Expanding HIV Testing Among Uganda Adults Who Utilize Traditional Healers
Phase: NA
Conditions: HIV/AIDS, Health Behaviors
Sponsor: Weill Medical College of Cornell University

Expanding HIV testing among Ugandan Adults who Utilize Traditional Healers:  
a cluster randomized controlled trial  
 
Version Date 1 August 2018 
 
 
WCMC IRB number: 18030119105 
MUST Ethical application number: 16/01-17 
Clinicaltrials.gov NCT #03718871 
 
Study sponsor: National Institute of Mental Health/US National Institutes of Health 
(K23MH111409) 
 
 
 
Principal Investigator: 
 
Radhika Sundararajan, MD PhD 
Assistant Professor  
Weill Cornell Department of Emergency Medicine and  
Center for Global Health 
525 East 68th Street 
New York NY 10068 
 
Co-Investigators: 
 
Juliet Mwanga-Amumpaire, MD 
Director, Epicentre Research Centre and  
Associate Professor of Pediatrics  
Mbarara University of Science and Technology 
Mbarara, Uganda 
 
Daniel Fitzgerald MD 
Director, Weill Cornell Center for Global Health 
402 East 67th Street 
New York NY 10068 
 
 
 
 

 
2 
Table of Contents 
ABBREVIATIONS ...................................................................................................................... 3 
1. PROTOCOL SUMMARY ........................................................................................................ 4 
2. BACKGROUND AND RATIONALE ....................................................................................... 5 
3. STUDY DESIGN ..................................................................................................................... 6 
3.1 DESIGN .............................................................................................................................. 6 
3.2 OVERALL APPROACH ........................................................................................................... 6 
4. RECRUITMENT AND ENROLLMENT .................................................................................... 6 
4.1 INCLUSION AND EXCLUSION CRITERIA ................................................................................... 6 
4.2 INFORMED CONSENT ........................................................................................................... 7 
4.3 SUBJECT ENROLLMENT ....................................................................................................... 7 
4.4 SAMPLE SIZE ....................................................................................................................... 7 
5. STUDY PROCEDURES.......................................................................................................... 7 
5.1 INTERVENTION ARM ............................................................................................................. 7 
5.2 CONTROL ARM .................................................................................................................... 8 
5.3 FOLLOW UP ......................................................................................................................... 8 
6. STATISTICAL CONSIDERATIONS ....................................................................................... 8 
6.1 OUTCOMES ......................................................................................................................... 8 
6.2 ANALYSIS PLAN ................................................................................................................... 8 
6.3 INTERVENTION EVALUATION ................................................................................................. 8 
7. DATA COLLECTION AND MONITORING ............................................................................. 9 
7.1 TRAINING AND CONSIDERATIONS .......................................................................................... 9 
7.2 PRIVACY AND CONFIDENTIALITY ........................................................................................... 9 
7.3 DATA SAFETY AND MONITORING ........................................................................................ 10 
7.4 ADVERSE EVENT REPORTING............................................................................................. 10 
7.5 QUALITY ASSURANCE ........................................................................................................ 11 
7.6 EXPECTED OUTCOMES ...................................................................................................... 11 
8. HUMAN SUBJECTS ............................................................................................................ 11 
8.1 PROBLEMS ANTICIPATED ................................................................................................... 11 
8.1.2 Psychological risks.................................................................................................... 11 
8.1.3 HIV test related discomfort ........................................................................................ 12 
8.1.4 Possibility of false HIV test results ............................................................................ 12 
8.1.5 Loss of confidentiality ................................................................................................ 12 
8.2 Reasonableness of risks .............................................................................................. 13 
8.3 Obtaining Informed Consent ........................................................................................ 13 
9. DISSEMINATION AND PUBLICATION ................................................................................ 14 
REFERENCES ......................................................................................................................... 15 
 

 
3 
 
ABBREVIATIONS 
 
 
AIDS 
Acquired immunodeficiency syndrome 
ART 
Antiretroviral therapy 
DSMB 
Date Safety and Monitoring Board 
HIV 
Human immunodeficiency virus  
IRB 
Institutional Review Board 
ISS 
Immune suppression syndrome 
MUST 
Mbarara University of Science and Technology 
NIH 
National Institutes of Health 
NIMR 
National Institute of Medical Research 
PI 
Principal Investigator 
POC 
Point of care 
PrEP 
Pre-exposure prophylaxis 
TH 
Traditional healer 
WCMC 
Weill Cornell Medical College 
WHO 
World Health Organization 
 
 

 
4 
1. PROTOCOL SUMMARY 
 
Study Summary: HIV antiretroviral therapy has the potential to dramatically decrease HIV 
transmission worldwide1; yet, a barrier to ending the AIDS epidemic in low-resource settings is 
the fact that healthcare is largely provided by traditional or spiritual healers rather than 
biomedical providers2-4, and there are no strategies in place to identify HIV-infected patients 
among Traditional Healer patients and link them to HIV care. In order to reach the UNAIDS 90-
90-90 benchmarks HIV services must reach marginalized populations in endemic regions5, such 
as in southwestern Uganda. Uganda is one of seven sub-Saharan African countries accounting 
for 90% of all new HIV infections in this region6. HIV prevalence is 7.3%, with ~1.5 million 
people living with HIV/AIDS and 99,000 new infections in 20147. However, only 50% of sexually 
active Ugandans have ever tested for HIV8,9. Like much of sub-Saharan Africa, the majority of 
Ugandans utilize traditional and faith-based healers10,11. Healers are more accessible than 
biomedical providers in resource-poor settings. Use is driven by preference as well as 
accessibility: healers are considered uniquely qualified to treat afflictions believed incurable by 
biomedicine12. They are respected community leaders who shape clients’ utilization of HIV 
services4. Those who utilize traditional healers may present to biomedical facilities late in their 
illness, or not at all13.  
 
