Improving Uptake and Adherence to HIV Prevention Services With PrEP, HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of California, San Francisco

i 
 
A MEDICAL RESEARCH COUNCIL (MRC)/UGANDA VIRUS RESEARCH INSTITUTE 
(UVRI)/LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE (LSHTM) UGANDA 
RESEARCH UNIT  COLLABORATIVE STUDY 
 
 
 
PROTOCOL VERSION 7.0 
12 Jan 2019 
 
 
Study title:  Improving uptake and adherence to HIV prevention services with PrEP and HIV self testing for 
HIV negative high risk young women aged 15-24 in Kampala, Uganda  
 
Short title: The POPPi (Prevention on PrEP) study 
 
Sponsor: NIH / National Institute of Mental Health (NIMH) 
Grant # MH114523-01 
 
 
 
 
 

2 
NAMES OF APPLICANTS AND COLLABORATING INSTITUTIONS
Rachel L King, Study PI 
 
 
 
 
UCSF 550 16th Street, 3rd Floor 
 
 
 
San Francisco, CA 94158-1224 USA  
 
 
Tel: +256 785304516  
 
 
 
 
E-mail: rach@vtx.ch / rachel.king@ucsf.edu  
 
Lisa Butler,– Sub-grantee PI  
 
 
 
Institute for Collaboration on Health,  
 
 
 
Intervention, and Policy 
 
 
 
 
University of Connecticut  
 
 
 
 
2006 Hillside Road, Unit 1248 
 
 
Storrs, CT  06269-1248 
 
 
 
 
Tel: +1 (617) 500-8209 
 
 
 
 
Email:  Lisa.Butler@uconn.edu 
 
 
 
 
Andrew Abaasa, Co-Investigator 
 
 
 
MRC/UVRI/LSHTM  Uganda  Research Unit 
 
Box 49, Entebbe, Uganda  
 
 
 
 
Tel: +256712976987  
  
 
 
 
Email: andrew.abaasa@mrcuganda.org 
 
 
Project Role: Statistician 
 
 
 
 
 
Jaco Homsy, Co-Investigator 
UCSF Site Investigator  
MU-JHU, Old Mulago Hill Rd 
Kampala, Uganda  
Tel: +256 772747097  
E-mail: jaco251099@vtx.ch/jaco.homsy@ucsf.edu 
 
 
 
NIMH Program Officer:  
 
 
Susannah Allison, PhD 
 
 
5601 Fishers Lane, Room 9E26  
 
 
Rockville, MD 20852, USA  
 
Tel: +1-240-627-3861 Tel: +1-301-443-3034  
 
E-mail: allisonsu@mail.nih.gov 
 
 
 
 
 
Janet Seeley,  – Sub-grantee PI 
MRC/UVRI/LSHTM Uganda Research Unit 
P.O. Box 49, Entebbe, Uganda 
Tel: ++256 774 778 869, Fax: +256 414 543002 
 
E-mail: janet.seeley@lshtm.ac.uk 
janet.seeley@mrcuganda.org  
 
Yunia Mayanja, Co-Investigator 
MRC/UVRI/ LSHTM Uganda Research Unit  
P.O. Box 49, Entebbe, Uganda 
E-mail: Yunia.Mayanja@mrcuganda.org 
 
Elly Katabira Co-Investigator 
College of Health Sciences, Mulago Hospital 
Box 7072 
Kampala, Uganda 
Tel: +256772401749 
 
Victor Musiime,  Co-Investigator 
College of Health Sciences, Mulago Hospital P.O. 
Complex, Box 7072 
Kampala, Uganda 
Tel: +256772401749 
E-mail: vmusiime@jcrc.org.ug 
 
 
 
 
 
NIMH Grants Management Specialist: 
 
NSC BG Rm 6138, 6001 Executive Blvd 
Rockville MD 20852, USA 
E-mail: rmunk@mail.nih.gov 
 
 
 
 
 
 
 

3 
 
 
 
