Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)
Phase: PHASE4
Conditions: Syphilis
Sponsor: London School of Hygiene and Tropical Medicine

 
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Syphilis self-testing to expand test uptake among men who 
have sex with men (SST): A Pilot RCT in Zimbabwe and 
China 
 
 
ISRCTN 
NCT (clinicaltrials.gov) 
 
 
 
V1.2 
26 November 2019 
 
 
 
 
 
 
SPONSOR: London School of Hygiene & Tropical Medicine  
FUNDERS: MRC/DFID/Wellcome/NIHR Joint Global Health Trials Funding Scheme 
STUDY COORDINATION CENTRE: LSHTM 
 
LSHTM ethics reference: Pending 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Protocol authorised by: 
 
Name:  
Joe Tucker 
Role: Chief Investigator 
Signature: 
 
Date:   
 
 
  
Name: 
 
Role:  
Signature: 
 
Date:   
 
 
  
Name: 
 
Role: Sponsor Representative 
Signature: 
 
Date:   
 
 
  
Main Contacts 
 
Trial Management Group 
 
Chief Investigator:  
Joe Tucker  
Clinical Research Department 
London School of Hygiene & Tropical Medicine 
 
Co-investigators:  
Rashida Ferrand  
Clinical Research Department 
London School of Hygiene & Tropical Medicine 
 
Katharina Kranzer 
Clinical Research Department 
London School of Hygiene & Tropical Medicine 
 
Michael Marks 
Clinical Research Department 
London School of Hygiene & Tropical Medicine 
 
Fern Terris-Prestholt 
Department of Global Health and Development 
London School of Hygiene & Tropical Medicine 
 
Cheng Wang 
Department of STD Control 
Dermatology Hospital of Southern Medical University 
 
Weiming Tang 
Department of STD Control 
Dermatology Hospital of Southern Medical University 
 
Imelda Mahaka 
Pangaea Zimbabwe AIDS Trust 
 
Definate Nhamo 
Pangaea Zimbabwe AIDS Trust 
 
 
 

 
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Trial Coordination Centre 
For general queries, supply of trial documentation, and collection of data, please contact: 
 
Michael Marks 
Clinical Research Department 
London School of Hygiene & Tropical Medicine 
Michael.marks@lshtm.ac.uk 
 
 
 
Clinical Queries 
Clinical queries should be directed to Michael Marks who will direct the query to the appropriate person. 
 
Sponsor 
 
 
London School of Hygiene & Tropical Medicine is the main research sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Research Governance and Integrity 
Office: 
 
 
 
London School of Hygiene & Tropical Medicine 
Keppel Street 
London WC1E 7HT 
Tel: +44 207 927 2626 
Email: RGIO@lshtm.ac.uk 
 
Funder 
This study is funded through an MRC/DFID/NIHR/Wellcome Joint Global Health Trials grant awarded to 
the investigators. 
 
This protocol describes the Zim-China-SST study and provides information about procedures for entering participants. 
The protocol should not be used as a guide for the treatment of other participants; every care was taken in its drafting, 
but corrections or amendments may be necessary. These will be circulated to investigators in the study, but centres 
entering participants for the first time are advised to contact the trials centre to confirm they have the most recent 
version.  
 
Problems relating to this trial should be referred, in the first instance, to the study coordination centre.  
 
This trial will adhere to the principles outlined in the International Conference on Harmonisation Good Clinical Practice 
(ICH GCP) guidelines, protocol and all applicable local regulations.  
 