Study Aim and Overall Study Design: Develop a POC HIV testing intervention at TH locations 
using a cluster randomized study design. This study will be conducted among TH clients at 10 
TH practice locations, to be compared with a control group receiving usual TH care. This pilot 
will offer HIV testing at TH practice sites to 250 TH clients. Primary outcome for this study will 
be rates of HIV testing among TH clients. Secondary outcomes will include i) number of new 
HIV diagnoses among TH clients, ii) socio-demographic factors that predict HIV testing, and iii) 
percentage of patients with +HIV POC test who successfully link to HIV care in 3 months.  
This novel approach will have significant public health impact by expanding HIV testing and 
linkage to care, thereby reducing morbidity, mortality, and HIV transmission in a highly endemic 
region. This approach could be scaled for delivery in other HIV-endemic, medically pluralistic 
communities. Pilot results will be integrated with data from ongoing research in southwestern 
Uganda to propose a large-scale, cluster-randomized trial of this community-based HIV testing 
program in Eastern Africa.   
 
Study Duration: 12 months (July 2019 – June 2020) 
 
Primary Endpoint: Rate of HIV testing among TH clients at 3 months 
 
Secondary Endpoints: i) number of new HIV diagnoses among TH clients at 3 months post 
enrollment; ii) percentage of patients with +HIV POC test who successfully link to HIV care at 3 
months post enrollment and iii) variables that predict HIV testing.  
 
 
 
 
 
 
 
 
 

 
5 
2. BACKGROUND AND RATIONALE 
 
HIV antiretroviral therapy (ART) has the potential to dramatically decrease HIV transmission 
worldwide1,2. UNAIDS has set the goal that 90% of HIV-infected people should be tested and 
know their status, so they can access life-saving ART14,15. In order to reach the UNAIDS 
benchmarks, HIV testing must reach marginalized populations in endemic regions16. 
Decentralized5, community-based4,5 approaches have been promoted as the key to expanding 
access to HIV care within low-resource settings. However, successful implementation of 
community-based services requires an understanding of the social and cultural context that 
influence community engagement with HIV services. Specifically, many HIV endemic regions 
are also medically pluralistic communities, where multiple explanatory frameworks for health 
and disease co-exist. In these areas, HIV testing and ART clinical care do not occur in isolation; 
traditional healers are commonly utilized instead of or concurrently with biomedical services8,9. 
Therefore, the success of decentralized, community-based HIV services must be founded upon 
a thorough understanding of medical pluralism, and engagement with traditional healers as 
stakeholders in community health.  
 
Uganda is one of seven sub-Saharan African countries accounting for 90% of all new HIV 
infections in this region17. HIV prevalence is 7.3%, with ~1.5 million people living with HIV/AIDS 
and 99,000 new infections in 20146. However, only 50% of sexually active Ugandans have ever 
tested for HIV7. These data indicate poor progress towards the UNAIDS 90-90-90 targets for 
ending the HIV epidemic8,9. Our study will characterize factors that shape HIV testing behavior 
among communities with poor biomedical engagement and pilot an intervention to expand 
access to HIV testing. Patients prefer to visit traditional healers to treat “African” diseases, 
believed incurable by biomedicine16. Healers in sub-Saharan Africa serve as herbalists, 
counselors, social workers, spiritual guides, and legal advisors12. Pregnant women may prefer 
healers as home birth attendants over biomedical facility deliveries10,12,13,18-21. Healers are 
authorities on health concerns, and considered more credible sources of health information than 
healthcare workers or biomedical clinicians18,20,21. As higher rates of HIV testing3,11,13 and 
improved engagement with HIV care22 are correlated with regular contact with a health provider, 
healers are potential partners for HIV-infected clients throughout the care continuum23-25. Our 
study will investigate feasibility of involving TH in HIV testing and pilot an intervention to expand 
HIV testing within communities that use traditional medicine.  
 
An AIDS-free generation cannot be achieved until HIV care is expanded to communities where 
the burden of disease continues undetected26-28. Healers have access to patients and potential 
influence to promote HIV testing and engagement with ART services. The proposed research 
holds promise for dramatically expanding HIV testing and early engagement with HIV services 
to a large population who otherwise may not access biomedical care. 
 
 
 

 
6 
3. STUDY DESIGN  
 
3.1 Design: Previously conducted qualitative work and observational data will inform 
implementation of a pilot study, offering HIV testing at traditional healer locations in 
southwestern Uganda. No compensation will be provided for healers in the intervention or 
control arms of the intervention. We will follow Ugandan National protocols29 to administer 
voluntary HIV counseling and testing at healer practices in Mbarara District. Clustering for this 
trial will occur at the level of healer practices. For the intervention arm, we will recruit 250 clients 
from ten healer practice locations. For the 
control arm, we will observe 250 healer 
clients at ten healer locations undergoing 
“enhanced standard of care”, where healers 
will participate in a pre-trial educational 
session describing community HIV resources 
available for clients, and how to access them. 
Enrollment will take place from twenty 
traditional healer practices, over a period of 
four months. The follow up period will be 
three months. Primary outcome for this 
intervention will be rates of HIV testing among 
TH clients (Figure).  
 
3.2 Overall Approach: We will select twenty 
traditional healer practices to participate in 
this study from among the ~170 known 
practices in this District, and group them by 
specialty (herbalist, birth attendant, spiritualist, bone 
setter). Within each specialty group, we will randomly 
select half to participate in the intervention arm (N=10); the remaining half will participate in the 
control arm (N=10). Healers in both study arms will keep a log of participants indicating whether 
HIV testing was delivered (intervention) or if the participant was referred to HIV testing (control). 
Many healers have little formal education and describe themselves as “illiterate”; study logbooks 
will be created accordingly. Research assistants will create stickers with de-identified study 
identification numbers for each participant. The healer will place the participant ID sticker in the 
log book (thereby avoiding the need to be able to write numbers); logs will show pictures for 
receiving point-of-care HIV testing, or not testing (in the intervention arm), or referral to the 
District HIV clinic for HIV testing, or not referring (for the control group). Healers will circle the 
corresponding picture for each participant based on the outcome of the session. Research 
assistants will be on site, or reachable via mobile phone, to answer any questions the healers 
have about record keeping or study procedures. 
 
