Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: University of Alabama at Birmingham

Title:  Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya 
(Jamii Bora) 
NCT Number: NCT03547739 
Document: Study Protocol, Statistical Analysis Plan, Consent Forms 
Document Date: February 14, 2022 

 
 
 
 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
TESTING STRATEGIES FOR COUPLE ENGAGEMENT IN PMTCT AND 
1 
FAMILY HEALTH IN KENYA 
2 
 
3 
INVESTIGATORS AND INSTITUTIONAL AFFILIATIONS: 
4 
Name 
Organization 
Role on Project 
Janet Turan 
University of Alabama at Birmingham (UAB) 
Principal Investigator 
Zachary Kwena 
Kenya Medical Research Institute (KEMRI) 
Site Principal Investigator 
Elizabeth Bukusi 
Kenya Medical Research Institute (KEMRI) 
Co-Investigator 
Lynae Darbes 
University of Michigan (UM) 
Principal Investigator 
Abigail Hatcher 
University of North Carolina, Chapel Hill 
Co-Investigator 
Harsha Thirumurthy 
University of Pennsylvania  
Co-Investigator 
Thomas M. Braun  
University of Michigan 
Co-Investigator  
Maria Pisu 
University of Alabama at Birmingham (UAB) 
Co-Investigator 
Van T. Nghiem 
University of Alabama at Birmingham (UAB) 
Co-Investigator 
 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
 
 
8 
ABSTRACT/ SUMMARY 
9 
Despite the potential for antiretroviral therapy (ART) to improve maternal health and reduce mother-to-
10 
child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants 
11 
remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where 
12 
antenatal care attendance is high but crucial drop-offs occur in uptake of, and adherence to, key 
13 
maternal and child health and prevention of mother-to-child transmission (PMTCT) services. Many 
14 
pregnant women avoid couple HIV testing or do not adhere to PMTCT services because they fear 
15 
negative consequences of HIV for their relationship with their male partner. Men can play a crucial 
16 
decision-making and supportive role for family health, but male partners of pregnant women in Kenya 
17 
are poorly engaged in PMTCT and only 4.5% have recently tested for HIV themselves. Many pregnant 
18 
women prefer to engage in couple HIV testing and counseling (CHTC) to facilitate disclosure of HIV 
19 
sero-status (positive or negative) to their partners—often shortly after participating in individual HIV 
20 
testing. This preference highlights the potential for couples-focused approaches, and the need to 
21 
develop new strategies to engage male partners in HIV-related programs and services. Thus, we 
22 
propose to conduct a three-arm couple-randomized controlled trial among 800 pregnant women 
23 
attending antenatal clinics (533 HIV-positive and 267 HIV-negative at baseline) and their primary male 
24 
partners. We will randomize couples to home-based visits, multiple HIV self-test kits, or the standard 
25 
care of male partner invitation letters and follow them up for 18 months postpartum to (a) determine the 
26 
impact of a couples-focused home-based intervention on our primary outcome of couple HIV testing for 
27 
pregnant women and their male partners (assessed through proportion reporting couples testing, yield 
28 
of new HIV+ diagnoses of male partners, and identification of new sero-discordant couples) as 
29 
compared to HIV self-test kits for couples and standard care; (b) examine the impact of the intervention 
30 
on HIV prevention behaviors (PrEP and condom use),facility delivery, and postnatal healthcare 
31 
utilization for all participants; as well as secondary health outcomes of maternal VL suppression, and 
32 
HIV-free child survival up to 18 months for couples living with HIV; as compared to HIV self-test kits for 
33 
couples and standard care and; (c) compare the cost-effectiveness of the home-based couples 
34 
intervention to less resource-intensive strategies of standard care and HIV self-test kits for couples. 
35 
Despite its promise, a home-based intervention may require more resources and it is important to 
36 
assess whether it offers greater value for money than other strategies, which may cost less but be less 
37 
impactful. This theory-based couples intervention has strong potential to increase couples HIV 
38 
testing and use of essential health services by pregnant women and their male partners. 
39 
 
40 
LAY SUMMARY 
41 
HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-
42 
Saharan Africa. This is despite the potential for antiretroviral therapy (ART) to improve maternal health 
43 
and reduce mother-to-child transmission of HIV. This is particularly true in Kenya, where antenatal care 
44 
attendance is high but crucial drop-offs occur in uptake of and adherence to key maternal and child 
45 
health and prevention of mother-to-child transmission (PMTCT) services. Many pregnant women avoid 
46 
couple HIV testing or do not adhere to PMTCT services because they fear negative consequences of 
47 
HIV for their relationship with their male partner. Men can play a crucial decision-making and supportive 
48 
role for family health, but male partners of pregnant women in Kenya are poorly engaged in PMTCT. 
49 
Many pregnant women prefer to engage in couple HIV testing and counseling (CHTC) to facilitate 
50 
disclosure of HIV sero-status (positive or negative) to their partners. This preference highlights the 
51 
potential for couples-focused approaches, and the need to develop new strategies to engage male 
52 
partners in HIV-related programs and services. Thus, we propose to conduct a three-arm couple-
53 
randomized controlled trial among 800 pregnant women attending antenatal clinics (533 HIV-positive 
54 
and 267 HIV-negative at baseline) and their primary male partners to test whether seeking to test 
55 
couples at home or provide them with self-tests can enhance male HIV testing and better health 
56 
outcomes to mother and child and generally the health of the family. We will enroll couples into either 
57 
home-based visits or multiple HIV self-test kits, or the standard care of male partner invitation letters to 
58 
(a) determine the impact of a couples-focused home-based intervention on couple HIV testing for 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
pregnant women and their male partners; (b) examine the impact of the intervention on HIV prevention 
60 
behaviors (PrEP and condom use), facility delivery, and postnatal healthcare utilization for all 
61 
participants; as well as secondary health outcomes of maternal VL suppression, and HIV-free child 
62 
survival up to 18 months for couples living with HIV; as compared to HIV self-test kits for couples and 
63 
standard care and; (c) compare the cost-effectiveness of the home-based couples intervention to less 
64 
resource-intensive strategies of standard care and HIV self-test kits for couples. 
65 
 
 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
 
67 
INTRODUCTION/BACKGROUND: 
68 
New strategies are needed to promote linkage to and retention in PMTCT and HIV treatment for 
69 
pregnant and postpartum women. Despite the demonstrated success of ART for the treatment of 
70 
maternal HIV disease and PMTCT,[1-3] HIV prevalence among mothers and infants in Kenya remains 
71 
persistently high.[4] While rates of antenatal HIV testing have been increasing over time—90% of 
72 
women attending antenatal care were tested in 2014[5] compared to 83% in 2010[6]—only 
73 
approximately half of women testing HIV-positive (54%) received the full course of antiretrovirals and 
74 
only a portion of these women completed the series of steps required for efficacious PMTCT, known as 
75 
the "PMTCT cascade".[7, 8] The PMTCT cascade begins with the testing of pregnant women for HIV 
76 
during antenatal care (ANC), incorporates ART throughout the pregnancy and in the postpartum period, 
77 
and involves treating both the mother and the infant.[7] Among those who initially access PMTCT, rates 
78 
of subsequent drop-out are high; a recent systematic review and meta-analysis found that loss to 
79 
follow-up in PMTCT programs in sub-Saharan Africa was around 49%.[9] 
80 
 
81 
Fears and experiences of HIV-related stigma, discrimination, and violence are key barriers to 
82 
completion of the PMTCT cascade in sub-Saharan Africa. It has been noted that fixing the PMTCT 
83 
coverage problem could prevent as many infant HIV deaths as would developing more effective drug 
84 
regimens.[8, 10] However, multiple social factors that contribute to dropout rates for the PMTCT 
85 
cascade must be addressed in order to increase cascade retention rates.[10-12] Fears of stigma, 
86 
discrimination, and violence are common themes in narratives of pregnant women affected by HIV.[10-
87 
12] Studies in sub-Saharan Africa suggest that these social factors are among the most important 
88 
barriers to pregnant women’s acceptance of HIV testing during antenatal care and to their participation 
89 
in programs for PMTCT.[11, 13-18] Theoretical frameworks indicate that different dimensions of 
90 
stigma—anticipated stigma, perceived community stigma, enacted stigma (discrimination), and 
91 
internalized stigma—adversely affect quality of life, healthcare access, and health outcomes for 
92 
persons living with HIV,[19] and research suggests that stigma from close persons may have a 
93 
significant impact.[20-23]Our research in Kenya has found that fears and experiences of stigma from a 
94 
male partner decrease antenatal HIV testing, limit linkage to HIV care, and reduce the uptake of skilled 
95 
childbirth services.[24-27] Two systematic reviews also suggest that stigma, violence, and 
96 
discrimination hinder PMTCT uptake despite more efficacious regimens and improved guidelines in 
97 
sub-Saharan Africa.[28, 29] 
98 
 
99 
Lack of disclosure of HIV testing and test results to male partners is a significant barrier to 
100 
health service utilization by pregnant and postpartum women. In addition, non-disclosure of HIV 
101 
status between partners—often resulting from fears of stigma, discrimination, and violence—has been 
102 
found to limit PMTCT uptake in sub-Saharan Africa.[30, 31] Disclosure of HIV status has important 
103 
benefits including gaining access to social support, lowering risk of HIV transmission to partners, 
104 
obtaining appropriate medical treatment, decreasing stress, and creating closer relationships with 
105 
others.[31-34] In a systematic review of sub-Saharan African studies, partner non-disclosure was 
106 
associated with poor PMTCT uptake both quantitative (6 of 9) and qualitative (17 of 24) studies.[29] For 
107 
many HIV-positive pregnant women, lack of disclosure to partners has drastic health implications: it 
108 
limits their ability to link and adhere to HIV care for their own health; it poses a risk for sexual 
109 
transmission of HIV if the male partner is still HIV-negative;[35-37] it increases the odds of non-optimal 
110 
adherence to PMTCT interventions[38, 39] and increases the risk of vertical transmission of HIV.[40] 
111 
Studies have revealed long delays between HIV-positive diagnosis and disclosure,[41], [42] and one 
112 
study in Kenya found that 4 years after diagnosis, individuals were still secretive about their status and 
113 
were only slowly beginning to make plans to disclose to their partners.[43]Kenya now emphasizes 
114 
lifelong ART treatment for all HIV-positive women early in pregnancy,[44]rendering timely disclosure 
115 
and linkage to HIV care even more urgent. 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Pregnant women testing HIV-negative and their male partners are a high-risk group for incident 
118 
infection. Women who initially test HIV-negative, but who have potential to seroconvert during 
119 
pregnancy, and their male partners are a crucial group for interventions. Often pregnant women and 
120 
partners feel “safe” after an HIV-negative test result at the ANC clinic.[45]Studies have found around 
121 
3% seroconversion rates during and after pregnancy among previously HIV-negative pregnant women 
122 
in sub-Saharan African settings [46],[47] These women are at high risk of becoming HIV-infected during 
123 
late pregnancy, receive no counseling on infant feeding, no PMTCT services, and have an increased 
124 
risk of MTCT.[46, 48, 49] Since HIV transmission risk increases by more than 2-fold during pregnancy, 
125 
it is likely that uninfected women and their male partners are at heightened risk of incident infection and 
126 
contribute a significant number of vertically transmitted HIV cases.[46, 47, 50-52] Promoting couples 
127 
testing among HIV-negative pregnant women is therefore essential to reducing HIV acquisition risk.  
128 
 