 
 
 
 
 
 
Table of Contents 
1. INTRODUCTION 
7 
1.1 
BACKGROUND 
7 
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2.  STUDY OBJECTIVES 
8 
3.  STUDY DESIGN 
9 
3.1 
STUDY OUTCOME MEASURES 
10 
3.2 
RISKS AND BENEFITS 
10 
4. SELECTION AND WITHDRAWAL OF PARTICIPANTS 
11 
4.1 
INCLUSION CRITERIA 
11 
4.2 
EXCLUSION CRITERIA. 
11 
4.3 
WITHDRAWAL CRITERIA 
11 
5. RANDOMISATION AND ENROLMENT PROCEDURE 
12 
5.1 
RANDOMISATION OR REGISTRATION PRACTICALITIES 
12 
5.2 
BLINDING 
12 
6. TRIAL INTERVENTION 
13 
AMONG MEN IN THE CONTROL GROUP, THEY WILL RECEIVE A LIST OF LOCAL CLINICS 
THAT CAN PROVIDE FREE SYPHILIS TESTING. 
13 
7. SAFETY REPORTING 
14 
7.1 
DEFINITIONS 
ERROR! BOOKMARK NOT DEFINED. 
7.2 
CAUSALITY 
ERROR! BOOKMARK NOT DEFINED. 
7.3 
REPORTING PROCEDURES 
ERROR! BOOKMARK NOT DEFINED. 
8. ASSESSMENT AND FOLLOW-UP 
15 
8.1 
TRIAL CLOSURE 
15 
9. STATISTICS AND DATA ANALYSIS 
16 
10. MONITORING 
17 
10.1 
RISK ASSESSMENT 
17 
10.2 
MONITORING AT STUDY COORDINATION CENTRE 
17 
10.3 
MONITORING AT LOCAL SITE 
17 
11. REGULATORY ISSUES 
18 
11.1 
ETHICS APPROVAL 
18 
11.2 
CONSENT 
18 
11.4 
CONFIDENTIALITY 
18 
11.5 
INDEMNITY 
19 
11.6 
SPONSOR 
19 
11.7 
FUNDING 
19 
11.8 
AUDITS AND INSPECTIONS 
19 
12. TRIAL MANAGEMENT 
20 
13. PUBLICATION POLICY 
21 
14. REFERENCES 
22 
APPENDICES 
23 
 
GLOSSARY OF ABBREVIATIONS 
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HIV 
Human Immunodeficiency Virus 
LMIC 
Low and Middle Income Countries 
MSM 
Men who have sex with Men 
SST 
Syphilis Self Testing 
STI 
Sexually Transmitted Infections 
SAE 
Serious Adverse Event 
SUSAR 
Serious Unexpected Event 
 
KEYWORDS 
Syphilis 
Sexually Transmitted Infections 
Self-Testing 
 
 

 
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STUDY SUMMARY 
 
TITLE Syphilis self-testing to expand test uptake among men who have sex with men 
(SST): A Pilot RCT in Zimbabwe and China 
 
DESIGN Single Blind Prospective Pilot RCT 
AIMS What is the effectiveness and cost-effectiveness of a community-based syphilis self-
testing intervention (comprising a self-test kit integrated with HIV self-testing, 
simplified pictorial guidance, and photo-verification) to increase syphilis diagnosis 
and treatment among MSM (primary outcomes)? What is the effectiveness of the 
intervention to improve sexual behaviours, social outcomes, self-testing usability, 
and HIV test uptake (secondary outcomes)? 
 
OUTCOME MEASURES Proportion of individuals who undertake a syphilis test; among those who 
receive a test, the proportion of individuals who receive appropriate post-
testing services. We will also collect qualitative data on attitudes to syphilis self-
testing and quantitative data on syphilis prevalence to inform a subsequent 
clinical trial.  
POPULATION Two hundred MSM; 100 recruited in China and 100 recruited in Zimbabwe. 
 
ELIGIBILITY All residents of selected communities are eligible to participate in the study 
INTERVENTION Syphilis Self Testing: 
Treponemal rapid syphilis test kit to all individuals in the intervention arm of 
the pilot accompanied by simplified pictorial instructions on finger prick blood 
sample collection.  
Control Group 
Provision of a list of local clinics that can provide free syphilis testing. 
DURATION 6 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. 
INTRODUCTION  
 
1.1 
BACKGROUND  
 
 
Syphilis infection is a major global health problem, leading to substantial morbidity among key 
populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM) are 
disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been increasing 
amongst MSM in many countries in the last decade[1–4].  
 