4. RECRUITMENT AND ENROLLMENT  
4.1 Inclusion and Exclusion Criteria: Inclusion criteria for healer clients are 1) 18 year of age 
or older; 2) able to provide informed consent, 3) not known to be HIV infected; 4) willing to be 
contacted for monthly follow up for 3 months; and 5) willing to complete an exit survey after 3 
months. For the intervention (HIV testing) arm, participants must agree to receive their POC HIV 
test results. Exclusion criteria include being under the age of 18, incapable of giving informed 
consent, previously being diagnosed with HIV, being unwilling to receive HIV test results, and 
Figure. Approach for HIV testing pilot  

 
7 
unwilling to participate in the testing intervention. Participating healers are eligible to participate 
if they meet the UNAIDS definition of traditional healer8, and are willing to participate in study 
procedures. We will select from among healers with patient volume greater than 7 patients per 
week in order to ensure that participant recruitment progresses in a timely manner for this pilot 
study.  
4.2 Informed Consent: We will obtain written informed consent from both traditional healers 
(N=20) and their clients (N=500) participating in this study. Participating clients must consent to 
providing three telephone contact numbers (self, friend, and family member), home address, 
and permission for the research team access to medical records from the District HIV clinic. In 
addition, they must consent to a home visit, if they are not reachable for follow up via phone. 
Healers must consent to keeping a logbook of which patients received HIV testing (intervention 
arm) or referred to HIV testing (control arm). 
4.3 Subject Enrollment: One research assistant will be assigned to each arm of the study and 
will base themselves at healer practices to consecutively enroll 25 clients from each healer until 
we reach as sample size of N=500 (four-month enrollment period). The research assistant will 
assign a unique study ID number to each participant, collect demographic information, and 
locator information for the participant and two back up contacts. This information will be used for 
monthly follow-up assessments, and to deliver the exit interview. 
4.4 Sample size: N=250 adults will be enrolled in each arm. Community-based HIV-testing in 
sub-Saharan Africa has excellent uptake (~97%)30; based on these data, we expect 90% uptake 
of HIV testing in our intervention arm. Assuming HIV prevalence is equivalent to that in our 
cross-sectional study (9%), we will identify ≥20 newly diagnosed HIV-infected patients among 
our sample of TH clients ([250 x .90] x 0.09 = 20.25). This aim is exploratory in nature. Sample 
size will be calculated based on data from an observational census of traditional healers in the 
study area and will be included in a forthcoming amendment.  
5. STUDY PROCEDURES 
5.1 Intervention arm: Healers assigned to the intervention arm (N=10) will attend a half-day 
training session prior to trial initiation, led by District HIV clinic staff. This training session will 
demonstrate proper use and disposal of the point-of-care HIV testing kit and provide training 
regarding patient pre- and post-test counseling. Healers will be instructed to discuss the benefits 
of linking to HIV care, including importance of initiating treatment for HIV infection, reducing 
possible transmission to others, and health benefits of starting ART early, as part of post-test 
counseling. In addition, this training session will discuss resources available at the ISS clinic, 
including mental health counselors, family and partner support groups, counselors trained to 
discuss serostatus disclosure strategies, and reproductive health counselors. Supplies for point-
of-care HIV testing and biohazard-compliant disposal will be provided to healers at the start of 
the trial. HIV 1/2 antibody point of care test (Oraquick©) will be administered to participants who 
agree to test. This test is non-invasive, conducted using oral fluids (rather than whole blood), 
and is FDA-approved for adult use, with results in 20 minutes. Test results are clearly marked 
with lines, rather than letters or numbers; this test is validated for use by non-medical personnel, 
with 99.9% specificity and 91.6% sensitivity. Clients with positive tests will be referred to the HIV 
clinic for Western Blot confirmation, and linkage to care. Following the healer visit, participants 
will be contacted once per month, for a period of 3 months, to assess for POC test results, and 
linkage to care for those who test HIV+.  

 
8 
5.2 Control arm: Control arm healers (N=10) will participate in a half-day session prior to trial 
initiation, led by District HIV clinic staff. This educational session will discuss WHO and Ministry 
of Health guidelines for HIV testing, who should receive HIV testing and how often, and where 
to receive it. Participating patients of healers will then receive “enhanced standard of care” as 
part of the control arm of the trial. Following the visit, study staff will contact the client once per 
month, for 3 months, to assess for HIV testing since enrollment in the study.  
5.3 Follow up: We will contact participants using their mobile phone numbers. If unable to 
reach after multiple attempts, study staff will call the backup contact to inquire about the 
participant’s (taking care not to mention HIV). If this inquiry is not informative, study staff will visit 
the participant’s home, wearing unmarked clothes and not speaking about HIV with anyone 
except privately with the participant. In 2014, a Pew Research Center survey indicated that 65% 
of Ugandans owned a mobile phone (http://www.pewglobal.org/2015/04/15/cell-phones-in-
africa-communication-lifeline/); therefore, we anticipate that a majority of participants will have a 
mobile contact number. If unable to reach the participant at their mobile phone number after 
multiple attempts, the backup contact will be called. If no mobile number is available for the 
participant, we will ask for a mobile number for a backup contact to use for communication. 
Study staff will call the backup contact to attempt to speak with the participant (taking care not to 
mention HIV). All calls will be made from study cell phones, not linked to any hospital or clinic, 
such that caller ID or callbacks to the outgoing number will not indicate correlation with HIV 
research. This process will be followed for participants in both the intervention and control 
groups. If these inquiries via phone are not informative, a single member of the study staff will 
visit the participant’s home at the address provided, via personal vehicle, wearing unmarked 
clothes. This staff member will ask to speak with the participant, and will not discuss the study, 
or the topic of HIV with anyone, except privately with the participant. If home visits are 
necessary to establish follow-up, we will send a gender-matched staff member (i.e., female staff 
member for female participant), to minimize suspicion from family or partners who may not be 
aware of client’s participation in the study.  This staff member will describe him/herself as a 
friend from Mbarara, who is inquiring about the whereabouts of the participant.  
6. STATISTICAL CONSIDERATIONS 
6.1 Outcomes:  The primary outcome for this Aim is rate of HIV testing among TH clients. 
Secondary outcomes will include i) new HIV diagnoses among TH clients, ii) patients with +HIV 
test who successfully link to HIV care in 3 months30, and iii) variables that predict HIV testing. 
The results of this Aim are central to demonstrating feasibility for a subsequent R01 proposal.  
6.2 Analysis plan: Descriptive statistics will characterize participants and summarize the data. 
A multi-level logistic regression model – with individual clients in level 1 nested within healers in 
level 2 – will be used to calculate the odds ratio for primary outcomes within three months in the 
intervention compared with the control arms. Adjusted analyses will be conducted as secondary 
or sensitivity analyses using multivariable, multi-level analyses for both binary and continuous 
variables. All analyses will be performed in R software. 
6.3 Intervention evaluation: 3 months following enrollment, all participants will be contacted for 
an exit survey to understand experiences of participation in the study, undergoing HIV testing, 
or deciding not to test. In-depth interviews will be conducted with participating healers at the 
close of the intervention to obtain feedback on delivering POC testing at their practice locations 
and assess how the study may have impacted their beliefs and practices. 
 