 
TABLE OF CONTENTS 
 
LIST OF ABBREVIATIONS .............................................................................................................................................. 4 
SUMMARY OF PROPOSED WORK ............................................................................................................................... 5 
B. RATIONALE ................................................................................................................................................................... 10 
C. AIMS .................................................................................................................................................................................. 11 
D. STUDY DESIGN AND METHODS ............................................................................................................................ 12 
Overview of study design .................................................................................................................................................... 12 
D.1 Study setting ................................................................................................................................................................................ 13 
D.2 Intervention Components ......................................................................................................................................................... 14 
Intervention flow diagram .................................................................................................................................................. 14 
D.3 Procedures -  Phase 1 ................................................................................................................................................................. 15 
D.3.1 Conduct facility site assessments .......................................................................................................................................................... 15 
D.3.2  Qualitative data collection ..................................................................................................................................................................... 15 
D.3.3 Operationalize curricula .............................................................................................................. Error! Bookmark not defined. 
D.4 Phase 2; Pilot RCT ..................................................................................................................................................................... 16 
D.4.1 Design of manuals and materials ............................................................................................. Error! Bookmark not defined. 
D.4.2 Standardize intervention materials .......................................................................................... Error! Bookmark not defined. 
D.4.3 Finalize study instruments and digital data collection forms ......................................... Error! Bookmark not defined. 
D.4.4 Overview of Staff training ......................................................................................................... Error! Bookmark not defined. 
D.4.5 Training Staff Counsellors/Mobilizers on HIV self-test .................................................. Error! Bookmark not defined. 
D.4.6 Field test intervention .................................................................................................................. Error! Bookmark not defined. 
D.4.7 Eligibility, screening and recruitment .................................................................................... Error! Bookmark not defined. 
C.4.8  Randomization. ............................................................................................................................. Error! Bookmark not defined. 
D.4.9  Ethical Considerations ............................................................................................................... Error! Bookmark not defined. 
D.4.10 Intervention Group Session Procedures. ............................................................................. Error! Bookmark not defined. 
D.4.11 PrEP Initiation and Monitoring. ............................................................................................ Error! Bookmark not defined. 
D.4.12 Follow-up Procedures. .............................................................................................................. Error! Bookmark not defined. 
D.4.13 Training trial participants on HIV self-test ........................................................................ Error! Bookmark not defined. 
D.4.14 Exit Interviews. ........................................................................................................................... Error! Bookmark not defined. 
          D.4.15 Oral PrEP (Truvada) adherence counselling:  ........................................................... Error! Bookmark not defined. 
D.5 Measures ...................................................................................................................................... Error! Bookmark not defined. 
D.5.1 Primary outcome measurement ................................................................................................ Error! Bookmark not defined. 
D.5.2 Secondary Outcomes ................................................................................................................... Error! Bookmark not defined. 
D.5.3 Mediators. ........................................................................................................................................ Error! Bookmark not defined. 
D.6 Phase 3 ......................................................................................................................................... Error! Bookmark not defined. 
D.7 Retention Plan ............................................................................................................................ Error! Bookmark not defined. 
D.8 Data quality and management ................................................................................................ Error! Bookmark not defined. 
D.9 Quantitative Data Analysis ..................................................................................................... Error! Bookmark not defined. 
D.10 Qualitative Data Analysis ...................................................................................................... Error! Bookmark not defined. 
E. SIGNIFICANCE OF THE PROPOSED WORK ................................................... Error! Bookmark not defined. 
F. Timeline ............................................................................................................................................................................. 16 

4 
LIST OF ABBREVIATIONS  
 
ANC  
Antenatal care 
ART  
Antiretroviral therapy 
ARV  
Antiretroviral 
CAB  
Community Advisory Board 
FGD   
Focus group discussion 
FP 
 
Family planning 
FSW  
Female sex worker 
G/C  
 
Gonorrhea / chlamydia 
GCP 
 
Good Clinical Practices 
GHWP 
Good Health for Women Project 
HIV ST 
HIV Self Test 
HTC  
HIV testing and counseling 
IEC  
 
Independent Ethics Committee 
IPV 
 
Interpersonal violence 
IRB 
 
Institutional Review Board  
KII 
 
Key informant interview 
LSHTM           London School of Hygiene and Tropical Medicine 
PCR   
Polymerase chain reaction 
PE 
 
Peer educator 
PMTCT 
Prevention of mother-to-child HIV transmission 
PrEP  
Pre-exposure prophylaxis 
RCT 
 
Randomized Controlled Trial 
REC   
Research and Ethics Committee 
SMS  
Short messaging system 
SOC 
 
Standard of care 
SOP 
 
Standard operating procedure 
SRH 
 
Sexual and reproductive health 
sSA  
 
Sub-Saharan Africa 
STI 
 
Sexually transmitted infection 
UCSF   
University of California San Francisco 
UNCST  
Uganda National Council for Science and Technology 
UVRI  
Uganda Virus Research Institute 
YAB  
Youth Advisory Board 
YWHR 
Young women at high risk 
WHO  
World Health Organization 
 
 
 