Though syphilis infection can be successfully treated with penicillin, most individuals with early stages of 
syphilis are asymptomatic and so they do not seek testing and treatment, resulting in onward 
transmission[5]. Therefore, expanding syphilis testing so that individuals receive a timely diagnosis and 
treatment, plays a key role in the control of syphilis transmission [6]. However, syphilis testing rates 
remain low among MSM in low- and middle-income countries (LMICs). Studies in several countries and 
the United Kingdom suggest that increases in syphilis screening are associated with increased detection of 
asymptomatic infectious syphilis with relative falls in secondary syphilis for both HIV-positive and HIV-
negative MSM suggesting an interruption of syphilis progression [7–10].  
 
1.2 
RATIONALE FOR CURRENT STUDY 
 
A growing evidence base supporting HIV self-testing shows that self-testing kits based on the same 
proposed clinical pathways are feasible and reliable[11,12]. The proposed study will leverage this body of 
evidence and apply it to syphilis self-testing. A small body of evidence suggests some MSM in China 
already use Syphilis Self Testing (SST)[13] but there is limited data about its use more broadly in LMICs 
and no prospective RCT data on whether SST may promote increased syphilis testing and linkage to care. 
There is momentum in China to expand syphilis testing among MSM and in Zimbabwe to make health 
services more MSM-friendly. This study will build on this momentum, moving forward syphilis prevention 
and control. Increasing syphilis testing and related service uptake among MSM may contribute to 
decreased HIV risk in this population. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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2.  STUDY OBJECTIVES 
 
This is a pilot RCT designed to inform the design of a subsequent large scale RCT. 
 
Study Aims: 
What is the effectiveness and cost-effectiveness of a community-based syphilis self-testing intervention 
(comprising a self-test kit integrated with HIV self-testing, simplified pictorial guidance, and photo-
verification) to increase syphilis diagnosis and treatment among MSM (primary outcomes)? What is the 
effectiveness of the intervention to improve sexual behaviours, social outcomes, self-testing usability, and 
HIV test uptake (secondary outcomes)? 
 
Objectives: 
i) Pilot a comprehensive HIV/syphilis self-testing intervention among 200 MSM over a period of six 
months 
ii) Measure acceptability and feasibility of using syphilis self-test kits 
iii) Optimise the use of sending a test kit photograph for results reporting 
iv) Determine optimal methods for distributing self-test kits  
v) Identify clinical sites in the two cities for facility-testing and linkage to care; vi) estimate the sample size 
for a future trial 
vii) Estimate MSM retention within a self-testing trial 
viii) Estimate the cost of intervention delivery and inform our future trial. 
 
 
 

 
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3.  STUDY DESIGN 
 
 
This is a pilot study conducted in China and Zimbabwe. It aims to collect initial data on the feasability of 
implementing syphilis self-testing to establish if a large scale-RCT of this approach would be appropriate 
and, if so, to inform the design of this trial.  
 
Stage 1 Formative Work. 
This element will be conducted only in Zimbabwe as we have previously conducted similar formative 
work in China.  
 
Formative work will assess several questions 
1) What is the best way to obtain confirmation of self-testing.  
In China participants sent a photograph of their test result through an encrypted instant message to a 
coordinator; then men received a small incentive after uploading. We will explore practicalities and 
acceptability of this approach or alternative strategies in Zimbabwe.  
 
2) We will field test our surveys on the experience of self-testing amongst MSM in Zimbabwe. We will base 
our initial survey instruments off tools used among Chinese MSM before and then refine them for use in 
the Zimbabwe component of the study.  
 
Stage 2 Pilot RCT 
We will recruit 100 MSM in Harare and 100 MSM in China to join the pilot program. Both settings have an 
active MSM communities that has been successfully engaged in previous HIV self-testing research.  
 
Study Arms: 
Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) 
Arm 2:  One arm will receive standard free facility-based syphilis testing (Control Arm).  
 
Recruitment: 
Men in both sites will be recruited through two methods: in-person at MSM community-based 
organizations that currently operate HIV self-testing programs and online through banner advertisements 
that advertise HIV self-testing. This was shown in our feasibility work to be an appropriate sampling 
frame for MSM. 
 
