Conditions: Pre-Exposure Prophylaxis Sexually Transmitted Diseases, Bacterial HIV Infections
Keywords: HIV acquisition HIV risk PrEP adherence
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 212
Healthy volunteers: yes

Brief summary:
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs. In sub-Saharan Africa, young women are a priority population for HIV prevention and targeted to initiate PrEP, given their high HIV incidence rates and promising success from a strategy that can be used without the engagement of male partners. A key question in the field is whether young women using PrEP have ongoing HIV risk and adhere to PrEP sufficiently to have protection from HIV when they have condomless sex with HIV-infected partners. The only true way to know whether a heterosexual woman is sexually exposed to HIV or has a partner with high HIV risk is to test for HIV and STIs in her male partner(s) and quantify HIV viral levels, if any are detected. Yet engaging men in clinic-based HIV testing is challenging. More recent efforts have focused on using HIV self-testing kits to respond to demands on men's time and reluctance to seeking preventive healthcare. The availability of PrEP also provides a new incentive for men to test.

By leveraging an ongoing study of bone health with concurrent use of PrEP and injectable DMPA (often known as Depo Provera® or depot medroxyprogesterone acetate), we have opportunity to engage a new cohort of young men and objectively measure HIV and common STIs in these young men and link the results to women's use of PrEP. The primary objective of this study is to determine whether young women's adherence to PrEP aligns with the HIV status and risk of their male partners. To address its primary objectives, this study will leverage: 1) an ongoing study among young women and 2) a novel cohort of young men who are current sexual partners of the young women in the ongoing study to objectively measure PrEP use, HIV, and HIV factors related to HIV risk. This study will provide a framework for understanding how and when young women and men decide to take PrEP, estimate the proportion of women that are benefitting from HIV protection when they have male partners with or at high risk of acquiring HIV, and provide a novel opportunity to engage young men in PrEP delivery and as supporters of women's PrEP use.

Detailed description:
The proposed research will engage a new cohort of young men, whose female partners are already engaged in the Kampala Women's Bone Study. Women in the Kampala Women's Bone Study will be invited to engage in this novel study to recruit their male partners. Women's HIV risk is directly related to the HIV status and risk of their male sexual partners and thus, we will leverage our ongoing cohort of KWBS young women to recruit their male sexual partners for a new men's study. Men will be offered PrEP, diagnostic STI testing and treatment, and followed for 6 months to assess PrEP continuation and STIs. Men's data will be linked to data from their female sex partners in the parallel KWBS study to determine whether women's PrEP use aligns with HIV risk and exposure.

B. Study Aims Aim 1. To determine whether young women's adherence to PrEP aligns with the HIV status of their male partners Men engaging in this study will have HIV testing at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV status.

Aim 2. To determine whether young women's adherence to PrEP aligns with the HIV risk of their male partners Men engaging in this study will have testing for common curable STIs (Chlamydia trachomatis and Neisseria gonorrhoeae) at enrollment, month 1 and quarterly for up to 6 months. Results from this testing will be linked to data from the participant's female sex partner that characterize her PrEP use to determine whether her PrEP use aligns with his HIV risk (defined by the results from his STI testing).

Aim 3. To determine whether young men's adherence to PrEP aligns with the HIV status and risk of their female partners We will offer PrEP to HIV-negative men enrolled in this study and track PrEP initiation, refills, and adherence to PrEP (based on self-report and drug levels). The frequency of high PrEP adherence will be compared among men with female partners infected and uninfected with HIV or another STI.

C. Primary exposure The primary exposure is male infection with HIV (Aim 1), NG or CT (Aim 2) and female infection with HIV, NG, or CT (Aim 3).

D. Primary outcomes The primary outcome will be PrEP used by women with sufficient daily adherence to confer HIV protection (6-7 doses in the past week or TFV ≥40ng/mL) for periods when women are dispensed PrEP. When PrEP is not dispensed, the TFV level will be assigned as 0 ng/mL.

For Aim 3, the primary outcome will be PrEP used by men with sufficient daily adherence to confer HIV protection (4 doses in the past

Arms:
arm 1: Male participants whose partners are enrolled in the parent study (Kampala Women's Bone study). All male participants will undergo the same study procedures at each visit, such as HIV and STI testing, and urine tenofovir testing if on PrEP. arm 2: Female participants from the parent study (Kampala Women's Bone study) will be enrolled to recruit their male sexual partner(s). All female participants will receive HIV testing, STI testing, and urine tenofovir testing (if on PrEP) at quarterly visits.

Interventions: intervention 1: Daily oral PrEP intervention 2: Daily oral PrEP
Intervention descriptions: intervention 1: All participants will be offered daily oral PrEP at each visit intervention 2: All participants will be offered daily oral PrEP at each visit.

Protocol document:
Prot_SAP_000.pdf: 
Aligning PrEP and HIV Study Protocol 
Version 1.0  
23rd July 2019   
 
 
PROTOCOL: 
 
Alignment of PrEP use with HIV risk in young women and men 
 
 
 
Aligning PrEP and HIV Exposure 
 
 
Version 1.0  
July 23rd 2019  
 
 
 
Funding: 
Eunice Kennedy Shriver National Institute for Child Health and Human Development  
R21HD098923 
 
 


Aligning PrEP and HIV Study Protocol 
Version 1.0  
23rd July 2019   
CONTENTS 
I. 
Acronyms .......................................................................................................................... 4 
II. 
Study Team ....................................................................................................................... 5 
III. Summary ........................................................................................................................... 6 
IV. Backgound ........................................................................................................................ 7 
V. Methods ............................................................................................................................11 
A. Overall Design ..............................................................................................................11 
B. Study Aims ...................................................................................................................11 
C. Primary exposure .........................................................................................................11 
D. Primary outcomes ........................................................................................................11 
E. Hypothesis ....................................................................................................................12 
F. 
Location ........................................................................................................................12 
G. Population .....................................................................................................................12 
H. Eligibility for men .........................................................................................................12 
Inclusion criteria: ................................................................................................................12 
Exclusion criteria: ...............................................................................................................12 
I. 
Eligibility for women ....................................................................................................12 
J. 
Sample size ...................................................................................................................13 
K. Study power ..................................................................................................................13 
L. 
Recruitment ..................................................................................................................13 
Overall ...............................................................................................................................13 
Talking points .....................................................................................................................13 
Recruitment brochures .......................................................................................................14 
HIV self-test kits .................................................................................................................14 
Contact with study recruitment team ..................................................................................14 
M. 
Retention ...................................................................................................................14 
N. 
General study procedures ........................................................................................14 
Informed consent ...............................................................................................................14 
Procedures for women .......................................................................................................15 
Procedures for men ...........................................................................................................15 
Screening and Enrollment ..................................................................................................15 
Follow up ...........................................................................................................................15 
Visit-specific procedural tables ...........................................................................................16 
Study exit ...........................................................................................................................17 
O. 
Special circumstances .............................................................................................17 
HIV seroconversion ............................................................................................................17 
P. Safety monitoring .........................................................................................................17 
VI. Data collection .................................................................................................................18 
VII. Linkage with data from women in the existing KWBS cohort ......................................18 


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VIII. Data analysis ....................................................................................................................18 
IX. Human Subjects considerations .....................................................................................18 
X. Clinical research site .......................................................................................................20 
XI. Data sharing and ownership ...........................................................................................21 
XII. Dissemination plan ..........................................................................................................21 
XIII. References .......................................................................................................................22 
 
 
 


Aligning PrEP and HIV Study Protocol 
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I. 
ACRONYMS  
 
AGYW  
Adolescent girls and young women 
ART 
 
Antiretroviral Treatment  
CT 
 
Chlamydia trachomatis 
DAIDS  
Division of AIDS 
DMPA  
Depo medroxyprogesterone acetate 
EC 
 
Ethics Committee  
EIA 
 
Enzyme-linked immunosorbent assay 
HBV   
Hepatitis B virus   
HIV  
 
Human Immunodeficiency Virus  
HIVST  
HIV self-test  
IDI 
 
Infectious Disease Institute  
IPV 
 
Intimate Partner Violence  
IRB 
 
Institutional Review Board  
KWBS  
Kampala Women’s Bone Study  
NG 
 
Neisseria gonorrhoeae  
PrEP   
Pre-exposure prophylaxis  
RNA 
 
Ribonucleic acid  
STI 
 
Sexually Transmitted Infection  
TFV 
 
Tenofovir  
WHO  
World Health Organization  
 
 


Aligning PrEP and HIV Study Protocol 
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23rd July 2019   
II. 
STUDY TEAM  
Makerere University, Kampala, Uganda 
Andrew Mujugira, MBChB, PhD  
Timothy Muwonge, MBChB, MPH  
 
 
 
University of Washington, Seattle, USA 
Renee Heffron, PhD, MPH 
Jared Baeten, MD, PhD 
Deborah Donnell, PhD 
 
Stroger Hospital of Cook County, Chicago, USA 
Sybil Hosek, PhD   
 
 
 


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23rd July 2019   
III. 
SUMMARY 
Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV 
prevention and its availability is rising through demonstration projects and full-scale national 
programs. In sub-Saharan Africa, young women are a priority population for HIV prevention and 
targeted to initiate PrEP, given their high HIV incidence rates and promising success from a 
strategy that can be used without the engagement of male partners. A key question in the field is 
whether young women using PrEP have ongoing HIV risk and adhere to PrEP sufficiently to have 
protection from HIV when they have condomless sex with HIV-infected partners. The only true 
way to know whether a heterosexual woman is sexually exposed to HIV or has a partner with high 
HIV risk is to test for HIV and STIs in her male partner(s) and quantify HIV viral levels, if any are 
detected. Yet engaging men in clinic-based HIV testing is challenging. More recent efforts have 
focused on using HIV self-testing kits to respond to demands on men’s time and reluctance to 
seeking preventive healthcare. The availability of PrEP also provides a new incentive for men to 
test.  
 