5 
SUMMARY OF PROPOSED WORK 
Background: Sub-Saharan Africa (sSA) is home to the fastest growing and youngest population in the world and 
includes countries with the highest HIV prevalence globally. More than half of sSA's population is under 25 years 
of age. Men and women aged 10-24, defined as ‘young people’ by the United Nations Population Fund (UNFPA), 
represent one third of the sSA population and this proportion continues to grow. Young sex workers, new to sex 
work, are much more vulnerable than their older colleagues to violence, STIs and HIV. The illegality of sex work 
in Uganda contributes to the risk these young women face. Effective STI and HIV prevention, care, support, and 
reproductive health services are critical to keeping this young vulnerable population healthy. Evidence on 
interventions that address uptake and adherence to HIV prevention services for high-risk populations is limited, 
and interventions that address young women at high risk (YWHR) are almost non-existent.  
We propose to develop and conduct a pilot intervention trial including PrEP and HIV self-testing for HIV-
uninfected women 15- to 24-years old who engage in high-risk sexual activity in Kampala, Uganda, and to 
evaluate its feasibility, acceptability and potential effect on PrEP uptake and adherence as well as repeat HIV self-
testing. We will embed this study within our existing cohort study (NIMH R01 HD085805-01, PI King) that has 
revealed the need for greater attention to young sex workers soon after their initiation into the work. The 
intervention will focus on increasing initiation of PrEP among HIV-uninfected YWHR with enhanced adherence 
support, uptake of and adherence to repeat HIV self-test, and motivation to adopt and sustain sexual risk reduction 
behaviors for STI, HIV, and unplanned pregnancy. 
Aims and Objectives: The main aim is to develop and assess an intervention to enhance initiation and adherence 
to PrEP among HIV negative YWHR. The specific aims are (1) To conduct formative research to enhance our 
understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women 
(aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities 
for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and 
culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing 
for young women at high risk for HIV; (4) to translate lessons learned from the pilot study to the design of a larger 
RCT.  

6 
A. BACKGROUND 
Sub-Saharan Africa (sSA) is home to the fastest growing and youngest population in the world and includes 
countries with the highest HIV prevalence globally. More than half of sSA's population is under 25 years of age; 
men and women aged 10-24, defined as ‘young people’ by the United Nations Population Fund, represent one third 
of the sSA population and this proportion continues to grow.1  
Young women in sSA who are economically and educationally disadvantaged are at high risk of engaging in 
transactional sex. Transactional sex is a spectrum of economic interactions that varies from gift-giving to formal 
commercial sex work.2 Factors such as age difference3 and power disparity2,4,5 between couples exist in most 
transactional sex situations. In some cases, sex work is the only source of family income, while in others, women 
use informal-transactional sex to supplement income or to augment social-status or material gain.6 Transactional 
sex may be situational or temporary, associated with acute shortfalls in cash, need for school fees or food 
insecurity.7 The prevalence of transactional sex varies by country and urban context in sSA,8 with approximately 
11.8% of girls and adolescent females reporting some exchange of sex for material goods in Uganda.9-11  
Young women aged 15- to 24-years old involved in transactional sex work must be considered one of the 
highest risk populations in high HIV prevalence countries.12,13 Globally, female sex workers (FSW) of all ages are 
over 10 times more likely to be infected with HIV than women in the general population.14 In sSA in 2012, the 
average HIV prevalence among FSW was greater than 35%.14 Throughout the world, 20-40% of sex workers enter 
sex work as adolescents with a mean age of entry of 16 years, and those under 16, new to sex work are much more 
vulnerable than their older colleagues to violence, STIs and HIV.15-21 The illegality of sex work in Uganda further 
enhances the risk these young women face. Young people in Uganda have an HIV prevalence of 3.7% nationally,22 
yet young FSW have about a four to seven times higher prevalence of HIV.22,23 Despite rising numbers of young 
FSW and their recognized vulnerability, there have been very few interventions globally that have targeted this 
group.21 
Adolescent and young women in Uganda are highly vulnerable to HIV, unplanned pregnancy and poor reproductive 
health outcomes. Adolescents are at especially high risk of maternal mortality, miscarriage and other complications 
in pregnancy.24 Young Ugandans have less access to health services than adults, and even less so to HIV prevention 

7 
and care services.25 Awareness of and knowledge about HIV transmission, reproductive health and contraceptive 
methods are poor among HIV-positive adolescents.10,11 The large and growing population of young Ugandans face 
a range of social, economic, and health challenges,26,27  yet their concerns may sometimes be overlooked in health 
agendas and programs.  
 