129 
Despite recognition that male partners play a major role in uptake of services by pregnant 
130 
women, most PMTCT programs have not been successful in engaging men. Male partners are 
131 
clearly a key factor in retention of women and infants in the PMTCT cascade. When male partners are 
132 
uninvolved in HIV testing and antenatal care, women are less likely to:1)accept ART,[53, 54]2) deliver 
133 
in a health facility, and 3) adhere to care.[55] Thus, it is unsurprising that scholars globally have 
134 
advocated for engaging men in PMTCT.[53-58] Yet, most antenatal HIV testing strategies have not 
135 
been successful in reaching out to men,[58, 59] making it challenging for men to become involved or for 
136 
HIV-negative pregnant women to learn their partner’s status.[60] This is compounded by gender norms 
137 
that limit men’s ability to involve themselves in pregnancy and label ANC clinics and health facilities as 
138 
“female spaces.”[60-62] Our research[63] and that of others[64, 65] shows that men themselves desire 
139 
more involvement in PMTCT and antenatal services, but are unlikely to use traditional clinic-based 
140 
services. Innovative approaches that do not involve facilities are necessary to ensure that male partner 
141 
involvement occurs in a safe and supportive way.[62, 65, 66] 
142 
 
143 
Couples HIV counseling and testing (CHTC), an evidence-based intervention, offers potential to 
144 
engage men and women, but has been underutilized in the PMTCT context. Based on evidence of 
145 
the need to include both pregnant women and their male partners in PMTCT, programs across Africa 
146 
have increasingly called for CHTC.[39, 54, 66] Yet, most CHTC programs are implemented in clinics, 
147 
making it unlikely that pregnant women and male partners will utilize them given poor male attendance 
148 
in many settings.[59, 62, 67, 68]In Kenya, while the majority of pregnant women receive HIV testing, 
149 
only 4.5% of their male partners underwent HIV testing within the last 12 months.[5]Further, many 
150 
women, including pregnant women, express interest in participating in couples testing following 
151 
individual testing—regardless of sero-status. Although women receive individual testing in antenatal 
152 
care, participating in CHTC with their partners offers a safe environment for sero-status disclosure, 
153 
combined with tailored counseling and solution-building for the couple.[69] 
154 
 
155 
There is also a need to compare and contrast different approaches for increasing male 
156 
engagement and couples testing, including innovative approaches such as HIV self-testing 
157 
(HIVST).[70-72]With HIVST, individuals collect their own sample and perform a simple, rapid HIV 
158 
antibody test in the absence of a provider. Existing research shows a high level of acceptability and 
159 
demand for HIVST across a wide range of populations and settings, as well as good accuracy in the 
160 
hands of lay users.[73-78] A major development in the rapidly growing field of HIVST occurred in 
161 
December 2016, when the WHO called for the scale-up of HIVST.[79]With its increased convenience 
162 
and privacy, HIVST can make it easier for pregnant women and their partners to test together. One 
163 
strategy that has received attention recently is the provision of HIV self-test kits to pregnant women for 
164 
use by both partners of the couple - a “secondary distribution” strategy that members of our team have 
165 
developed and tested, with promising results. Early evidence from Malawi[80] and Kenya[76, 81, 
166 
82]suggests this approach is feasible, safe, and promising, but further research is needed to establish 
167 
how health outcomes and behaviors compare to standard care and to home-based couples testing 
168 
interventions. 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
  
170 
We propose to test the efficacy and cost-effectiveness of a home-based intervention to facilitate 
171 
HIV couples testing and disclosure in order to increase use of PMTCT and family health 
172 
services. Our study will assess effects on our primary outcome of couples testing uptake, as well as on 
173 
secondary outcomes of HIV prevention behaviors, PMTCT and maternal child health service utilization 
174 
and HIV-related health outcomes of HIV-free child survival and VL suppression. This approach aligns 
175 
with increased efforts to engage male partners as a means to promote PMTCT retention,[82, 83]but will 
176 
be among the first studies to address fears of disclosure of HIV status and harness couples’ 
177 
relationships to improve maternal and child health outcomes.  
178 
 
179 
STUDY AIMS 
180 
We will conduct a three-arm couple-randomized controlled trial among 800 pregnant women attending 
181 
antenatal clinics (533 HIV-positive and 267 HIV-negative at baseline) and their primary male partners. 
182 
We will randomize couples to home-based visits, multiple HIV self-test kits, or the standard care of 
183 
male partner invitation letters. We will follow couples for 18 months postpartum to assess impact and 
184 
cost-effectiveness of the intervention on health behaviors and health outcomes. We propose the 
185 
following specific aims: 
186 
Aim 1: To determine the impact of a couples-focused home-based intervention on our primary outcome 
187 
of couple HIV testing for pregnant women and their male partners (assessed through proportion 
188 
reporting couples testing, yield of new HIV+ diagnoses of male partners, and identification of new sero-
189 
discordant couples)as compared to HIV self-test kits for couples and standard care. 
190 
Aim 2:To examine the impact of the intervention on HIV prevention behaviors (PrEP and condom 
191 
use),facility delivery, and postnatal healthcare utilization for all participants; as well as secondary health 
192 
outcomes of maternal VL suppression, and HIV-free child survival up to 18 months for couples living 
193 
with HIV; as compared to HIV self-test kits for couples and standard care. 
194 
Aim 3:To compare the cost-effectiveness of the home-based couples intervention to less resource-
195 
intensive strategies of standard care and HIV self-test kits for couples. Despite its promise, a home-
196 
based intervention may require more resources and it is important to assess whether it offers greater 
197 
value for money than other strategies, which may cost less but be less impactful. 
198 
 
199 
JUSTIFICATION &  INNOVATION: 
200 
Our study strategy builds upon our team’s extensive formative and pilot research and innovates in 
201 
multiple ways as detailed below: Firstly, it focuses on couples. Recent literature and WHO guidance 
202 
have called for a renewed emphasis on couples to enhance PMTCT and HIV prevention efforts[84-
203 
90]and couple-focused interventions have been found to be beneficial in a range of HIV treatment and 
204 
prevention programs.[91-93]Arecent meta-analysis by Crepaz and colleagues found that couples-based 
205 
interventions were more effective than individual approaches for both HIV testing and nevirapine 
206 
uptake.[94]However, there are few couple interventions for pregnant women and male partners in low 
207 
resource settings.[95],[96]Our proposed study fills this gap by targeting expectant mothers and fathers 
208 
as a couple. Distinct from existing programs like mothers2mothers[97] our intervention is conducted by 
209 
a pair of lay health workers (one male and one female) who engage both partners of the couple, and 
210 
promote positive relationship dynamics(e.g., communication) in the promotion of family health. 
211 
Secondly, it makes use of a theoretical framework based on couple interdependence. Extensive 
212 
research has shown that couple relationship factors are associated with health behavior change and 
213 
health outcomes.[98-101]Similar associations have been found in HIV research, where partner 
214 
dynamics influence both prevention and treatment adherence.[102] Yet, couples-based theories are 
215 
only just beginning to be applied to HIV-related health behavior in sub-Saharan 
216 
Africa.[87],[103]Although one intervention study in Kenya found that home-based couple strategies may 
217 
improve male uptake of HIV testing,[104]the proposed study would be among the first research to test 
218 
an intervention based on an interdependence model of communal couple coping and behavior 
219 
change[105]on PMTCT-related and maternal health outcomes. 
220 
Thirdly, it attempts to reach beyond the clinic with home-based interventions and with HIV 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
self-testing.  Most current couples testing strategies require both partners to come to the clinic, 
222 
thereby reaching only a minority of couples. Although home-based HIV counseling and testing has 
223 
proven to be feasible in Kenya,[106-108]home-based strategies rarely target pregnant women and 
224 
partners.[109],[110]A recent study in Kenya achieved high acceptance rates for home-based HIV 
225 
testing (82% of around 25,000 people), yet among couples who tested, less than half were tested 
226 
together.[111]We propose a home-based approach to reach both pregnant women and male 
227 
partners in a space that is safe, convenient, inexpensive, and less stigmatizing than men 
228 
accompanying a woman to the ANC clinic, thereby increasing the likelihood of male involvement, 
229 
and leveraging couple-level factors for positive health outcomes. We will compare our home-based 
230 
intervention to one that relies on secondary distribution of HIV self-test (HIVST) kits by women to their 
231 
partners, which will expand the evidence base on whether HIVST can play a useful role in PMTCT and 
232 
HIV risk reduction. This will come at a time when many SSA countries are actively developing HIVST 
233 
policies. Fourthly, it integrates with MCH and family health. Our intervention responds to the growing 
234 
demand for PMTCT and HIV services to be integrated within existing Maternal and Child Health (MCH) 
235 
services.[112, 113]Home visits are designed for all pregnant couples (regardless of woman’s initial HIV 
236 
test result at the ANC clinic) and include topics important for maternal, paternal, and child health during 
237 
pregnancy and postpartum. This approach capitalizes on men’s heightened concern for family health 
238 
during pregnancy,[114] and is more likely to engage men than approaches that focus solely on HIV-
239 
related health. 
240 
 
