 days) after the device is removed. If you agree and are selected to participate in an in-person 
interview, you will be reimbursed for your time and transportation to the interview site and 
provided a snack during the interview.  
To receive ShangRing circumcision, you must also provide your contact information and 
alternative information for contacting you, including a physical address, and you must consent to 
being contacted by text, phone and visits if needed, to make sure you get the ShangRing 
removed in case you are unable to return to the clinic. Alternative contact information may 
include workplace, school or cell number belonging to a friend or relative through whom you 
can be reached.   If you do not return to the clinic to have it removed in time, we will need to use 
your contact information to reach or visit you.  If we send you a text message, it will include your 
name and specify the name and phone number of our clinic. But the purpose of appointment 
visit will not be included in the text message reminder. 
 
You may come to the clinic at any time if you have concerns or a problem related to 
circumcision. You will be given instructions for how to care for your wound.  For any care 
needed after normal clinic hours, or any concerns at any time, please call the 24-hour clinic 
phone number provided:  
 
Primary #+_________________________(Site specific or assigned to the clinician on call) 
 
Secondary #_________________________(Site specific) 
 
 
In the unlikely event of a complication, the medical team would also like to request your 
permission to take photographs of your penis.  This will help us to learn about possible 
complications so that we can better prevent them. It is up to you to decide whether or not to 
allow photographs, and you can still participate and receive ShangRing surveillance activity 
whether or not you agree to have photographs taken. If you agree, your permission will still be 
asked before any photograph is taken.  There are no risks to you related to the pictures taken 
because your name will not be attached to the photograph but only your program identification 
number. Your face or other body parts will not be photographed. Any photographs of your 
penis that may be taken, as well as all information collected from you in the surveillance, will be 
kept in your file in a locked cabinet at the clinic to be accessed only by clinic staff responsible for 
your care. 
 
Risks/discomforts 
There are some risks and discomforts with ShangRing circumcision.  
• You may have some pain during the week you are wearing the ShangRing device because of 
the pressure on the penis. You may also have some pain when you have erections before the 
ring is removed.  
• As with any circumcision, there are risks of infection, delayed healing, and other 
complications.  Rarely, these can be serious, requiring more surgery or hospitalization to 
treat.  Very rarely, there can be death or deformity due to the procedure.  In order to 

51 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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minimize these risks, your providers follow careful quality standards and you will be educated 
about correct wound care. 
 
Benefits 
The benefits of being circumcised include lowered risk of HIV infection for men who are 
currently HIV-negative; lowered risk of some sexually transmitted infections, and improved 
hygiene. The benefit of circumcision from the ShangRing device compared to surgical 
circumcision may include less time and less pain from the procedure, the ability to return to work 
or your regular activities sooner, and a better appearance of the penis after the circumcision has 
healed because no stitches are used. By participating in this surveillance activity, you will provide 
additional information about ShangRing that the MOH will use to guide further and more 
widespread use of this device for circumcision. You will also be compensated for your time, 
including reimbursement for time and travel to all ShangRing related follow-up visits to the 
clinics, and for the qualitative interview, if applicable. The value of compensation will be 
determined based upon the cost of transportation, and is expected to be between 16,000-22,000 
Tanzanian Shillings. You will be reimbursed at the clinic, upon the conclusion of your visit, for 
each visit after the initial placement visit (device removal, healing assessment, and interview, if 
applicable).  
 
Alternatives:  You can choose not to be circumcised, or you can choose to be circumcised 
using the surgical method. 
 
Do you have any questions? 
 
What does your signature on this consent form mean? 
Your signature on this form means: 
• You have been informed about this program’s purpose, procedures, and possible benefits 
and risks of the procedure. 
• You have been given the chance to ask questions before you sign. 
• You have voluntarily agreed to be in this program and to return for device removal. 
• You agree to be contacted by phone, through friends, at your workplace, home or any 
other place for device removal or any other necessary follow ups. 
• You have been informed that you will not be charged for the treatment received. 
• You have been informed that you will not be given monetary compensation for 
participating, except for reimbursement for time and travel. 
 
 
 
 
 
I understand and accept the benefits and risk for taking part in this program as stated above.  
I have decided on my own free will to take part (or allow my child to take part) in this program.  
 
Name of client: 
 
 
Name of guardian if applicable:  _____________________________ 
 
Signature of client, or guardian if client is a minor: 
 
 
 
 
 
 
 
Day 
 
Month 
Year 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
If Volunteer Cannot Read the Form Himself, A Witness Must Sign Here: 
I was present throughout the entire informed consent process with the volunteer.  All 
questions from the volunteer were answered and the volunteer freely decided whether to 
accept the benefits and risk for taking part in this program. 
 
 
 
 
 
 
 
Signature of Witness  
 
 
 
 
 
 
 
Date  
 
 
 
 
  
Printed Name of Witness 
 
 
I certify that I have explained to the client (and volunteer if applicable) the nature and purpose, the 
potential benefits, and possible risks associated with participating in this program. 
 
 
 
 
 
Signature of Clinic Staff Person Who Obtained Consent 
 
 
 
Date  
 
 
  
Printed Name of Clinic Staff Person Who Obtained Consent 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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Appendix III – Additional Informed Consent Form for Photography 
 

54 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Additional Informed Consent Form for Photography 
Volunteer Agreement for Photography 
This Additional Informed Consent Form for Photography during the program has been read and explained 
to me.  I have had a chance to ask questions about the program. I have agreed to take part as a volunteer. I 
have freely decided to allow clinic staff to take pictures of my penis during this program. I also understand 
that if I agree, the clinic staff will still ask my permission before pictures are taken at any contact. 
 
 YES, I also agree to have clinic staff take photographs of my penis during this program. 
 NO, I do not agree to have program staff take photographs of my penis during this 
program. 
 
 
 
 
 
Signature or Thumb Print of Volunteer   
 
 
 
 
Date  
 
 
  
Printed Name of Volunteer 
 
If Volunteer Cannot Read the Form Himself, A Witness Must Sign Here: 
I was present throughout the entire informed consent process with the volunteer.  All questions from the 
volunteer were answered and the volunteer freely decided whether to permit photography of his penis 
during this review.  If he agrees, the volunteer also understands that he will be asked for his permission 
before photographs are taken at each visit/before each occurrence. 
 
 
 
 
 
Signature of Witness  
 
 
 
 
 
 
 
Date  
 
 
  
Printed Name of Witness 
 
 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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Appendix IV – Additional Informed Consent Form for Qualitative Interview 
 
 
 

56 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Additional Informed Consent Form for Qualitative Interview 
 
Purpose of the Qualitative Interview 
You are being asked to participate in an interview meant to evaluate your experience with the 
ShangRing device. The purpose of this interview is to gauge the attitudes of men who have 
received a ShangRing device-based circumcision, in order to evaluate its acceptability to 
clients. Information derived from these interviews will be used to inform the use of the 
ShangRing device in the Tanzania voluntary medical male circumcision program. 
 
Why you are being asked to participate 
You are being asked if you want to take part in this qualitative interview because you received a 
ShangRing circumcision as part of the program being done by the Ministry of Health, 
Community Development, Gender, Elderly and Children (MoHCDGEC) and its partners to 
offer 575 circumcisions using the ShangRing device in selected health facilities.  
 
Procedures 
If you are one of the 50 clients selected to take part in this activity, you will be asked a series 
of questions by an interviewer that are designed to assess your feelings and attitudes about 
your ShangRing circumcision. All of your answers are confidential, and you will not be 
quoted by name in any report that is produced as a result of this program. The interview will 
last for approximately one hour (60 minutes). You will be reimbursed for your time and for 
transportation costs to and from the interview site, and provided a snack during the interview. 
You may choose not to participate in this interview, not to answer certain questions, or to end 
the interview whenever you wish.  
 
Do you have any questions? 
 
Volunteer Agreement for Qualitative Interview 
This Additional Informed Consent Form for Qualitative Interview has been read and explained to me.  I 
have had a chance to ask questions about the interview. I have agreed to take part as a volunteer. I have 
freely decided to participate in this interview.  
 
 YES, I agree to participate in a qualitative interview. 
 NO, I do not agree to participate in a qualitative interview. 
 
 
 
 
 
Signature or Thumb Print of Volunteer   
 
 
 
 
Date  
 
 
  
Printed Name of Volunteer 
 
If Volunteer Cannot Read the Form Himself, A Witness Must Sign Here: 
I was present throughout the entire informed consent process with the volunteer.  All questions from the 
volunteer were answered and the volunteer freely decided whether to participate in this interview.   
 
 
 
 
 
Signature of Witness  
 
 
 
 
 
 
 
Date  
 
 
 Printed Name of Witness 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
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Appendix V - Assent Form for Male Circumcision by ShangRing (For Ages 13-17) 
 
 

58 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Assent Form for Male Circumcision by ShangRing (For Ages 13-17) 
 
 
What you should know about this program: 
• This form explains what will happen if you get circumcised using the ShangRing device.  
• Please read it carefully and take as much time as you need. Someone can read the material 
to you, if you are not able to read by yourself. 
• A device called ShangRing is now available as a new method of circumcising males who 
are 13 years old or older and who do not have HIV. The ShangRing device has been in 
China and other countries and has been studied in Kenya, Uganda, and Zambia You 
have the chance to choose whether to be circumcised by the ShangRing device or 
through the normal surgical method. 
 
Purpose of the implementation pilot 
You have the chance to take part in a program being done by the Ministry of Health, 
Community Development, Gender, Elderly and Children (/MoHCDGEC) and its partners to 
offer 575 circumcisions using the ShangRing device.  
The purpose of this program is to learn more about using the ShangRing in Tanzania to decide if 
it should be offered all over the country. 
ShangRing circumcision is different from surgical circumcision because the client does not need 
stitches after the procedure. It is faster, but the device must stay on the penis for 7 days before it 
is taken off. But, most men and boys who have been circumcised using the device are not 
bothered while wearing the device. 
 
Why you are being asked to participate 
You are being asked if you want to take part in this program because you have come to the clinic for 
circumcision, you are 13 years old or older more, and have agreed to take an HIV-test.  
 
If you choose to take part in this activity, you will be checked to see if you are eligible for 
circumcision using the ShangRing device.  This will include taking an HIV test. 
 
Procedures 
If you are eligible and agree to ShangRing circumcision, the health care team will apply a cream 
to your penis to prevent pain during the procedure. 
 
The ShangRing will be placed on your foreskin, squeezing it tightly to prevent bleeding.  The rest 
of your penis is protected and will not be squeezed.  Then your foreskin will be removed and the 
ShangRing will be left in place to protect the wound while it heals.  
 
Do not to try to remove the device yourself, because it can cause bleeding and infection. Contact 
the clinic immediate if the device comes off or moves. 
 
You will be asked to come back to the clinic on the seventh day to have the ring taken off. You 
will also be asked to return 6 weeks (42 days) after the device is removed in order to look at 
healing. If you are not healed 6 weeks after the device is removed, you will be asked to return to 
the clinic once a week, until you are completely healed.  
 

59 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
You will be asked to answer some questions by telephone three days after the ShangRing is taken 
off. You will be asked questions about how well you are recovering from your circumcision.    
 
To receive ShangRing circumcision, your parents must also provide: 
• A telephone number and backup number 
• Your physical address 
• Your parents must agree to being contacted by text, phone and in-person visits. This 
information is needed to make sure you get the ShangRing removed in case you are 
unable to return to the clinic 
• Your parents must also agree to come back to the clinic with you when you have the 
device taken off, and when you come back for your healing visit 
 
The backup number may be a number at your workplace or school, or a cell number belonging 
to a friend or relative where we can reach them.   If you do not return to the clinic to have the 
ShangRing removed in time, we will need to use this contact information to reach or visit you.  If 
we send your parents a text message, it will include your name and the name and phone number 
of our clinic. But the reason of the visit will not be included. 
 