This project is set within the Good Health for Women Project (GHWP), a study set up to investigate HIV 
and STI epidemiology and to enhance prevention strategies among women involved in high-risk sexual behavior in 
Kampala which has provided important data on the prevalence of HIV among this population and barriers faced by 
the young women engaged in high risk sexual activity. In 2011, the GHWP reported an HIV prevalence of 37%, 
among a cohort of 1,027 FSWs; of these, only 58% knew their HIV status at time of enrolment; 53% reported 
consistent condom use with paying clients in the last month.28  Other studies have reported similar HIV prevalence 
and found young age to be a strong predictor of greater vulnerability to HIV, STI and violence.15-21 28,29 GHWP 
results have shown high rates of STI,30 the complexity and risks associated with sex work location, young age and 
FSW capacity to reduce harm,6,29 how gender inequities have led to sex work and limited FSWs’ ability to protect 
themselves.31 Currently, GHWP participants 15-24 years old have an HIV prevalence of 28% and 24% report 
consistently using condoms. HIV incidence was 3.66/100 person-years (PY) and declined from 6.80/100PY in the 
first calendar year of the study enrollment.29 HIV/AIDS is now the leading cause of death for women aged 15–29 
years in sSA.32-34 There is a dearth of evidence for effective interventions to increase HIV testing, prevention, 
adherence, retention in care amongst adolescents.33,34 It is widely recognized that adolescents are difficult to reach 
as they often fall between pediatric and adult care.35,36 To adequately reach youth, integrated structural, behavioral 
and biomedical, multi-level approaches will be required. Thus, combining biomedical approaches such as PrEP and 
HIV self-test with a prevention package, including behavioral and structural components as part of a comprehensive 
approach delivered by peers and counselors, could help to reduce HIV infection in young sex workers in diverse 
settings worldwide.37  
Trials among different high-risk populations have demonstrated high efficacy of tenofovir-based PrEP in 
reducing HIV transmission.38,39 40Thus, the 2015 WHO guidelines recommend PrEP for HIV-negative partners of 
HIV-infected individuals or populations engaged in high-risk behavior in settings with ≥3% annual HIV 

8 
incidence.41. A recent study in South Africa and the US reported that adherence to daily PrEP is more difficult for 
younger populations, and low adherence was associated with decreased efficacy in all PrEP trials. 42 Barriers at the 
individual level included limited familiarity with antiretroviral-based prevention, stigma, storage, and social 
support, as well as structural hurdles including healthcare financing for PrEP, healthcare provider bias and ease 
with PrEP drugs, and the lack of youth-friendly health services. In its 2016 Consolidated Guidelines for HIV 
Prevention and Treatment, Uganda has approved PrEP for demonstration and pilot studies specifically for high-risk 
populations such as sex workers.43 
HIV self-testing (HIVST) was recommended by WHO in the 2014 comprehensive HIV care guidelines, and 
HIV testing guidelines from the Uganda Ministry of Health (2016), for use in demonstration projects. HIVST is 
defined as an individual performing and interpreting his/her own HIV test44,45. It has the potential to be 
implemented at a wide scale with a minimal requirement for trained health-workers, and would thus be highly 
suited for FSW with low access to services. In addition, it is convenient since individuals perform HIVST in their 
own time, without having to present to a clinic at fixed hours. HIVST has been shown to be acceptable in a wide 
array of populations globally 46-54. It has recently been assessed in a number of settings in sub-Saharan countries, 
where it was found safe and accurate among the general population. Interest and acceptability in self-testing (HIV 
ST) is highest among high-risk groups55-57. In Malawi, 92% of adult participants in a high prevalence setting opted 
for supervised self-testing over provider-delivered tests.58 Respondents from a range of studies report that self-
testing would reduce HIV testing stigma, a significant barrier to testing among young people. We will adapt a 
protocol that is being tested in Kenya among adult sex workers in Nairobi and Kisumu that found a high (98%) 
acceptance, gave accurate results and helped linkage to care. HIV ST could increase convenience and 
confidentiality, which are important testing barriers and can be especially useful for repeat testing in high HIV 
prevalence and incidence groups who may not visit health facilities regularly for long-term follow-up.56,57,59,60 
Repeat HIV self-tests can be empowering, can be a motivator to remain healthy and HIV-free, and can fit perfectly 
with PrEP. The Kenyan FSW study found that peers were able to assist with the tests, found no reports of harm, and 
that tests were empowering to users and can be cost-efficient.61  
Peer educators (PE) have an important role in health promotion for HIV prevention and PrEP.  Numerous studies 