 
9 
7. DATA COLLECTION AND MONITORING 
 
7.1 Training and Considerations: All study staff will receive extensive human 
subjects/research ethics training, including the need for complete confidentiality and to 
approach questions with sensitivity and in a supportive manner and to provide appropriate 
referrals when needed. All interviews, surveys and HIV tests will be conducted in private. Study 
staff will be trained not to press participants to answer questions or engage in intervention 
activities that seem to be distressing to them, and sessions are terminated if the participant is 
too distressed, too fatigued, or too frustrated by the effort. Qualitative interviews will be 
terminated if the participant is too distressed, too fatigued, or too frustrated by the effort. In the 
event that significant depression symptoms or suicidality are noted, the staff will be instructed to 
follow procedures in the safety protocol, which include immediately contacting Dr. Mwanga-
Amumpaire to arrange referral to appropriate service agencies at Mbarara Regional Referral 
Hospital or within the community, and reporting incidents or concerns to Dr. Mwanga-
Amumpaire or the US-based PI, Dr. Sundararajan. 
 
7.2 Privacy and Confidentiality: We will safeguard against loss of confidentiality in a number 
of ways. To minimize risk during the consent process, all recruitment and consent for 
participation will be done in a private tent, with closed panels. Individuals will be recruited 
separately and undergo informed consent separately (regardless of whether they arrived at the 
healer location with a friend or family member). This will reduce risk of loss of confidentiality as 
well as risk of coercion from others. All interviews, surveys, and POC HIV testing will take place 
in private locations. Pretest and post-test counseling will similarly take place in private tents, 
therefore minimizing risk of loss of confidentiality during relaying of HIV testing results. During 
the follow up period, study stuff will not identify the project as one related to HIV; study staff will 
contact the participant via mobile phone. They will be instructed not to discuss anything related 
to the study except with the participant. They may visit the participant’s home if unable to 
contact via phone numbers provided. For this, they will wear unmarked clothes and not speak 
about HIV or the study with anyone, except in private with the participant.  
 
Loss of confidentiality will also be minimized through de-identification of study data. Only the 
participant’s study ID number will appear in the paper or computer-generated files. The key to 
participants’ code number will be encrypted in a computer file, which will be kept in locked 
offices at MUST. Only Dr. Sundararajan (PI), Dr. Mwanga-Amumpaire, and the research 
assistants will be able to unencrypt these computer files. In addition, all study staff will be asked 
to sign a confidentiality pledge. In signing this pledge, the researcher agrees not to divulge the 
identity of any study participant outside of the study team, nor discuss the particularities of any 
participant’s story with anyone outside the study team.  
 
Study participants may feel reticent to share information about sexual orientation, and this may 
be a limitation of our study approach. However, the vast majority of HIV transmission in sub-
Saharan Africa occurs through heterosexual intercourse31, and therefore we do not anticipate 
that unwillingness to disclose homosexual orientation will negatively impact our data collection 
or results. Participants will be reminded during questionnaire administration that answers 
regarding sexual orientation will be kept between study participant and research team, and that 
numerous mechanisms are being undertaken to safeguard their identity, including de-
identification of study data.  
 
For potential participants for the testing intervention arm who presents with sexual partners, we 
will carry out private, individual recruitment and consent, and request if we could include the 
partner in the HIV testing process.  If permission is granted by the participant, then we will 1) 

 
10 
assess if the partner meets criteria for inclusion as a participant; 2) if s/he meets inclusion 
criteria, the participant will undergo informed consent; and 3) we will conduct the remainder of 
the study procedures with both members of the couple present, and participating. If the partner 
does not meet criteria for inclusion, then the partner will be present for his/her partner’s study 
procedures. If permission is refused, we will continue with pre-test counseling, testing, relaying 
of POC HIV test results, and post-test counseling in private. We will specifically train our 
research assistants to conduct post-test counseling that discusses issues specific to 
serodiscordant couples, including reducing risk of HIV transmission, reproductive issues and 
efficacy of PrEP. In addition, we will encourage the participant to disclose to his/her partner, and 
refer them to the HIV clinic, which has counselors who specifically assist clients with serostatus 
disclosure strategies and has resources for serodiscordant couples. By following a strict 
strategy of individual, private consent, our study procedures seek to reduce coercive influences 
from partners or family members who may be present with the participant.  
 