You may come to the clinic at any time if you have concerns or a problem related to 
circumcision. You will be given instructions for how to care for your wound.  For any care you 
need when the clinic is closed, or any concerns at any time, please call the 24-hour clinic phone 
number provided:  
 
Primary #+_________________________(Site specific or assigned to the clinician on call) 
 
Secondary #_________________________(Site specific) 
 
 
It is unlikely, but if you have a problem because of the circumcision, the medical team will ask 
for your permission to take photographs of your penis.  This will help us to learn about possible 
problems so that we can better stop them from happening. It is your choice whether or not to 
allow photographs. You can still participate even if you do not want to have photographs taken.  
 
If you agree, your permission will still be asked before any photograph is taken.  There are no 
risks to you related to the pictures taken because your name will not be attached to the 
photograph. Your face or other body parts will not be photographed. Any photographs of your 
penis that may be taken, as well as all information collected from you, will be kept in your file in 
a locked cabinet at the clinic, and only clinic staff taking care of you will be able to open it. 
 
You and your family will not be charged for your circumcision as part of this program, this also 
includes treatment if you need to return to the clinic for any reason after your surgery. You and 
your family will also not be paid to participate in this program, but your family will be given 
money to cover the cost of travel to and from the clinic.  
 
Are there risks or discomforts? 
There are some risks and discomforts with ShangRing circumcision.  
• You may have some pain during the week you are wearing the ShangRing device because of 
the pressure on the penis. You may also have some pain when you have erections before the 
ring is removed.  

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
• As with any circumcision, there are risks of infection, delayed healing, and other 
complications.  Rarely, these can be serious, and you may need more surgery or 
hospitalization to treat.  Very rarely, there can be death or permanent damage to the penis 
due to the procedure.  In order to reduce these risks, your health care team follows careful 
quality standards and you will be taught correct wound care. 
 
What are the benefits? 
The benefits of being circumcised include: 
• Less risk of HIV infection for males who are HIV-negative right now 
• Less risk of some sexually transmitted infections 
• Improved hygiene.  
 
The benefits of circumcision from the ShangRing device compared to surgical circumcision may 
include: 
• Less time and less pain from the procedure 
• The ability to return to work or your regular activities sooner 
• And the penis may look better after it has healed because no stitches are used.  
 
By participating in this program, you will provide additional information about ShangRing that 
the MoHCDGEC will use to guide further and more widespread use of this device for 
circumcision.Your family will also be paid back for its time and travel costs, including for time 
and travel to all ShangRing related follow-up visits to the clinics (16,000-22,000 Tanzanian 
Shillings per visit, depending upon cost of travel). 
 
What are my other choices? 
 
You can choose not to be circumcised, or you can choose to be circumcised using the surgical 
method. 
 
Do you have any question? 
 
What does your guardian’s signature on this form mean? 
Your signature on this form means: 
• You know about this program’s purpose, procedures, and possible benefits and risks of 
the procedure. 
• You have been given the chance to ask questions before you sign. 
• You have voluntarily agreed to be in this program and to return for device removal. 
• You agree to be contacted by phone, through friends, at your workplace, home or any 
other place for device removal or any other necessary follow ups. 
• You have been informed that you will not be charged for the treatment received. 
• You have been informed that you will not be paid for participating, except for 
reimbursement for transportation costs to the clinic to have the device removed. 
 
 
 
 
 
Parent/Guardian Assent: 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
 
 
Client Assent: 
 
Your parent/guardian has given parental consent because you are below the age of consent 
according to the law. However, the decision to be circumcised or not is yours and you have the final 
decision.   If you sign below, it means that you agree to be circumcised using the ShangRing method. 
 
Client Assent signature:   ______________________________ 
 
 
If Parent/Guardian Cannot Read the Form Himself, A Witness Must Sign Here: 
I was present throughout the entire informed consent process with the volunteer and their 
guardian.  All questions from the volunteer were answered and the volunteer and 
parent/guardian freely decided whether to accept the benefits and the risk of participating in 
this program. 
 
 
 
 
 
 
Signature of Witness  
 
 
 
 
 
 
 
Date  
 
 
 
 
  
Printed Name of Witness 
 
 
I certify that I have explained to the volunteer and their parent/guardian the nature and purpose, the 
potential benefits, and possible risks associated with participation in this program. 
 
 
 
 
 
Signature of Clinic Staff Person Who Obtained Consent 
 
 
 
Date  
 
 
  
Printed Name of Clinic Staff Person Who Obtained Consent 
 
 
 
I understand and accept the benefits and risk for taking part in this program as stated above.  
I have decided on my own free will to allow my child to take part in this program.  
 
Name of client: 
 
 
Name of guardian if applicable:  _____________________________ 
 
Signature of client, or guardian if client is a minor: 
 
 
 
 
 
 
 
Day 
 
Month 
Year 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Appendix VI – Informed Consent Form for Photography (For Ages 13-17) 
 
 

63 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Additional Informed Consent Form for Photography (For Ages 13-17) 
Parent/Guardian Agreement for Photography 
This Additional Informed Consent Form for Photography during the program has been read and explained 
to me.  I have had a chance to ask questions about the program. I have agreed that my child may participate 
as a volunteer. I have freely decided to allow clinic staff to take pictures of my child’s penis during this 
program. I also understand that if I agree, the clinic staff will still ask both my child’s and my permission 
before pictures are taken at any contact. 
 
 YES, I also agree to have clinic staff take photographs of my child’s penis during this 
program. 
 NO, I do not agree to have program staff take photographs of my child’s penis during 
this program. 
 
 
 
 
 
Signature or Thumb Print of Volunteer   
 
 
 
 
Date  
 
 
  
Printed Name of Volunteer 
 
 
Client Assent: 
 
Your parent/guardian has given parental consent because you are below the age of consent according to the 
law. However, the decision to be agree to be photographed is yours and you have the final decision.   If you 
sign below, it means that you agree to allow clinic staff to take pictures of your penis as part of this 
program. 
 
Client Assent signature:   ______________________________ 
 
If Volunteer Cannot Read the Form Himself, A Witness Must Sign Here: 
I was present throughout the entire informed consent process with the volunteer and their parent/guardian.  
All questions from the volunteer and their parent/guardian were answered and the volunteer and their 
parent/guardian freely decided whether to permit photography of his penis during this review.  If he agrees, 
the volunteer and their parent/guardian also understands that they will be asked for permission before 
photographs are taken at each visit/before each occurrence. 
 
 
 
 
 
Signature of Witness  
 
 
 
 
 
 
 
Date  
 
 
  
Printed Name of Witness 
 
 

64 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Appendix VII – Case Report Form (CRF) – Screening  
 
 
 

65 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
 
 
 
 
CASE REPORT FORM – SCREENING 
 
Evaluation of the safety and acceptability of the ShangRing device for male circumcision in 
Tanzania 
 
 
Site Code:   
 
 
Client ID # (CID):  
 
 
 
 
 
 
 
*A copy of the full SOP Manual is available upon request. 
 

66 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
INSTRUCTIONS FOR THE PROPER COMPLETION OF THE CRF  
Please follow the instructions below:  
 
1. Use a ball-pen, DO NOT use a pencil, a marker or a fountain pen.  
2. Make sure to place the separator provided under the last copy of each page so that data 
recorded on one page does not copy to the next.  
3. Subject initials will be comprised of the first letter of the first name followed by the first 
letter of the surname.  
4. Fill in the form in a clear, concise and readable way. Use common medical terminology.  
5. Correct wrong data by crossing out the information with a single line and writing the 
correct data next to it.  The evaluation coordinator, or the site coordinator in the 
evaluation coordinator’s absence, will initial and date the correction.  
a. Example: 07/03/1969 corrected to 09/03/1969 (with initials and date of the 
correction) 
6. Complete all the available boxes, DO NOT leave empty fields.  
a. For evaluations not performed record ND (not done).  
b. For data not relevant to the subject or stage of evaluation record NA (not 
applicable).  
c. If you do not know the data, please use the initials UNK (unknown).  
d. Use leading zeroes if necessary (e.g.: 15 mg = 0 1 5 mg).  
e. Make sure to complete every header on each page.  
7. Please make sure to circle the correct option whenever it is requested.  
8. Please DO NOT add wording to CRF pages unless required. For any additional 
comments please use the Comments Sheet at the end of the CRF modules.  
9. Dates (e.g., date of birth, date of visit) will be recorded in the DD/MM/YYYY format. 
a. Example: 19 June 2017 will be recorded as 19/06/2017 
10. CID is the Client Identification Number. It comprises the initials of the site followed by 
the four digit enrollment date and the three digit subject consecutive number. Example: 
Subject number 1 in Good Hope Health Center enrolled on July 21 will be GH2107001. 
11. Time will be recorded in 24:00 format.  
a. Example: 6:15 pm will be recorded as 18:15  
 

67 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Client’s CID: 
ELIGIBILITY CONFIRMATION 
 
Inclusion Criteria 
 
 
 
 
 
 
(check appropriate box) 
Male 13 years or older 
Yes 
No 
Wants to be circumcised 
Yes 
No 
Is uncircumcised 
Yes 
No 
HIV sero-negative 
Yes 
No 
Able to communicate in English or Swahili 
Yes 
No 
Lives within 30 km of the facility 
Yes 
No 
Agrees to be circumcised using the ShangRing device 
Yes 
No 
Capable and willing to provide written informed consent (18 years and older), 
or written informed consent from parent (13-17 years) 
Yes 
No 
If 13-17 years old, parent/guardian agrees to be present during circumcision 
(skip if client is older than 17) 
Yes 
No 
Penis fits into one of the 18 ShangRing ring sizes 
Yes 
No 
Able to understand the evaluation procedures and requirements 
Yes 
No 
Agrees to abstain from sexual intercourse and masturbation, for six (6) weeks 
post removal (i.e., seven (7) weeks total) 
Yes 
No 
Willing to provide valid contact information (i.e., telephone number, address of 
residence, place of employment and other locator information) 
Yes 
No 
Has an activated cell/mobile phone or access to a cell/mobile phone 
Yes 
No 
 
 
 
Agrees to complete brief evaluation surveys to assess satisfaction: post-
placement and post-removal 
Yes 
No 
Any "NO" answer disqualifies the subject from participating in the evaluation 
 
Exclusion Criteria 
 
 
 
 
 
 
(check appropriate box) 
Male below 13 years  
Yes 
No 
Correct fitting ShangRing size is not available 
Yes 
No 
Has the following diseases: hypospadias, hydrocele, scrotal hernia, balanitis, 
epispadias  
Yes 
No 
Known bleeding/coagulation abnormality  
Yes 
No 
Is cognitively impaired  
Yes 
No 
Has a serious chronic illness, which is not well-controlled (subject not feeling 
well or has significant medical complaints)  
Yes 
No 
Has an active genital infection, current urethral discharge, or other STI 
symptom 
Yes 
No 
Has another condition, which in the opinion of the supervising circumcision 
coordinator (a medical doctor) prevents the subject from undergoing 
circumcision with the ShangRing device 
Yes 
No 
Any "YES" answer disqualifies the subject from participating in the evaluation 
 
 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Client’s CID: 
INFORMED CONSENT VERIFICATION 
 