By leveraging an ongoing study of bone health with concurrent use of PrEP and injectable DMPA 
(often known as Depo Provera® or depot medroxyprogesterone acetate), we have opportunity to 
engage a new cohort of young men and objectively measure HIV and common STIs in these 
young men and link the results to women’s use of PrEP. The primary objective of this study is to 
determine whether young women’s adherence to PrEP aligns with the HIV status and risk of their 
male partners. To address its primary objectives, this study will leverage: 1) an ongoing study 
among young women and 2) a novel cohort of young men who are current sexual partners of the 
young women in the ongoing study to objectively measure PrEP use, HIV, and HIV factors related 
to HIV risk. This study will provide a framework for understanding how and when young women 
and men decide to take PrEP, estimate the proportion of women that are benefitting from HIV 
protection when they have male partners with or at high risk of acquiring HIV, and provide a novel 
opportunity to engage young men in PrEP delivery and as supporters of women’s PrEP use.  
 
 


Aligning PrEP and HIV Study Protocol 
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23rd July 2019   
IV. 
BACKGROUND 
Oral PrEP is the latest biomedical intervention to be added to a growing of body of proven HIV 
prevention strategies. Oral PrEP is recommended by the World Health Organization and many 
Ministries of Health worldwide, including in Uganda, where HIV incidence is often greatest among 
young women [1-3]. In Uganda, clinical guidelines for PrEP became available in 2016 and the 
Ministry of Health is coordinating targeted scale up of PrEP for people with greatest HIV risk [2]. 
In Kampala, the capital city, PrEP is accessible through programs for key populations (e.g. sex 
workers, men who have sex with men, adolescent girls and young women (AGYW) and negative 
members of HIV serodiscordant couples, as well as through demonstration projects and clinical 
research.  
As with any newly adopted intervention, there are key delivery questions that need to be 
understood to ensure efficient and effective scale up of PrEP on a population level. A large 
unanswered question for PrEP delivery is how well PrEP users execute daily pill taking and 
whether persistent PrEP use aligns with HIV exposure and risk. Initial demonstration projects 
among young women have found high degrees of PrEP uptake, with >80% of women offered in 
our ongoing program in western Kenya and South Africa [4]. However, programs are beginning 
to report high levels of client drop-off. Daily adherence is especially important for women to 
achieve tissue concentrations commensurate with HIV protection from PrEP [5]. Adherence may 
be greater among women who use PrEP for ≥3 months but it is not clear if adherence patterns 
and persistence align with HIV risk. Persistence with PrEP is important to provide protection 
during periods of oscillating HIV risk but PrEP could be discontinued when risk is no longer 
present (e.g. when a stable partner living with HIV is virally suppressed), thereby removing the 
low risk of medication toxicities [6]. 
PrEP adherence aligning with risk 
A large unanswered question for PrEP delivery is how well PrEP users comply with daily pill taking 
and whether PrEP use aligns with HIV exposure and risk. Daily compliance with pill-taking is 
especially important for women to achieve tissue concentrations commensurate with protection 
Table 1. Scenarios of PrEP adherence and HIV risk in 7 days prior to sample/data collection. 
Green boxes indicate scenarios where PrEP use aligns with HIV risk. 
Protection from PrEP (defined 
as TFV >40ng/ml or Wisepill 
data indicates 6-7 openings in 
the week prior to sampling) 
Low/no protection from PrEP 
(defined as TFV <40ng/ml or 
Wisepill data indicates <6 openings 
in the week prior to sampling) 
No sexual HIV risk: 
No sex in the past 
week 
PrEP not necessarily needed if 
sex is not occurring and is not 
expected to occur soon 
Lack of sufficient PrEP use aligns 
with lack of sex 
Low/No sexual HIV 
risk  
PrEP aligns with HIV risk if 
condomless sex is anticipated in 
the near future 
PrEP aligns with HIV risk if 
condomless sex is not anticipated in 
the coming week 
High sexual HIV risk 
Possible sexual exposure to HIV 
aligns with PrEP adherence 
sufficient to provide protection 
from HIV infection 
Possible sexual exposure to HIV and 
PrEP adherence insufficient to 
provide HIV protection  
TFV: tenofovir, the circulating metabolite of TDF-based medication that can be used as a marker of short-
term adherence 


Aligning PrEP and HIV Study Protocol 
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from PrEP.[5] Initial demonstration projects of PrEP focusing on young women have found high 
degrees of uptake, estimated above 80% of women offered in our ongoing program in western 
Kenya and South Africa [4]. However, a number of programs are also beginning to report high 
levels of client drop-off. Adherence may be greater among women who use PrEP for ≥3 months 
but it is not clear if adherence patterns align with HIV risk. Continuous PrEP use is important to 
provide protection during periods of oscillating HIV risk but PrEP could be discontinued when risk 
is no longer present (e.g. when a partner living with HIV is virally suppressed, when a partnership 
is stably monogamous and both partners are HIV-negative), thereby removing side effects and 
the low risk of medication toxicities (Table 1 shows how PrEP use could overlay with HIV risk) [6].  
Delivering PrEP to young women 
Young women are a focus of HIV prevention programs in many settings due to their high HIV 
incidence rates and unique vulnerability. For young people, preventive health services are viewed 
as “user-friendly” when they are efficient and offer convenient solutions to sexual and reproductive 
health problems including confidential HIV testing, contraception (including condoms), and self-
care when available [7]. In settings that follow guidelines for syndromic management of STI, 
diagnostic STI testing and treatment can be a demand-creation approach [8]. When STI testing 
is part of PrEP delivery, young people have been motivated to attend refill visits in order to receive 
STI testing and treatment and receive PrEP adherence counseling at that time [9]. Recent 
estimates of asymptomatic curable bacterial STIs – Neisseria gonorrhea (NG) and Chlamydia 
trachomatis (CT) – have been alarmingly high with prevalence estimates of 30-40% in Western 
Kenya and South Africa [9, 10] indicating high rates of condomless sex and often the presence of 
untreated infection that can compromise immune function and ease entry of HIV and other 
pathogens [9-11].  
Delivering PrEP to young men 
Momentum for the delivery of comprehensive preventive health services to young men, who are 
typically isolated from preventive health care, is growing and can be leveraged to introduce PrEP 
[12, 13]. Young men value health care services that do not interfere with paid work or compromise 
confidentiality [14]. Interventions that meet men outside of traditional facility settings and integrate 
HIV prevention with full service preventive health care, such as care for hypertension and 
diabetes, offers convenience and may increase salience of preventive behaviors yielding greater 
recruitment of young men for clinical services [15]. HIV self-testing (HIVST) is another approach 
being tested as a strategy to engage young men to know their HIV status and link them to services 
whether HIV-negative (e.g. PrEP initiation) or HIV-positive (e.g. ART initiation). Studies among 
pregnant women, men who have sex with men, and female sex workers have found that 
secondary distribution of HIVST kits can increase frequency of HIV testing among male partners 
and HIVST kits yield accurate results [16-18]. In these studies, reports of partner-perpetrated 
violence were rare, indicating that people potentially used discretion when choosing partners to 
whom to offer HIVST [17]. 
Factors influencing PrEP adherence among adolescents 
A key developmental feature of adolescence is a decreased ability to appraise risk and this may 
influence adolescent PrEP use [19]. For adolescents, risk taking provides high-level stimulation 
yielding a satisfying experience and often occurs in the presence of friends [20]. In later 
adolescence (ages 20-24 years) when self-regulatory abilities are more fully developed, risk 
appraisal and avoidance behavior emerges alongside choices and behaviors that minimize risk 
[21]. With regards to sexual behavior, adolescents may exude optimistic bias and invulnerability 
to unintended pregnancy or STIs, including HIV and often cite the pressure of social norms that 
dissuade use of condoms, especially in the context of trusting a partner [22]. With PrEP, 
adherence can be impacted by individual feelings of optimism and invulnerability which are often 