241 
STUDY DESIGN/METHODOLOGY 
242 
 
243 
A. Study design 
244 
To accomplish the study aims, we will conduct a three-arm couple-randomized trial of the home-based 
245 
couples intervention in 24 communities in southwestern Kenya. We will recruit pregnant women (and 
246 
subsequently their male partners) from ANC clinics, collect baseline questionnaire data, and randomize 
247 
those who are willing to either the home-based couple intervention (estimated n=267 couples), the HIV 
248 
self-test kits intervention (n=267 couples) or the standard care arm (estimated n=267 couples). Each 
249 
arm will include 178 HIV-positive women at baseline and 89 HIV-negative women at baseline.   
250 
We will assess initial couples 
251 
testing uptake and results with a 
252 
brief phone-based assessment 
253 
prior to birth and conduct follow-
254 
up assessments with both 
255 
women and men at 3 and 12 
256 
months after expected infant 
257 
delivery date of the infant. 
258 
Midline and final questionnaires 
259 
will assess primary and 
260 
secondary outcomes along with 
261 
potential mediators. Brief phone 
262 
assessments at 6 and 18 
263 
months will ascertain the HIV 
264 
status of infants and reconfirm 
265 
any couples testing behaviors (Fig 3). A subset of young women at or below age 24 years (n=30) and a 
266 
subset of women who have experienced intimate partner violence (n=30) will be selected to participate 
267 
in in-depth qualitative interviews following birth of their infants in order to gain in-depth understanding of 
268 
how these factors (young age, IPV) affect women’s postnatal healthcare utilization and secondary 
269 
health outcomes. These in-depth interviews will also allow for a deeper understanding of the 
270 
experiences of young women and women impacted by IPV in their healthcare utilization after delivery 
271 
and how the intervention may have impacted Aim 2 outcomes. 
272 
 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
B. The setting 
274 
The area formerly known as Nyanza Province in Kenya has the highest HIV prevalence in the 
275 
country, with approximately 14% of adults 15-49 years of age testing HIV-positive.[115] Maternal 
276 
mortality in the region is 669 per 100,000 live births,[116] or more than four times the national 
277 
target.[117]This region represents 54% of the country’s new infant HIV infections and 45% of its need 
278 
for PMTCT services.[118]The R34 research took place in Migori County, which borders Tanzania 
279 
and Lake Victoria, where our team has worked for over a decade. We will now expand to include 
280 
other high volume clinic sites in this region. This setting is a priority area for interventions among 
281 
pregnant women and male partners. In addition to high HIV prevalence among pregnant women 
282 
(18%) and high rates of MTCT (7-10%),[119] there are significant dropouts of women and infants 
283 
along the PMTCT cascade.[120]The clinics in this setting provide integrated ANC/MCH and HIV 
284 
services and are implementing the Option B+ strategy, in which all pregnant and breastfeeding 
285 
women are immediately initiated on life-long ART, regardless of CD4 count or HIV disease 
286 
stage.[121] 
287 
 
288 
C. Conceptual framework 
289 
We adapted the Interdependence Model of Health Behavior Change to understand mechanisms 
290 
through which this intervention may impact health outcomes(Fig 1).[105] 
291 
 
292 
This model extends beyond an individually-based understanding of health behavior change (e.g., health 
293 
beliefs, self-efficacy) by positing that both partners influence one another’s health decisions and 
294 
behaviors.[122] It hypothesizes that by shifting motivations and relationship dynamics, interventions can 
295 
make lasting impacts on how couples initiate and maintain healthy behaviors: 
296 
• Predisposing characteristics of couples include both intrinsic qualities (e.g., socio-demographics such 
297 
as age, education, marital status) and variables that have the potential to be modified through 
298 
intervention (e.g., perception of health threat; couple communication). We have adapted this part of 
299 
the model to include specific aspects of the Kenyan cultural setting elucidated in our preliminary 
300 
studies, including the influence of extended family members and the type of union (including 
301 
polygamous unions).[123] 
302 
• Transformation of motivation helps couples move from a self-centered understanding of a health 
303 
issue to a relationship-centered perspective.[105] This process occurs when health issues are 
304 
interpreted as having significance for the relationship or family, rather than simply for oneself.[124]We 
305 
hypothesize that couple home visits by lay health workers, which aim to positively impact relationship 
306 
dynamics (e.g., intimacy, satisfaction) and improved communication will facilitate a “transformation of 
307 
motivation” which will make couples more likely to accept and undergo couples testing.  
308 
• The Interdependence Model suggests that communal coping can help couples make health-related 
309 
decisions jointly and mutually support one another’s goals around MCH, PMTCT uptake, linkage to 
310 
HIV care and treatment. Communal coping is influenced by outcome efficacy, or the couple’s belief 
311 
that a solution can be found to the health challenge, and couple relationship efficacy. Communal 
312 
coping includes enhanced communication, joint decision-making, and working together to try new 
313 
behaviors. Our pilot research suggests that the home-based couples visits aid the couple in 
314 
developing efficacy to engage in key health services for maximum impact for all—including the 
315 
infant.[125] 
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Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
 
318 
D. The intervention: In the Jamii Bora R34 pilot intervention, lay health workers delivered three home-
319 
based couples visits (two home visits during pregnancy; one postpartum) following enrollment of 
320 
women at an ANC clinic. We will increase the number of home visits to five: 2 during pregnancy, 1 at 
321 
six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 
322 
months after the birth. During the COVID-19 pandemic, the study will adopt teleconferencing to have as 
323 
an option for delivering couple sessions for participants not comfortable with face-face contact, until the 
324 
COVID-19 situation is under control. At each home visit, the health workers will meet with the woman 
325 
and her partner together. The two booster visits will focus on repeat HIV testing, infant health 
326 
messages, family planning, male health, IPV prevention, mental health, and HIV prevention. Key 
327 
elements of the intervention sessions are presented in Table 1 and include: 
328 
a. Maternal, child, and 
329 
family health 
330 
information. Drawing on 
331 
our team’s prior experience 
332 
in engaging couples in 
333 
pregnancy and postpartum 
334 
services,[126, 127] this 
335 
component focuses on 
336 
general family health 
337 
promotion during the peri-
338 
natal period. This is also an 
339 
opportunity for couples to 
340 
ask questions about 
341 
pregnancy, labor, and delivery. Lay health workers help couples develop strategies for service 
342 
utilization. Specific content focuses on IPV prevention and mental health issues (e.g., depression). 
343 
b. Couple relationship skill-building. Each visit includes couple relationship/communication content, 
344 
including exercises on use of “I language”, listening skills (initiator and receiver), and negotiation skills 
345 
[128]. 
346 
c. Offers of Couple HIV Testing and Counseling (CHTC) services. CHTC has been shown to 
347 
increase male involvement and linkage to care in many sub-Saharan African settings.[84, 85, 129-
348 
132]The Centers for Disease Control CHTC Training Curriculum includes modules for mutual 
349 
disclosure, tailored prevention, and treatment strategies for discordant and concordant 
350 
couples.[133]Disclosure assistance allows a couple to discuss HIV test results and strategies in a safe 
351 
and supportive setting,[134] and sessions include techniques to encourage communication between 
352 
partners.[135]In our intervention, pregnant couples are encouraged to test together, even if one or both 
353 
have tested individually previously, given that women often engage in CHTC to facilitate partner 
354 
disclosure. Couples have the opportunity to engage in CHTC at any of the couple home visits, as we 
355 
found in the pilot that some couples required time to be ready to accept CHTC and couples may need 
356 
to test more than once during the longer study period. 
357 
d. Linkage to clinic-based services. Lay health workers actively link couples to family health and HIV 
358 
prevention and treatment services (including PrEP for discordant couples) at nearby clinics.    
359 
Our team’s prior research suggests that 87% of pregnant women in this region live with their male 
360 
partner,[136]making home visits an optimal approach to reach couples. Recognizing that some pregnant 
361 
women may live in extended family households where privacy is difficult to maintain,[137] in each 
362 
community we will identify a location for couple sessions that participants may choose if privacy cannot 
363 
be assured in the home.  Use of lay health workers contributes to sustainability, given the lack of 
364 
professional counselors in this setting. 
365 
 
366 

 
 
 
 
10 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
In each of the home visits, participants shall be offered handouts containing key health messages 
367 
relevant to the stage of pregnancy and encourages to read (see attached). 
368 
 