Has the client been informed according to the protocol? 
Yes 
No 
Has the consent been obtained before any evaluation related procedures? 
Yes 
No 
Has the client signed the photography consent form? (Declining photography 
does not exclude the client from participating) 
Yes 
No 
Has the client provided a phone number and agreed to be contacted by 
evaluation staff 
Yes 
No 
Has the client signed the consent form? 
Yes 
No 
Consent Date: 
 
 
Has the client been provided with a photocopy of the signed consent form? 
Yes 
No 
Does the client agree to participate in the in-person qualitative interview three 
weeks post-removal? (If yes have client complete in-person interview consent 
during post-MC counseling)  
Yes 
No 
Does the client agree to return for a healing assessment 6 weeks post-removal, 
and subsequent weekly healing visits if not healed at 6 week post-removal 
visits? 
Yes  
No     
 
Date of Birth (day/month/year): 
 
Age in Years: 
 
Include a copy of the signed consent with this form in client evaluation file 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in 
Shinyanga, Tanzania. Version 4. October 22, 2018. 
Client’s CID: 
CLIENT CONTACT INFORMATION 
 
First Name:___________________________    Surname:_____________________________ 
 
Contact number(s)     Home:_____________________  Mobile:______________________                 
 
Work: _______________________________________ 
 
Preferred time to receive evaluation calls:__________________________________________ 
 
Address and description of area of residence: 
 
 
 
Place of employment: ____________________________________________________ 
 
Family member/friend name: _____________________________________________ 
 
Contact number(s): ______________________________________________________ 
 

70 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix VIII – Tanzania MoHCDGEC Male Circumcision Client Form 
 
 

71 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 
 

72 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 

73 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 
 
 

74 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 

75 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix IX – Case Report Form (CRF) – ShangRing Device 
 
 

76 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
CASE REPORT FORM – ShangRing DEVICE 
 
Evaluation of the safety and acceptability of the ShangRing device for male circumcision in Tanzania 
 
 
Site Code:   
 
 
Client ID # (CID):  
 
 
 

77 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
INSTRUCTIONS FOR THE PROPER COMPLETION OF THE CRF  
 
Please follow the instructions below:  
 
1. Use a ball-pen, DO NOT use a pencil, a marker or a fountain pen.  
2. Make sure to place the separator provided under the last copy of each page so that data recorded on 
one page does not copy to the next.  
3. Subject initials will be comprised of the first letter of the first name followed by the first two letters 
of the surname.  
4. Fill in the form in a clear, concise and readable way. Use common medical terminology.  
5. Correct wrong data by crossing out the information with a single line and writing the correct data 
next to it.  The evaluation coordinator, or the site coordinator in the evaluation coordinator’s 
absence, will initial and date the correction.  
a. Example: 07/03/1969 corrected to 09/03/1969 (with initials and date of the correction) 
6. Complete all the available boxes, DO NOT leave empty fields.  
a. For evaluations not performed record ND (not done).  
b. For data not relevant to the subject or stage of evaluation record NA (not applicable).  
c. If you do not know the data, please use the initials UNK (unknown).  
d. Use leading zeroes if necessary (e.g.: 15 mg = 0 1 5 mg).  
e. Make sure to complete every header on each page.  
7. Please make sure to circle the correct option whenever it is requested.  
8. Please DO NOT add wording to CRF pages unless required. For any additional comments please 
use the Comments Sheet at the end of the CRF modules.  
9. Dates (e.g., date of birth, date of visit) will be recorded in the DD/MM/YYYY format. 
a. Example: 19 June 2017 will be recorded as 19/06/2017 
10. CID is the Client Identification Number. It comprises the initials of the site followed by the four 
digit enrollment date and the three digit subject consecutive number. Example: Subject number 1 in 
Good Hope Health Center enrolled on July 21 will be GH2107001. 
11. Time will be recorded in 24:00 format.  
a. Example: 6:15 pm will be recorded as 18:15   
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Ministry of Health, Community Development, Gender, Elderly and Children 
 
ShangRing Device Case Report Form 
(Attach form to VMMC Client Form) 
 
Part 1 – Client Eligibility and Consent 
 
 
Client ID Number:_______________________            Date of Visit (dd-mm-yyyy):________________ 
 
Client is eligible for ShangRing circumcision (circle one)?     Yes     No     If No, Specify Reason:________  
 
____________________________________________________________________________________ 
 
Confirmation of client’s eligibility (circle one): 
1. In good health:   Yes     No 
 
2. Counseled:           Yes     No 
 
3. Consented:           Yes     No     N/A (13-17 years old) 
 
4. If 13-17 year-old client, consent by parent/guardian and assent by client:   Yes     No     N/A 
 
If ‘No’ for any of the above, explain: _____________________________________________ 
 
 
Part 2 – ShangRing Device Placement Procedure 
 
Device size: _____________       Expiration Date (dd-mm-yyyy):________________ 
 
If the device application is not the same day as the screening report, has there been a change in the genitals 
(compare to screening visit report)?     Yes      No 
 
Time placement procedure began (e.g. 14:30):_________________________ 
 
Time placement procedure ended (e.g. 14:45): ________________________ 
 
Comments: _________________________________________________________________________________ 
___________________________________________________________________________________________
___________________________________________________________________________________________ 
 
Was the device applied according to its Instructions for Use (circle one)?      Yes      No 
 
If “No,” explain in detail:_______________________________________________________________________ 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________ 
 
Was the penis disinfected before applying the device (circle one):      Yes      No 
 
What form of anesthesia was used? Indicate injection/cream, what kind for each, and for injection provide 
dosage:__________________________________________________________ 
 
Please Attach ShangRing Label Here: 
 
 
 
 
 
 
 
 
 
Was there an Adverse Event during placement (circle one)?     Yes     No 
 
If yes, how would you rate the AE (circle one, refer to definitions below):     Mild     Moderate     Severe      
 
Severity cannot be classified (if problem with placement or device malfunction) 
 
NB: If any Moderate, Severe, or Severity not classified adverse events above are checked, complete the AE form. 
 
Full name and surname of clinician placing device: _________________________________________________ 
 
Signature: ________________________                  Cadre (e.g. physician, nurse): __________________________ 
 
Full name and surname of assistant: _____________________________________________________________ 
 
Signature: ________________________                  Cadre (e.g. physician, nurse): __________________________ 
 
 
 
 
Adverse Event Definitions: 
 
Mild: classification indicates minimal or no intervention is required beyond reassurance and observation 
 
Moderate: classification relates to those AEs that are neither mild nor severe, require intervention, and are 
usually managed on site 
 
Severe: classification requires extensive intervention with referral or specialist input 

80 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Part 3 – Post-Application Evaluation and Assessment (Before Discharge) 
 
Dressing intact and holding penis against abdomen (circle one)?     Yes     No 
 
Client given post-procedure written instructions (circle one)?     Yes     No 
 
Clinical disposition of client, including AE management: _____________________________________________ 
 
Oral analgesia given (circle one)?     Yes     No             Drug (name, dose, quantity dispensed): _______________ 
 
Scheduled removal date (dd-mm-yyyy): __________________________________ 
 
Discharged by (Full name and surname): __________________________________________________________ 
 
Signature: ________________________                  Cadre (e.g. physician, nurse): __________________________ 
 
 

81 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix X – ShangRing Post-Placement Survey 
 
 

82 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
ShangRing Post-Placement Survey 
[Table to be completed by Evaluation Staff] 
Date (dd/mm/yyyy): 
 
Client ID: 
 
Name of Survey Administrator: 
 
Facility: 
 
 
Introduction: Thank you for agreeing to complete this survey to evaluate your experience with the ShangRing 
circumcision device. This survey asks a few brief questions about your experience in having the ShangRing device 
placed. Your name will not be recorded anywhere on this survey, and your replies will be kept completely 
confidential. In this survey there are no right or wrong answers. We are most interested in your honest opinions 
and reactions to these questions. You may also refuse to answer any question you wish for any reason. The 
information that you provide will help to determine the future use of ShangRing in Tanzania. If you have any 
questions about the survey, please do not hesitate to follow up with evaluation staff. If you have difficulty 
reading or understanding any of the questions, evaluation staff are on hand to read and help you interpret the 
questions. 
 
1. Why did you choose to have a ShangRing circumcision instead of surgical circumcision (circle answer 
option below)? 
 
I thought 
ShangRing would 
be less painful 
 
I didn’t want an 
injection 
 
I had heard about 
ShangRing before 
 
No Reason 
 
Other (comment 
below) 
Comment:_________________________________________________________________________ 
 
2. How did you find the placement process for the ShangRing device (circle answer option below)? 
 
It was about what I 
expected 
 
It was easier than I 
expected 
 
It was harder than I 
expected 
 
I did not have any 
expectations for the 
placement 
 
Other (comment 
below) 
Comment:_________________________________________________________________________ 
 
3. How did you find the pain of your circumcision during the ShangRing device placement (circle answer 
option below)? 
 
It was about what I 
expected 
 
It was less painful 
than I expected 
 
It was more painful 
than I expected 
 
I did not have any 
expectations about 
pain  
 
Other (comment 
below) 
Comment:_________________________________________________________________________ 
 
4. At this point, would you recommend the ShangRing to someone you know who is considering 
circumcision (circle answer option below)? 
 
Yes 
 
No 
 
I don’t know at this 
time 
 
Other (Comment 
below) 
 
Comment:_________________________________________________________________________ 
 
 

83 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix XI – ShangRing Post-Removal Survey 
 
 
 

84 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
ShangRing Post-Removal Survey 
 
[Table to be completed by Evaluation Staff] 
Date (dd/mm/yyyy): 
 
Client ID: 
 
Name of Survey Administrator: 
 
Facility: 
 
 
Introduction: Thank you for agreeing to complete this survey to evaluate your experience with the ShangRing 
circumcision device. This survey asks a few brief questions about your experience with ShangRing now that the 
device has been removed. Your name will not be recorded anywhere on this survey, and your replies will be kept 
completely confidential. In this survey there are no right or wrong answers. We are most interested in your 
honest opinions and reactions to these questions. You may also refuse to answer any question you wish for any 
reason. The information that you provide will help to determine the future use of ShangRing in Tanzania. If you 
have any questions about the survey, please do not hesitate to follow up with evaluation staff. If you have 
difficulty reading or understanding any of the questions, evaluation staff are on hand to read and help you 
interpret the questions. 
 
 
1. How much discomfort did you experience while wearing the ShangRing device over the past seven days 
(circle answer option below)? 
 
I had no discomfort 
while wearing the 
ring 
 
I had minor 
discomfort while 
wearing the ring 
 
I had moderate 
discomfort while 
wearing the ring 
 
I had a lot of 
discomfort while 
wearing the ring 
 
Other (comment 
below) 
 
Comment:_________________________________________________________________________ 
 
2. How much did the ring affect you while performing day-to-day activities (circle answer option below)? 
 
It did not affect me 
at all 
 
It only affected me 
while performing 
certain activities 
 
It affected me 
during all activities, 
but I could still do 
them 
 
It prevented me from 
performing certain 
activities 
 
Other (comment 
below) 
Comment:_________________________________________________________________________ 
 
3. After having worn the ring for a week, would you still choose to do ShangRing for circumcision, or would 
you choose surgery (circle answer option below) 
 
I would definitely 
choose ShangRing 
again 
 
 
I would probably 
choose ShangRing 
again 
 
I would probably 
choose surgery 
 
I would definitely 
choose surgery  
 
I don’t know 
Comment:_________________________________________________________________________ 
 
 
(Survey is continued on next page) 
 

85 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
4. How satisfied are you with the appearance of your circumcision (circle answer option below)? 
 