MUST has completed numerous research studies on human subjects and maintained full 
confidentiality of participant records over the preceding decade. MUST has close collaborative 
relationships with the local HIV clinic, with no-cost resources for testing, treatment and 
counseling; participants will be referred to these resources as necessary over the course of this 
research. Due to the nature of this research, we will ensure that study staff undergo training on 
good clinical practices for human subjects research, with extensive piloting of informed consent 
and study practices, until staff are comfortable and knowledgeable. Specifically, we will train 
them to identify situations where coercion may be occurring as to avoid placing undue risk on 
the potential participant. Refresher courses on relevant topics will be carried out as needed, at 
least once every 6 months.  
 
7.3 Data Safety and Monitoring: No stopping rules have been defined for this project, given 
the minimal risks to participants. The research procedures are minimally invasive and present 
low risks to the study participants. Subjects are volunteers and may drop out of the study at any 
time, without any recourse. They are informed of such during the consent process.  
 
This study is a pilot intervention, so a DSMB is not required. The PI, Dr. Sundararajan, and local 
Co-Investigators will review study progress during bi-monthly conference calls. MUST and 
WCMC IRBs will receive reports annually. Additionally, if necessary, we may utilize the services 
of the Weill Cornell Medical Center’s Data Safety and Monitoring Board (DSMB), which has 
been designed to ensure the safety and welfare of participants and the validity and 
confidentiality of data. The board’s responsibilities include reviewing protocols, informed 
consent documents, and plans for data safety and monitoring, evaluating the progress of 
intervention trials, participant risk versus benefit, periodic assessments of data quality and 
timeliness, and other factors that can affect the safety of study participants. The board makes 
recommendations to the PI and NIH (e.g., the observed beneficial or adverse effects of the 
study, interim analysis of efficacy). The WCMC DSMB meets monthly. The DSMB will receive 
all adverse event reports and will review stopping rules and interim analyses, where applicable. 
Data analysis will be conducted every 3 months and discussed with the research team. Annual 
reports will be submitted to the WCMC IRB, MUST IRB and NIMH.  
 
7.4 Adverse Event Reporting: The Principal Investigator, Dr. Sundararajan, and the Weill 
Cornell Medical Center IRB will be directly responsible for monitoring the security of the data 
and safety of participants. Project staff will report emotionally distressed participants to Dr. 
Sundararajan and Dr. Mwanga-Amumpaire. Dr. Mwanga-Amumpaire will be responsible for 
evaluating and referring the participant to an appropriate agency at MUST or in the community. 
Drs. Sundararajan and Mwanga-Amumpaire will be responsible for immediately reporting any 

 
11 
breaches of protocol, breakdowns in the consent process, violations of confidentiality of the 
data, complaints by participants or any serious problems or adverse events. An incident report 
will be filed with Dr. Sundararajan. Incident reports, serious problems or adverse events will be 
reported to the WC IRB by Dr. Sundararajan. The IRB will report to NIH and DHHS if warranted. 
Requests for the use of these data by persons outside of the project will be decided upon by the 
PI, Dr. Sundararajan and a committee comprised of coinvestigators. The IRB will be informed 
and any concerns will be addressed before data are released. 
 
As participation in this study involves minimal commitment, we do not anticipate any negative 
impact from study closure or from the subject voluntarily leaving the study. Study subjects will 
not be terminated for any specific reason. All potentially adverse events or serious problems will 
be reported by Dr. Mwanga-Amumpaire within 48 hours on a standard form and this information 
will be immediately shared with Dr. Sundararajan for reporting to the Weill Cornell IRB with a 
copy to the Office of Human Subjects. Study staff will also be debriefed on a weekly basis to 
address issues that have come up throughout the course of data collection. All project staff will 
receive verbal and written instructions pertaining to the rules governing the maintenance of 
confidentiality upon completion of the study or if they leave the study before its completion. 
 
7.5 Quality Assurance: The PIs will oversee data quality control and assurance. They will 
review all informed consent documents and study eligibility checklist forms. Dr. Sundararajan 
and Dr. Mwanga-Amumpairewill review data files for internal validity and completeness and 
send queries to the data management team in Mbarara each week. The team will respond to 
queries within one week. During the trial, all informed consent and data collection documents 
will be verified by the study research coordinator. 
 
7.6 Expected Outcomes: The goal of the proposed research is to expand access and 
engagement with HIV testing in Mbarara by delivering point of care tests at traditional healer 
locations. This study also has important benefits to healthcare delivery in Uganda as it focuses 
specifically on early diagnosis of HIV, the leading cause of hospital admissions in this country. 
The primary and secondary outcomes of the proposed intervention seek to improve health in 
these regions such that morbidity and mortality are decreased as a result of linkage to 
outpatient care. The proposed study has the potential to improve rates of HIV testing throughout 
Uganda, reduce HIV transmission and improve linkage to care. People from other African 
countries who utilize the services of traditional healers may benefit in the future from the 
knowledge gained in this study. The results of this study may be expanded to improve access to 
HIV testing among adults in Uganda and other similar settings. Outcomes will be used to better 
understand factors influencing engagement with HIV services in endemic areas, where 
traditional medicine is commonly used. We also hope that the Community Advisory Board 
formation will facilitate positive, ongoing relationships between healers, biomedical providers, 
and patients. 
 