9 
have demonstrated that young people want information especially from trusted sources such as health care 
providers or teachers.62,63 Acting as a bridge between communities and health facilities, Peer leaders and peer 
educators s can provide education, expedite access to the clinic, and promote adherence to health recommendations.  
Studies in Uganda have shown that community members view PE as knowledgeable and trustworthy in matters of 
health and would seek their advice if they had a medical problem.64 Using peers in studies among young people 
have revealed that peer support as part of a comprehensive strategy to provide cognitive-behavioral counseling by a 
trusted adult has been effective.65 Identifying effective strategies for improving uptake of adolescent HIV testing 
and re-testing for high risk groups66 as well as successful uptake and adherence to effective prevention means 
including PrEP is critical for the survival of high risk youth and for the prevention of onward HIV transmission.  
This study could play a key role in understanding the complex connections between high risk sexual behavior, 
sexual relationship dynamics, socio-cultural relationship bargaining and sexual partnership decision-making that 
result in protected and unprotected sex in this highly vulnerable population. It will also help designing more 
effectively tailored interventions for HIV prevention and treatment for YWHR. Combining effective biomedical, 
behavioral and structural approaches is of key interest to Uganda’s Ministry of Health as a potentially efficient way 
to reach marginalized populations at high risk for HIV acquisition. We propose to develop and pilot test a multi-
component intervention to improve uptake and adherence to PrEP and repeat HIV self-testing by HIV-negative 
YWHR 15- to 24-years old who are highly vulnerable to STI and HIV in Kampala, Uganda. We hypothesize that, 
combined with knowledge, skills and health-related self-efficacy, access to PrEP and HIV self-testing will act 
synergistically to prevent HIV and improve health outcomes of YWHR. Targeting young women who are initiating 
sex work will enable us to understand ways to enhance the potential impacts of a combined structural-behavioral 
intervention on health outcomes to be tested in a larger clinical trial. The study will provide important evidence to 
inform Uganda’s HIV counseling and testing policy for adolescents and key populations, and will offer essential 
information for other countries striving for UNAIDS 90-90-90 target. In sum, this study could play a key role in 
understanding the complex connections between high-risk sexual behavior, sexual relationship dynamics, socio-
cultural relationship bargaining and sexual partnership decision-making that result in protected and unprotected sex 
in this highly vulnerable population. It will also help designing more effectively tailored interventions for HIV 

10 
prevention and treatment for YWHR. 
 
B. RATIONALE 
Targeting young Ugandan women at high risk for HIV (YWHR) and their social and sexual networks represents 
an innovation over traditional individual, partner or age-limited categories. Descriptive data that have been gathered 
on adolescent and young women engaged in high risk sexual activity in high HIV prevalence settings in sSA, 
though limited, reveal that they remain one of the most neglected, vulnerable, and underserved populations with 
regards to sexual and reproductive health (SRH) and HIV prevention services.67,68  
Combining the network and peer-led approaches that together put HIV combination prevention fully in control 
of women by using PrEP and repeat HIV self-tests may increase empowerment, acceptability, and penetration into 
networks and ultimately increase effectiveness in reaching this highly marginalized population. We believe it is key 
to focus our intervention on these women as soon as possible after they enter the sex trade in order to effect primary 
HIV prevention rather than wait until they attend the clinic after they may have already been infected. Preceding the 
design and pilot of our intervention with an in-depth qualitative formative phase will allow us to optimize the early 
identification of these women in their community, the delivery of interventions and the design of our study based 
on a more thorough understanding of the location, mobility and networks of young women at risk in Kampala.  
We propose to use an innovative approach to linking HIV-negative YWHR to PrEP. Our participatory co-
design approach is to engage YWHR in dialogue with researchers to co-develop intervention content and materials 
that are responsive to the needs of the target group. We propose to use established co-design strategies to refine 
aspects of the intervention and related materials to tailor them to our population. We will engage in conversation 
young women who represent the intervention target population as well as individuals with biomedical, and program 
expertise and experience with ‘communities’ who do not generally meet and discuss together. This participatory 
design process will ensure YWHR the opportunity to engage meaningfully in designing an intervention that is 
responsive to their needs and concerns.  
Our study will be the first to use HIV self-tests for repeat testing among YWHR in sub-Saharan Africa. Few 
adolescent friendly services are available in Uganda, and stigma towards adolescent sexuality is pervasive among 
health workers. Self-test is a novel option that may allow a substantial proportion of these women to retest with the 