I am very satisfied 
 
I am satisfied 
 
I am dissatisfied 
 
I am very 
dissatisfied 
 
I don’t know 
 
Comment:_________________________________________________________________________________ 
 
5. At this point, would you recommend the ShangRing to someone you know who is considering 
circumcision (circle answer option below)? 
 
Yes 
 
No 
 
I don’t know at this 
time 
 
Other (Comment 
below) 
 
Comment:_________________________________________________________________________ 
 
 
 
 

86 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix XII – ShangRing Case Report Form: Client Follow-Up Form  
 
 
 

87 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
CASE REPORT FORM – ShangRing DEVICE FOLLOW-UP 
 
Evaluation of the safety and acceptability of the ShangRing device for male circumcision in Tanzania 
 
 
Site Code:   
 
 
Client ID # (CID):  
 
 
 
 
 
 

88 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
INSTRUCTIONS FOR THE PROPER COMPLETION OF THE CRF  
 
Please follow the instructions below:  
 
1. This form is to be used for ALL follow-up visits, including the removal visit, and unscheduled visits. 
2. Complete a new form at each follow-up visit. 
3. Use a ball-pen, DO NOT use a pencil, a marker or a fountain pen.  
4. Make sure to place the separator provided under the last copy of each page so that data recorded on 
one page does not copy to the next.  
5. Subject initials will be comprised of the first letter of the first name followed by the first two letters 
of the surname.  
6. Fill in the form in a clear, concise and readable way. Use common medical terminology.  
7. Correct wrong data by crossing out the information with a single line and writing the correct data 
next to it.  The evaluation coordinator, or the site coordinator in the evaluation coordinator’s 
absence, will initial and date the correction.  
a. Example: 07/03/1969 corrected to 09/03/1969 (with initials and date of the correction) 
8. Complete all the available fields, DO NOT leave empty fields.  
a. For evaluations not performed record ND (not done).  
b. For data not relevant to the subject or stage of evaluation record NA (not applicable).  
c. If you do not know the data, please use the initials UNK (unknown).  
d. Use leading zeroes if necessary (e.g.: 15 mg = 0 1 5 mg).  
e. Make sure to complete every header on each page.  
9. Please make sure to circle the correct option whenever it is requested.  
10. Please DO NOT add wording to CRF pages unless required. For any additional comments please 
use the Comments Sheet at the end of the CRF modules.  
11. Dates (e.g., date of birth, date of visit) will be recorded in the DD/MM/YYYY format. 
a. Example: 19 June 2017 will be recorded as 19/06/2017 
12. CID is the Client Identification Number. It comprises the initials of the site followed by the four 
digit enrollment date and the three digit subject consecutive number. Example: Subject number 1 in 
Good Hope Health Center enrolled on July 21 will be GH2107001. 
13. Time will be recorded in 24:00 format.  
Example: 6:15 pm will be recorded as 18:15  
 
 

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ShangRing Client Follow-Up Form 
 
Client ID Number: ___________________________      Date of visit (dd-mm-yyyy): _______________________ 
 
Date of ShangRing Device Placement (dd-mm-yyyy): ________________________________________________ 
 
Contact Type (select one):  
 
• 
On-site visit (specify name of facility/site): _________________________________________________ 
 
• 
Off-site visit (specify location, i.e. work, home, school): _______________________________________ 
 
• 
Phone contact (number called): __________________________________________________________ 
 
Type of Visit (select one): 
 
• 
Removal visit (specify days since device placement): ______ 
 
• 
Day 42 post-placement healing assessment (specify day if client comes in on different day): ______ 
 
• 
Post day 42 follow-up healing assessment (specify days since device placement): ________ 
 
• 
Unscheduled visit (specify days since device placement): ______ 
 
Is there a photographer present to take pictures of the procedure (circle one):     Yes     No     
(If ‘No,’ do not proceed until a photographer is available. Photos must be taken with the photo frame, including 
client ID number, date and pain score before and after device removal). 
 
Has there been a change to the client’s medication since device placement (circle one):     Yes     No 
(If ‘Yes,’ please record the medication on the medications CRF page). 
 
Summary of Follow-Up: 
 
Clinical course leading to client’s visit today: ______________________________________________________ 
___________________________________________________________________________________________
___________________________________________________________________________________________ 
Care/advice provided: ________________________________________________________________________ 
___________________________________________________________________________________________
___________________________________________________________________________________________ 
Medication given (circle one)?     Yes     No      
 
If yes, drug (name, dose and total quantity dispensed):______________________________________________ 
 
 

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For removal visit, was anesthesia required during removal (circle one):     Yes     No     NA (not removal visit) 
 
If “Yes,” what?______________________________________________ 
 
For removal visit, were there any device-related events or AEs that occurred during the removal (circle one): 
 
Yes            No               NA (Device not removed this visit) 
 
If “Yes,” please record on Adverse Events form. 
 
For removal visit, provider evaluation from 1 to 10 (1 being worst): ______________ 
 
Name of provider who removed the ShangRing device: ______________________________________________ 
 
Healing status observed by clinician (select one):     Healed      Not Healed      NA (pre-day 42 visit) 
 
Clinical healing defined as: clinical healing after MC by any method is intact epithelium (unbroken skin) covering 
the wound as judged by the provider on visual inspection, meaning that none of the following are present: 
sutures, scabbing, drainage, moisture, gaps between epithelial edges or ulceration. 
 
Was client instructed not to masturbate until completely healed (select one)?     Yes     No     NA (client healed) 
 
Was client reminded to abstain from sexual intercourse until completely healed (select one)?      
 
Yes          No          NA (client healed) 
 
Was client reminded to return to the site in the event of any unexpected situation, in case of pain, or if client 
has not yet had ring removed, if ring is displaced (select one)?        Yes       No   
 
Adverse Events 
 
Was there an Adverse Event seen/reported during follow-up (select one):     Yes     No 
 
If yes, how would you rate the AE (circle one, refer to definitions below):     Mild     Moderate     Severe      
 
Severity cannot be classified (if problem with placement) 
Adverse Event Definitions: 
 
Mild: classification indicates minimal or no intervention is required beyond reassurance and observation 
 
Moderate: classification relates to those AEs that are neither mild nor severe, require intervention, and are 
usually managed on site 
 
Severe: classification requires extensive intervention with referral or specialist input 

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NB: If any Moderate, Severe, or Severity not classified adverse events above are checked, complete the AE form. 
 
 
For unscheduled visits, has the client experienced a device-related event or AE since his last visit (select one): 
 
Yes          No            NA (not an unscheduled visit) 
 
For unscheduled visits, please describe the reason for the unscheduled visit:____________________________ 
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________ 
 
Is circumcision progressing as expected (select one)?      Yes       No 
 
If “No,” please explain:________________________________________________________________________ 
___________________________________________________________________________________________
___________________________________________________________________________________________ 
 
 
 
Assessment (Before Discharge) 
 
Clinical disposition and AE management: _________________________________________________________ 
 
Next visit date, if applicable (dd-mm-yyyy): _______________________________________________________ 
 
Discharged by (Full name and surname): __________________________________________________________ 
 
Signature: ________________________________ 
 
 

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Version 4. October 22, 2018. 
Appendix XIII – Introductory script for contacting ShangRing clients by phone 
 
Introductory script for contacting ShangRing clients by phone 
 
May I please speak to ________________? 
If yes, proceed to next paragraph 
If no, is there better time to call you later? If yes, schedule appointment follow another call 
 
My name is ______________ and I am calling from ______________ (name of health facility) to follow 
up on your appointment to visit our clinic on ____________ (date) for____________ (purpose of missed 
appointment). At your last visit to our clinic you indicated that you would come for __________ 
(purpose of missed visit e.g. review or device removal). May I ask if you may be available for this 
appointment at a different time? 
 
Schedule another appointment for clinic visit or for home visit by providers depending on his 
availability. 
If the client is not at home, but another person answers the phone, a message will not be left for the 
person who answers the phone. Proceed as follows; 
My name is______________. 
May I know when he is likely to be back for me to call him on this same number or can you guide me on 
how else I can reach him? 
Depending on the response, schedule another call or follow guidance given on how to reach him. 
 
 

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Appendix XIV – ShangRing Adverse Event Day 3 Post-Removal AE Check-in Call Form 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
ShangRing Adverse Event Check-in Call Form 
Client ID: 
 
Instructions 
This form is to be used during the call with clients to check for signs of adverse events three days following the 
removal of the ShangRing device. The questions below are meant to evaluate whether the client is potentially 
experiencing an adverse event in the aftermath of their circumcision. After introducing yourself, and informing the 
client of the purpose of the call, ask the client each question on the list. For any ‘yes’ answers, probe for more 
information. If any of the information the client offers suggests an adverse event, advise that the client come to the 
clinic immediately for further evaluation. 
 
 
Questions 
1. Are you experiencing pain that keeps you from doing anything you normally do?     Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
2. Has swelling, tenderness or pain around the wound gotten worse since your circumcision?     Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
3. Have you noticed any expanding redness around the wound area, or red streaking spreading from the wound?     
Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
4. Have you noticed any pus or fluid coming from the wound area?     Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
5. Have you felt like you have had a fever in the past few days, or experienced chills, shaking, breaking into 
sweats more than usual?     Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 

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6. Are you still bleeding from the wound area?     Y    N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
7. Are you experiencing any difficulty urinating?     Y     N 
a. If yes: Advise the client to visit the clinic to be evaluated 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
8. Are you experiencing any other new problems since the surgery?     Y     N 
a. If yes: Ask the client to describe the symptoms, and record below. If the symptoms are concerning 
advise the client to visit the clinic to be evaluated. 
Note any comments:____________________________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
 
Upon conclusion, thank the client for their time and remind them of their visit for the healing assessment in 39 days’ 
time. If the client is one of those selected to participate in the qualitative interview, remind them of the date of the 
interview.  
 
 
 

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Version 4. October 22, 2018. 
Appendix XV – ShangRing Active Surveillance: Device Placement and Follow-up Log 
 
 

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ShangRing Active Surveillance: Device Placement and Follow-up Log 
Client Full Name and 
Surname 
Chart # 
Date of SR 
placement 
(dd/mm/yy) 
Returned 
for Day 7 
Removal? 
Y/N) 
Follow-up attempts if client did not return on Day 7  
Attempt 1: 
date, type, 
outcome 
Attempt 2: 
date, type, 
outcome 
Attempt 3: 
date, type, 
outcome 
Attempt 4: 
date, type, 
outcome 
Attempt 5: 
date, type, 
outcome 
Attempt 6: 
date, type, 
outcome 
Attempt 7: 
date, type, 
outcome 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix XVI: ShangRing Evaluation Pilot: Log of Client ShangRing Eligibility and Acceptance 
 
 
 

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ShangRing Evaluation Pilot: Log of Client ShangRing Eligibility and Acceptance 
For all clients eligible on initial intake for ShangRing circumcision please fill out a line below. 
To be completed during pre-MC counseling. 
 