8. HUMAN SUBJECTS 
 
8.1 Problems Anticipated:  
 
8.1.2 Psychological risks: For Aim 1, some participants may find it distressing to discuss past 
HIV testing behaviors, their healthcare seeking trajectory, or experiences with biomedical 
providers. All study staff will be trained not press participants to answer questions or discuss 
information that seem to be distressing to them, and to terminate sessions if the participant is 
overly distressed, fatigued, or frustrated by the effort. In the event that clinically significant 
depressive symptoms, suicidality, or other psychiatric conditions are noted, the staff will be 

 
12 
instructed to report any incidents or concerns to Dr. Mwanga-Amumpaire, who will assess the 
participant, offer needed support or arrange for appropriate referral to a counselor or community 
service provider. In addition, the PI, and all team members have completed Human Subjects 
Training and Certification Program or equivalent certification at their institution. Dr. 
Sundararajan has had experience conducting social science research among international, 
marginalized populations and received previous training in the ethical issues that may arise, and 
procedures utilized to handle protection against risks. Dr. Mwanga-Amumpaire has years of 
experience conducting confidential and interviews regarding sensitive topics among socially 
marginalized and key populations. All study staff will receive extensive human subjects/research 
ethics training, including the need for complete confidentiality and to approach questions with 
sensitivity and in a supportive manner and to provide appropriate referrals when needed. 
Qualitative interviews will be terminated if the participant is too distressed, too fatigued, or too 
frustrated by the effort. In the event that significant depression symptoms or suicidality are 
noted, the staff will be instructed to follow procedures in the safety protocol, which include 
immediately contacting Dr. Mwanga-Amumpaire to arrange referral to appropriate service 
agencies at MUST or within the community, and reporting incidents or concerns to the US-
based PI, Dr. Sundararajan. 
 
It is possible that participants may be identified by others as receiving HIV testing, including 
healthcare personnel, or sexual partners, or become the subject of HIV-related stigma through 
participating in this study. In addition, any time a person receives a new diagnosis of being HIV-
infected there is a possibility that they will be exposed to stigma from family, partners and other 
members in their community; external stigma in these cases may involve rejection, 
estrangement, loss of employment or harassment32. Internal stigma may also develop, resulting 
in shame, depression, and psychological isolation. For women, being HIV-infected may be 
associated with higher risk of experiencing intimate partner violence. We will work with healers 
and HIV clinic staff to educate the community to lessen stigma against HIV. Healers will provide 
post-test counseling for all participants, which will include resources to support their 
psychosocial health, and provide resources for partners and family members.  
 
8.1.3 HIV test related discomfort: The Oraquick testing process is non-invasive and produces 
results based on oral fluid samples. We do not anticipate any physical discomfort as a result of 
the tests administered in the intervention.  
 
8.1.4 Possibility of false HIV test results: Given the high specificity and sensitivity of the rapid 
tests (99.9% specificity and 91.6% sensitivity), false positives and negatives are unlikely. 
Participants with positive rapid HIV tests will be referred to the Mbarara Referral Hospital HIV 
clinic for confirmatory testing, and where they will have CD4 testing and subsequent clinical 
evaluation. They will be provided specific instructions on how to get there and what to do when 
they arrive. Healers in the intervention arm will undergo training prior to trial implementation to 
ensure they are delivering the point of care tests correctly. We note that these point of care tests 
have been validated for use among laypersons, with extremely high sensitivity/specificity. 
Research assistants will work with intervention arm healers every few days to ensure testing 
procedures are followed. Patients with positive HIV testing will be directed to the Mbarara 
Referral Hospital HIV clinic for confirmatory testing. Patients with negative HIV tests will be 
counseled to follow up in 3-6 months for re-testing, as is standard protocol according to 
Ugandan HIV testing guidelines.  
 
8.1.5 Loss of confidentiality: Though this study will include both HIV-infected and non-infected 
adults, it is possible that participants may be identified by others, including healthcare 
personnel, as being HIV infected by participating in this study. We will safeguard against this by 

 
13 
conducting interviews, recruitment, and point-of-care testing in private locations. All subject data 
will be de-identified using a study identification number consisting of a unique code unrelated to 
any patient identifying information, as per Good Clinical Practice guidelines. Any identifiers 
linked to the participant will be secured and only available to study staff, to ensure subject 
confidentiality. Study data will be stored in a locked room at MUST, and on a password protected, 
encrypted computer. Access to study data will be limited to study staff only. No personally 
identifiable information will be available during data coding, organization, analysis, or publication. 
NIMR computers and servers are protected by firewall protection and are only accessible with a 
password. Study staff will be trained in Good Clinical Practice regarding maintaining 
confidentiality. We will provide intensive counseling and education to all participants on the 
importance of confidentiality. In keeping with Ugandan Ministry of Health policy, MUST and 
Mbarara Regional Referral Hospital does not divulge individual HIV or other results to any third 
party. 
 
For monthly follow up in Aim 3, study staff will contact the participant via mobile phone. They will 
be instructed not to discuss anything related to the study except with the participant. They may 
visit the participant’s home if unable to contact via phone numbers provided. For this, they will 
wear unmarked clothes and not speak about HIV or the study with anyone, except in private 
with the participant. Participants will be asked to report any breeches in confidentiality, and 
these will be reported to the IRBs. 
 
8.2 Reasonableness of risks: The research procedures are minimally invasive and present 
low risks to the study participants. The possible risks include the possibility that participants will 
become emotionally distressed during the interview process and the potential loss of 
confidentiality. We have described procedures for dealing with emotional distress or threats to 
harm self/others, and for minimizing the risk of loss of confidentiality, if it should arise. Given the 
minimal risks and the safeguards that will be put in place, we believe that the importance of the 
knowledge to be gained outweighs the potential risks to the subjects involved.  
 
8.3 Obtaining Informed Consent: Written and verbal informed consent will be completed for 
each participant. During informed consent, the research assistant and potential participant will 
find a suitable, private location. All potential participants will be told that information gathered in 
the study is confidential, voluntary, and they are free to take breaks or terminate their 
participation at any time. A written copy of the informed consent form will be presented in 
Runyankole or English, depending on the preference of the potential participant. This form will 
be reviewed orally, and potential participants given opportunity to ask questions. The research 
assistant will pause after each section and check for understanding by asking the potential 
participant to describe critical points in his/her own words. If the potential participant agrees to 
participate, written consent will be documented via signatures from both the research assistant 
and participant. For those unable to write, they will be allowed to place a thumbprint or “X”, with 
a witness co-signing to ensure proper methods of informed consent have been followed. Each 
research aim of the study will have its own consent form. Please see those documents attached to 
this application. No additional consent is necessary. Traditional Healers are considered to have 
special roles in their communities, as trusted authorities on health, culture and relationships33 and 
should be considered key stakeholders for any community-based interventions. As such, their 
participation and support of this project is highly regarded within specific cultural context. 
However, this support does not tacitly provide community consent. We will require individual, 
informed consent for all participants.  
 