369 
 
370 
E. Comparison Groups 
371 
HIV self-test kits to pregnant women for use together with their male partner: In order to 
372 
compare our intervention with a promising, but less resource-intensive, approach for encouraging 
373 
couple and male partner testing, women in one study group will receive HIVST kits for themselves 
374 
and their male partner. Trained study staff will provide4oral-fluid-basedrapid HIV test kits 
375 
(OraQuickRapid HIV-1/2 Antibody Test, OraSure Technologies – approved for use in Kenya) during 
376 
pregnancy and up to 4additional kits after the birth. Each test will be accompanied with an 
377 
instruction sheet that describes step-by-step self-testing procedures in multiple languages. Study 
378 
staff will also provide participants with a brief demonstration of how to use the tests. Participants will 
379 
be encouraged to offer a test kit to their male partner or to use both test kits to undertake couples 
380 
testing if they feel comfortable doing so. They will also be counseled on how to talk to their partners 
381 
and the possibility of adverse partner reactions. Following Kenya’s HIV testing services guidelines, 
382 
participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is 
383 
obtained, and an invitation for confirmatory testing at a clinic will be included with each test. The 
384 
procedures used in the HIVST group are adapted from our experience developing and testing this 
385 
intervention in Kenya and have been found to be feasible and safe.[76, 77] 
386 
Standard care: All women in standard care are encouraged to come to the clinic with their male 
387 
partner and are encouraged to undergo CHTC. Clinic staff give women who attend alone a referral 
388 
letter to invite the male partner to ANC at the next visit. When couples come together to ANC, they 
389 
are given priority in the line to receive services. Despite these measures, our site assessments for 
390 
the current study indicate that less than 25% of pregnant women currently participate in couples 
391 
testing during ANC visits.  
392 
Rationale for the comparison groups: The HIVST and Standard Care arms are lower-cost by 
393 
design, since they do not include extensive health-related counseling and home visits. It is important 
394 
to compare our home-based couples intervention with these approaches for both efficacy and cost-
395 
effectiveness, since male invitation letters are the current standard and HIVST has shown promise 
396 
in boosting male partner and couples testing. This is crucial as policymakers may have a natural 
397 
reluctance to adopt more expensive interventions without strong evidence that they are more 
398 
effective that cheaper alternatives. 
399 
F. Study procedures and methods 
400 
Start-up activities: Using protocols and training materials developed during the R34 Study and pilot 
401 
studies of HIVST kits for pregnant women in Kisumu, we will train lay health workers in informed 
402 
consent processes, privacy and confidentiality, community sensitization strategies, maternal, paternal, 
403 
and child health messages, CHTC protocols for couples with different sero-status combinations, 
404 
information and counseling for HIV self-test kit distribution, and protocols for IPV and mental health risk 
405 
assessment and support. All health workers at study health facilities will receive training on risk 
406 
assessments, counseling, and referrals from protocols developed during our prior studies (See Human 
407 
Subjects for details). 
408 
Study population: The target populations are pregnant women identified in the ANC facilities and their 
409 
male partners. Marriage rates are high in Kenya, with over 85% of pregnant women identifying as 
410 
currently married in our prior studies in this region.[138]The majority (87%) of women presenting for first 
411 
ANC visits in Kenya are in the 2nd and 3rd trimesters of pregnancy,[139]but given importance of early 
412 
initiation of ART for maternal health and PMTCT,[140] we will enroll women as early as possible. We 
413 
will select women at 36 weeks of pregnancy or less, to have time to deliver at least one home visit 
414 
during pregnancy.  
415 
Sample size: Based on site assessments conducted in the summer of 2017, we had earlier 
416 
conservatively estimated that each clinic will have an average of 5 eligible HIV-positive pregnant 
417 
women per month (we will enroll both newly diagnosed women and known positives), for a total of 96 
418 

 
 
 
 
11 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
women from each of the 8 clinics in 24 months (n=960). By then, we were confident that we will identify 
419 
the required number of HIV-negative women (n=480) in the same time period (total HIV-positive and 
420 
HIV-negative N=1,440). However, we have observed fewer than 5 eligible HIV positive pregnant 
421 
women in the 18 clinics we are currently operating in thus requiring us to increase the number of clinics 
422 
to 24. The additional six clinics are necessary because of the lower than anticipated participant 
423 
enrolment numbers due to COVID 19 pandemic and healthcare worker’s strike that affected the 
424 
numbers of pregnant women visiting health facilities and consequently our study accruals in the year 
425 
2020 and 2021. Using a stratified randomized design, we will recruit HIV-negative women in balanced 
426 
numbers to HIV-positive women (1:2) each month, to ensure that these two groups are balanced over 
427 
time. Given our experience in the R34 pilot study (which had more stringent eligibility criteria), we 
428 
conservatively estimate a 75% participation rate for male partners in the study (target sample N=800 
429 
couples). If we subsequently experience as much as 17% loss-to-follow-up of couples (based on the 
430 
14% we experienced in the R34 pilot), we will still have approximately 664 couples (221 couples in 
431 
each randomized group) for analysis. With a loss-to-follow-up rate as high as 20% (leaving 640 
432 
couples), we will still have strong power to detect differences in our primary couples testing outcome 
433 
(Table 2). 
434 
 
435 
Two groups of n=30 women each will be purposively selected from enrolled participants and invited to 
436 
participate in in-depth qualitative interviews. The samples will include women who are HIV-positive or -
437 
negative and who participated in the different arms of the trial. One group will include women ≤24 years 
438 
of age, and the other group will comprise women of any age who have reported IPV at any time during 
439 
the trial.  
440 
 
441 
Recruitment and enrollment: Pregnant women presenting at ANC clinics who meet study inclusion 
442 
criteria will be asked if they would like to participate in a study about approaches for supporting 
443 
pregnant couples on family health issues (including HIV) during pregnancy and postpartum. If 
444 
interested, informed consent will be obtained for study participation and for contacting her male partner. 
445 
Those interested in participating but not comfortable with face- to- face contact due to COVID -19 
446 
pandemic will be asked to participate remotely via the phone after safety and privacy has been 
447 
ascertained. 
448 
 
449 
Postpartum women enrolled in the trial who are eligible to participate in the in-depth qualitative 
450 
interviews will be contacted by a researcher and invited to participate in an interview (at least 12 
451 
months postpartum for the young women and ≤24 months postpartum for the women with IPV) at a 
452 
private location at a date/place of her choosing, after going through the informed consent process 
453 
described below. Interviews will be led by experienced qualitative interviewers in a local language (Luo, 
454 
Kiswahili, or English) using IRB-approved interview guides developed by the research team. To 
455 
contribute to the achievement of Aim 2, these interviews will explore topics that influence health 
456 
behaviors and outcomes, such as reproductive health, relationships, HIV, and IPV. 
457 
 
458 
Obtaining informed consent: A lay health worker will consent eligible women and their male partners 
459 
separately. As was done in the R34 pilot study, with the woman’s permission we will subsequently 
460 
contact her primary male partner, arrange to meet with him in a community location, and conduct 
461 
informed consent and the baseline questionnaire. For participants who wish to enroll in the study but 
462 
prefer virtual/remote participation, we will conduct consenting process on the phone.  The study staff 
463 
shall read the consent word for word and verify the participant’s understanding before obtaining verbal 
464 
consent. Verbal consent shall be taken by asking the participant to repeat the participant declaration 
465 
statement written in the tail end of the consent as the staff audio records. All participants choosing to be 
466 
consented remotely will be informed of recording their declaration to participate and the consent form 
467 
will be kept safely for signing by the participant when COVID-19 spread is brought under control. These 
468 
initial sessions will also include screening for IPV based on our team’s existing protocols, and all 
469 
participants will receive information about available services.[141]Participants reporting severe IPV in 
470 

 
 
 
 
12 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
the past 6 months will not be included in the randomized part of the study, since participation in a 
471 
couples intervention may not be appropriate for this group. All participants will be asked to provide 
472 
informed consent for data abstraction from their medical records.  
473 
 
474 
Women who are eligible and interested in participating in the in-depth qualitative interviews will undergo 
475 
the informed consent process with study staff and sign a consent form specific to the interview. 
476 
 
477 
Randomization: We will recruit pregnant women attending ANC clinics to participate in the study until 
478 
we have achieved a sample size of 800 women (two-thirds HIV-positive at baseline) and 800 male 
479 
partners. Women will complete baseline questionnaires at the ANC clinic and men will be asked to 
480 
complete the questionnaire in a community location. After baseline interviews have been completed 
481 
with both partners, we will randomize couples to one of the three approaches to increase couple 
482 
engagement in HIV prevention and maternal and child health. Couples will receive a sealed envelope 
483 
labeled with their newly assigned study ID numbers, which will contain their random assignment. If the 
484 
participants are not comfortable with face-to-face contact during the COVID-19 pandemic, 
485 
randomization can be carried during a joint phone call with the couple, in which case the couple will be 
486 
informed of the envelope randomly picked by the study staff out of the container, and their randomly 
487 
assigned study arm. Random assignments will be computer generated and will be stratified by clinic 
488 
and couple HIV status. Blocked randomization with randomly permuted block sizes will be used to 
489 
assure approximately equal numbers in each study arm and in each HIV status group in any given time 
490 
period. Based on our prior experience in the R34 pilot study, at the end of this process we expect to 
491 
have at least 267 couples (both male and female partners consented and enrolled) in each study arm 
492 
(178 in which the woman is HIV-positive at baseline and 89 in which the woman is HIV-negative at 
493 
baseline). 
494 
Study arms: After randomization, a lay health worker will obtain detailed locator information (including 
495 
cell phone contacts). If they were randomized to the home visit intervention arm, the worker will consult 
496 
with them about optimal times for a home visit. As described above, the intervention arm will consist of 
497 
5 home visits conducted together by one female and one male lay health worker. The HIV self-test kit 
498 
arm will consist of distribution of pairs of self-test kits to women at up to 4 time points (twice during 
499 
pregnancy and twice after the birth)The standard care arm will offer standard clinic-based services, 
500 
including giving the pregnant woman a letter for her male partner inviting him to the clinic, and the 
501 
option for women and partners to return to the clinic for male partner HIV testing or CHTC (although our 
502 
past clinical experience in this setting and the results of the R34 study suggest uptake of these services 
503 
is low). 
504 
Data collection and measures: Data will be collected from multiple sources (see below and Table 1): 
505 
o Baseline questionnaires with all study participants will be conducted with women and male partners 
506 
through phone or in-person assessment depending on their preference during this challenging period 
507 
of COVID-19. These questionnaires will assess baseline measures, including socio-demographic 
508 
characteristics of both partners, couple relationship measures, and stigma. These measures, which 
509 
were used successfully in the R34 pilot, will be interviewer-administered on tablets in the participant’s 
510 
preferred language (Swahili, Luo, or English), as per procedures piloted in the R34. 
511 
o Brief phone-based assessment of HIV testing uptake and results will occur at 8 weeks after study 
512 
enrollment (during pregnancy) and around 6 months after the birth: All participants (women and men) 
513 
will be contacted via mobile phone and asked to respond to a brief confidential survey on HIV testing 
514 
(individual or couples) and results 8 weeks after study enrollment and around 6 months after the birth. 
515 
This assessment will capture in more “real-time” any HIV testing behavior that occurs before the first 
516 
follow-up questionnaire at 3 months after the birth, and between 3 and 12 months after the birth. 
517 
o Follow-up questionnaires with women and male partners will occur at 3 months after the birth (after 6-
518 
week home visit) and around 12 months after the birth (during the 4 weeks following the final 12-
519 
month home visit). Follow-up questionnaires will assess the same constructs as at baseline, as well 
520 
as process and outcome measures, and be administered on tablets in the participant’s preferred 
521 
language during research visits or through phone by gender-matched independent interviewers. 
522 

 
 
 
 