*If client gives a reason for declining ShangRing that can fall into these categories give the corresponding number if applicable: 1 – I don’t want to try a 
new procedure, 2 – I heard about someone else’s negative experience, 3 – I don’t want to have to get an HIV test, 4 – I’m afraid it will hurt too much. If 
the client gives a different reason for refusing ShangRing, write the client’s reason in the comment box.
Date (dd/mm/yy) 
Client Name 
Interested in ShangRing?  
(Y/N) 
Eligible after medical 
screening?  (Y/N) If no, why? 
Consents to ShangRing? (Y/N) 
If no, why?* 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 
Appendix XVII – ShangRing Post-Operative Care Instructions 
 

[Version, Date] 
Post-operative Care instructions 
101 
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Version 4. October 22, 2018. 
Post-Operative Instructions 
These post op care instructions will be included in pre-and post-procedure counselling for each client. 
For minors, the same guidance will be given to parents or guardians. A copy will also be given to clients 
or parents/ guardians to carry home.  
Wearing the ShangRing 
1. It is recommended that, back at home, you rest until you have gotten used to the ShangRing being in 
place. 
2. Do not try to remove or reposition the ShangRing yourself, and keep the penis clean and dry. 
3. After the day of circumcision, you may shower or use clean bottled water to rinse the wound while the 
ShangRing is in place as long as you carefully dry the penis and ShangRing afterwards. Do not go swimming 
or wash in a bathtub. 
4. Do not take part in any intensive activities (e.g. playing soccer or other strenuous manual work in 
construction sites or farms) to avoid dislocation of the ring. In the case of heavy sweating, be sure to clean 
and dry the body immediately to keep the wound from being infected, which would delay healing. 
5. DO NOT HAVE SEX (INCLUDING MASTURBATION) while the ShangRing is in place. This can damage the 
wound, displace the device, and increase risk of infection and transmitting diseases. 
6. Try not to allow your penis to dangle freely. Tightly fitted briefs are recommended in order to keep the 
penis from drooping downward and to keep the ring in place and avoid skin abrasion. 
7. In the event that you experience mild pain (including during an erection), especially in the first few days 
after the circumcision, over-the-counter pain medications such as paracetamol (acetaminophen), naproxen 
or ibuprofen can be used for pain relief. If the pain is excessive, contact your health care provider for 
further advice. Urinating may help to quickly end an erection. 
8. Keep the circumcised area clean and dry. This will promote proper healing. When urinating, use a piece 
of toilet paper or cloth to prevent urine from seeping into the circumcision area, possibly resulting in 
infection. 
9. Do not apply ointment or cream on or around the circumcised area. Also you should not apply traditional 
remedies or any other substances (e.g. herbs, soil, cow dung). This may slow the healing process, and can 
also increase risk for infection, including tetanus, which can be fatal. 
10. You may experience slight swelling around the ShangRing. This is normal as long as it does not cause 
you too much discomfort. Wearing tightly fitted briefs to keep the penis facing up should help prevent 
swelling. 

[Version, Date] 
Post-operative Care instructions 
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11. Seven days after your circumcision, return to the clinic to have the ShangRing removed. Do not try to 
remove or reposition the ShangRing yourself. This can cause serious bleeding or infection.  If the device 
does come off or gets moved, contact the clinic immediately 
After Removal of the ShangRing 
1. Keep the bandage clean and dry and remove the bandage before going to sleep. In the event that the 
bandage does get wet, replace the bandage immediately. Replace the bandage in the morning after 
removal and repeat for one additional day. Starting on the third day, you can wash the penis and the 
wound area normally and leave the bandage off. 
2. Do not apply ointment or cream on or around the wound. Also you should not apply traditional remedies 
or any other substances (e.g. herbs, soil, cow dung). This may slow the healing process, and can also 
increase risk for infection, including tetanus, which can be fatal. 
3. DO NOT HAVE SEX (INCLUDING MASTURBATION) within the 6 weeks after your circumcision or until the 
wound has healed completely.  Early sex can damage the wound and increase risks of disease transmission.  
If you absolutely cannot avoid having sex before 6 weeks, masturbation is safest, and sex with condoms is 
safer than unprotected sex.  After six weeks, you should use condoms to protect the circumcision wound 
(as well as to reduce the transmission of HIV and other infections) for three months, even after it appears 
completely healed. 4. Expect the complete healing of the wound may take 3 to 4 weeks, or longer.   
When to come to clinic or call your doctor  
While wearing the ShangRing or after removal, contact your health care provider at cell phone #: 
_____________________or __________________, or visit the clinic: 
1. If you notice bleeding from around the ShangRing or from the wound after the ShangRing surgery or the 
ShangRing removal. 
2. If you experience difficulty passing urine. 
3. If you experience seriously painful swelling, increasing redness, bruising, elevated temperature around 
the wound, fever, or the discharge/appearance of pus. 
4. If there is severe swelling around the ShangRing, or around the area in which the ShangRing was placed 
which causes you discomfort. 
5. If you experience excessive pain (including during an erection) while the ring is still in place. 
6. If the ShangRing is damaged or comes off accidentally (partially or completely). 
7. If you have any other inquiries or concerns.  
 
 
 
 

 
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Appendix XVIII – Adverse Event Reporting Form 
 
Client ID: 
 
Device Related Events Form 
 
Has the participant experienced a device related event per protocol?  This includes mild, moderate and severe AE, 
expected side effects such as common post-operative findings, occurences resulting from participants’ failure to follow 
instructions, and device malfunctions. Please consult the Adverse Event Classifications and Definitions: During Device Placement 
or Wearing and During or After Device Removal for clarification and definition of adverse events.   If the client is determined 
to have experienced an adverse event, please complete below.  
 
If this is an AE defined as moderate or severe, also fill in the corresponding AE form. Note, that notifiable adverse 
events must also be reported also per PEPFAR and national guidelines.  
 
 

 
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Client ID: 
 
Device Events Form 
Device Event  
(Indicate type) 
Evaluation Phase 
Start/Onset 
 
Anesthetic Related 
Problem 
 
Bleeding 
 
Pain 
 
Scarring/Disfigurement 
Poor cosmetic result or 
excess skin removal 
 
Device Displacement 
 
Device detachment 
 
Infection 
 
Injury to penis 
 
Sexual effects/ 
undesirable sensory 
changes 
 
Wound Disruption 
 
Excess swelling of 
penis/scrotum 
 
Hematoma 
 
Difficulty with removal 
 
Difficulty urinating 
 
Excessive skin removal 
 
Other 
 
 
During placement        While in place 
(before discharge) 
 
During removal            After removal 
 
Date: 
 
Time: 
 
 
Severity 
(Consult definitions for grading classification) 
Events/AE Code  
(Consult definitions for codes) 
 
Mild 
 
Moderate 
 
Severe 
    
 
Moderate or Severe AE 
Relationship to Device 
 
Yes             No 
 
If “Yes,” complete adverse events form 
 
Unrelated 
 
Possibly 
 
Definitely 
Action 
Pain VAS (see below) 
 
None               Pharmaceutical          
 
Surgical                Non-surgical           
 
Evaluation termination          
 
Other        Specify: ________________ 
 
Complete when resolved or at final visit 
Outcome 
End/Termination 
 
Resolved           Resolved with sequel  
 
Persistent          Unchanged          
 
Unknown 
Date: 
 
Time: 
 
Visual Analog Scale (VAS): 
I have checked all data introduced to this form until this point and verified that they are complete, correct 
and reconcilable with the original documentation. 
Evaluation Coordinator’s Signature: ____________________________ 
Date:__________________ 
 
0 
Very happy, no hurt 
 
2 
Hurts just a little bit 
 
4 
Hurts a little more 
 
6 
Hurts even more 
 
8 
Hurts a whole lot 
 
10 
Hurts as much as you 
can imagine 

 
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Client ID: 
 
 
Adverse Events (AE) Form 
 
Has the participant experienced a moderate or severe AE per protocol?  If "No", do not enter information on this 
form. If the AE is defined as severe, notify the principal investigators based on the evaluation protocol.  
 
Adverse 
Event 
Start/Onset 
Status 
Device Event 
Number 
 
    
Date: 
 
Time: 
 
Date/time observed (if different): 
    
New  
 
Ongoing 
 
 
 
Action 
Severity 
(Consult definitions for 
grading classification) 
AE Code  
(Consult definitions 
for codes) 
 
None            Pharmaceutical         Surgical  
 
Non-surgical          Evaluation termination          
 
Other         Specify: _________________________  
 
Moderate 
 
Severe  
If severe, complete 
information below 
 
Date of SAE report to evaluation investigators: 
Was the SAE a result of protocol 
departure? 
Yes 
   No 
If “Yes,” please specify:  
 
 
 
Date of last visit and last visit number: 
 
Date the device was applied: 
 
Please describe the SAE in block letters (use 
following page if additional space is needed): 
Choose criteria for SAE: 
Death  
 
 
Permanent disability 
 
 
Life threatening 
 
 
Hospitalization or prolongation of 
inpatient hospitalization  
 
 
Required intervention to prevent 
one of the above  
 
 
          Other: 
Outcome 
End/Termination 
 
Resolved           Resolved with sequel  
 
Persistent         Unchanged         Unknown 
Date: 
 
Time: 
 
 
 
 

 
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Please add any additional comments related to this AE.  Please write in block letters and sign and date your 
comments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
I have checked all data introduced to this form until this point and verified that they are complete, correct 
and reconcilable with the original documentation. 
 
Evaluation Coordinator’s Signature: 
 
 
 
 
 
 
Date: 
 
 
 

 
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Appendix XIX: Adverse Event Classifications and Definitions: During Device Placement or Wearing and During or After 
Device Removal* 
 
Adverse Event 
Mild 
Moderate 
Severe 
During Device Placement or Wearing 
AN: Anesthetic Related 
Problem (A1-AN) 
Mild localized swelling allergic 
reaction at injection site without 
swelling and systemic reaction. 
Reaction to anesthetic including light-
headedness, nervousness, dizziness 
that resolves spontaneously and not 
requiring use of medicines or 
equipment from the emergency 
cart/kit/list of emergency 
commodities at VMMC site and no 
transfer to another facility or 
admission to hospital. 
Symptoms of severe systemic allergic 
reaction to local anesthetic including 
rash, urticaria, angioedema, and 
shortness of breath, or symptoms of 
overdose of local anesthetic including 
light-headedness, nervousness, 
confusion, dizziness, drowsiness, ringing 
of ears, blurred or double vision, 
sensations of heat, cold or numbness, 
twitching, tremors, convulsions, 
unconsciousness, respiratory 
depression, bradycardia, or hypotension 
requiring use of medicines or equipment 
from the emergency cart/kit/list of 
emergency commodities or 
hospitalization to manage. 
BL: Bleeding 
A1/A2-BL: Bleeding during 
placement or wearing that is more 
significant than usual or spotting of 
the bandage or clothing with blood; 
both easily controlled 
A1/A2-BL: Bleeding during placement 
or wearing that requires a pressure 
dressing to control without surgical re-
exploration of the wound or removal 
of the device. 
A1/A2-BL: Bleeding during placement or 
wearing that requires blood transfusion, 
transfer to another facility, or 
hospitalization; or bleeding that requires 
surgical exploration, removal of device, 
placement of sutures, hospitalization, or 
transfer to another facility. 
PA: Pain 
A1-PA: Client expresses discomfort, 
however is able to remain still and 
cooperate for the procedure. 
A1-PA: Client expresses discomfort 
and is not able to cooperate well with 
procedure. 
A1-PA: Client rates pain as very severe. 
SD: Scarring/disfigurement/ 
poor cosmetic result; excess 
skin removal; injury to penis 
Excess skin removal–NA  
 
A1-SD: Injury to penis–limited 
superficial injury not requiring 
additional intervention. 
Excess skin removal–NA  
 
A1-SD: Injury to penis–abrasion or 
small laceration of the glans or shaft 
Excess skin removal–NA  
 
A1-SD: Injury to penis–injury that 
requires surgical intervention to stop 
bleeding or repair. 

 
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requiring pressure dressing, but 
surgical repair is not required. 
 