Intervention: 
In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the 
intervention arm of the pilot, delivered through MSM community facilitators or the mail. This is similar to 

 
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existing rapid treponemal test kits that are available at many clinical facilities. Participants may request a 
further SST kit at any point during the 6 months of follow-up.  Kits will be accompanied by simplified 
pictorial instructions on finger prick blood sample collection. Among men in the control group, they will 
receive a list of local clinics that can provide free syphilis testing. 
 
Data Collection: 
For individuals in the intervention am we will aim to obtain photographic confirmation of test uptake. 
Men will send an encrypted instant message with a photograph of their test result to the local study 
coordinator. Among men who do not have a smart phone, they will send a unique five-digit code along 
with their test result to the study coordinator. 
 
We will conduct cross-sectional surveys at baseline and six months later to assess sexual risk behaviours, 
HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey data tool we 
will conduct in-depth interviews with a small number of participants to gain additional data about their 
experience of syphilis self-testing.  
 
Duration 
Participants in the Pilot RCT will be followed up to 6 months 
 
3.1 
STUDY OUTCOME MEASURES 
 
Outcomes 
PROPORTION OF INDIVIDUALS WHO UNDERTAKE A SYPHILIS TEST; AMONG THOSE WHO RECEIVE A TEST, THE 
PROPORTION OF INDIVIDUALS WHO RECEIVE APPROPRIATE POST-TESTING SERVICES. WE WILL ALSO COLLECT 
QUALITATIVE DATA ON ATTITUDES TO SYPHILIS SELF-TESTING AND QUANTITATIVE DATA ON SYPHILIS PREVALENCE 
TO INFORM A SUBSEQUENT CLINICAL TRIAL.  
 
 
3.2 
RISKS AND BENEFITS 
If improved screening for syphilis translated to improved linkage to care then patients should receive 
earlier effective treatment for their syphilis. This would be anticipated to have direct benefits 
(prevention of morbidity related to syphilis) as well as potential for indirect benefits (reduced risk of 
HIV acquisition associated with syphilis).  Patients who test positive for syphilis will be encourage to 
link to care where they will receive standard treatment for syphilis in line with national guidelines.  
 
 

 
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4. 
SELECTION AND WITHDRAWAL OF PARTICIPANTS  
 
4.1 
INCLUSION CRITERIA 
Men who must meet the following criteria: currently residing in Guangzhou or Harare and planning to 
remain for the next six months; ever had anal or oral sex with another man; born biologically male; no 
history of syphilis testing in the past 12 months; at least one sexual risk factors (defined as condomless 
anal sex sex with a man, in a non-monogamous relationship with men, more than three male sexual 
partners, positive STI diagnosis in the past, currently taking HIV PrEP); 16 years or older; willing to 
provide a mobile phone number (for follow-up); have a stable residence where you can receive self-test 
kit packages (only for Guangzhou); able to provide informed consent. 
 
4.2 
EXCLUSION CRITERIA. 
Individuals not consenting to participate in the study. 
 
4.3 
WITHDRAWAL CRITERIA 
Study participation is voluntary and study participants can withdraw at any time. The number of 
withdrawals will be recorded and only data collected prior to withdrawal will be included in the 
analysis.  Only data collected prior to withdrawal will be included in the analysis.   
 
 
 
 

 
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5. 
RANDOMISATION AND ENROLMENT PROCEDURE 
 
5.1 
RANDOMISATION OR REGISTRATION PRACTICALITIES 
 
Individuals will be randomised by generating random numbers in STATA and generating a sequence 
for each of the two clinics. The assignment will be written on cards and placed in sealed envelopes. 
 
5.2 
BLINDING  
 
This is a single-blinded study. It is not possible to blind participants as to whether they have undergone 
SST or not. Investigators responsible for performing the primary analysis (linkage to care) will be blinded 
to study arm.  
 