13 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
o Brief phone 18-month assessments will capture infant HIV status, couples testing behavior, and viral 
523 
loads. 
524 
o Medical records: Medical records will be abstracted to obtain objective (non self-report) data on 
525 
healthcare utilization and health outcomes for all participants in the study. 
526 
o A couple visit form will be filled by lay health workers at each couple visit. The form will include 
527 
information on topics covered, CHCT uptake and result, assessments of negative life events, 
528 
including IPV (conducted with women and men individually),[142] other services provided, and 
529 
process measures. This form, along with records of observations of visits by supervisors, will be used 
530 
to assess intervention fidelity. 
531 
o Qualitative interviews: Utilizing one-to-one interviews, we will qualitatively explore experiences and 
532 
perceptions of the home-based couples intervention, as well as other influences on health behaviors 
533 
and outcomes of younger women and of women experiencing IPV.   
534 
 
535 
TABLE 1.  Factors to be Assessed in Data Collection 
 
Factors 
Study measurements 
Group and timing 
PREDISPOSING 
FACTORS 
Socio-demographics 
Age, education, literacy, ethnicity, religion, occupation 
All participants at 
baseline and follow-ups 
 
 
 
Relationship 
characteristics 
Marital status, type of union (monogamous/polygamous), 
relationship duration 
Household conditions 
House type, ownership of household goods, persons living in 
household, food insecurity, alcohol use (ref AUDIT-C) 
Pregnancy & fertility 
Parity, gravidity, number of living children 
TRANS-
FORMATION OF 
COUPLE 
MOTIVATION 
AND COUPLE 
COPING 
Couple relationship 
dynamics 
Relationship Satisfaction[143], Dyadic Trust[144], Couple 
communication[145], Interpersonal closeness[146], Sexual 
Relationship Power Scale[147], Commitment[148] 
All participants at 
baseline and follow-ups 
Disclosure  
Reports of disclosure to others from both partners[149] 
 
HIV-related couple  
Male partner support for MCH specific,  social support[150], 
Couple communal coping[151], Network of Relationships 
Social Provision Scale (ref) 
 
OTHER 
POTENTIAL 
MODERATORS 
AND 
MEDIATORS  
Pregnancy 
intendedness 
One item measure of the intendedness of the current 
pregnancy[152] 
All participants at 
baseline and follow-ups 
Perceptions of stigma 
Anticipated stigma and perceived community HIV-related 
stigma scales[153, 154] 
Stigma experience  
Anticipated, enacted, and internalized HIV-related 
stigma[155] 
HIV-positive participant 
IPV 
Dyadic version of WHO intimate partner violence 
measure[156] 
All participants at 
baseline and follow-ups 
 
 
HIV treatment beliefs 
Adaptation of the Beliefs about Medications 
Questionnaire[157] 
Depression 
PHQ-8[158] 
Anxiety 
GAD-7[159] 
COUPLE HIV 
TESTING 
(PRIMARY 
OUTCOME) 
Couple HIV testing 
Couples HIV testing uptake during observation period (Y/N)*   
All participants at 
follow-ups 
 
 
HIV re-testing 
Re-testing for HIV during pregnancy and postpartum * 
New male HIV+ tests 
Number of new HIV+ test results of male partners* 
Discordant couples 
Number of new serodiscordant couples identified  
HEALTH 
CARE 
UTILIZATION 
 
 
PMTCT practices 
Mother’s use of ARVs for PMTCT *, Prophylactic ARVs for 
the infant *, infant feeding practices  
HIV-positive women at 
follow-ups 
Use of MCH services 
Number of ANC visits*, Childbirth with a skilled attendant 
(Y/N), Postnatal check-ups* 
All participants at 
follow-ups 
PREP uptake 
Initiation of PrEP 
Discordant partners at 
follow-ups 
Woman’s HIV care 
linkage and 
engagement 
Time to linkage in HIV care,*Enrollment in HIV care 
(Y/N),*Self-reported ART adherence, [160] Number of HIV 
visits*  
HIV-positive women at 
baseline and follow-ups 
Man’s HIV care 
linkage 
Time to linkage in HIV care,* Enrollment in HIV care (Y/N),* 
Self-reported ART adherence, [160] Number of HIV visits*  
HIV-positive men at 
baseline and follow-ups 
Infant HIV testing 
Date and result of infant HIV test * 
Parents of HIV-exposed 
infants at follow-ups 
PROCESS 
MEASURES 
Intervention content  
Topics covered, services delivered, referrals made during 
couple visits 
All intervention 
participants at follow-

 
 
 
 
14 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Participation 
Number of couple home visits completed, number of HIV self-
tests received/used 
ups 
 
Social consequences  
Positive and Negative Life Events measures[142] 
Acceptability 
Satisfaction with intervention components, intervention 
content, and mode of delivery, attitudes toward PrEP and HIV 
self-testing  
 
SECONDARY 
HEALTH  
OUTCOMES 
Viral suppression 
Viral Load < 200 copies (undetectable)* 
All HIV-positive 
participants at baseline 
and follow-ups 
HIV-free child survival 
Child alive and HIV-free at 18 months after the birth* 
* Measures to be confirmed through medical records 
536 
 
537 
Inclusion/exclusion criteria  
538 
Our inclusion criteria are: (a) women at 36 weeks of pregnancy or less (b) 15 years of age or older (c) 
539 
has been offered HIV testing at ANC, (d) is currently in a stable relationship with a male partner and 
540 
living with that male partner, (e) has not yet participated in couple HIV testing during this pregnancy, 
541 
and (f) not in an HIV-positive concordant relationship Male partners are the person identified by the 
542 
pregnant woman as her primary male partner and should also be 15 years of age or older. 
543 
 
544 
STATISTICAL/ANALYSIS PLAN 
545 
Sample size and power calculations 
546 
The couple testing uptake outcome (primary outcome) will be assessed including both HIV-positive and 
547 
HIV-negative women/couples. All three arms will be compared with each other (3 comparisons), so our 
548 
Type I error rate is 0.05/3 = 0.017 (two-sided). With three repeated measurements (baseline, 3 months, 
549 
and 12 months) and compound symmetry 
550 
covariance structure, correlation between 
551 
the observations on the same subject was 
552 
assumed to be 0.50. With N=300 couples 
553 
in each arm, our study will have >80% 
554 
power to detect statistically significant 
555 
differences in couple testing uptake of 30-
556 
40% either intervention arm and 23% in 
557 
the control arm (Table 2). We 
558 
conservatively used rates that are lower 
559 
than proportions observed in the R34 
560 
study and studies of HIVST kits with 
561 
pregnant women. The secondary 
562 
outcomes are HIV-free child survival at 18 months and maternal viral load suppression at 18 months. 
563 
HIV-free child survival up to 18 months will be assessed only in HIV-positive women with live births, 
564 
with approximately N=200 in each arm. Based on prior estimates from sub-Saharan Africa,[161, 162] 
565 
we expect proportions≥90% of HIV-free survivors in each arm. As there would be 2 comparisons (each 
566 
intervention arm versus the control arm), we set our Type I error rate to 0.05/2 =0.025 (two-sided) when 
567 
calculating power. If Arm 3 has a survival rate of 91%, the study will have power > 80% when Arms 1 
568 
and 2 have survival rates of 98% or higher. The other secondary outcome of maternal viral load 
569 
suppression at 18 months will be assessed only in HIV-positive women with around N=200 in each 
570 
arm. From Table 2, if Arm 3 has a maternal viral load suppression rate of 85%, the study will have 
571 
power > 80% when Arms 1 and 2 have maternal viral load suppression rates of 95% or higher.  We 
572 
used PASS software for these calculations (NCSS, version 11). 
573 
 
574 
Data analysis 
575 
Primary analyses to address Aim 1: We will use all longitudinal measures of couple testing in a 
576 
marginal model to compare rates among the three study arms.  We will use a marginal modeling 
577 
approach because our primary interest is to estimate the population-average effect of intervention 
578 
participation on each outcome rather than the effect for a hypothetical average subject or couple. 
579 

 
 
 
 
15 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Moreover, within-subject and within-couple correlations among outcomes are nuisance parameters, not 
580 
quantities of interest to be modeled explicitly.  Our models will include a dummy variable indicating 
581 
study group (Arm 1 vs Arm 3; Arm 2 vs Arm 3), as well our stratifying variables and other additional 
582 
covariates such as couple relationship length, if necessary. Little adjustment for confounding should be 
583 
necessary due to our randomization. We will employ robust standard errors to obtain correct inferences 
584 
because inference will be valid if the chosen correlation structure is slightly misspecified.[163]  
585 
Statistical significance will be for p<0.017 for the three pairwise comparisons of the three arms to 
586 
account for multiple comparisons. Between-arm differences for the other outcomes in Aim 1 (mean 
587 
numbers of new HIV+ diagnoses of male partners and new sero-discordant couples) will be modelled 
588 
with GEE. 
589 
Primary analyses to address Aim 2:Each of the outcomes examined in Aim 2, including rates of HIV 
590 
prevention behaviors (PrEP and/or condom use), facility delivery, postnatal healthcare utilization, 
591 
maternal VL suppression, and HIV-free infant survival up to 18 months, is binary (yes/no).  Between-
592 
arm comparisons for the probabilities of these outcomes are facilitated with the same GEE models 
593 
described for Aim 1. 
594 
 
595 
Supplementary mediation analyses for Aims 1 and 2:Our assessment for potential mediation and 
596 
moderation will follow the approach described by Valeri and Vanderweele.[164] We will refer to the 
597 
treatment effect estimates from these models as Estimates A.  We will then fit a second model, which 
598 
takes our original GEE model and incorporates possible mediating variables, such as couple 
599 
relationship dynamics and social consequences. We will refer to the parameter estimates for these 
600 
three covariates as Estimates B.  We will then determine the direct and indirect effects of the treatment 
601 
on each of the outcomes in Aims 1 and 2, with 
602 
corresponding standard error estimates 
603 
determined using bootstrap methods as 
604 
described by Whittle, etal.[165] These models 
605 
can also be adjusted for any potential 
606 
confounders that are discovered, although we 
607 
expect the randomization to account for a 
608 
majority of any potential confounding. 
609 
Supplementary dyadic analyses for Aims 1 
610 
and 2: Analyses with intact dyads enable 
611 
investigation of couple-based research 
612 
questions of how relationship dynamics affect 
613 
behavior change in partnerships. For example, 
614 
we might investigate whether one’s own 
615 
relationship satisfaction or one’s partner’s 
616 
relationship satisfaction is more associated 
617 
with couple testing uptake. To that end, we will 
618 
extend the analyses described above to 
619 
include actor and partner effects for covariates 
620 
and mediators. Actor effects describe the 
621 
influence that one’s standing on independent or mediating variables of interest (e.g., communication, 
622 
intimacy) has on one’s own dependent variables (e.g., virologic control) whereas partner effects 
623 
describe the influence that one’s standing on independent variables has on the dependent variables of 
624 
one’s partner (e.g., partner’s virologic control). This technique illuminates the effects that partners in 
625 
intimate relationships can have on both their and their partner’s behavior.  In order to fit an actor-
626 
partner interdependence model (APIM)[166] to our data, we will change our GEE model to a random-
627 
effects model so that we can include a random effect for each couple, that will allow us to divide the 
628 
variation in outcomes into within- and between-couple effects.  Auto-regressive errors will be assumed 
629 
for the longitudinal measures. 
630 
 