Aligning PrEP and HIV Study Protocol 
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positioned 
within 
the 
broader 
context 
of 
family/peer, community and 
structural factors outlined in 
the social-ecological model 
[23]. This framework has 
been applied in numerous 
studies seeking to identify 
novel delivery approaches 
for 
HIV 
prevention 
interventions 
for 
young 
women and has drawn 
attention to the role that 
male partners may play to 
support or undermine PrEP 
use by young women [8, 24-
26].  
Summary of unaddressed 
questions 
In summary, PrEP is being 
scaled up nationally in 
Uganda and young people 
are an important target 
when they have substantial 
HIV risk. The question of 
whether young people align 
PrEP 
use 
and 
high 
adherence to PrEP with 
actual 
HIV 
risk 
and 
exposure is not yet fully 
addressed. We hypothesize 
that this alignment in the 
context of oscillating HIV 
risk may be challenging for 
young 
people 
and 
counselors can assist if we 
gain better understanding 
of the underlying alignment 
of risk and PrEP use and 
reasons for mal-alignment.  
Overall goal for this protocol 
This 
protocol 
describes 
methods and procedures 
for enrolling a new cohort of 
young men in order to 
provide testing for HIV and 
common curable STIs and 
offer men PrEP. Data from 
Table 2. Objective measures of HIV risk and PrEP use collected 
through the parent Kampala Women’s Bone Study and Kampala Men’s 
Study  
Kampala Women’s Bone 
Study (KWBS) 
• HIV  
• PrEP execution:  
o Tenofovir concentration in 
blood/urine 
o Daily pillbox openings 
(Wisepill™) 
o Self-report 
• PrEP persistence: 
o Pharmacy dispensation 
records 
• HIV risk 
o 
Yc DNA (marker of 
semen 
exposure/condomless 
sex) 
o 
C. trachomatis 
o 
N. gonorrhoeae 
Young male partners of KWBS 
women joining the novel 
cohort established by the 
“Aligning PrEP and HIV 
exposure” protocol 
• HIV 
• HIV risk 
o 
C. trachomatis 
o 
N. gonorrhoeae 
• PrEP execution:  
o Tenofovir concentration in 
urine 
• 
Self-report 
Figure 1. The social-ecological model that can be applied to 
understand factors influencing adolescent PrEP use 
 


Aligning PrEP and HIV Study Protocol 
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the men enrolling will be linked to data being collected among their young female sex partners in 
the Kampala Women’s Bone Study, including women’s adherence to PrEP, HIV status and STI 
diagnoses. The anonymous linkage of data between male and female sex partners will permit us 
to answer questions about HIV risk and exposure and how this aligns with PrEP use by each 
sexual partner.  
Our parent study, the Kampala Women’s Bone Study (KWBS) 
We are currently conducting a longitudinal observational study of bone health among 500  women 
ages 16-25 who initiate PrEP concurrently with the common injectable contraceptive, depot 
medroxyprogesterone acetate (DMPA, R01HD089843 PI: Heffron). In this study, we aim to 
determine whether young women using DMPA and PrEP will experience greater decreases in 
bone mineral density and markers of bone turnover and resorption relative to women using only 
one of the products (i.e. DMPA but not PrEP, PrEP but not DMPA) or neither. This clinically-driven 
parent study objectively measures bone health, PrEP adherence, and infection common curable 
STIs (Table 2). By anonymously linking data from the women in KWBS with data from their male 
partners, we can objectively measure alignment of PrEP use and HIV risk and exposure. 
Recruitment for KWBS began in May 2018, 304 (60%) have been enrolled as of July 2019, and 
retention is high: only 5.2% of expected month-1, 2.2% of month-3, and 3.3% of month-6 visits 
have been missed to date. The cohort has self-reported high behavioral risk for HIV (Table 3), 
22% were treated for a genital infection at enrollment (syndromically diagnosed), and 91% 
initiated 
PrEP 
at 
enrollment. Through 
our 
counseling, 
women 
are 
encouraged to use 
PrEP 
with 
high 
adherence 
and 
to 
discontinue 
PrEP 
during 
sustained 
periods with little risk. 
We are beginning to 
observe some PrEP 
discontinuations and 
some early decliners 
have initiated PrEP, 
indicating 
the 
potential 
for 
fluctuating risk and 
desire for PrEP.  
Impact 
By leveraging data 
already collected from 
young women in our 
ongoing study, the Kampala Women’s Bone Study, and engaging a new cohort of young men for 
this protocol, we have an ideal platform to study whether PrEP use aligns with HIV exposure and 
sexual HIV risk among young women and their male sex partners, using objective measurement 
of HIV risk, PrEP adherence, and sexual behavior. An additional high impact result is an 
opportunity to identify strategies to engage young men in HIV prevention services through a novel 
cohort study. Findings demonstrating alignment of PrEP use and HIV risk will strengthen 
Table 3. Characteristics of young women ages 16-25 enrolled in KWBS 
Number enrolled (as of 15 April 2019) 
240 
Initiating PrEP at enrollment 
91% 
% expected M6 study visits not attended 
3.3% 
% accrued person time among women initiating PrEP at 
enrollment when PrEP was not dispensed (women switching 
onoff PrEP) 
10% 
% accrued person time among women non initiating PrEP at 
enrollment when PrEP was dispensed (women switching off 
on PrEP) 
17% 
% aged 16-20 
61% 
Number of sex acts, past 3 months, median (IQR) 
24 (9-72) 
% sex acts, past 3 months, that were condomless 
35% 
Number of male sex partners, past 3 months, median (IQR) 
2 (1-5) 
% male partners that were new, past 3 months 
40% 
Treated for syndromically-diagnosed STI at enrollment visit* 
22% 
*Primary STI symptom was vaginitis or vaginal discharge. 


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confidence in programmatic PrEP delivery to young people. Findings demonstrating mis-
alignment will be dissected to understand circumstances leading to over- or under-use of PrEP 
and opportunities for PrEP programs to improve alignment. All findings will be relevant for oral 
PrEP programs as well as novel PrEP strategies that are in the development pipeline, such as 
intravaginal rings and injectable PrEP. 
V. 
METHODS 
A. 
Overall Design  
The proposed research will engage a new cohort of young men, whose female partners are 
already engaged in the Kampala Women’s Bone Study. Women in the Kampala Women’s  Bone 
Study will be invited to engage in this novel study to recruit their male partners. Women’s HIV risk 
is directly related to the HIV status and risk of their male sexual partners and thus, we will leverage 
our ongoing cohort of KWBS young women to recruit their male sexual partners for a new men’s 
study. Men will be offered PrEP, diagnostic STI testing and treatment, and followed for 6 months 
to assess PrEP continuation and STIs. Men’s data will be linked to data from their female sex 
partners in the parallel KWBS study to determine whether women’s PrEP use aligns with HIV risk 
and exposure.  
B. 
Study Aims  
Aim 1. To determine whether young women’s adherence to PrEP aligns with the HIV status 
of their male partners 
Men engaging in this study will have HIV testing at enrollment, month 1 and quarterly for up to 6 
months. Results from this testing will be linked to data from the participant’s female sex partner 
that characterize her PrEP use to determine whether her PrEP use aligns with his HIV status. 
Aim 2. To determine whether young women’s adherence to PrEP aligns with the HIV risk 
of their male partners 
Men engaging in this study will have testing for common curable STIs (Chlamydia trachomatis 
and Neisseria gonorrhoeae) at enrollment, month 1 and quarterly for up to 6 months. Results from 
this testing will be linked to data from the participant’s female sex partner that characterize her 
PrEP use to determine whether her PrEP use aligns with his HIV risk (defined by the results from 
his STI testing). 
Aim 3. To determine whether young men’s adherence to PrEP aligns with the HIV status 
and risk of their female partners 
We will offer PrEP to HIV-negative men enrolled in this study and track PrEP initiation, refills, and 
adherence to PrEP (based on self-report and drug levels). The frequency of high PrEP adherence 
will be compared among men with female partners infected and uninfected with HIV or another 
STI. 
 
C. 
Primary exposure  
The primary exposure is male infection with HIV (Aim 1), NG or CT (Aim 2) and female infection 
with HIV, NG, or CT (Aim 3). 
D. 
Primary outcomes 
The primary outcome will be PrEP used by women with sufficient daily adherence to confer HIV 


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protection (6-7 doses in the past week or TFV ≥40ng/mL) for periods when women are dispensed 
PrEP. When PrEP is not dispensed, the TFV level will be assigned as 0 ng/mL. 
 
For Aim 3, the primary outcome will be PrEP used by men with sufficient daily adherence to confer 
HIV protection (4 doses in the past week), measured by self-report or objective measures (daily 
monitoring or drug levels). 
E. 
Hypothesis 
Women and men will continue to use PrEP when their partners refuse HIV testing or disclose STI 
infections.  
F. 
Location  
This study will take place at the Infectious Diseases  Institute (IDI)-Kasangati research clinic, 
located in the Kasangati area of Kampala in close proximity of several public health care facilities. 
G. 
Population 
The proposed study will enroll 200 young men who are male sexual partners of women in the 
current KWBS parent study. This demographic has a high risk for HIV acquisition thus it is ideal 
to provide them with diagnostic testing, prevention and treatment services for HIV and STIs, and 
prevent transmission to their female partners. Women from KWBS will also be engaged to discuss 
the study with their male partners and to have their data anonymously linked to their male partners 
who join this study.  
H. 
Eligibility for men 
Inclusion criteria:  
- 
Men ages ≥18  
- 
Has a female sexual partner enrolled in the Kampala Women’s Bone Study  
- 
Willing and able to provide informed consent  
Exclusion criteria:  
- Has any other condition that would preclude the ability to provide informed consent, make 
study participation unsafe, complicate the interpretation of study findings or otherwise 
interfere with achievement of the study objectives, in the investigator’s discretion. 
 