11 
help of a trained peer. There are limited data available on self-testing among similar groups, but what exists show a 
high level of acceptability69 and low levels of social harm.70,71 
HIV testing in urban hotspot areas will enhance effectiveness of these strategies in complex contexts and social 
environments, and will help overcome two key challenges of PrEP delivery; (1) identifying the most vulnerable 
communities to use PrEP and (2) enhancing adherence through repeat self-tests in a very high-risk population. It is 
premised on the hypothesis that offering acceptable strategies for HIV retesting by YWHR coupled with motivation 
to remain HIV negative through a peer-led community-engaged approach using a PrEP/repeat self test will 
empower YWHR to adopt risk reducing behavior.  
C. AIMS 
We propose to design and refine key elements of our intervention components in order to maximize the probability 
of success in a definitive trial. The goal of the study is to develop and pilot test a multi-component structural and 
behavioral intervention targeting HIV-negative young women (15- to 24-years old) who engage in high-risk sexual 
activity in Kampala, Uganda, in order to increase uptake of, and adherence to combination HIV prevention services 
using PrEP, HIV self-tests, condoms and family planning. As currently conceptualized, the planned intervention 
will be delivered in two group sessions followed by two one-on-one counseling sessions. We will conduct the study 
in three integrated phases over 3 years: 
Phase 1: will consist of formative research to enhance our understanding of barriers and opportunities for PrEP and 
HIV testing uptake and adherence as well as to better understand the dynamics of the social and sexual networks, 
mobility and context of young women (15- to 24-years old) engaged in high risk sexual behavior in Kampala, 
Uganda. In our current R01 study (A Cognitive Behavioral And Structural HIV Prevention Intervention for Young 
Ugandan Sex Workers) we have found that hot spots are not static and must be identified regularly with the input of 
key informants who are peers of our target population. We will collect qualitative data using in-depth interviews 
and focus group discussions with key stakeholders: a) HIV-positive YWHR, b) HIV-negative YWHR, c) male 
partners of YWHR, d) peer educators, e) health workers and f) policy makers (including ministry of health 
officials). The objective of these discussions will be to identify the opportunities and multiple levels of barriers to 
specific HIV prevention services as well as the acceptability, feasibility, challenges to our preliminary intervention 

12 
components (Table 1). We will examine our planned approach with respect to social and cultural relevance as well 
as necessary resources, and how to operationalize the intervention components most efficiently considering existing 
services, the knowledge, capacity and attitudes of potential participants, as well as the different contexts they are 
living in (eg cramped shared housing; high mobility). We will use participatory co-design methods to produce and 
pilot a training curriculum and associated materials for use in intervention group sessions. These materials will be 
refined with input from a youth advisory board (YAB) in a second series of focus group discussions with members 
of the target population.  
Phase 2: Will be informed by Phase 1. We will conduct a small pilot RCT study (N=60) to assess the feasibility, 
acceptability, and preliminary effects of the intervention on PrEP uptake and adherence.  
Phase 3: We will review qualitative and quantitative data on intervention feasibility, acceptability and potential 
effectiveness from Phase 2 in collaboration with the Community Advisory Board (CAB) and Youth Advisory Board 
(YAB) to seek consensus about refinements to be made for formulating an R01 application to assess the efficacy of 
the intervention in a larger RCT. The setting, conceptual framework and activities of each phase are described 
below. 
D. STUDY DESIGN AND METHODS 
OVERVIEW OF STUDY DESIGN  
In this pilot study, we propose to conduct formative research and then develop and evaluate a combination 
prevention intervention through a randomized controlled trial comparing intervention vs GHWP care among high-
risk young people. 
 
 
 
 
 
 
 

13 
STUDY SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase III – Develop R01 
 
D.1 Study setting 
We will conduct this study at the GHWP Clinic in Kampala. The GHWP clinic is located in a densely populated 
slum area of southern Kampala with retail shops and roadside kiosks selling general merchandise, and bars, which 
are the main hotspots in the area. The current HIV prevalence among women in the cohort who are 15-24 years is 
about 31% and 38% in all participants. The GHWP clinic currently provides mobilization, testing and counseling, 
and ART.28,72 At GHWP, all eligible participants receive HIV care and treatment, including ART, in accordance 
with Uganda MoH Guidelines. Peer educators associated with the clinic visit YWHR to provide information, 
education and referral related to uptake and retention to clinic services according to established visit protocols. The 
existing GHWP infrastructure, highly skilled staff, and proven recruitment system31,73,74 are strong assets to this 
study. Participants will be recruited from hotspots (generally bars and lodges) in Kampala according to established 
and tested protocols. The clinic currently provides free medical and counseling services, free male and female 
condoms, HIV and STI testing and treatment to all high risk women, their partners and their children under 5 years 
Referral from hotspots
Phase I - Formative research: Focus group discussions and 
interviews on content and format of the intervention as well as 
acceptability and feasibility of the intervention 
Phase II - Mini- 
randomized trial 
Results to inform intervention 
Participant screening, 
enrolment & randomization 
(N=60 HIV-negative YWHR) 
1- Intervention- (N=30) 
group sessions with HIVST 
2-Control – (N=30) 
GHWP standard of care  
 