631 
TABLE 3. AIM 2 QUALITATIVE INTERVIEW TOPICS 
Theme 
Topics           
Contraceptive 
Use 
 
Male partner 
support 
 
Health Care 
Utilization 
(1) Knowledge and use of contraceptives 
before current pregnancy and postpartum 
 
(2) Support and dependability of male 
partner for maternal and child health  
 
(3) Barriers to utilization of health care 
services for pregnant women and partners  
 
Interventions 
 
(4) perceptions of the home visits for 
couples and the HIVST kit interventions 
 
IPV 
(5) Perceptions of change in violence and 
the role of pregnancy and HIV in IPV 
HIV Care and 
Treatment 
(6) Perceptions of change in HIV care and 
treatment over pregnancy and postpartum 

 
 
 
 
16 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Qualitative data will be analyzed to elucidate themes and lessons to further inform our quantitative 
632 
analysis (Table 3). Interviews will be audio-recorded and transcribed, translated (if necessary), and 
633 
then coded and analyzed using a thematic analysis approach. 
634 
 
635 
Accounting for potential missing data. We will also investigate and address incomplete data issues 
636 
in our sample. Missing data within and between each wave of measurement should be minimal due to 
637 
our careful interviewer training and cohort retention. However, intermittent missing responses are 
638 
inevitable and some participants will be lost to follow-up. Our GEE models for Aims 1 and 2 make the 
639 
assumption that missing data occur completely at random (MCAR). We will use univariate analyses 
640 
such as chi-square and t-tests to assess whether individuals with complete data for any given analysis 
641 
are different from those with incomplete data. These analyses will be extended to explore differential 
642 
attrition by intervention group membership using logistic regression or analysis of variance (ANOVA) 
643 
models. If our assumption of MCAR appears questionable, we will model the missingness pattern with 
644 
logistic regression to estimate the probability of each subject’s data is missing, conditional on their 
645 
observed data.  We can use these weights in an inverse-probability weighted GEE model and compare 
646 
the results to those produced from models using only the observed data. 
647 
Sex as a biological variable. This study includes both men and women all analyses described above 
648 
will be run separately by sex assigned at birth, with the exception of the dyadic analyses, which build in 
649 
participant sex intrinsically, since we will use APIMs for distinguishable dyads distinguished by gender.  
650 
 
651 
Cost-Effectiveness Analysis for Aim 3: We will assess the cost-effectiveness of the home-based 
652 
couples intervention compared to two less resource-intensive strategies of HIVST kits and standard 
653 
care. We hypothesize that this community-based intervention will prove to be a cost-effective strategy 
654 
compared to the alternative strategies. However, cost-effectiveness might be sensitive to the intensity 
655 
of services provided, levels of compensation, extent of training, levels of adherence to ART treatment, 
656 
and other attributes. We will develop a decision analysis model using Tree Age Pro 2017 software 
657 
(Williamstown, MA, USA). We will use data on costs, changes in HIV status, and mortality to provide 
658 
inputs into a modified Markov model allowing for both transitions between health states and the 
659 
occurrence of transient adverse health outcomes. Markov models are among the most frequently used 
660 
modeling techniques in clinical decision analysis and health-economic evaluation, and are particularly 
661 
helpful when a decision analysis involves the analysis of risk over long periods of time.[167, 168] The 
662 
modification we propose will be a state transition model. State transition models combine Markov health 
663 
state transitions with the probability that individual will experience transient events that lead to either a 
664 
different health state (e.g. HIV transmission) or that can carry significant costs or mortality risk, such as 
665 
hospitalization for an opportunistic infection. State-transition models have been utilized in many 
666 
different populations and diseases, including diabetes, cardiovascular disease, HIV and malaria.[169-
667 
171] 
668 
The final integrated decision model will consist of two parts. In the first part, a couple consisting of a 
669 
pregnant woman in antenatal care and her male partner, will be assigned to an arm of the decision 
670 
model (couple home visits, HIV self-test kits, standard of care). The probabilities of health state 
671 
transitions (e.g. changes in HIV status, viral load suppression, death) and adverse events will differ 
672 
based on the assigned arm of the decision model. Each woman and male partner enters the model as 
673 
HIV-negative or HIV-positive.  Once a participant enters a new health state (HIV transmission), they 
674 
remain in that health state until suffering a next event (HIV transmission of a partner or death). In the 
675 
second part of the model, infant’s transition states are considered (HIV-positive, HIV-negative, died). 
676 
These two parts will then be integrated into one overall model.   
677 
Cost-effectiveness analytical plan: In our analysis, we will follow The WHO Guide to Cost-
678 
Effectiveness Analysis for the conduct of CEA that is most applicable to developing countries.[172] To 
679 
determine the cost-effectiveness of the intervention, we will calculate incremental cost-effectiveness 
680 
ratios (ICERs) for the intervention versus each comparator (standard of care; distribution of HIV self-
681 
test kits). The numerator of the ratio is the difference in costs expressed in US (purchasing parity 
682 
adjusted) Dollars; the denominator is the difference in effectiveness.[172, 173] A 10-year time horizon 
683 

 
 
 
 
17 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
will be used because an extrapolation beyond this would be associated with substantial increases in 
684 
uncertainty as to future developments in HIV prevention and treatment, as well as the lasting 
685 
effectiveness of the intervention. ICERs will be compared to the gross domestic product (GDP) as per 
686 
WHO recommendations to derive the following three categories of cost-effectiveness: highly cost- 
687 
effective (less than GDP per capita), cost-effective (between one and three times GDP per capita), and 
688 
not cost-effective (more than three times GDP per capita).  
689 
Following WHO Guide[172, 174], the effectiveness of the intervention will be assessed using the 
690 
Disability Adjusted Life Year (DALY) as the unit of effectiveness. One DALY represents a year of 
691 
healthy life lost due to death or disability.[175] We will calculate the DALY as the sum of the years of life 
692 
lost (YLL) and the years lost due to disability (YLD) that would be saved for each HIV infection averted 
693 
by study arm based on estimates and disability weights from the Global Burden of Disease (GBD).[176] 
694 
We will calculate the direct costs of each strategy utilizing established guidelines for costing HIV 
695 
interventions[177, 178] from a program perspective using micro-cost techniques. Cost estimation will 
696 
involve a uniform cost data collection protocol at each study site. We will conduct observations and 
697 
interviews with purposively selected sample of health care providers, study and assistant study 
698 
coordinators, finance and administration officers, to identify program activities on which resources were 
699 
spent. Expenditures will be classified in one of four categories; (i) personnel (including fringe benefits); 
700 
(ii) recurring supplies and services; (iii) durable equipment; and (iv) facility space. The costs of the 
701 
program will be identified through interviews with administrative, finance and human resources officers, 
702 
supplemented by direct observation in a limited number of formal “time and motion” studies. Costs for 
703 
equipment and facility space (likely a small portion of total costs) will be amortized on a straight-line 
704 
basis over their expected useful life assuming no salvage value. Other costs considered include 
705 
laboratory, medication, and healthcare costs. We will account for costs related to increased use of 
706 
PrEP, HIV or pregnancy-related services. Research costs (e.g. costs related to consenting and 
707 
research-participation), any medical costs incurred offsite, or higher-level program costs incurred by the 
708 
county/national government or donors will be excluded from the programmatic costs. Costs and DALYs 
709 
will be discounted at a 3% rate.[172] 
710 
A key element of cost-effectiveness analysis involves properly accounting for the uncertainty 
711 
associated with the ICER. Such ratios are estimates based on a sample of individuals. They are subject 
712 
to sampling error, and performing the same trial over and over would lead to different estimates of the 
713 
ratio. A variety of sensitivity analyses will be used to assess the performance of our state transition 
714 
models.[172] One-way sensitivity analyses will be used to determine which model parameters are most 
715 
important in determining whether the intervention can be considered cost-effective. Some anticipated 
716 
parameters include certain clinical practice situations such as decreased testing, initiation, adherence 
717 
and retention into care, and varying costs of inputs, particularly for the antiretrovirals. Markov Chain 
718 
Monte Carlo probabilistic sensitivity analyses simulations will then be used to test the robustness of the 
719 
model findings to uncertainty in the parameter inputs.  
720 
 
721 
TIME FRAME 
722 
 
723 
 
724 
 
725 
Study Activity                      Months 
1-6 
7-12 
13-18 
19-24 
25-30 
31-36 
37-42 
43-48 
49-54 
55-60 
Preparations/Adaptation/IRB 
 
 
 
 
 
 
 
 
 
 
 
Training & Community Sensitization 
 
 
 
 
 
 
 
 
 
 
Recruitment &BL questionnaires 
 
 
 
 
 
 
 
 
 
 
 
 
Initial home visits 
 
 
 
 
 
 
 
 
 
 
 
 
Brief assessment: couple testing 
 
 
 
 
 
 
 
 
 
 
 
 
3 month postpartum questionnaires 
 
 
 
 
 
 
 
 
 
 
12 month postpartum questionnaires 
 
 
 
 
 
 
 
 
 
 
 
 
18 month postpartum assessment 
 
 
 
 
 
 
 
 
 
 
 