 
 
 

 
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6. 
TRIAL INTERVENTION  
 
6.1 
Name and description of investigational medicinal product(s) 
 
We will use treponemal syphilis test kits that have already been approved by the Chinese Food and Drug 
Association.  These kits are similar to HIV self-testing kits in terms of operation. They have excellent 
sensitivity, specificity. More details about these syphilis test kits is described in Wang et al., Clinical 
Infectious Diseases, 2019. 
 
Syphilis Self-Test Arm 
In the intervention arm we will provide a treponemal rapid syphilis test kit to all individuals in the 
intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing 
rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by 
simplified pictorial instructions on finger prick blood sample collection.  
 
Control Arm 
 
Among men in the control group, they will receive a list of local clinics that can provide free syphilis 
testing. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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7. 
SAFETY REPORTING 
 
 
7.1 
DEFINITIONS   
 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or study participant  
Serious Adverse 
Event (SAE) 
A serious event is any untoward medical occurrence that: 
Results in death 
Is life-threatening 
Requires inpatient hospitalisation or prolongation of existing hospitalisation 
Results in persistent or significant disability/incapacity 
Consists of a congenital anomaly or birth defect 
 
Other ‘important medical events’ may also be considered serious if they 
jeopardise the participant or require an intervention to prevent one of the 
above consequences.     
 
7.2 
REPORTING PROCEDURES 
Depending on the nature of the event the reporting procedures below should be followed.  Any questions 
concerning adverse event reporting should be directed to the Chief Investigator in the first instance.   
 
7.2.1 Non serious AEs 
 
The harms associated with self-testing are low. We will capture data on patient experience associated with 
self-testing through patient report and interviews using standard CRFs. Given the low risk nature of the 
intervention only unexpected non-serious AEs will be reported.  
 
7.2.2 Serious AEs 
 
Serious Adverse Events (SAEs) should be reported to the study coordination centre within 24 hours of the 
local site being made aware of the event.  The harms associated with self-testing are low and there are no 
anticipated SAEs. 
 
An SAE form should be completed and submitted to the study coordination centre with as much detail of 
the event that is available at that time.  If awaiting further details, a follow up SAE report should be 
submitted promptly upon receipt of any outstanding information.  SAEs will not require reporting or be 
considered to be SUSARs unless the severity of the event was considered to be unexpected.   
 
Any events relating to a pre-existing condition or any planned hospitalisations for elective treatment of a 
pre-existing condition do not need reporting as SAEs. 
 
 
Contact details for reporting SAEs 
Fax: xxx, attention xxx 
Please send SAE forms to: xxx 
Tel: xxx (Mon to Fri 09.00 – 17.00) 
 
 
 
 
 
 

 
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8. 
ASSESSMENT AND FOLLOW-UP  
 
Baseline Data Collection 
At baseline we will collect basic demographic data and data on sexual risk behaviours, HIV and syphilis 
testing experiences, and self-testing experiences. 
Follow-Up Data Collection 
For individuals in the intervention am we will aim to obtain photographic confirmation of test uptake. 
Men will send an encrypted instant message with a photograph of their test result to the local study 
coordinator. Among men who do not have a smart phone, there are two options for returning results: 
texting (using their analog mobile phone) a five-digit code along with test results to the study coordinator; 
dropping off the self-test kit at the local study site in Guangzhou or Harare, respectively.  
We will repeat collection of data on sexual risk behaviours, HIV and syphilis testing experiences, and self-
testing experiences at the end of the study period. In addition to the survey data tool we will conduct in-
depth interviews with a small number of participants to gain additional data about their experience of 
syphilis self-testing. 
Data on linkage to care will be obtained from administrative clinic records. Each site will provide the 
name of a single STD clinic where they can receive free treatment. In Guangzhou, this will be the 
Dermatology Hospital of Southern Medical University (2 Lujing Road, Guangzhou). In Harare, this will be a 
site chosen by the Pangaea Zimbabwe AIDS Trust based on previous research experience, penicillin 
availability, and key population training. 
 
 
8.1 
TRIAL CLOSURE 
The trial is planned to run over a 6 month period. The trial will be complete at the end of this 6 month 
period.   
 