I. 
Eligibility for women 
Inclusion criteria: 
− 
Participating in the Kampala Women’s Bone Study 
− 
Willing to talk with male sex partners about the new study for men and refer men for 
study recruitment 
Exclusion criteria: 
− 
Has concerns about potential social harm stemming from anticipated conversations 
with male sex partners about the new study for men such that study staff would 
discourage the women from participation 
− 
Investigator discretion 


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J. 
Sample size  
We will enroll approximately 200 male and 300 female participants into this study  
K. 
Study power  
Power calculations are based on the primary aim to determine alignment of women’s PrEP use 
with male sex partner’s STI 
infection status. Using an 
estimate that 20% of men 
will be infected with STI/HIV 
at any visit and 50% of their 
female partners will have 
protective PrEP levels, we 
estimate that we will have 
≥80% power to detect a 
relative risk of ≥2.00 and 
≥90% power to detect a 
relative risk of ≥2.30 in 
comparisons 
of 
the 
proportion of female visits 
with PrEP protection between visits when male partners had HIV risk or no HIV risk (assuming 
that α=0.05). If 70% of their female partners have protective PrEP levels, power will be 80% for a 
RR of 1.57 and 90% for a RR of 1.72 (Table 4). 
L. 
Recruitment 
Overall 
Women will be recruited to join this study by outreach staff at the IDI-Kasangati facility at the 
end of routine study visits for the KWBS. 
For young men who are sex partners of women in KWBS, we will leverage women participating 
in KWBS to recruit 200 of their current male sex partners. Women will be asked to consent to 
participate in recruitment of their male sex partners and to have their data anonymously linked to 
their male partner data. This will be a separate consent form and women may decline this 
component without any change to their participation in KWBS. Women with concerns about 
potentially experiencing violence from their male partner will be discouraged from recruiting this 
or any other male partners for the study and we will have staff trained in violence prevention 
available to counsel these women. The IDIK research clinic has established relationships with 
well-known organizations that specialize in IPV prevention and counseling in the event that a 
KWBS woman needs to be referred for more in-depth care. Ultimately, each woman’s participation 
will be at her own discretion. Women engaging in this new study will be provided with multiple 
strategies to talk with male sex partners about the new study: talking points, recruitment 
brochures, HIV self-testing kits, and contact information for study recruitment staff. 
Talking points 
Women enrolled in KWBS will be provided talking points to guide them to think about how to 
recruit male partners. Talking points will include benign messages about a new research study 
for men and provide ideas about how to promote the men’s study without disclosing information 
about their own recent HIV test/status or PrEP use (see Appendix for draft talking points). 
Table 4. Aim 2 power: Proportion of women with PrEP at 
protective level needed to see significant differences by male 
partner HIV risk, with ≥80% or ≥90% power. 
Male partner HIV 
risk (HIV or STI 
infection) 
PrEP at protective level, % (RR) 
Yes, exposed, N=40 
50% 
70% 
Unexposed, N=160 
 
 
For 80% power 
24.6% (RR=2.0) 
44.6% (RR=1.5) 
For 90% power 
21.5% (RR=2.3) 
40.8% (RR=1.7) 
Power calculated by nQuery Advisor using power for Chisquared test comparing two 


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Recruitment brochures 
Women will also be given recruitment materials such as brochures, to give to their male partners 
that feature information on the benefits of STI testing and treatment, an introduction to PrEP and 
its availability for HIV-negative men through the study clinic. Recruitment materials will encourage 
men to call study recruitment officers or come to the IDIK research clinic. Draft brochures and 
other recruitment materials will be submitted to the research ethic committee for approval. 
HIV self-test kits 
HIV self-testing is being rolled out in Kampala by The President’s Emergency Plan for AIDS Relief 
(PEPFAR) partners coordinated by the Ministry of Health. To align with this strategy, the study 
will also have HIVST in stock that will be available for women to take to male partners, should 
they desire. The IDIK research clinic is already using HIVST in a number of ongoing PrEP studies, 
including with pregnant women living with HIV and women engaging in transactional sex 
(NCT03484533, NCT03426670). HIVST are accompanied by written instructions in English and 
Luganda with pictures and diagrams that explain how to use them and provide a 24-hour phone 
number in case of reactive results, questions or help with the kit. Anyone reporting reactive results 
to study staff will be encouraged to come to the research clinic and anyone who does not come 
within one week will be traced via phone or an in-person visit if possible. We will follow good 
clinical practice guidelines to ensure that all people with a reactive result are supported and 
provided with confirmatory testing, treatment and care.  
Contact with study recruitment team 
Once women have initiated conversation with their male partner, they will be encouraged to let 
the recruitment team know and arrange a time for their male partner to talk with a member of the 
recruitment team. This will be done by having the recruitment officer call the woman at a mutually-
agreeable time when she can offer her phone to her male partner, facilitating a one-on-one 
conversation with the recruitment officer. This method will maintain anonymity of the potential 
male participant and permits contact without the woman providing her partner’s phone number to 
the recruitment officer. This recruitment strategy has worked well for our ongoing study that 
recruits male partners of HIV-infected pregnant women (NCT03484533). Women can also bring 
male partners to the study clinic for him to meet a recruitment officer in person or make other 
arrangements to introduce her partner to the recruitment officer.  
M. 
Retention 
We will leverage the long-established retention strategies of the community outreach team at the 
IDIK research clinic to ensure high rates of retention among male participants. Retention 
strategies include sending participants reminders before their upcoming target visit date (via SMS 
or phone call), calling participants the first day after a missed visit date, 3 days later, 1 week later, 
and 1 month later, and visiting participants in their home or place of work, when given permission, 
to offer them a free ride to the research clinic. In addition, a recruitment/retention officer will 
coordinate with the study team to ensure that study visits can be conducted on weekends and 
evenings and that men can be given expedited services, as necessary to align with work 
schedules and other obligations. 
N. 
General study procedures  
Informed consent 
Written informed consent will be obtained from each female participant in the KWBS, and each 
male study participant prior to conducting any research procedures. Participants agreeing to 
participate will sign the informed consent form and be offered copies of the informed consent 


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forms to take home. The informed consent forms will describe the purpose of the study, the 
procedures to be followed, the voluntary nature of the study, and the risks and benefits of 
participation, in accordance with all applicable regulations. The forms will be translated into 
Luganda and participants will select the language of their choice (either Luganda or English) for 
the informed consent process. Informed consent will be conducted in a quite space in the research 
clinic by a study staff member trained in human subjects and good clinical practice. 
Procedures for women 
Women enrolled in the KWBS will be asked by the study recruitment officers if they would be 
interested in recruiting their male partner for this new study. Recruitment officers will ensure that 
women understand fully their role, discuss and consider potential benefits and risks, such as 
inadvertent disclosure of HIV status, PrEP use, study participation, and intimate partner violence 
(IPV) and how to avoid them. Women with concerns about IPV will be discouraged from recruiting 
potential male perpetrators for the study and we will have staff trained in IPV prevention available 
to counsel these women. Women who are interested in recruiting their male partners will sign an 
informed consent form specific to partner recruitment and linkage of their male partners data, to 
their KWBS data.  
Following informed consent, the study staff will provide counseling messages and talking points 
for women to help them with the recruitment process and initiate the discussion with their male 
partner.  
Women will receive a recruitment brochure to give to their male partners. These brochures will 
include benign information on STI testing and health services available at the clinic, as well as 
contact information of study staff, whom they can call if they are interested in joining the study or 
have additional questions.  
Study staff will also provide women an HIVST kit, if they choose to deliver one to their male 
partner. To ensure that women feel comfortable with the recruitment process, study staff may also 
assist with role playing to act out talking points and delivery of the recruitment brochure and/or 
HIVST kit. 
Procedures for men 
Screening and Enrollment 
Following informed consent, men will be screened for their willingness to comply with study 
procedures, complete locator information, and assigned a unique ID. Eligible men will be enrolled 
into the study, on the same day if possible. Procedures on the day of enrollment will include: 1) 
HIV testing with PrEP dispensation or active referral to ART and HIV care depending on the 
results, 3) Hepatitis B and creatinine testing for men starting PrEP, 2) completion of 
questionnaires to assess demographic information, recent sexual behavior, partnership status, 
HIV risk perception, alcohol and drug use, mental health, and adherence to ART/PrEP, 4) 
diagnostic testing for N. gonorrhoeae and C. trachomatis using rapid tests with real time results. 
Results from creatinine testing will be available within 3-5 days from the laboratory. Any 
participants with abnormal creatinine/creatinine clearance will be contacted by the study clinician 
and asked to return for confirmatory testing. PrEP will be discontinued for any men with confirmed 
abnormal creatinine/creatinine clearance levels according to national guidelines.  
Follow up 
Follow up visits will be conducted 1, 3 and 6 months after enrollment. Procedures at each visit 
will include: 1) HIV testing with PrEP dispensation or referral to ART and HIV care depending on 
the results, 2) completion of questionnaires to assess recent sexual behavior, partnership status, 
HIV risk perception, and adherence to ART/PrEP, and 3) diagnostic testing and treatment for N. 