Cost-effectiveness analysis 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis/Write-up 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
18 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Aim 1 of this study is to determine the impact of a couples-focused home-based intervention on our 
726 
primary outcome of couple HIV testing for pregnant women and their male partners as compared to 
727 
HIV self-test kits for couples and standard care. There is a need to understand how COVID-19 has 
728 
influenced the Jamii Bora study, participating health facilities, and the study participants. There is also a 
729 
lack of data on how the new coronavirus has affected research teams and studies, both in their 
730 
perceptions of the pandemic and its potential effects on participants’ health and accessing resources. 
731 
We propose a standard of care health facility assessment, to assess the impact of the COVID-19 
732 
outbreak on standard care related to the HIV testing and counseling services for pregnant women and 
733 
male partners, and compare this to service provision in the pre-COVID-19 period. Data will be collected 
734 
for the period January to when the COVID-19 curve in Kenya starts to flatten. These data will be 
735 
collected from registers and electronic medical records from the eighteen health facility sites in Kisumu 
736 
and Migori counties. Additionally, we will survey our study staff and staff from other HIV prevention and 
737 
treatment studies in the region to further understand the effects of COVID-19 on participants as well as 
738 
staff to help the studies construct a positive response to the epidemic. 
739 
 
740 
COVID-19 RESTRICTIONS 
741 
To protect study participants, their families and research staff from the risk and spread of COVID-19, 
742 
the study will adhere to all Ministry of Health directives and well as SERU guidelines aimed at mitigating 
743 
the spread of COVID-19.  We will inform research participants of requirements to undergo COVID-19 
744 
screening and reporting of screening results to the local public health authorities whenever the results 
745 
may point at a possible infection with the disease, for their benefit. We will also provide participants and 
746 
staff with 3 ply face masks, avail hand washing stations at the study sites, and provide sanitizers.  We 
747 
will pre-screen participants before physical contact, check temperature and observe social distancing 
748 
requirement of 1.5 meters during face-to -face interaction with participants. Pens used for consenting 
749 
will be disinfected before and after individual use. We will inform the participants of the measures that 
750 
we will be taking during any form of face-to-face contact and unconditionally will respect their 
751 
preferences in terms of in-person versus remote study visits. We will also have daily mandatory 
752 
screening for staff who are making contact with participants and only those without any COVID-19 
753 
symptoms will be allowed to make contact with participants. The staff will also disinfect furniture and 
754 
sanitize their hands after every contact with a participant.  
755 
  
756 
 
757 
ETHICAL CONSIDERATIONS 
758 
This protocol will be reviewed by the Institutional Review Boards (IRB) of the University of Alabama at 
759 
Birmingham and the University of Michigan, Ann Arbor. In Kenya, the protocols will be reviewed by 
760 
KEMRI Scientific and Ethics Review Unit (SERU) (FWA# 00002066). We will ensure that all procedures 
761 
conform to US, Kenyan, and international ethical standards regarding research involving human 
762 
subjects.   
763 
 
764 
The proposed research will be conducted in collaboration with investigators of the Kenya Medical 
765 
Research Institute (KEMRI), county Ministry of Health (MoH) teams and clinics (see letters of 
766 
support),and U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) partners in counties in the 
767 
former Nyanza Province in southwestern Kenya. Our team already has long-standing positive 
768 
relationships with the local MoH teams and the study communities. Our intervention strategy takes 
769 
advantage of the extensive existing infrastructure of these partners and is a direct response to needs 
770 
identified by MoH and local clients and staff in the Nyanza Region. We have developed our research 
771 
strategy after extensive consultations with MoH county teams and other local partners. Prior to our pilot 
772 
study for this intervention, we conducted a series of meetings with the leadership and program staff to 
773 
obtain their input and guidance as to the best methods for delivering a couples intervention for pregnant 
774 
women and their male partners, and how such an intervention could best be incorporated into existing 
775 
support of these health facilities. Before beginning the proposed study, we will also consult with local 
776 
health workers, community leaders, and representatives of community groups (including HIV clinic 
777 

 
 
 
 
19 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
patient groups) in all study communities. We have purposely selected communities with active 
778 
Community Units for participation in this study in order to assure close consultation with the local 
779 
communities. The proposed research builds on our findings and our experience protecting human 
780 
subjects in our other studies conducted in rural Nyanza and other relevant settings, including the “A 
781 
Home-Based Couples Intervention to Enhance PMTCT and Family Health in Kenya” study, in which we 
782 
developed and piloted the intervention to be tested in the currently proposed R01 study 
783 
(R34MH102103, PI: Turan), the Maternity in Migori and AIDS Stigma (MAMAS) Study (NIMH 
784 
5K01MH81777, PI: Turan) and the Gender-Based Violence (GBV) Study (UCSF Center for AIDS 
785 
Research, PI:  Turan), Couples in Context: An RCT of a couples-based HIV prevention intervention 
786 
(NIMH R01 MH086346, PI: Darbes), A randomized trial to prevent HIV among gay couples (NIMH R01 
787 
MH110280, M-PI: Darbes), Self-testing study (Bill and Melinda Gates Foundation grant number 
788 
OPP1069673, PI: Thirumurthy) as well as during the ongoing “Maximizing adherence /retention for 
789 
women /infants in the context of Option B+, Kenya” (MOTIVATE) Study (R01HD080477, PI: 
790 
Turan/Abuogi). There will be a series of individual assessment interviews and intervention sessions as 
791 
detailed in the narrative of the proposal. Below, we detail our plans for the inclusion and protection of 
792 
human subjects. 
793 
 
794 
Potential Risks to the Subjects: 
795 
Human Subjects Involved: A total of 1600 individuals (800 couples) will be recruited to participate in this 
796 
research study (800 female and 800 male partners). Pregnant female participants will be recruited from 
797 
antenatal care (ANC) clinics. We will ask all women attending ANC clinics to participate in the study 
798 
until we have achieved a sample size of 800 women (two-thirds HIV-positive at baseline) and 800 male 
799 
partners who agree to participate in the study. After baseline questionnaires are completed, we will 
800 
randomize couples to one of three approaches for helping to increase couple engagement in maternal 
801 
and child health. Participants will receive a sealed envelope labeled with their newly assigned study ID 
802 
numbers, which will contain their random assignment. Random assignments will be computer 
803 
generated and will be stratified by clinic and the woman’s HIV status to assure approximately equal 
804 
numbers of couples in each study arm and in each HIV status group in any given time period. We 
805 
expect to enroll around 267 couples in each study arm (178 in which the woman is HIV-positive at 
806 
baseline and 89 in which the woman is HIV-negative at baseline). 
807 
 
808 
This study will thus involve recruitment of HIV-positive and HIV-negative or unknown HIV status 
809 
pregnant women at ANC clinics and their male partners, baseline questionnaires, randomization of 
810 
couples to one of the two interventions (home-based couples intervention or HIV self-testing for 
811 
couples) or standard care arms of the study, and participation in home or clinic visits or HIV self-testing 
812 
according to study arm. Follow-up questionnaires will be conducted with women and male partners at 3 
813 
months and 12 months after the expected due date (EDD) of the infant.  In addition, brief mobile phone 
814 
assessments of uptake of HIV testing and results will be conducted during late pregnancy and at 6 
815 
months after the birth, and a brief phone assessment of maternal and infant health outcomes will be 
816 
conducted at 18 months after the birth. 
817 
 
818 
For AIM 2 qualitative interviews with two groups of n=30 women each, a subset of young women and a 
819 
subset of women with IPV will participate in a brief one-on-one interview during the postpartum period. 
820 
 
821 
Criteria for inclusion or exclusion: The initial target populations are pregnant women identified in the 
822 
ANC clinics in the Nyanza Region of Kenya and their male partners. The vast majority (87%) of women 
823 
presenting for first ANC visits in Kenya are in the 2nd and 3rd trimesters of pregnancy, but given the 
824 
importance of early initiation of ART for maternal health and PMTCT, we will enroll women as early as 
825 
possible. We will select women at 36 weeks of pregnancy or less, to have time to deliver at least one 
826 
home visit during pregnancy. Other inclusion criteria are: (a) 15 years of age or older (b) has been 
827 
offered HIV testing at ANC, (c) is currently in a stable relationship with a male partner and living with 
828 
that male partner, (d) has not yet participated in couple HIV testing during this pregnancy, and (e) not in 
829 
an HIV-positive concordant relationship. Male partners are the person identified by the pregnant woman 
830 

 
 
 
 
20 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
as her primary male partner and should also be 15 years of age or older. More details regarding 
831 
inclusion of persons younger than 18 years is included in the Inclusion of Children attachment.  
832 
 
833 
For the qualitative interviews with young women, the inclusion criteria are: (a) 15-24 years of age (b) at 
834 
least 12 months postpartum (c) willingness/ability to give informed consent. For the qualitative 
835 
interviews with women who have experienced IPV, the inclusion criteria are: (a) experience of IPV 
836 
during the recent pregnancy and/or postpartum (b) ≤24 months postpartum (c) willingness/ability to give 
837 
informed consent. 
838 
 
839 
Collaborating sites where human subjects’ research will be performed and role of sites in performing 
840 
proposed research: The University of Alabama at Birmingham (UAB)will serve as the lead institution 
841 
and overall Coordinating Center for this project and is the home institution of one of the M-Principal 
842 
Investigators (Turan). UAB, along with the University of Michigan (home institution of M-PI Darbes) will 
843 
oversee the overall study design, development of the intervention protocol, development of assessment 
844 
materials, reports, data management and analysis, and relationship with the funding agencies. KEMRI 
845 
will be the implementation site of the project in Kenya. Other institutions (University of Pennsylvania, 
846 
University of Witwatersrand) are home institutions of Co-Investigators. All investigators will participate 
847 
in the study design, protocol development, instrument design, quality assurance, data analysis, and 
848 
production of manuscripts and presentation of findings from the study.  
849 
 