The research assistant will review the consent for orally and pause after each section in the 
consent form to check for understanding by asking the potential participant to describe critical 

 
14 
points in his/her own words. The research staff who will be responsible for obtaining informed 
consent will assess whether the potential participant has understood the study and consent form 
by asking key questions (e.g., “How much time will this take you?”; “What are the possible 
benefits for you?”). Because it is possible that some participants may be cognitively impaired, or 
they may not initially understand this second consent process, we will test all potential 
participants for their comprehension of critical in the consent form. Errors will be corrected, and 
these potential participants will then be asked if they need further clarification. If, after further 
attempts to clarify any misunderstandings, we determine that they may not fully comprehend the 
critical aspects of the study, they will not be enrolled. 
 
The vast majority of participants will be non-English speaking, as the primary language in this 
region is Runyankole. A written copy of the informed consent form will be presented in 
Runyankole or English, depending on the preference of the potential participant. This form will 
be reviewed orally, and potential participants given opportunity to ask questions. In addition, we 
anticipate a significant proportion of potential participants will have low literacy. For those 
unable to write, they will be allowed to place a thumbprint or “X”, with a witness co-signing to 
ensure proper methods of informed consent have been followed. 
 
Informed consent documents will be retained in locked filing cabinets and storerooms, 
accessible only to senior investigators or designated study staff. All study logs are identified by 
study ID numbers, and names are removed.  All computerized databases will only contain study 
ID numbers. The lists linking study numbers to names are kept separately in a password 
protected computer, accessible only to PI, Co-Investigator, and Project Manager. Clinicians and 
counselors have received training on the need to maintain full confidentiality of client data.  
 
9. DISSEMINATION AND PUBLICATION 
 
All collaborators will participate in data analysis and research dissemination. Preliminary results 
will be presented twice per year to the Community Advisory Board, and to the local academic 
community through conferences at MUST. Abstracts will be submitted to both international and 
domestic conferences, and we expect that our results will generate two peer reviewed 
publications (“HIV testing and traditional healing in northeastern Tanzania: results from a 
qualitative study”, and “Delivering HIV testing in eastern Africa at traditional healer practices: 
results from a pilot intervention”). Data from this pilot will serve as the foundation for an R01 
submission to the National Institute of Mental Health, for September 2020 (“A cluster-
randomized trial of HIV testing at traditional healer practices in eastern Africa”). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
15 
REFERENCES  
 
1. 
Mills EJ, Bakanda C, Birungi J, et al. Life Expectancy of Persons Receiving Combination 
Antiretrovial Therapy in Low-Income Countries: A Cohort Analysis from Uganda. Annals 
of Internal Medicine 2011;155:209–16.  
2. 
Bodeker G, Kabatesi D, King R, Homsy J. A regional task force on traditional medicine 
and AIDS. The Lancet 2000;355(9211):1284.  
3. 
Homsy J, King R, Balaba D, Kabatesi D. Traditional health practitioners are key to scaling 
up comprehensive care for HIV/AIDS in sub-Saharan Africa. AIDS 2004;18(12):1723–5.  
4. 
King R, Balaba D, Kaboru B, Kabatesi D, Pharris A, Homsy J. The Role of Traditional 
Healers in Comprehensive HIV/AIDS AIDS AIDS AIDS Prevention and Care in Africa: 
Untapped Opportunities. In: Marlink R, Tietelman SJ, editors. From The Ground Up. 
2009. p. 301–32. 
5. 
Camlin CS, Seeley J, Viljoen L, et al. Strengthening universal HIV “test-and-treat” 
approaches with social science research. AIDS 2016;30(6):969–70.  
6. 
Joint United Nations Program on HIV/AIDS (UNAIDS). PREVENTION GAP REPORT. 
2016.  
7. 
UNAIDS. The HIV and AIDS Uganda Country Progress Report [Internet]. 
httpwww.aidsuganda.org. 2015 [cited 2015 Sep 21];Available from: 
http://www.unaids.org/sites/default/files/country/documents/UGA_narrative_report_2015.
pdf 
8. 
D CALP, Knowlton AR. Micro-social structural approaches to HIV prevention: a social 
ecological perspective. AIDS Care 2006;17(sup1):1–82.  
9. 
Ministry of Health II. Uganda Aids Indicator Survey 2011 [Internet]. 2012 [cited 2015 Dec 
30];:1–252. Available from: 
https://www.usaid.gov/sites/default/files/documents/1860/Uganda_AIDS_Indicator_Surve
y_2011.pdf 
10. 
World Health Organization. WHO Traditional Medicine Strategy 2014 - 2023 [Internet]. 
httpapps.who.intmedicinedocspdfsese.pdf. 2013 [cited 2015 Dec 30];:1–74. Available 
from: http://apps.who.int/medicinedocs/pdf/s2297e/s2297e.pdf 
11. 
King R, Homsy J. Involving traditional healers in AIDS education and counselling in sub-
Saharan Africa: a review. AIDS 1997;11 Suppl A:S217–25.  
12. 
Green EC. Sexually transmitted disease, ethnomedicine and health policy in Africa. 
Social Science & Medicine 1992;35(2):121–30.  
13. 
Bodeker G, Carter G, Burford G, Dvorak-Little M. HIV/AIDS: Traditional Systems of 
Health Care in the Management of a Global Epidemic. The Journal of Alternative and 
Complementary Medicine 2006;12(6):563–76.  