 
 
 

 
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9. 
STATISTICS AND DATA ANALYSIS 
 
Sample Size 
Given that this is a feasibility study, the primary purpose is to assess the feasibility of syphilis self-testing 
among MSM in China and Zimbabwe. We will recruit 100 individuals in Zimbabwe and 100 individuals in 
China. 
 
Outcomes 
We will assess the number of MSM who perform a syphilis test in each of the two pilot arms. Among those 
who receive testing, we will  measure linkage to clinical services through administrative records at 
selected sites that receive training. We will compare the proportion of individuals linked to care between 
the two study arms.  
 
We will supplement our primary outcome analysis with a mixed-methods evaluation of our pilot 
intervention: 
 
1) We will conduct a process evaluation including both quantitative and qualitative metrics.  
Quantitative metrics will include the number the number of kits distributed, the number of kits with 
results reported, post-testing actions (e.g., confirmatory testing) as assessed by administrative records. 
Final in-depth interviews will provide an opportunity to assess for both benefits and harms associated 
with syphilis self-testing.  
 
2) Assessment of future large-scale trial outcome tools.  
As outlined above we will supplement this with secondary outcomes that include 
i)  photographic confirmation of self-testing 
ii) A structured questionnaire collecting data on sexual behaviours, social outcomes, self-testing usability, 
and HIV test uptake. 
 
3) We will evaluate retention by the number of MSM in the original cohort who complete the six-month 
survey instrument, who receive a test and post-testing clinical services in each of the study arms.   
 
Data Storage 
Data and all appropriate documentation will be stored for a minimum of 5 years after the completion 
of the study, including the follow-up period.   
 
 
 
 

 
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10. 
MONITORING 
 
10.1 
RISK ASSESSMENT 
This is considered a low risk study. Self-testing for HIV is a well established strategy and this study 
seeks to extend this approach to Syphilis. All testing kits used in the study are established, quality 
assured RDTs. Patients will receive standard treatment for syphilis in line with national guidelines.  
 
10.2 
MONITORING AT STUDY COORDINATION CENTRE 
Data will be entered directly into an electronic database at the time of the study.  
 
10.3 
MONITORING AT LOCAL SITE 
Site visits will take place at M0 (Baseline data collection) and M6 ((assessment of outcome).  
 
 
 

 
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11. 
REGULATORY ISSUES 
 
11.1 
ETHICS APPROVAL 
 
The Study Coordination Centre has obtained approval from the LSHTM Research Ethics Committee, the 
SMU Dermatology Institutional Review Board (China), and the Medical Research Council of Zimbabwe 
Institutional Review Board.  
Substantial protocol amendments will not be implemented until a favourable opinion has been granted from 
all ethics committee. Correspondence from both ethics committees will be maintained in the trial master 
file. As the duration of the study is 6 months the annual progress report will accompany the notification of 
the end of the study.  
 
 
11.2 
CONSENT  
 
Prior to performing any study specific procedure, written informed consent will be obtained for each 
subject. Information sheets explaining the study will be distributed to nurses who will be trained in 
explaining the study. These information sheets will also be available to study participants. Written consent 
will be obtained in the appropriate local language on all occasions.   
 
 
11.4 
CONFIDENTIALITY 
Subject confidentiality is strictly held in trust by the participating investigators, research staff, and the 
sponsoring institution and their agents. This confidentiality is extended to cover testing of biological 
samples and the clinical information relating to participating subjects. The study protocol, documentation, 
data and all other information generated will be held in strict confidence. No information concerning the 
study or the data will be released to any unauthorized third party, without prior written approval of the 
sponsoring institution. Authorized representatives of the sponsoring institution may inspect all 
documents and records required to be maintained by the Investigator, including but not limited to, 
medical records (office, clinic or hospital) and pharmacy records for the subjects in this study. The clinical 
study site will permit access to such records. All evaluation forms, reports and other records that leave the 
site will be identified only by the Subject Identification Number (SID) to maintain subject confidentiality. 
Clinical information will not be released without written permission of the subject, except as necessary for 
monitoring by HREC or regulatory agencies.  
 