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gonorrhoeae and C. trachomatis. PrEP use will be objectively measured by point-of-care urine 
tests, if kits become available during the study, and real time monitoring of PrEP adherence will 
be conducted using an electronic monitoring system that captures a date-time stamp each time 
the pill container is opened, if devices become available.[27] Participants using PrEP will have a 
creatinine test at the 6-month/study exit visit which aligns with Uganda national PrEP guidelines. 
For men who test HIV-positive, confirmatory HIV testing will be conducted according to Uganda 
national guidelines and PrEP will be discontinued. HIV-positive men will continue to be engaged 
until the end of their follow up time to collect sexual behavior data, but HIV testing will not be 
conducted once HIV-positive status is confirmed. Men will be counseled about ART initiation and 
ART adherence and HIV viral load testing will be conducted when HIV is first detected and 3 
months after ART initiation. IDIK is situated next to a public health facility that provides ART and 
is often a close collaborator to receive referred research participants for HIV care. 
Visit-specific procedural tables 
 
 
SCR 
ENR 
M1 
M3  
M6 & 
EXIT  
ADMINISTRATIVE & REGULATORY PROCEDURES 
Obtain informed consent 
X 
X 
 
 
 
Collect/update locator information 
X 
X 
X 
X 
X 
Collect/update demographic information 
X 
X 
 
 
 
CLINICAL & COUNSELING PROCEDURES 
HIV pre and post-test counseling 
X 
X 
X 
X 
X 
Risk reduction counseling & condom provision 
X 
X 
X 
X 
X 
If HIV negative: PrEP counseling, including 
adherence counseling 
X 
X 
X 
X 
X 
If HIV negative: PrEP provision, if desired 
X 
X 
X 
X 
X 
If HIV negative: PrEP pill count, if using PrEP 
 
 
X 
X 
X 
If HIV negative: Urine TFV testing (when kits are 
available), download of electronic monitoring data 
(if devices are available) 
 
 
X 
X 
X 
If HIV positive: ART referral  
X 
X 
X 
X 
X 
If HIV positive: ART counseling  
X 
X 
X 
X 
X 
Diagnostic testing and/or syndromic management 
of STIs 
X 
X 
X 
X 
X 
STI treatment  
[X] 
[X] 
[X] 
[X] 
[X] 
LABORATORY PROCEDURES  
If HIV negative: Creatinine testing when using 
PrEP 
X 
 
 
 
X  
If HIV negative: HBV surface antigen 
X 
 
 
 
 
HIV rapid test  
X 
X 
X 
X 
X 


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Study exit  
Approximately 6 months after enrolling, men will complete their last study visit. At this visit, men 
will be provided with referrals to clinics of their choice to continue receiving PrEP and any other 
clinical services needed.  
O. 
Special circumstances 
HIV seroconversion 
HIV rapid testing will be conducted quarterly during follow up. We expect the rate of HIV 
seroconversion to be very low, due to the use of PrEP and repeated counseling about HIV 
prevention and PrEP. However, in the event of HIV positive rapid test results, PrEP will be stopped 
immediately, and additional blood samples will be drawn for confirmatory HIV testing according 
to national guidelines. Men with confirmed HIV seroconversion will be extensively counseled and 
referred to local clinics providing antiretroviral medications and HIV care. Seroconverting men will 
remain in the study until their follow up period has ended and can continue to receive counseling 
services from study counselors as part of good clinical care. 
Partner Notification 
Research staff will follow national guidelines for assisted partner notification (APN) in the event 
of positive HIV diagnostic tests and take precautions to avoid safety problems. Modalities in the 
existing programmatic approach of APN include self-disclosure, assisted disclosure, or facilitated 
disclosure. Staff are well trained in counseling messages regarding the benefits of APN and are 
able to conduct APN activities depending on the participant’s preferences. Staff are also very 
experienced with counseling couples’ on issues of sexual health if couples choose to attend visits 
together.   
 
P. 
Safety monitoring  
Kidney function will be monitored at PrEP initiation and 6 months later, in accordance with 
Ugandan guidelines, using creatinine clearance calculated by Cockroft–Gault equation. The 
investigators will be responsible for continuous close monitoring of all adverse events that occur 
among study participants. For the purposes of this study, only serious adverse events (SAEs) and 
adverse events felt related to PrEP will be documented on case report forms.  Adverse events 
and the severity of clinical symptoms will be scored using the DAIDS Table for Grading the 
Severity of Adult and Pediatric AEs.[28] The study safety monitor will review clinical and laboratory 
SAEs in real time as they are reported by the site clinicians on CRFs and through email within 48 
hours of occurrence. As needed, the safety monitor will work to provide rapid consultation with 
clinicians regarding the management of toxicities. A Safety Review Team comprised of the study 
investigators and lead clinicians will review clinical and laboratory safety reports summarizing 
SAEs via conference call on an approximately quarterly basis. 
If rapid test positive: Confirmatory HIV testing and 
RNA quantification  
[X] 
[X] 
[X] 
[X] 
[X] 
BEHAVIORAL DATA COLLECTION   
Questionnaire completion 
 
X 
X 
X 
X 
Medical History questionnaire  
X 
X 
X 
X 
X 
X required procedure; [X] if clinically indicated  


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VI. 
DATA COLLECTION  
Demographic, behavioral and clinical data including STIs symptoms, sexual activity and PrEP 
adherence will be recorded electronically on case report forms (CRFs) directly entered by 
research staff into a secure web-based data management program. Results from off-site 
laboratory testing will be returned to the IDI research clinic and also entered into this system. 
Automated legal range checks will be programmed to reduce data entry errors and internal quality 
control reports will be run on a monthly basis. Paper backup forms will be available in the case of 
power or internet outages with online data entry once restored. On a weekly basis, the University 
of Washington data manager will archive a backup copy of the master dataset on secure servers 
at the University of Washington. 
VII. 
LINKAGE WITH DATA FROM WOMEN IN THE EXISTING KWBS COHORT 
Men in this study will receive a study brochure from their female partner who is participating in 
the KWBS study. The brochure will have a label affixed to it with a code that is anonymously 
linked to the study ID of the woman recruiting him. At the time of presenting to the IDIK research 
clinic, potential male participants will be asked to bring their brochure so that the code can be 
scanned, and a male ID can also be linked to the same code. Using the code will enable women’s 
ID to be linked to men’s ID(s). If an enrolling participant does not have a coded brochure, we will 
create a link to a woman’s ID by asking for the name of the woman who recruited him and 
accessing our link logs that are stored in a secure room with biometric access control.  
VIII. 
DATA ANALYSIS  
Data from each man and his female KWBS partner who recruits him will be longitudinally aligned 
using study visit dates. The primary exposure is male infection with HIV (Aim 1), NG, or CT (Aim 
2), or female infection with HIV, NG, or CT (Aim 3) and the primary outcome will be PrEP used 
by women/men with sufficient daily adherence to confer HIV protection for periods when PrEP is 
dispensed. When PrEP is not dispensed, we will assign a TFV level of 0 ng/mL. We will estimate 
the association between HIV risk and use of PrEP using GEE to account for repeated 
measurements. Models will adjust for key confounding factors (demographic, sexual behavior, 
clinical).  
IX. 
HUMAN SUBJECTS CONSIDERATIONS 
The protocol, informed consent forms (for cohort participation and for interviews of providers), 
and patient education and recruitment materials will be reviewed and approved by the IRBs/ECs 
responsible for oversight.  Subsequent to initial review and approval, the responsible IRBs/ECs 
will review the study at least annually. 
A. 
Study oversight  
The protocol study team will review a comprehensive set of safety and study operational data 
every 6 months to ensure that timelines are being met and the study will be able to answer its 
primary research questions. 
B. 
Informed consent  
We will perform paper-based consenting of participants in their preferred language.  After we have 
ensured that participants have read and understood the consent forms, we will ask them to 