 
16 
14. 
Andersen R, Newman JF. Societal and Individual Determinants of Medical Care 
Utilization in the United States. The Milbank Memorial Fund Quarterly Health and Society 
1973;51(1):95.  
15. 
Gelberg L, Andersen RM, Leake BD. The behavioral model for vulnerable populations: 
Application to medical care use and outcomes for homeless people. Health Services 
Research 2005;34(6):1273–302.  
16. 
Joint United Nations Program on HIV/AIDS (UNAIDS). 90-90-90: An ambitious treatment 
target to help end the AIDS epidemic [Internet]. 
httpwww.unaids.orgsitesdefaultfilesmediaasset--en.pdf. 2014 [cited 2015 Dec 30];:1–40. 
Available from: http://www.unaids.org/sites/default/files/media_asset/90-90-90_en_0.pdf 
17. 
Ellman T. Demedicalizing AIDS prevention and treatment in Africa. N Engl J Med 
2015;372(4):303–5.  
18. 
Ndyomugyenyi R, Neema S, Magnussen P. The use of formal and informal services for 
antenatal care and malaria treatment in rural Uganda. Health Policy Plan 1998;13(1):94–
102.  
19. 
Morris K. Treating HIV in South Africa–a tale of two systems. The Lancet 
2001;357(9263):1190.  
20. 
Bulterys M, Fowler MG, Shaffer N, et al. Role of traditional birth attendants in preventing 
perinatal transmission of HIV. BMJ 2002;324(7331):222–4.  
21. 
Kyomuhendo GB. Low use of rural maternity services in Uganda: impact of women's 
status, traditional beliefs and limited resources. Reproductive Health Matters 
2003;11(21):16–26.  
22. 
Ojikutu B, Nnaji C, Sithole-Berk J, Bogart LM, Gona P. Barriers to HIV Testing in Black 
Immigrants to the U.S. J Health Care Poor Underserved 2014;25(3):1052–66.  
23. 
Cabral HJ, Tobias C, Rajabiun S, et al. Outreach program contacts: do they increase the 
likelihood of engagement and retention in HIV primary care for hard-to-reach patients? 
AIDS Patient Care STDS 2007;21 Suppl 1(s1):S59–67.  
24. 
Tobias C, Cunningham WE, Cunningham CO, Pounds MB. Making the connection: the 
importance of engagement and retention in HIV medical care. AIDS Patient Care STDS 
2007;21 Suppl 1(s1):S3–8.  
25. 
Nyamathi A, Hanson AY, Salem BE, et al. Impact of a rural village women (Asha) 
intervention on adherence to antiretroviral therapy in southern India. Nurs Res 
2012;61(5):353–62.  
26. 
O'Laughlin KN, Wyatt MA, Kaaya S, Bangsberg DR, Ware NC. How treatment partners 
help: social analysis of an African adherence support intervention. AIDS Behav [Internet] 
2012;16(5):1308–15. Available from: 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3354325&tool=pmcentrez&ren
dertype=abstract 

 
17 
27. 
Audet CM, Hamilton E, Hughart L, Salato J. Engagement of Traditional Healers and Birth 
Attendants as a Controversial Proposal to Extend the HIV Health Workforce. Curr 
HIV/AIDS Rep 2015;12(2):238–45.  
28. 
Moshabela M, Zuma T, Orne-Gliemann J, et al. “It is better to die”: experiences of 
traditional health practitioners within the HIV treatment as prevention trial communities in 
rural South Africa (ANRS 12249 TasP trial). AIDS Care 2016;28 Suppl 3(sup3):24–32.  
29. 
Abdool Karim SS. Overcoming Impediments to Global Implementation of Early 
Antiretroviral Therapy. N Engl J Med 2015;373(9):875–6.  
30. 
Audet CM, Blevins M, Moon TD, et al. HIV/AIDS-related attitudes and practices among 
traditional healers in Zambézia Province, Mozambique. J Altern Complement Med 
2012;18(12):1133–41.  
31. 
Ugandan Ministry of Health. Uganda National Policy Guidelines for HIV Counselling and 
Testing. httpwww.who.inthivpubguidelinesugandaart.pdf. 2007;:1–41.  
32. 
King R. Collaboration with traditional healers in HIV/AIDS prevention and care in sub-
Saharan Africa. httpdata.unaids.orgpublicationsirc-pubjc-tradhealen.pdf. 2000;:1–57.  
33. 
Sharma M, Ying R, Tarr G, Barnabas R. Systematic review and meta-analysis of 
community and facility-based HIV testing to address linkage to care gaps in sub-Saharan 
Africa. Nature 2015;528(7580):S77–S85.  
 
 
 

 
18 
Summary of Changes to Protocol 
 
September 4, 2019:  
As planned in section 4.4 of the protocol, an observational census of traditional healers was 
conducted in the study area in 2018.  
 
Changes to the inclusion criteria for traditional healers were submitted as follows:  
We predetermined an 8-kilometer one-way travel distance to the ISS HIV clinic as the 
geographic boundary within which to include traditional healers as recruitment locations for this 
trial. This distance was established as a walking distance to one or more HIV testing resource 
are centralized. Twenty-five traditional healers were identified within this area. Traditional 
healers will be considered eligible for participation as cluster sites if they are 1) were aged 18 
years or older; 2) have a practice located within eight kilometers of the ISS clinic; 3) were 
identified in the 2018 population-level census of traditional healers in Mbarara District; and 4) 
delivered care to at least 7 patients per week. The final criterion excludes healers with average 
patient volumes in the lowest quartile in order to ensure that participant recruitment progresses 
in a timely manner for this pilot study.  
Changes to the sample size were submitted as follows: 
We assumed a baseline testing rate of 39% among our population based on Ministry of Health 
population-level data8. We predicted that the HIV testing rate would increase by 35% to 74% in 
the intervention arm. Using intracluster correlation coefficient estimate = 0.2, we calculated that 
we would need to include a minimum of 16 clusters total, with an average of 30 participants 
recruited per cluster (total sample size of 480 participants), to detect this difference, with 80% 
power and alpha = 0.05. We plan to recruit 20 healers as clusters in our study to maximize 
analytical power. Target enrollment number for clients will be 250 per study arm, divided equally 
among cluster sites in each study arm. 
 
Secondary outcome of “variables that predict HIV testing” was also removed