Primary outcome 
- Uptake and Adherence to PrEP 
Secondary outcomes**: 
- Uptake HIV ST as repeat testing 
- STI incidence (Gonorrhea/ Chlamydia) 
- Uptake and continued use of family planning 
- Retention in care 
Follow - up       up       to       12 months 
YWHR at GHWP clinic for enrolnment 
Screening for HIV,Hep B and creatine. Enrolment in the study 

14 
of age.  GHWP has over 4358 enrolled FSW, 36% of whom are under 24 years of age, and enrolment is open and 
ongoing. However, currently there are limited specialized services for young women engaged in some form of 
transactional sex at GHWP apart from our parent study (NIMH R01 HD085805-01 PI King) and neither PrEP nor 
HIV self-testing are currently offered as standard services.  
D.2 Intervention Components  
The content and structure of the intervention will include at a minimum 2 group sessions and 2 counseling sessions 
with YWHR (Table 1), which will be facilitated by trained peers and counselors. Group sessions will be limited to 
8 participants, last about 2- 3 hours, be participatory, youth-centered and include modeling, role plays, story-telling, 
and body-mapping – all strategies that we have previously found to be highly engaging with young people and 
lower literacy populations. As our population has low literacy, our techniques will be highly visual to ensure 
accessibility to information and avoid stigmatizing participants who cannot read. Sessions will be conducted in 
Luganda and/or English at the clinic, as it is comfortable and private and is where we conduct the intervention for 
our current R01. The clinicians will be blinded to the intervention. Google mapping of hotspots will be done at 
every scheduled visit . This intervention format will be revised based on findings of Phase 1 formative research 
INTERVENTION FLOW DIAGRAM 
Table 1: Intervention Components 
 
Screening:  HIV counseling and testing either in the community hot spots or in the clinic followed by: 
TWO GROUP SESSIONS covering multi-level factors informed by formative phase and parent study: 
1. 
Health empowerment: Barriers and strategies for health seeking, benefits, process and efficacy of 
PrEP, adherence support guidance, safer sex, HIV and reproductive health including STI prevention and 
treatment, family planning, child spacing  & contraceptive methods; Curriculum to be drawn from 
existing resources (current R01 + PrEP demonstration project; Dr Katabira) 
2. 
Initiating daily PrEP following MOH guidelines (300mg TDF + 200mg FTC) 
3. 
Social/Contextual empowerment: building a support network using SMS reminders designed by 
peers from parent study; focusing on gender and social norms; training in HIV self-testing; exploring 
issues around education and life ambitions, vocational training and alternative livelihoods; To be 
drawn/adapted from existing curricula 
 
TWO INDIVIDUAL COUNSELING SESSIONS covering: 
Personal history; cognitive behavioral therapy (CBT) as relevant ;  HIV/STI transmission risk at multiple 
levels; Uptake of PrEP, safer sex, family planning, violence prevention ; Adherence to PrEP, safer sex, 
family planning, clinic visits; Remaining HIV negative: re-testing using HIV self-test;  Exploring 
education and life ambitions, and alternative livelihoods 