11.5 
DATA MANAGEMENT 
Data will be managed according to International Conference on Harmonisation guidelines for Good 
Clinical Practices. Participants will receive a unique study identification (ID) number recorded on all 
forms. All data will be kept confidential and accessible only to trained study staff. All consent forms and 
survey information will be digital only. Notes about photographic confirmation will be added to respective 
surveys and permanently deleted 

 
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Quantitative data: Study databases will be managed by a dedicated data manager (DM) using SOPs 
developed according to the Institute procedures. All data will be checked and cleaned before being 
updated to the main database. The databases will be regularly backed up on the local server where back-
ups are maintained in the disaster recovery room and on tape media. Copies of the databases will be 
transferred to LSHTM using the secure server. ODK data will be uploaded directly to the LSHTM server. 
Paper questionnaires will be filed and stored in the archives for 5 years as per UNCST regulations.  
Qualitative data: All qualitative data will be collected on digital recording devices and transported to the 
study sites (PZAT in Harare, SMU in Guangzhou) on the day of collection. Audio-recorded qualitative data 
will be transcribed, including relevant non-verbal communications. No identifying information will be 
provided to individuals transcribing the data and they will also sign confidentiality agreements. The 
interviews will be transcribed verbatim and translated into English. After translation, interview 
summaries will be written for each interview – these will be both a descriptive and analytic synopsis of 
the interview. Interview summaries will be used to come up with a provisional coding framework. Five 
interviews will be coded line by line on paper by more than one researcher using the coding framework. 
Discrepancies will be resolved by discussion. Additional codes identified through line by line coding will 
be added to the framework. Names and other personal identifiers will be removed from transcripts before 
they are entered into NVivo 10, a qualitative data storage and retrieval program. Transcripts will then be 
coded using the modified coding framework. Codes will be grouped and emerging themes will be 
identified. Analytic memos will be written for each theme. 
 
11.6 
INDEMNITY 
London School of Hygiene & Tropical Medicine holds Public Liability ("negligent harm") and Clinical Trial 
("non-negligent harm") insurance policies which apply to this trial. 
 
11.7 
SPONSOR 
London School of Hygiene & Tropical Medicine will act as the main sponsor for this study.  Delegated 
responsibilities will be assigned locally.   
 
11.8 
FUNDING 
This study is funded as part by an MRC/DFID/Wellcome/NIHR Joint Global Health Trial Grant awarded to 
the investigators.  
 
11.9 
AUDITS AND INSPECTIONS  
The study may be subject audit by the London School of Hygiene & Tropical Medicine under their remit as 
sponsor, the Study Coordination Centre and other regulatory bodies to ensure adherence to GCP.  
 
 
 
 

 
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12. 
TRIAL MANAGEMENT 
 
A Trial Management Group (TMG) will be appointed and will be responsible for overseeing the progress of 
the trial.  The day-to-day management of the trial will be co-ordinated by Joe Tucker.  
 
All treatments in the study are being given for standard indications and the drugs have known safety 
profiles including in the setting of co-administration. A DSMB will therefore not be appointed.  
 
All data will be held jointly by LSHTM and collaborators. Data will be stored on an encrypted password 
protected server at both LSHTM.  
 
 
 
 

 
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13. 
PUBLICATION POLICY 
 
All publications and presentations relating to the study will be authorised by the Trial Management Group.  
The first publication of the trial results will be in the name of the Trial Management Group, if this does not 
conflict with the journal’s policy.  If there are named authors, these will include at least the trial’s Chief 
Investigator, Statistician and Trial Coordinator.  Members of the TMG and the Data Monitoring Committee 
will be listed and contributors will be cited by name if published in a journal where this does not conflict 
with the journal’s policy.  Authorship of parallel studies initiated outside of the Trial Management Group 
will be according to the individuals involved in the project but must acknowledge the contribution of the 
Trial Management Group and the Study Coordination Centre. 
 
 
 

 
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14. 
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First: 1 July 2019. doi:10.1093/cid/ciz603 

 
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APPENDICES 
1. Informed Consent Form 
2. Study Information Sheet 
3. Data Collection Forms