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append their signature on paper. Any participant who wants their consent form to take home will 
be given a copy.   
C. 
Risks  
Risks for this cohort include side effects from PrEP provided to the young men through the study 
clinic, and discomfort associated with blood draws, interviews, and STI and HIV counseling and 
testing. Intensive and ongoing counseling and monitoring of side effects and adverse events limit 
the risk for participants from the direct study procedures.  
For clinical data collection, standardized surveys will be used that will include questions on 
sensitive topics, such as sexual behavior. All participants will be extensively counseled about the 
risk and prevention of STIs, as well as the risk for HIV transmission with sex unprotected by a 
condom and/or PrEP and the importance of using condoms consistently and correctly. We expect 
that the risk of HIV transmission will actually be lower in this cohort than the general population 
of young men due to the careful attention that will be given to counseling about HIV risk and the 
provision of PrEP. Study staff will be aware of the potential for confidentiality issues with regards 
to test results from HIV testing that are part of a participant’s study documents.  
There is the potential for confidentiality issues with regards to study data. Although the study site 
will make every effort to protect participant privacy and confidentiality, it is possible that 
participants' involvement in the study could become known to others, and that social harms may 
result. However, the research staff has extensive experience in both individual and couples 
counseling, particularly on the topics of serodiscordance and HIV status disclosure. The research 
staff will provide couples counseling if the male participant chooses to involve their study partner, 
or individual counseling if the male participant chooses to keep his STI/HIV results confidential.  
D. 
Benefits  
Participants will receive individualized HIV and STI risk-reduction counseling and testing, access 
to PrEP medication, and free condoms. In addition, participants may benefit in the future from 
information learned from this study. 
E. 
Care for persons identified as HIV positive 
Men who test positive for HIV at enrollment or become infected with HIV later in the study will be 
referred immediately to HIV care centers and encouraged to initiate antiretrovirals in line with 
Ugandan national antiretroviral guidelines.   
F. 
Treatment for injury  
Participants will be asked to inform the clinic staff if they feel they have been injured because of 
taking part in the study. Injuries may also be identified during laboratory testing, and medical 
histories. Treatment for adverse events related to study participation will be provided by the 
research clinic. If treatment is required that is beyond the capacity of the clinic, the clinic staff will 
refer the participant to appropriate services or organizations that can provide care for the injury. 
The study based at IDI will cover the costs of the referral and treatment costs up to the time the 
participant is stable, or injury is resolved.  
F. 
Study records  
Complete, accurate, and current study records will be maintained and stored in a secure manner 
throughout the study. Study records include administrative documentation and regulatory 
documentation as well as documentation related to each participant enrolled in the cohort, 
including informed consent forms, chart notes, case report forms, laboratory requisitions, 
notations of all contacts with the participant, and all other source documents.   


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G. 
Confidentiality  
Every effort will be made to protect participant privacy and confidentiality to the extent possible.  
Personal identifying information will be retained at the local study site.  
 
X. 
CLINICAL RESEARCH SITE 
A. 
Site location 
The Infectious Diseases Institute (IDI)-Kasangati research clinic is part of the Infectious Diseases 
Institute, Makerere University College of Health Sciences. The facility is located next to Kasangati 
Health Center IV and has adequate space and equipment for ongoing and planned research 
studies. The Infectious Diseases Institute training team offers specialized courses in HIV 
management for health providers in Africa. For this study the focus of the training will be 
combination HIV prevention services including PrEP as well as STI prevention and treatment. 
B. 
Clinical facilities 
The site has a large training room that can accommodate up to 50 people, 3 clinical rooms, 6 
counseling rooms, a pharmacy, a phlebotomy room, a side lab, secure data room with data 
archive, administrative office space, wireless internet, telephone intercom system, community 
education offices, and a large waiting area which provide sufficient space for the execution of this 
study. 
C. 
Staff 
The Principal Investigator is a seasoned HIV/AIDS researcher and trainer, of local and 
international repute. He will lead the study team to maximize the scientific, ethical integrity of the 
study and ensure the training provided is of high quality.  The study employs in total  doctors,  
nurse counselors, a pharmacy technician, laboratory staff and  community educators/counselors, 
data personnel, qualitative research associates as well as support and administrative staff. The 
respective staff are overseen by a site coordinator, training coordinator and administrator. The 
study site previously implemented the Partners PrEP Study and the Partners Demonstration 
Project and is currently implementing the KWBS. The staff have substantial experience in the use 
of PrEP and its accompanying supportive services. The staff have been involved in the conduct 
of protocol specific training, development of outreach materials, and have skills in training of adult 
learners. 
D. 
Administrative procedures 
All administrative procedures regarding protocol compliance, study coordination, study activation, 
study monitoring, study records, and use of information and publications will be done according 
to good clinical practice. 
E. 
Laboratory considerations 
We will as much as possible use the public health laboratory facilities for routine laboratory 
monitoring. In situations where this is not possible, specimens will be collected and transported 
to the study collaborating laboratories. All specimen collection, transport, processing, testing, 
archiving, and results reporting will be conducted in accordance with good clinical and laboratory 
practice standards. The collaborating laboratories for the research clinic are the IDI Core 
Laboratory and the Immunology Laboratory in the Department of Medical Microbiology at 
Makerere College of Health Sciences. These are well-established labs with extensive experience 
in supporting clinical trials. External Quality Assurance (EQA) procedures will be followed 


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throughout the study and are overseen by the University of Washington International Clinical 
Research Center. 
 
XI. 
DATA SHARING AND OWNERSHIP 
During the conduct of the trial, the study database will remain confidential. After study completion, 
access to data will follow requirements of the Infectious Diseases Institute, National Institutes of 
Health and the University of Washington. The University of Washington International Clinical 
Research Center has a Manuscripts and Ancillary Studies Committee established to enable data 
and specimen collaborative work from studies conducted through the research group. Intellectual 
property and data generated under the proposed project will be administered in accordance with 
Uganda, University of Washington and NIH policies, including the National Guidelines for 
Research involving Humans as Research Participants (2014) [113] and the NIH Data Sharing 
Policy and Implementation Guidance of March 5, 2003. 
 
Materials 
generated 
under 
the 
project 
will 
be 
disseminated 
in 
accordance 
with 
University/participating institutional and NIH policies. Depending on such policies, materials may 
be transferred to others under the terms of a material transfer agreement. Access to databases 
generated under the project will be available for educational, research and non-profit purposes 
as approved by the relevant IRBs. Publication of data shall occur during the project, if appropriate, 
or at the end of the project, consistent with normal scientific practices. We will publish our findings 
in a timely fashion and will present unpublished data at appropriate research conferences. We 
are committed to collaboration in complex disease research and will participate in data-pooling 
studies as allowed by our currently established consent forms and IRBs. 
 
Data obtained from this research study are the property of the Infectious Diseases Institute of 
Makerere University and the University of Washington International Clinical Research Center. 
Local researchers shall have unrestricted access rights to datasets collected through this 
collaborative research project in accordance with Uganda guidelines. 
 
XII. 
DISSEMINATION PLAN 
 
Dissemination of study results will follow principles of good participatory practice. Study results 
will be disseminated through presentations to study participants, stakeholders and policy makers, 
and published in conference abstracts and peer-reviewed journals. Participants will be informed 
that if they so desire, they will be contacted at the end of the study for the purpose of informing 
them about study results. Trial results will also be shared with the community advisory board, the 
Ministry of Health, implementing partners and civil society groups with interest in reproductive 
health. 


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XIII. 
REFERENCES  
1. 
World Health Organization, Guideline on When to Start Antiretroviral Therapy and on Pre-
Exposure Prophylaxis for HIV. 2015, World Health Organization: Geneva, Switzerland. 
2. 
Ministry of Health Republic of Uganda, Technical Guidance on Pre-Exposure Prophylaxis 
(PrEP) for Persons at High Risk of HIV in Uganda. 2016, Ministry of Health: Kampala, 
Uganda. 
3. 
Ministry of Health Uganda, et al. Uganda Population-Based HIV Impact Assessment. 
UPHIA 
2016-2017. 
2018 
 
[cited 
2018 
15 
Aug]; 
Available 
from: 
https://phia.icap.columbia.edu/wp-content/uploads/2018/07/3430%E2%80%A2PHIA-
Uganda-SS_NEW.v14.pdf. 
4. 
Travill, D., et al., Sexual behavior and PrEP uptake among young African women in 
demonstration project about PrEP delivery. Abstract #WEPE219, in AIDS 2018. 2018: 
Amsterdam, Netherlands. 
5. 
Cottrell, M.L., et al., A Translational Pharmacology Approach to Predicting Outcomes of 
Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil 
Fumarate With or Without Emtricitabine. J Infect Dis, 2016. 214(1): p. 55-64. 
6. 
Baeten, J.M., et al., Antiretroviral prophylaxis for HIV prevention in heterosexual men and 
women. N Engl J Med 2012. 367(5): p. 399-410. 
7. 
World Health Organization, WHO Implementation Tool for PrEP of HIV Infection. Module 
12: Adolescents and young adults, W.H. Organization, Editor. 2018: Geneva, Switzerland. 
8. 
van der Straten, A., et al., Women's experiences with oral and vaginal pre-exposure 
prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One, 
2014. 9(2): p. e89118. 
9. 
Morton, J., et al., High prevalence of curable STIs among young women initiating PrEP in 
Kenya and South Africa. Abstract #WEPEC223, in AIDS 2018. 2018: Amsterdam, 
Netherlands. 
10. 
Barnabas, S.L., et al., Converging epidemics of sexually transmitted infections and 
bacterial vaginosis in southern African female adolescents at risk of HIV. Int J STD AIDS, 
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11. 
Francis, S.C., et al., Prevalence of sexually transmitted infections among young people in 
South Africa: A nested survey in a health and demographic surveillance site. PLoS Med, 
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12. 
Jhpiego. Lesotho's innovative Apex Clinic encourages older men to participate in HIV 
prevention 
services. 
2014 
 
[cited 
2018 
27 
August]; 
Available 
from: 
https://www.jhpiego.org/success-story/lesothos-innovative-apex-clinic-encourages-older-
men-to-participate-in-hiv-prevention-services/. 
13. 
MenStar Coalition. Global partners pledge over $1.2 billion to launch the MenStar 
Coalition. 
2018 
 