15 
 
D.3 Procedures -  Phase 1 
D.3.1 Conduct facility site assessments to assist future randomization procedures and power calculations. 
As part of Phase 1 and during the first year of the R34 project, a field team will conduct detailed mapping of all 
current hot spots for young women in urban Kampala including areas where high-risk youth congregate with their 
social networks. Ten communities with separate catchment areas and similar baseline characteristics will be 
identified as study sites (for the future R01 application) through qualitative and quantitative data collection using a 
mapping protocol that we have used in previous studies.75  Briefly, this protocol involves showing the participant a 
map of Kampala on Google-Maps and them pinning their hotspot(s). In-depth and key informant interviews and 
focus group discussions will assess acceptability, feasibility, challenges and potential uptake of the proposed 
strategies. We will examine the social and cultural relevance and how to operationalize the procedures considering 
the knowledge, attitudes and context of the target population. The maps will be kept highly confidential and 
anonymous in a locked cabinet in the study office.  Only study IDs will be used; no names and no telephone 
numbers will be connected to study participant information. In addition, we will collect information on predefined 
criteria (e.g. number and ages of potential participants at a given hotspot at the time of the visit, willingness to be 
enrolled, location, description of site [e.g., bar, lodge], and availability of space suitable for outreach testing). Site 
assessments will also serve as an opportunity for mobilization team to familiarize themselves fully for a smooth 
transition from the pilot to the proposed RCT.  A description of this clinical trial will be available 
on http://www.ClinicalTrials.gov, as required by U.S. Law.  This web site will not include information that can 
identify the participant.  At most, the web site will include a summary of the results.   
 
D.3.2  Qualitative data collection on risk, barriers to HIV prevention services and intervention content.  
 
 
 
 
 
 
 
Focus group discussions will be organized with HIV negative and positive YWHR, Peer Educators, male partners 
and other key stakeholders (Table 2) to inform the content and form of the intervention group discussions. The 
discussions will be held in the clinic and notes will be taken immediately. With YWHR, discussions will assess 
both the areas of risk behavior and barriers to accessing HIV prevention services as well as feasibility, acceptability 
and refinement of the intervention design and materials to be used in the next phase as well as documenting most 
relevant strategies for the target group. Discussions will focus on possible pathways of effectiveness such as 
Group 
Topic 
Method 
# participants 
 
Risk  
Intervention  
 
 
HIV negative YWHR 
x 
x 
FGD,  
Interviews 
8x2= 16 
8 
HIV positive YWHR 
x 
x 
FGD,  
Interviews 
1x8=8 
8 
Peer educators 
 
x 
FGD 
8 
Male partners 
x 
 
FGD 
8 
Key Informants (health 
workers, policy makers) 
 
x 
Interviews 
8 
TOTAL 
 
 
 
64 
Table 2: Qualitative Data Collection 

16 
knowledge, social support, motivation and skills. With PE and other key informants, the discussion will focus on 
topics surrounding how to develop and implement the intervention in the most effective, targeted manner.  With 
YWHR, PE and key informants, we will explore the following alternatives to simple self-report through group 
discussions and interviews with participants:   
1) Assisted ST; at the time of receiving the HIV ST, participants will be offered to perform it in the presence of 
their counselor who can then directly counsel the participant according to her questions and/or test result  
2) Delivery of the HIV self-test (ST) result strip into a labeled box just inside the clinic gate; each HIV ST strip will 
have a bar code on it and participants can drop their strip into the box as they enter or exit the clinic. At enrolment, 
these procedures would be explained in detail 
3) Participants with phones can report their HIV ST experience on a four-question phone-based short messaging 
system (SMS) survey: (Did you use your test? Was it easy or difficult? Would you use it again? Would you like 
help?) and upload their responses into a simple web-based portal. We are using web-based portals in other studies 
as well as on a national level for Ugandan PMTCT data entry and the development and use of the portal have 
proven simple, user-friendly and functional 76.  
D.4 Phase 2; Pilot RCT  
The pilot RCT will assess intervention feasibility/acceptability and control conditions to be used in a subsequent 
larger trial. We will examine preliminary impact on mediators and outcomes of interest. 
 
F. TIMELINE  
Table 6: Outline of Project Activities by Year and Quarter 
 
Year 1 
Oct 17-Sept 18 
Year 2 
Oct 18-Sept 19 
Year 3 
Oct 19-Sept 20 
Activities  
 
 
 
 
  
Quarter 
Q1 
 
Q2 
 
Q3 
 
Q4 
 
Q1 
 
Q2 Q3 
 
Q4 Q1 
Q2 Q3 Q4 
Planning & staff recruitment; Assemble YAB, 
 
 
 
 
 
 
 
 
 
 
 
 
Phase 1: Formative research 
 
 
 
 
 
 
 
 
 
 
 
Phase 2: Screening & enrolment Pilot Study 
 
 
 
 
 
 
 
 
 
 
 
Phase 2: Follow-up Pilot 
 
 
 
 
 
 
 
 
 
 
 
Phase 2: Analysis 
 
 
 
 
 
 
 
 
 
 
 
Phase 3: Translate results (feasibility and 
 
 
 
 
 
 
 
 
 
 
 

17 
 
 
 
 
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