During or After Device Removal 
BL: Bleeding 
B/C-BL: Small amount of bleeding 
from wound with no active bleeding 
and is controllable with new 
dressings or 5–10 minutes of manual 
pressure. 
B/C-BL: Bleeding that is not controlled 
by new dressings or 5–10 minutes of 
manual pressure or requires a special 
return to the clinic for a pressure 
dressing or additional skin sutures 
without surgical re-exploration of the 
wound. 
B/C-BL: Bleeding that requires surgical 
re-exploration, hospitalization, or 
transfer to another facility; or any case 
where blood transfusion or intravenous 
fluid is necessary. 
DD: Device Displacement 
A2-DD: NA 
A2-DD: Displacement of the device, 
including intentional movement of 
device by the client and/or self-
removal that does not require surgical 
intervention to correct, either because 
the device can be removed, 
repositioned, or replaced with a new 
device. 
 
A2-DD: Displacement of the device, 
including intentional movement of 
device by the client and/or self-removal, 
that requires surgical intervention to 
correct, or requires hospitalization or 
transfer to another facility to clinically 
manage. 
IN: Infection 
B/C-IN: Erythema or traces of serous 
discharge or infective process noted 
at wound margin. No intervention 
other than improved wound 
hygiene. 
B/C-IN: Discharge from the wound, 
painful swelling with erythema, or 
elevated temperature that requires 
use of oral antibiotics. 
B/C-IN: Cellulitis or abscess of the 
wound, or infection severe enough to 
require surgical intervention, 
hospitalization, or intravenous or 
intramuscular antibiotics. 
PA: Pain 
A2/B/C-PA: Client complaints of 
pain, not requiring more than 
standard postoperative analgesics 
and considered within normal 
thresholds associated with surgery 
A2/B/C-PA: Pain serious enough to 
result in disability (as evidenced by 
inability to work or perform activities 
of daily living) lasting for at least 1 day 
after device placement or removal. 
For programmes that utilize a visual 
analogue scale (VAS) for rating 
severity, a VAS score of 5–7 (on a 1–10 
scale). 
A2/B/C-PA: Pain serious enough to 
result in disability (as evidenced by 
inability to work or perform activities of 
daily living) lasting 2 or more days after 
device placement or removal. For 
programmes that utilize a visual 
analogue scale (VAS) for rating severity 
of pain, a VAS score of 8–10 (on a 1–10 
scale). 
SD: Scarring/disfigurement/ 
Poor cosmetic result; excess 
skin removal (C-SD) 
Scarring-complaints by client in the 
absence of discernible abnormal 
scarring/disfigurement. Torsion of 
Scarring-Discernible but re-operation 
not required. Usually noticed first by 
the client and reported to the 
Scarring-Discernible and requires 
reoperation or referral/transfer to 
another facility.  

 
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penis–torsion present but does not 
cause pain or discomfort. 
Insufficient skin removal–prepuce 
extends over the coronal margin but 
less than one third of the glans is 
covered in flaccid state. 
provider. Torsion of penis–torsion 
present that causes mild pain or 
discomfort with erection but does not 
require surgery to correct. 
Insufficient skin removal–prepuce 
partially covers glans when flaccid but 
surgical correction is not necessary. 
Torsion of penis–torsion present. 
Erections are painful and client cannot 
tolerate the appearance, discomfort, or 
pain. Surgery needed for correction. 
Insufficient skin removal–prepuce covers 
most of the glans when flaccid and 
surgical correction is necessary. 
Injury to Penis 
A2/B/C-SD: Injury to penis-limited 
superficial injury not requiring 
additional intervention. 
A1-SD: Injury to penis-bruise or 
abrasion of the glans or shaft requiring 
pressure dressing, but surgical repair 
is not required. 
A1-SD: Injury to penis-injury that 
requires surgical intervention to stop 
bleeding or to repair. Severing of the 
glans or shaft, injury to urethra or 
development of a fistula is also 
considered a severe AE. 
Excess Skin Removal 
C-SD: Excess skin removal-slight 
tightening of the skin observed; no 
surgical correction needed. 
C-SD: Excess skin removal-pulling of 
scrotal skin onto the penile shaft and 
wound disruption. 
C-SD: Excess skin removal-wound 
appearance is such that the wound has 
gaping edges or large or deep defects 
such that without revision, there would 
be significant scar formation. 
SX: Sexual 
Effects/Undesirable Sensory 
Changes 
C-SX: Occasional inability to have 
erection or dissatisfaction with 
sexual performance, no psycho-
behavioral consequences. 
C-SX: Post-operative changes that 
consistently impair or preclude sexual 
function for 3 to 6 months after 
surgery not present prior to surgery. 
C-SX: Post-operative changes that 
consistently impair or preclude sexual 
function for greater than 6 months after 
surgery that were not present prior to 
surgery. 
WD: Wound Disruption 
C-WD: Wound disruption but not 
extensive enough to require 
suturing for wound closure. 
C-WD: Muco-cutaneous gap > 1.0 cm 
in width, but no exposure of deeper 
tissue 
C-WD: Wound disruption exposing 
tissue deeper than subcutaneous tissue 
or requiring surgical intervention such as 
suturing or debridement. 
OA: Other AEs, Excess 
swelling of penis/scrotum 
including hematoma; other 
Excess swelling–mild swelling 
without signs of on-going bleeding. 
Excess swelling–symptoms/signs that 
require clinical intervention, but not 
surgical exploration.  
Other–other adverse events related to 
surgery that result in disability (as 
evidenced by loss of work or 
cancellation of normal activities) 
lasting for at least 4 days after surgery 
but not more than 7 days. 
Excess swelling–surgical exploration 
required to control bleeding or remove 
haematoma or symptoms/signs so 
extraordinary as to cause disability (as 
evidenced by loss of work or 
cancellation of normal activities) lasting 
for at least 8 days after surgery or device 
placement or removal as pertinent.  

 
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*Adapted from Appendix 3 of Adverse Event Action Guide For Voluntary Medical Male Circumcision (VMMC) by Surgery or Device, 2nd Edition, 2016
Other–other AE(s) related to the surgery 
that result in disability (as evidenced by 
loss of work or cancellation of normal 
activities) lasting for at least 8 days after 
surgery or device placement or removal, 
or result in hospitalization or 
referral/transfer to another facility. 
Difficulty Urinating 
N/A 
A2/C-OA: Symptoms that resolve with 
removal/repositioning of the device or 
dressing (transient difficulty urinating 
that resolves on its own would not be 
considered an AE). 
A1/C-OA: Complete obstruction and/or 
requires placement of a catheter, 
referral for treatment or surgery to 
correct. 

 
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Appendix XX - ShangRing Evaluation Pilot: Application Time Form 
 
 

 
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ShangRing Evaluation Pilot: Application Time Form 
(Enter time in 24 hour form, e.g. 18:00) 
Client ID # 
Date 
(DD/MM/YYYY) 
Overall Timeµ 
Begins 
Ends 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
µOverall Time: Begins upon the arrival of client in operating room, concludes once procedure is complete and client is released from operating room. 

 
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Appendix XXI - ShangRing Evaluation Pilot: Removal Time Form 
 
 

 
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ShangRing Evaluation Pilot: Removal Time Form 
(Enter time in 24 hour form, e.g. 18:00) 
Client ID # 
Date 
(DD/MM/YYYY) 
Device Removal Begins* 
(Time) 
Device Removal Ends* 
(Time) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Begin/End Time: Time begins when client is admitted to the room for device removal. Time ends when device is removed and client is ready to be 
released. 

 
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Appendix XXII – Client Qualitative Interview Guide  
 
In-Depth Qualitative Interviews  
Date (dd/mm/yyyy): 
 
Name of Moderator: 
 
Name of Note-Taker: 
 
Facility: 
 
Start Time:  
 
End Time: 
 
 
Introduction 
Thank you for agreeing to participate in this interview. The purpose of this interview is to discuss your opinions 
around circumcision and ShangRing. In order to do this, I will ask you questions about your experience with the 
ShangRing device for male circumcision. This interview, and your replies will be kept completely confidential. I 
will not record your name or link anything you say in a way that will make it easy to identify you. In this 
interview there are no right or wrong answers. We are most interested in your honest opinions and reactions to 
these questions. You may also refuse to answer any question you wish for any reason. The interview should last 
approximately one hour, though you may end it at any time. The interview will be recorded, but your name will 
not be included on the recording, and we will not store the recording in a way that can be used to identify you. 
You may request a break should you need one. Please feel free also to help yourself to the provided snack. And 
if you need them, the rest rooms are located [provide directions]. The information that you and others provide 
will help to determine the future use of ShangRing in Tanzania. 
Are there any questions before we begin? 
 
1. How old are you in complete years? 
 
2. Where do you currently reside? 
 
3. What is the highest level of formal schooling you completed? 
 
4. Are you currently in a relationship with someone such as a spouse or partner? [Note for interviewer: if 
yes ask question 5, if no, skip to question 6]. 
 
5. What is your relationship with this person? 
 
6. What was the primary reason you decided to get circumcised? 
 
7. What made you decide to try the ShangRing device? 
 
8. What made you choose to try the ShangRing device instead of surgical circumcision?  
 
9. Did you tell anyone that you had a ShangRing circumcision? If so, what was their reaction? [Note for 
interviewer: probe for who the person was, gender, relationship to the client, etc.]. 
 
10. How was the process of having the ShangRing device put on your penis? 
 

 
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11. What was it like during the seven (7) days that you had the device on? [Note for interviewer: probe for 
issues related to pain including with erections, limits on activities including sex and masturbation, 
hygiene]. 
 
12. How was the removal process? 
 
13. What have you been told about the healing process? [Note for interviewer: probe for things they have 
been told to do and what not to do until healing is complete. Clarify any information that is not correct 
regarding abstinence until healing is complete and future condom use]. 
 
14. How would you describe your experience since the ShangRing device was removed? [Note for 
interviewer: probe for perceptions regarding how the healing process is progressing]. 
 
15. How would you describe your satisfaction with your circumcision?  
 
16. Are you satisfied with the result? 
 
17. What did you like about the procedure? 
 
18. What did you dislike? 
 
19. Was the information about the circumcision process with the ShangRing device clear and accurate? 
 
20. In your opinion, what kind of messages could make VMMC more appealing to men? 
 
21. In your opinion, are there messages that could make ShangRing an appealing option for VMMC for men 
who may not want to have surgery? 
 
22. Is there anything else related to ShangRing that you would like to comment on or ask? 
 
23. Do you have any comments related to ShangRing or medical male circumcision in general? 
 
Note for Interviewer: Thank the client for their time, and provide the following reminders: 
• 
When/where to return for the day 49 (42 days post-removal) healing assessment. 
• 
The importance of good hygienic processes while the wound continues to heal, and how to keep the 
penis and wound clean and free of potential infection, including the importance of tetanus mitigation 
strategies. 
• 
That the client should return to the evaluation site in case of any unexpected event, for example if there 
is severe discoloration of the penis, signs of infection (purulence), severe or increasing pain, or any other 
significant concern they may have. 
• 
Painful erections may continue to occur during the night as the wound heals. 
• 
The client is encouraged to call any time with any questions or concerns. 
• 
The importance of continued abstention from sex or masturbation for 6 weeks (42 days), following the 
removal of the ShangRing device, or until the penis is fully healed (whichever comes last).   
 
 
 

 
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Appendix XXIII – Consent form for Provider Interviews and Surveys 
 
 

 
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Consent Form for Provider Interviews and Surveys 
 
 
What you should know about this program: 
• This consent form explains the purpose and requirements of the provider interviews and surveys  
• Please read it carefully and take as much time as you need.  
 