[cited 
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27 
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Available 
from: 
http://www.menstarcoalition.org/menstar.pdf. 
14. 
Teo, C.H., et al., Barriers and facilitators to health screening in men: A systematic review. 
Soc Sci Med, 2016. 165: p. 168-176. 
15. 
Havlir, D., et al. SEARCH community cluster randomized study of HIV "test and treat" 
using multi-disease approach and streamlined care in rural Uganda and Kenya. Abstract 
#WEAX0106LB. in AIDS 2018. 2018. Amsterdam, the Netherlands. 
16. 
Masters, S.H., et al., Promoting Partner Testing and Couples Testing through Secondary 
Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med, 2016. 13(11): p. 
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17. 
Thirumurthy, H., et al., Promoting male partner HIV testing and safer sexual decision 
making through secondary distribution of self-tests by HIV-negative female sex workers 


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and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet 
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Wesolowski, L., et al., Distribution of HIV Self-tests by HIV-Positive Men Who Have Sex 
with Men to Social and Sexual Contacts. AIDS Behav, 2019. 23(4): p. 893-899. 
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Steinberg, L., Risk taking in adolescence: what changes, and why? Ann N Y Acad Sci, 
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Spear, L.P., The adolescent brain and age-related behavioral manifestations. Neurosci 
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Keating, D., Cognitive and brain development, in Handbook of Adolescent Psychology, 
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Sommer, M., S. Likindikoki, and S. Kaaya, “Bend a Fish When the Fish Is Not Yet Dry”: 
Adolescent Boys’ Perceptions of Sexual Risk in Tanzania. Archives of Sexual Behavior, 
2015. 44(3): p. 583-595. 
23. 
Latkin, C.A. and A.R. Knowlton, Micro-social structural approaches to HIV prevention: a 
social ecological perspective. AIDS Care, 2005. 17 Suppl 1: p. S102-13. 
24. 
Psaros, C., et al., HIV Prevention Among Young Women in South Africa: Understanding 
Multiple Layers of Risk. Arch Sex Behav, 2018. 47(7): p. 1969-1982. 
25. 
Celum, C.L., et al., Rethinking HIV prevention to prepare for oral PrEP implementation for 
young African women. J Int AIDS Soc, 2015. 18(4 Suppl 3): p. 20227. 
26. 
Amico, K.R., et al., Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP 
Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework. 
AIDS Behav, 2017. 21(5): p. 1361-1375. 
27. 
Spinelli, M.A., et al., Low tenofovir level in urine by a novel immunoassay is associated 
with seroconversion in a preexposure prophylaxis demonstration project. Aids, 2019. 
33(5): p. 867-872. 
28. 
Chirgwin, K.D., et al., Menstrual function in human immunodeficiency virus-infected 
women without acquired immunodeficiency syndrome. J Acquir Immune Defic Syndr Hum 
Retrovirol, 1996. 12(5): p. 489-94. 
 

ICF_001.pdf: 
Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
 
Consent Form for Male Partners  
Alignment of PrEP use with HIV risk in young women and men 
The Align Study 
Consent Version 1.0 
23rd July 2019 
 
Investigator 
Qualifications 
Institution 
Telephone  
Andrew Mujugira  
MBChB, PhD 
Infectious Diseases Institute 
Kampala, Uganda 
+256 392 265 887  
 
Renee Heffron 
MPH, PhD 
Associate Professor 
University of Washington, 
Seattle, USA 
+1 206 520 3817 
 
INFORMED CONSENT  
We are asking you to volunteer for a research study. This study is for men who are partners of 
women in the Kampala Women’s Bone study (KWBS), which is another study we are running at 
this site. In this study, we will provide STI testing and treatment, including testing for HIV. If you 
are HIV-negative, we will counsel you about HIV prevention and offer you pre-exposure 
prophylaxis, or PrEP. Before you decide whether to take part in the study, we would like to explain 
the purpose of the study, the risks and benefits, and what would be expected of you if you join 
the study. This study is sponsored by the University of Washington and the National Institutes of 
Child Health and Human Development, which are located in the USA, in partnership with 
Makerere University in Uganda. The study has been approved by the Mildmay Uganda Research 
Ethics Committee.  
If you decide to continue in the research study, you will be asked to sign this consent form or 
make your mark in front of a witness. We will give you a copy of this form. This consent form might 
contain some words that are unfamiliar to you. Please ask us to explain anything you may not 
understand. 
PURPOSE OF THE STUDY  
Research has shown that a medication taken every day can be used to prevent men and women 
from getting new HIV infections – a concept called pre-exposure prophylaxis or PrEP. The term 
PrEP means to have protection against HIV before exposures occur. The purpose of this study is 
to understand how women and men decide to take PrEP based on their risk of getting HIV. Your 
chances of getting HIV can be based on your behavior and test results, and the behavior and test 
results of your sexual partners. We would like to better understand if men and women decide to 
use PrEP well when their chance of getting HIV is higher.   
In this study we will provide testing and treatment for some sexually transmitted infections (STIs) 
including HIV. If you test positive for any, we will provide you with treatment or refer you to a clinic 
of your choice. If you test negative for HIV, we will offer you PrEP. You do not have to initiate 
PrEP if you do not wish to.  


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
If you choose to enroll in this study, you will be given a unique study ID that will be kept 
confidential. To help us understand your risk, we will link your study ID to your partners study ID. 
This anonymous link will be password protected in our study’s computer system. Your information 
will be kept confidential and we will not tell your partner about your STI or HIV test results unless 
you would like us to do so.  
Approximately 200 men will be enrolled in this study at this clinic. Each man will be in the study 
for up to 6 months.   
 
YOUR PARTICIPATION IS VOLUNTARY  
This consent form gives information about the study that we will discuss with you. Once you 
understand the study, and if you agree to take part, we will ask you to sign your name or make 
your mark on this form. We will offer you a copy to keep.  
 
Before you learn about the study procedures, it is important that you know the following:  
 
• 
You do not have to join this study if you do not want to.  
• 
You may decide not to take part in the study, or to withdraw from the study at any time, 
without losing your regular medical care.  
• 
If you decide not to take part in this study, you can still join another research study later, 
if one is available and you qualify.  
• 
You may be asked about joining other studies. Due to the time commitment from being in 
this study, you may not be eligible to join this study if you are in other studies. If you do 
not agree to join these other studies, you may still take part in this study. 
 
STUDY PROCEDURES 
If you decide to take part in the study, your first visit will continue today after you read, discuss, 
and sign or make your mark on this form.  At study visits, several things will happen:  
 
• 
You will be asked questions about your medical history and sexual behavior. 
• 
You will undergo testing for some STIs, like gonorrhea and chlamydia, and be provided 
with your results as quickly as possible. If you are positive for any STIs, we will provide 
you with treatment according to Uganda national guidelines.  
• 
You will be tested for HIV using a rapid kit. If you test positive, we will refer you to treatment 
and care. If you test negative, we will offer you PrEP. If you would like to take PrEP, we 
will provide counseling on how to take PrEP every day.  
• 
If you decide to take PrEP, we will ask your permission to obtain a blood sample (up to 35 
ml/about 3 tablespoons] so we can check for your kidneys for their health. We will test you 
again about 6 months after you start using PrEP. If at any time you have an abnormal 
result, we will contact you so that you will know and schedule you to return for another 
visit to recheck the result and evaluate you. 


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
• 
If you decide to take PrEP, the pharmacy staff will provide you with new bottles of pills to 
last until your next visit. You will be asked to answer questions about the pills you took 
during the previous month and be counseled about methods for not forgetting to take your 
pills during the following month. Please bring bottles with you to each clinic visit.  
• 
If we find that you have any STIs, including HIV, study counselors will talk with you about 
ways that you could tell your sex partners about these results. Counselors will be able to 
assist you to tell you partners according to your wishes. If you do not wish to tell your 
partners about your results, you can continue to be in this study and receive care at this 
clinic. 
After today’s visit, we will schedule you to have study follow-up visits in one month, two months 
later, then three months after that. Each visit will take about 60 minutes at this clinic. If you are 
unable to come to the research clinic for a study visit, we can do the visit procedures away from 
the research clinic, at your home or a more convenient location, if you agree to that.  
HIV INFECTION 
If you have a positive HIV test during the study: 
• 
The study staff will talk with you about this test result and what this means for you. We will 
complete confirmatory testing according to national guidelines of Uganda.  
• 
If you were previously taking the PrEP medication you will be asked to stop taking the 
medication and we will refer you to treatment.  
IMPORTANCE OF NOT SHARING PrEP MEDICATION 
It is very important that you do not share PrEP medication with partners or with anyone else. The 
medications contained in PrEP are used to treat HIV infection, but they are only effective as HIV 
treatment if they are used in combination with other medications. Thus, PrEP by itself is only for 
HIV-negative people and it should be accompanied by regular HIV testing and adherence 
counseling.  
RISKS AND/OR DISCOMFORTS  
You may feel discomfort or pain when your finger is pricked for the HIV rapid test. You may feel 
dizzy or faint. You may have a bruise where the needle goes into your arm if we need to collect 
blood from your arm.  
 