Purpose of the Provider Interviews and Surveys 
You are being asked to participate in these interviews because you have been selected to take part in a 
program being done by the Ministry of Health, Community Development, Gender, Elderly and Children 
(MoHCDGEC) and its partners to offer 575 circumcisions using the ShangRing device in selected health 
facilities. Although ShangRing has been successfully used in other countries, the purpose of this program is 
to learn more about using this method of circumcision for large numbers of males in Tanzania to decide 
whether to begin offering it all over the country. This includes evaluating the opinions of providers who 
have experience performing the ShangRing procedure. Specifically, it is important to learn your honest 
opinion on the ShangRing device on a number of topics including: 
• The value of the ShangRing training 
• The technical ease or difficulty in performing ShangRing circumcisions, including length of time, 
and safety for both the provider and the client 
• Your preference in performing ShangRing or surgical circumcisions 
• Whether or not ShangRing will appeal to men compared to surgical circumcision 
 
Procedures 
If you agree to participate in the ShangRing program, you will be interviewed at two points in time, and 
asked to complete one survey. 
 
The first interview will take place upon the completion of your ShangRing training. At this time you will be 
asked for your thoughts on the training process – including the curriculum; and for your preliminary 
thoughts on the ShangRing device – both in terms of your opinions on performing the procedure, and how 
you believe potential clients will feel about the procedure. 
 
The second interview will take place about halfway through the program, after you have had a chance to 
perform ShangRing circumcisions on clients for some time. This interview will be used to evaluate your 
opinions on performing the procedure as part of clinical practice, what you like and dislike about using the 
device, anything you have observed from the men receiving the procedure, and your opinions on the future 
use of ShangRing within Tanzania’s VMMC program. 
 
The survey will be administered upon the completion of the program. It is meant to evaluate your feelings 
both on the training prior to the start of the program, and you experience using the device throughout the 
duration of the program.  
 
The interviews are expected to last 30 minutes to an hour each. The survey is 20 questions long, including 
16 multiple-choice questions, and 4 questions with written responses, and is expected to take 15-20 minutes 
to complete. 

 
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Confidentiality 
We wish to learn your honest opinion through the interviews and survey, there are no right or wrong 
answers, and all of your answers are confidential. Your name will not be written on any notes taken by the 
note-taker or moderator. And no comments or quotes that you give in the interview or in the written 
answers on the survey that could potentially be used to identify you will be included in any evaluation 
report. You will also not be asked to provide your name on the survey. 
 
Risks 
While the above steps will be taken to ensure your confidentiality, there is always a chance, however small, 
that somehow evaluation staff or others reviewing your answers will be able to discern your identity. This 
could be due either to human error, or based on information available in the answers you give. As we 
indicate, however, we desire your honest opinion – and we anticipate the risk to you professionally, even if 
you are identified, to be very small.  
 
Benefits 
The benefits of your participation in the interviews and the survey are that your opinion will be strongly 
considered by decision-makers when evaluating the findings of the program, and determining the future of 
the ShangRing device in Tanzania. You will not be paid for your participation, but you will be offered a 
snack during the interviews.  
 
Alternatives:  You can choose not to participate in the ShangRing evaluation program, and subsequently 
will not be trained in its use. 
 
Do you have any questions? 
 
What does your signature on this consent form mean? 
Your signature on this form means: 
• You have been informed about this program’s purpose, procedures, and possible risks and benefits 
and the steps taken to ensure your confidentiality 
• You have been given the chance to ask questions before you sign. 
• You agree to complete the interviews at the conclusion of the ShangRing training and halfway 
through the program 
• You agree to complete the survey upon the conclusion of the program 
• You have been informed that you will not be given monetary compensation for participating 
 
I understand and accept the benefits and risk for taking part in this program as stated above.  
I have decided on my own free will to take part this program.  
 
Name of Provider: 
 
 
Signature of Provider: 
 
 
 
 
 
 
 
Day 
 
Month 
Year 
 
 

 
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Appendix XXIV – Phase 1 Provider Interview Guide 
 
Provider Interview Guide – Phase 1 to be Administered Upon Completion of Provider ShangRing Training 
Date (dd/mm/yyyy): 
 
Name of Moderator: 
 
Name of Note-Taker: 
 
Facility: 
 
Start Time:  
 
End Time: 
 
 
Introduction 
In this interview, I will ask you questions about your experience and thoughts about the ShangRing device for 
adult male circumcision now that you have been trained in its use. To protect your confidentiality, I will not 
record your name or link anything you say in a way that will make it easy to identify you. The interview will be 
recorded, but your name will not be included on the recording, and we will not store the recording in a way that 
can be used to identify you. In this interview there are no right or wrong answers. Thus, I would like your honest 
opinion and reaction to the questions that I ask. The information that you and others provide will help to 
determine the future use of ShangRing in Tanzania.  
 
Are there any questions before we begin? 
 
1. What is your role/position? 
2. What are your thoughts about medical male circumcision for HIV prevention? 
3. Prior to the training, what had you heard about the circumcision device called ShangRing? 
4. Now that you have been trained in its use, what are your thoughts about this method of circumcision? 
5. Do you think males will be interested in ShangRing circumcision? 
6. How was the training?  
7. Do you feel the training adequately prepared you to perform circumcisions using the ShangRing device? 
8. What aspect of the training was the most valuable? 
9. What was the least helpful part of the training? 
10. Are the procedures around the ShangRing device and its use clear and easy to understand? 
11. Do you have any additional thoughts or comments related to the ShangRing device that you would like 
to share? 
 
12. Do you have any final comments on ShangRing or medical male circumcision in general? 
 
 
 

 
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Appendix XXV – Phase 2 Provider Interview Guide 
 
Provider Interview Guide – Phase 2 to be Administered At Evaluation Halfway Point (After 250 total 
ShangRing circumcisions) 
Date (dd/mm/yyyy): 
 
Name of Moderator: 
 
Name of Note-Taker: 
 
Facility: 
 
Start Time:  
 
End Time: 
 
 
Introduction 
In this interview, I will ask you questions about your experience with the ShangRing device, now that you have 
used it to perform medical male circumcisions as part of this evaluation. To protect your confidentiality, I will 
not record your name or link anything you say in a way that will make it easy to identify you. The interview will 
be recorded, but your name will not be included on the recording, and we will not store the recording in a way 
that can be used to identify you. In this interview there are no right or wrong answers. Thus, I would like your 
honest opinion and reaction to the questions that I ask. The information that you and others provide will help to 
determine the future use of ShangRing in Tanzania.   
 
Are there any questions before we begin? 
 
1. What feedback have you heard from males circumcised with the ShangRing? [Note for interviewer: 
probe for positive and negative aspects] 
 
2. What kind of services or support that are not currently being offered would need to be provided if 
Tanzania is to increase the use of ShangRing? 
 
3. Do you think males would be interested in receiving ShangRing circumcisions?  
 
4. What do you like about performing circumcisions with ShangRing? 
 
5. What do you dislike? 
 
6. What has changed since you performed your first ShangRing circumcision? 
 
7. Are the standard procedures for use of the ShangRing device clear and easy to understand? 
 
8. What is your experience talking with men about ShangRing? [Note for interviewer: probe for what is 
easy and difficult, and what the provider likes and dislikes] 
 
9. In your opinion, what factors will impact the ability to use ShangRing in more sites and offer this type of 
circumcision to more men? [Note for interviewer: follow up about structural/managerial/organizational 
factors in the health clinic, as well as individual patient factors]. 
 

 
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10. What aspects of providing medical male circumcision with the ShangRing device do you find personally 
difficult? [Note for interviewer: follow up with questions on what could help address these difficulties, 
and what personal strategies the provider used to address them]. 
 
11. What issues do you think most impact a man’s decision to have a ShangRing circumcision? 
 
12. What are your thoughts on providing ShangRing circumcision compared to using conventional surgical 
circumcision techniques? [Note to interviewer: probe to see if provider feels very strongly about one 
technique or the other, and if yes follow up to inquire why provider feels this way] 
 
13. What are your thoughts on what kinds of messages that could make VMMC more appealing to men? Are 
there messages related to Shang Ring in particular that you think would resonate in men who are 
reticent to go for a standard surgical circumcision?   
 
14. Which men do you think would be most interested in ShangRing? Do you have any suggestions on 
strategies for reaching these men? (I.e. where to find these men, what medium should be used to 
deliver the message, etc.). 
 
15. Is there anything else related to ShangRing that you would like to comment on or ask? 
 
16. Do you have any final comments related to ShangRing or male circumcision in general? 
 
 
 
 

 
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Appendix XXVI – ShangRing Evaluation Provider Survey 
 
ShangRing Evaluation Provider Survey 
 
Introduction 
 
You are receiving this survey because you participated in the {insert project name} as a provider. This 
survey is meant to gauge your opinions on the ShangRing circumcision device. Your opinions will be used 
to inform the acceptability of the ShangRing device among providers, and will guide further 
implementation of the ShangRing device in Tanzania’s voluntary medical male circumcision program. 
 
All opinions expressed in this survey are anonymous and confidential. Your words may be used in future 
reports and analyses created as part of this program, but they will not be attributed to you.  
 
Please answer all questions below per the directions provided. Many questions are rated on a 1 – 5 scale. 
Some questions are open ended and offer you the chance to expand upon your answers. 
 
When complete, please return this survey to: 
 
 
Section 1 – ShangRing Training 
 
This section is meant to evaluate the training you received on the ShangRing device prior to the beginning 
of the program. Please select the rating for each question based upon the following criteria: 
 
5=Strongly Agree    4=Agree    3=Neither Agree nor Disagree     2=Disagree    1=Strongly Disagree 
 
1. The trainers possessed strong subject matter expertise:                                                   
 
 
 
5  
4 
3 
2 
1 
2. The trainers had the ability to explain and illustrate concepts:  
 
          
 
 
 
5  
4 
3 
2 
1 
3. The trainers successfully and completely answered participant questions that arose:       
 
    
5  
4 
3 
2 
1 
4. The information received during training was useful and applicable:   
       
 
 
    
5  
4 
3 
2 
1 
5. The pace of the training was appropriate:  
 
 
 
 
    
 
 
     
5  
4 
3 
2 
1 
6. The training was appropriate for your level of experience:   
 
 
    
 
 
       
5  
4 
3 
2 
1 
7. The training materials were useful and applicable:  
 
 
 
     
 
 
      
5  
4 
3 
2 
1 

 
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8. The training adequately prepared you for performing male circumcision with the ShangRing device: 
5  
4 
3 
2 
1 
9. What did you like most about the training? _______________________________________________ 
_________________________________________________________________________________________________ 
_________________________________________________________________________________________________ 
_________________________________________________________________________________________________  
10. What recommendations do you have for improving the training? ______________________ 
_________________________________________________________________________________________________ 
_________________________________________________________________________________________________ 
_________________________________________________________________________________________________ 
 
Section 2 – Performing ShangRing Circumcisions 
This section is meant to evaluate your feelings on using the ShangRing device to perform voluntary medical 
male circumcisions. Please select the rating for each question based upon the following criteria: 
 
5=Strongly Agree    4=Agree    3=Neither Agree nor Disagree     2=Disagree    1=Strongly Disagree 
 
11. I found ShangRing circumcisions to be easy to perform: 
 
 
 
 
 
 
5  
4 
3 
2 
1 
12. Compared to surgical circumcision, ShangRing circumcisions were easier to perform: 
 
 
5  
4 
3 
2 
1 
13. Compared to surgical circumcision, ShangRing circumcisions were faster to perform: 
 
 
5  
4 
3 
2 
1  
14. Compared to surgical circumcision, I find ShangRing to be a safer procedure:  
 
 
 
5  
4 
3 
2 
1 
15. I prefer performing ShangRing procedures over surgical circumcision: 
 
 
 
 
5  
4 
3 
2 
1 
16. Clients receiving ShangRing appear happier with their circumcision than clients receiving 
surgical circumcision:  
 
 
 
 
 
 
 
 
 
 
5  
4 
3 
2 
1 
17. I would advise that clients select ShangRing circumcision over surgical circumcision (if they are 
eligible for ShangRing): 
 
 
 
 
 
 
 
 
 
 
5  
4 
3 
2 
1 
18. If possible, I would like to continue offering ShangRing circumcision to clients:  
 
 
5  
4 
3 
2 
1 

 
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19. Is there anything in particular you would like to comment on in comparing conventional surgical 
circumcision with ShangRing circumcision? __________________________________________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
20. Do you have any final comments on ShangRing or male circumcision in general?____________ 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
 
 
 

 
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Appendix XXVII: Employee Confidentiality Agreement 
 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Tanzania 
Employee Confidentiality Agreement 
 
I recognize that in carrying out my assigned duties as a staff member on the ShangRing Pilot Evaluation in Tanzania, I 
may obtain access to private information about persons in this evaluation that was provided with the assumption of 
confidentiality. I understand that I am prohibited from disclosing or otherwise releasing any personally identifying 
information, either directly or indirectly, about any individual in the evaluation. If I am responsible for any breach of 
confidentiality, I understand that civil and/or criminal penalties may be brought against me. I acknowledge that my 
responsibility to ensure the privacy of protected health information contained in any electronic records, paper 
documents, or verbal communications to which I may gain access shall not expire, even after my employment or 
affiliation with this evaluation has terminated. 
By my signature, I acknowledge that I have read, understand, and agree to comply with the terms and conditions of this 
Confidentiality Agreement. 
 
Employee name (printed): ___________________________  
 
Employee signature: _______________________________  
 
Date: _____________________ 
 
Supervisor name (printed): __________________________ 
 
Supervisor signature: ______________________________  
 
Date: ___________________ 
 
 
 
 

 
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Appendix XXVIII – ShangRing Evaluation Client Withdrawal Log 
 
ShangRing Client Withdrawal Log 
 
 
 
 
Client Name 
Client ID 
Date Enrolled 
Date Withdrawn 
Reason(s) for Client Withdrawal 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix XXIX – WHO ShangRing Prequalification 
 

 
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Appendix XXX – Data Use Agreement 
 
 

 
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Data use agreement  
DATA SOURCE 
Name of study  
 
Data description  
 
NAME AND ORGANSIATION’S DETAILS OF PERSON REQUESTING DATA  
Name  
 
Organisation  
 
Email address  
Cell number  
 
DETAILS OF DATA USE 
Purpose 
 
Period  
 
From        /       /201            to            /         / 201 
Ethics regulatory authority 
approving study: 
 
Study Approval Number: 
 
Title of study:  
 
Aim of study: 
 
 
 
CONDITIONS OF USE (TICK EACH ITEM AGREED TO) 
 
  I will not attempt any linkage or combination of the study data to identify individuals 
for any purpose  
 
  I agree to make no attempt to learn the identity of any persons included in these 
data. If I should discover the identity of a person inadvertently, I will advise the Tanzanian 
Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC)  
of any such discovery in writing within 2 business days.  
 
  I agree to utilize data officially received from MoHCDGEC authorized staff person I 
will also not send data via email attachments. 
 

 
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  I will not carry individual-level data on hardcopy listings or forms 
 
  I will keep all hard copies of analysis and locked in a secure location.  
 
 Within seven (7) business days from the end of my authorized period of data use, 
defined above, I agree in consultation with Tanzania MoHCDGEC, to destroy the study 
encrypted data file and notify the MoHCDGEC data manager that this file has been 
destroyed.  
   
 I agree to notify the MoHCDGEC in writing if I will be changing positions within seven 
(7) business days prior to my planned change or exit date.  I agree not to take copies of 
the data, data analysis, printouts, runs, graphs, etc. with me when I change positions.  
 
  I will only access data on secured computers or through secure connections. A 
computer or connection is considered secure if access is through my site’s secure data 
network, which typically is a VPN (virtual private network) at the institution. 
 
 I will review all data documentation provided by the MoHCDGEC data manager for 
the analysis datasets prior to using the data to ensure that I am correctly using the 
variables in the datasets. I will contact the MoHCDGEC, if I have any questions about the 
correct use of data. 
 
 I will promptly inform the MoHCDGEC, of any deviation from these guidelines. 
 
 I will acknowledge the contribution of MoHCDGEC by including its contributors as an 
author, the PIs, the funders and study participants in any publication of this data. 
(Example below) 
 
The researchers acknowledge the contribution of all study participants and the XXX study team.  
Protocol: XXX funded by XXX under terms of the cooperative agreement xxx.      
 
 I will not copy data or share data with persons other than those identified in the 
official proposal.   
 
 I will submit all reports based on ShangRing evaluation study data to the MoHCDGEC 
for clearance, in accordance with MoHCDGEC and Funder guidelines prior to public 
release for review and comment.   
 
I understand that I am responsible for agreed upon costs incurred in the preparation and 
delivery of data and MoHCDGEC will be reimbursed for those costs within 30 days of 
notification.  
 
 
 
 

 
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Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 
This agreement may be amended by mutual written agreement of the Parties. Additionally, this agreement 
may be terminated immediately upon mutual written consent of both Parties or unilaterally by either Party 
with sixty (60) days’ written notice to the other Party. 
 
 
 
_______________________  
 
_______________________ 
 
___________ 
Name (Print)  
 
 
 
Signature   
 
 
 
Date 
 
 
_________________________________________________________________________________ 
Mailing address, email address, or fax number to receive copy of this signed agreement 
 
List other data user (add list of other users) 
 
 
 
 
 
 
Approved by: 
 
Print Name: ___________________________     Title: ______________________ 
 
 
Signature: ____________________________     Date: ______________________ 
 
 
 

 
134 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
Appendix XXXI – Investigator Qualifications 
 
*CVs available upon request  
 
 
Name  
Surname 
Affiliation 
SEV (CDC Staff 
Only) 
Qualifications* 
Gissenge 
 
Lija 
Head, HIV Prevention Unit, Tanzania 
Ministry of Health, Community 
Development, Gender and Children 
-- 
• 
MD 
Boniface 
Nguhuni 
Division of Health, Social Welfare & 
Nutrition Services, President’s Office – 
Regional Administration and Local 
Government (PORALG) 
 
• 
MD 
• 
MsC 
Lucy 
Mphuru 
IntraHealth International 
-- 
• 
MD 
Catharine  
Laube 
McDonald 
Jhpiego 
-- 
• 
BA 
Mainza 
Lukobo-Durrell Jhpiego 
-- 
• 
DrPH 
Stephanie 
Davis 
CDC-Atlanta 
13563 
• 
MD 
• 
MPH 
Melissa 
Habel 
CDC-Atlanta 
19100 
• 
MPH 
Jonas 
Hines 
CDC-Atlanta 
6212 
• 
MD 
Lawrence 
Hinkle 
CDC-Atlanta 
8564 
• 
MSPH 
Carlos 
Toledo 
CDC-Atlanta 
7632 
• 
PhD 
 
Daimon 
Simbeye 
CDC-Tanzania 
6320 
• 
MPH 
Koku 
Kazaura 
CDC-Tanzania 
18317 
• 
DDS 
• 
MPH  
Mbaraka 
Amuri 
CDC-Tanzania 
2740 
• 
MD 
• 
MPH  

 
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16 Barone MA, Li PS, Awori QD, Lee R, Goldstein M. Clinical trials using the ShangRing™ device for male circumcision in 
Africa: a review. Transl Androl Urol 2014;3(1):113-124. 
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18 Ibid. 
19 ICAP at Columbia University, Tanzania HIV Impact Assessment Survey (THIS) Summary Sheet: Preliminary Findings, 2016-
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23 World Health Organization. Framework for clinical evaluation of devices for male circumcision. September 2012. 
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136 
Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania. 
Version 4. October 22, 2018. 
 
24 Population Services International and the College of Surgeons of East, Central and Southern Africa. Adverse event action 
guide for voluntary medical male circumcision (VMMC) by surgery or device: 2nd Edition, 2016. Retrieved from: 
https://www.malecircumcision.org/resource-bundle/adverse-event-guide.  
25 Clinical VMMC Wound Healing Expert Committee. Wound healing after voluntary medical male circumcision. 
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https://www.malecircumcision.org/sites/default/files/document_library/definition_wound_healing_after_VMMC.pdf.  
26 The United republic of Tanzania, President’s Office Regional Administration and Local Government – Shinyanga Region. 
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27 National Bureau of Statistics in collaboration with the Office of the Chief Government Statistician. The 2011-2012 
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28 Ministry of Health, Community Development, Gender, Elderly and Children. Tanzania Demographic and Health Survey 
and Malaria Indicator Survey, 2015-2016. December 2016. Available: https://dhsprogram.com/pubs/pdf/FR321/FR321.pdf.  
29PS, et. al. Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed 
removal leads to detachment. J Acquir Immune Defic Syndr. July 2012; 60(3):e82-9. Available: 
https://www.ncbi.nlm.nih.gov/pubmed/22343180   
30 Barone MA, Li PS, Awori QD, Lee R, Goldstein M. Clinical trials using the ShangRing™ device for male circumcision in 
Africa: a review. Transl Androl Urol 2014;3(1):113-124. 
31 World Health Organization. Framework for clinical evaluation of devices for male circumcision. September 2012. 
Retrieved from: http://apps.who.int/iris/bitstream/10665/75954/1/9789241504355_eng.pdf?ua=1. 
32 Awori Q, Lee R, Li P, Zulu R, Agot K, Combes S, Simba R, Hart C, Lai JJ, Zyambo Z, Goldstein M, Feldblum P, Barone M. 
Surgical outcomes of newly trained ShangRing circumcision providers. J Acquir Immune Defic Syndr 2016;72:S13-S17. 
33 WHO. Tetanus and voluntary medical male circumcision: risk according to circumcision method and risk mitigation. World 
Health Organ. 2016; (August). Retrieved from: http://apps.who.int/iris/bitstream/10665/250146/1/WHO-HIV-2016.19-
eng.pdf?ua=1. 
34 Barone et. al, Clinical trials using the ShangRing™ device for male circumcision in Africa. 
35 Ibid. 
36 Ibid. 
37 Ibid. 
38 Westercamp M, Jaoko W, Mehta S, Abuor P, Siambe P, Bailey RC. Changes in male circumcision prevalence and risk 
compensation in the Kisumu, Kenya population 2008-2013. J Acquir Immune Defic Syndr 2013: doi: 
10.1097/QAI.0000000000001180. 
39 Westercamp N, Agot K, Jaoko W, Bailey RC. Risk compensation following male circumcision: results from a two-year 
prospective cohort stud of recently circumcised and uncircumcised men in Nyanza Province, Kenya. Aids Behav 2014; 18: 
1764. doi:10.1007/s10461-014-0846-4. 
40 Pebody, R. No evidence of risk compensation after circumcision in three African cohorts. NAM Aidsmap 22 February 
2017. Retrieved from: http://www.aidsmap.com/page/3119859/.  
41 Barone et. al, Clinical trials using the ShangRing™ device for male circumcision in Africa.