You may become embarrassed, worried, or anxious when talking about your sexual practices, 
ways to protect against HIV and other infections passed during sex, and your HIV test results. 
You may become worried or anxious while waiting for your test results. If you find out that you 
have HIV, you could become worried or anxious. Talking about HIV and finding out your test 
results could cause problems between you and your partners, family, or community. Trained 
counselors will help you deal with any feelings or questions you may have.  
 
The study staff will make every effort to protect your privacy and confidentiality while you are 
having the study procedures.  However, it is possible that others may learn of your participation 
here and, because of this, may treat you unfairly or discriminate against you. For example, you 
could have problems getting or keeping a job, or being accepted by your family or community.  
 


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
You may have symptoms or adverse effects while participating in the study. These symptoms or 
adverse effects may be due to participation in the study or due to illnesses that have no relation 
to the study, like a cold or flu. All persons who participate in this study will be watched carefully to 
monitor their health. You should tell the doctor of the study clinic about any symptoms that you 
feel while you are participating in the study. You will be given a telephone number where a study 
clinician will be available 24 hours a day, 7 days a week. You should call this number if you 
experience any serious symptoms.  
 
Risks potentially related to the PrEP medication  
The adverse effects that can occur in a small proportion of people taking PrEP are well known 
because the medication has been used by many people. Some mild adverse effects are expected 
to occur in up to 1 in 10 persons who take PrEP. Other adverse effects are more serious but are 
expected to occur in less than 1 in 100 persons who take PrEP. Occasional adverse effects 
include: mild problems of kidney function that are only detected by laboratory tests; lack of 
energy/fatigue; upset stomach, vomiting, soft or liquid stools; dizziness. Rare adverse effects 
include: rash; liver function problems; serious kidney damage; allergic reaction. Small changes in 
the mineral density of bones were observed in studies of people who were given PrEP, but the 
changes in the mineral density of the bones did not cause any fractures, or other problems that 
bothered the patients. Lactic acidosis has occurred in HIV-infected persons taking the medicine 
used as PrEP, in combination with other drugs. Lactic acidosis is a condition that can produce 
shortness of breath, nausea, and liver failure. This is a serious adverse effect of some medications 
used for HIV infection. You should call or come to the study clinic if you have unexplained 
increased or decreased urination, weight loss, cramps, muscle pain, dizziness, excessive 
fatigue, nausea, vomiting, or shortness of breath. If you have these symptoms, or any other 
symptoms that concern you, the study staff will evaluate your symptoms and determine 
whether you should stop your PrEP pills.  
 
Other medications  
 
Risk of acquiring HIV infection and drug resistance  
You may become infected with HIV during this study from your sexual partner(s). Study 
counselors will talk with you about all the HIV prevention options that are available to you to 
prevent HIV, like using condoms and keeping your number of sexual partners low. You could 
become infected with a strain of the HIV virus that could be resistant to PrEP or other medications 
used for HIV treatment. Resistance to antiretroviral medications may make effective HIV 
treatment more difficult and may limit your treatment options. You will be able to discuss treatment 
and the generation of resistance to medications with the study doctor.  
If you have concerns about being part of this study, you can ask the study doctor. 
BENEFITS  
You may or may not get direct benefit from being in this study. You or others may benefit in the 
future from information learned in this study. You also may get some personal satisfaction from 
being part of research on HIV. You will also get counseling services, free condoms, testing and 
treatment for STIs and PrEP.  
NEW FINDINGS  


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
You will be told any new information learned during this study that is important for your health or 
might cause you to change your mind about staying in the study. You will be told when the results 
of the study may be available, and how to learn about them. 
COSTS TO YOU  
There is no cost to you for being in this study. Treatments available to you from the study will be 
given free of charge.  
REASONS WHY YOU MAY BE WITHDRAWN FROM THE STUDY  
You may be removed from the study without your consent for the following reasons:  
 
• 
The study is stopped or canceled.  
• 
The study staff feel that staying in the study would be harmful to you.  
ALTERNATIVES TO PARTICIPATION  
There may be other studies going on here or in the community that you may be eligible for. If you 
wish, we will tell you about other studies that we know about. There also may be other places 
where you can go for HIV counseling and testing. We will tell you about those places if you wish. 
If you do not wish to be involved in the study, we will refer you to another clinic where you may 
be able to access PrEP without participating in this study. 
REIMBURSEMENT  
You will receive Shs 30,000 (fifty thousand shillings) at each scheduled visit for time, 
inconveniences and transport costs. 
DATA USE FOR FUTURE STUDIES  
The information and/or specimens that we obtain from you for this study might be used for future 
studies. If we do so, we will remove anything that might identify you from the information and 
specimens. Then, your information and specimens may be used for future research studies or 
given to another investigator without getting additional permission from you. It is also possible 
that in the future we may want to use or share study information that might identify you. If we do, 
a review board will decide whether or not we need to get additional permission from you. 
 
CONFIDENTIALITY  
Efforts will be made to keep your personal information confidential. However, absolute 
confidentiality cannot be guaranteed. Your personal information may be disclosed if required by 
law. Any sample from you or information about you will be identified only by code. The link 
between your name and code will be kept in a secure location at the study clinic only. Using a 
computer, we will link your information and your partner’s information using only the codes that 
you have been assigned. We will not discuss any information about you with your partner unless 
you give written permission, and we will encourage you to be present during the discussion. Any 
publication of this study will not use your name or identify you personally.  
 


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
Your study records may be reviewed by study staff and representatives of:  
 
• 
The Mildmay Uganda Research Ethics Committee 
• 
The Uganda National Council for Science and Technology 
• 
The Uganda National Drug Authority 
• 
Uganda Ministry of Health 
• 
The University of Washington  
• 
The United States National Institutes of Health 
 
RESEARCH-RELATED INJURY  
The study staff will monitor your health while you are in this study. If you have any health problems 
between visits, please contact the study staff. If you have a medical emergency that requires 
immediate care, please contact the study staff immediately on telephone number 0392-265 
883/4/5 and quickly go to the nearest regional government hospital.  
 
If you are injured from participating in this study, the study staff will give you immediate necessary 
treatment for your injuries until complete cure or stabilization. If you require medical care that the 
study clinic cannot provide, the study doctors will refer you to the appropriate services or 
organizations that can provide care for the injury, and care for you until the injury resolves. Study 
participants who experience research related injury are covered by this study. This study based 
at IDI will cover the costs of the referral and treatment costs up to the time you are stable, or injury 
is resolved. There is no program for monetary compensation. You do not give up any legal rights 
by signing this consent form. 
PROBLEMS OR QUESTIONS  
If you ever have any questions about this study, or if you have a research-related injury, you 
should contact Dr. Andrew Mujugira, Infectious Diseases Institute, Kampala, Uganda on 
telephone number +256 392 265 887.   
 
If you have questions about your rights as a research participant, you should contact the 
chairperson of Mildmay Uganda Research Ethics Committee, Ms. Harriet Chemusto or the office 
of this committee at Research Office, Kiddukiro House, Mildmay Uganda, Telephone: 0392-
174236. 
 
STATEMENT OF CONSENT AND SIGNATURES  
I have read this form, or had it read to me. I have discussed the information with study staff. My 
questions have been answered. I understand that my decision whether or not to take part in the 
study is voluntary. I understand that if I decide to join the study I may withdraw at any time. By 
signing this form, I do not give up any rights that I have as a research participant.  
 


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
 
Participant Name (print) 
 
Participant Signature/Thumbprint    
 
                Date 
 
Study Staff Conducting 
Consent (print) 
 
 
 
Study Staff Signature 
 
Date 
 
Witness name (print) 
 
Witness signature 
 
Date 
 
 
 
 
PERMISSION FOR FUTURE CONTACT REGARDING OTHER STUDIES: 
 
__________ 
I give permission for the study team to contact me in the future about other 
studies 
__________ 
I do NOT give permission for the study team to contact me in the future about 
other studies 
 
 
 
 
 
PERMISSION FOR OFF-SITE STUDY VISITS  
 
In case you have missed study visits and all efforts to get you via telephone or through 
other contact you have fail, study staff may visit you at your home. In addition, if you are 
unable to come to the study clinic to complete scheduled visit activities it may be 
necessary for study staff to visit you at your home or another location to complete study 
visit procedures. The study personnel will explain in great detail the requirements to do 
these visits (like the conditions of the place, the type of visit and the duration of it) and the 
procedures to maintain your information in a confidential manner. However, it is important 
that you know that visits to your home could lead to people in your neighborhood knowing 
about your participation in this study.   
 
For us to be able to visit you, we will need you to give us permission to do so, please read 
carefully the following statement and initial and date one option. Choosing not to be visited 
outside of the study clinic will not affect your participant in this study.  
 


Male Partner Consent Form 
Version 1.0  
 
23 July 2019 
 
 
Please initial and date one option:  
__________ 
I DO give permission for the study team to conduct off-site study visits if I 
am unable to come into the research clinic 
__________ 
I do NOT give permission for the study team to conduct off-site study 
visits if I am unable to come into the research clinic