850 
Sources of materials 
851 
Research material: Research data will be collected from the participants via individual questionnaires 
852 
for research purposes only, administered in private settings. Questionnaires will be administered by a 
853 
trained interviewer, and will pertain to demographic characteristics, ANC, HIV prevention and treatment 
854 
behavior, and relationship dynamics. Questionnaire data will be collected via a tablet computer 
855 
technology, which was used in our prior work in this site. The UAB server to which the data is uploaded 
856 
is secure, and neither identifying information nor actual survey data are stored on the tablets  
857 
themselves—it is uploaded at the end of each day, following completion of the questionnaires.  All 
858 
individuals will be given a confidential study identification number and all data will be labeled only with 
859 
this identification number. There will only be one master list linking participants’ names and study 
860 
identification numbers. We will keep this list separate from all other materials in a locked file in a locked 
861 
office at the KEMRI study site. We will keep a back-up file of this list on a password protected computer 
862 
file, and select KEMRI study staff (site PI, Study Coordinators, and Interviewers) will have access. 
863 
Access will be necessary by KEMRI staff for tracking purposes.  Digital audio files from the couples’ 
864 
counseling sessions (again for QA purposes only) will be kept in a password protected, encrypted 
865 
computer file. Some participants will undergo testing for HIV, either as individuals or in a couples-based 
866 
session (CHTC). The testing will either be done at their home by counselors, or self-administered using 
867 
HIV self-test (HIVST) kits. All counselors that conduct HIV testing will be certified test counselors, who 
868 
are separate from interviewers, who have received specific training in couples-based HIV counseling 
869 
and testing, in addition to individual-level testing. 
870 
 
871 
Potential Risks: 
872 
The potential risks to participants are detailed as follows: 
873 
• 
Some participants may be uncomfortable answering questions about their relationships, their 
874 
health, and/or their medical conditions, including pertaining to HIV: all information used in 
875 
enrollment and recruitment describing the research activities will include a detailed description 
876 
of the content and expected participation of the respondent, such that the respondent is aware 
877 
of the nature of the questions to be included in the surveys. Respondents will complete their 
878 
questionnaires separately from their partner, such that individuals will not be aware of their 
879 
partner’s responses. Informed consent documents will inform research participants of this, and 
880 
the need to keep answers to questions confidential. Participants will have the option to refuse to 
881 
answer or skip any questions on the questionnaires that they are uncomfortable answering.  
882 
• 
Some participants may be uncomfortable talking with their partner or a counselor about their 
883 
medical conditions or history, pregnancy, or may feel uneasy about having HIV testing done. 
884 
Each of the study counselors will be trained, and have experience, in the provision of individual 
885 

 
 
 
 
21 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
HIV testing and counseling (HTC) and couples HIV Testing and Counseling (CHTC), and thus 
886 
will have experience in answering research participants concerns about HIV testing, 
887 
comprehending the HIV testing process, and concerns around discussing HIV with a partner or 
888 
counselor. At each study site we will follow existing protocols for HIV testing, which include 
889 
establishing the client’s willingness, readiness and comprehension of the HIV testing process. 
890 
• 
For participants who provide their name and address or other personally identifying information 
891 
to study personnel, there is a risk that these data could be unintentionally disclosed to someone 
892 
not authorized to access the data, compromising the confidentiality of the participant. In 
893 
particular, women and men might face serious social risks (disruption of family, discrimination, 
894 
and/or physical harm) if their HIV status were to be disclosed without their consent. These risks 
895 
could be posed if questionnaires are not conducted with the utmost attention to confidentiality, 
896 
or if home or clinic visits, or HIVST kit distribution are conducted in a way that results in 
897 
inadvertent disclosure of HIV status to community members. To reduce this risk, all staff will be 
898 
carefully trained in confidentiality and contact information for the study participants will be kept 
899 
in a password protected location, with access restricted to authorized study staff.  
900 
• 
Participants who learn that they are HIV-positive may be distressed to learn of their health 
901 
condition. This poses the greatest emotional and physical risk to participants in the research 
902 
study. The informed consent documents will outline the HIV testing process, stating that results 
903 
will be delivered the same day, and will explain in full what a positive, negative or indeterminate 
904 
HIV test result mean. The counselor will assess the individual’s readiness to receive both the 
905 
HIV test and the result, following standard HIV testing guidelines. The study counselors (Study 
906 
Arm 1),as well as clinic-based healthcare providers (standard care, Study Arm 3),are 
907 
experienced in the delivery of HIV test results, and will follow standard clinic guidelines for 
908 
results delivery. Individuals (or couples) receiving positive HIV test results will be provided with 
909 
counseling, confirmatory testing, linkage to health workers at the nearest government health 
910 
facility, and referrals to HIV care. All those receiving a positive result will be given referrals to 
911 
the free HIV services at the nearest health facility and linked directly to a clinic outreach worker 
912 
who can assist them in finding appropriate care.  In our R34 pilot study, all participants testing 
913 
HIV-positive in the context of the home-based couples intervention were successfully linked to 
914 
HIV care. Those who receive HIV-positive results from an HIVST kit (Study Arm 2) will have 
915 
received detailed information when receiving the kits about how and where to obtain counseling 
916 
and confirmatory testing, as well as specific referrals for free HIV care and treatment services at 
917 
the nearest government health facility. 
918 
• 
It is also possible that having a discussion about relationship dynamics, pregnancy, and/or HIV 
919 
with a participant’s partner might lead to subsequent conflict, or even violence, within their 
920 
relationship. To ameliorate this risk, we propose to screen out those with a history of recent (in 
921 
the past 6 months) severe intimate partner violence (IPV) in the relationship. It is possible that 
922 
new, incident, episodes of IPV may occur in the course of the study. This will be recorded 
923 
through questionnaires on the surveys at each study visit. Counselors will be trained to assess 
924 
the severity of the violence, in order to determine the level of response necessary. Detailed 
925 
protocols from our prior studies, including the R34 pilot of this home-based couples intervention 
926 
in Kenya, have been developed in order to appropriately provide assessment, services, and 
927 
referrals as needed. Individuals reporting IPV will be provided with referrals to locally 
928 
appropriate services, per the standard protocols for the handling of IPV at each of the study 
929 
sites. Individuals reporting IPV will be offered the opportunity to also meet individually with the 
930 
study counselor, and will be provided with referrals to local services. 
931 
• 
Similarly, individuals may test positive for HIV at a follow-up visit, and this may be the result of a 
932 
previously undisclosed outside sexual partner. For couples in the baseline visit, if one tests 
933 
positive for HIV and one tests negative, the standard protocol for a CHTC session is to describe 
934 
to the couple how this may have occurred – through a contact prior to the relationship, or 
935 
through contact outside of the relationship – to remind the couple that we cannot identify from 
936 
where the infection came, and to focus the counseling session on future risk reduction efforts 
937 
and communal coping. Counselors are trained on blame diffusion techniques. For follow-up 
938 
sessions, the protocol may vary slightly. Incident positives identified during follow-up may still 
939 
have been infected from either their main partner or an outside partner. In the case of an 
940 

 
 
 
 
22 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
incident positive, the counselor will describe the possible routes of infection to the couple (from 
941 
the main or an outside partner) and will focus on developing a risk reduction plan for the couple 
942 
that is future focused. In the CHTC training, which all counselors have received, emphasis is 
943 
placed on key skills of blame reduction, tension and anger diffusion, and on keeping the session 
944 
focused on future prevention efforts. 
945 
 
946 
• 
There is also a risk that one member of the couple may feel coerced into participating in the 
947 
activities. In our previous RCT of CHTC in South Africa we included a question on whether the 
948 
subject felt coerced into the enrollment and screening documents: approximately 10% reported 
949 
feeling coerced. Given this, we will adopt a similar process and will include a question on 
950 
coercion in the enrollment documents: any couples in which one member reports feeling 
951 
coerced will be offered individual VCT, per standard clinic guidelines, and will not be 
952 
randomized. 
953 
• 
Although not a risk caused by the trial, a potential ethical issue that arises is the counselor or 
954 
study staff learning that one member of a couple is having risky sex outside the relationship, 
955 
and not disclosing this risk to their main partner. The issue of disclosure of sex risk outside the 
956 
relationship is difficult. If we inform participants in the consent process that information about 
957 
sex outside the relationship would be disclosed to an unknowing partner, then we will likely 
958 
reduce truthful reporting and bias against consent by the participants who are in most need of 
959 
intervention. However, we also appreciate an ethical imperative to protect our study participants. 
960 
We suggest the following compromise, which is now used in the provision on CHTC in clinical 
961 
settings. First, all couples will have a session with a counselor, which will provide a supportive 
962 
and protective environment in which to disclose such risk from sex outside the relationship. 
963 
Second, all couples will be counseled in their initial session about the benefits of using 
964 
condoms, and condoms are provided at the study health facilities at no cost to the participants. 
965 
Third, if we identify a situation in which outside sex partners are reported, but not disclosed in 
966 
the couple’s discussion with the counselor, and either partner reports unprotected sex in the 
967 
primary relationship, we will make a referral to the health workers present at each study site, 
968 
which will be provided at no cost to the participants.  
969 
• 
Physical risks of the actual HIV testing are minimal. The test only requires the participant 
970 
provide a blood via a finger prick.  
971 
• 
Risks related to couple home visits that include offer of CHTC:  Due to the potential risks of HIV 
972 
status disclosure it is clear that home-based strategies need to be carefully designed. 
973 
Considerations include how to inform the community about upcoming home visits, how to 
974 
approach the home without causing unwanted disclosure, how to explain the need for privacy to 
975 
other family members or neighbors, what package of information and services to offer, and how 
976 
to handle potential couple conflict that may arise as a result of HIV status disclosure. Our own 
977 
formative research[69], preliminary results of our couple home-visiting R34 pilot study,  and 
978 
other research in similar settings[110] suggests that home-based couple visits can be 
979 
conducted in a safe and acceptable manner in rural East Africa.  
980 
• 
Risks related to HIVST distribution to pregnant woman for use together with their male partner: 
981 
There are potential risks of adverse social consequences related to women offering HIVST kits 
982 
to their male partners.  Drs. Thirumurthy (Co-Investigator) and Agot (Consultant) conducted a 
983 
cohort study of distribution of HIV self-test kits to HIV-negative women at ANC and postpartum 
984 
clinics in Kisumu, (Bill and Melinda Gates Foundation grant number OPP1069673, PI: 
985 
Thirumurthy). Pregnant/postpartum women were instructed on use of oral fluid based rapid HIV 
986 
tests and received three self-tests. Structured interviews were conducted with participants at 
987 
enrolment and over 3 months to determine how self-tests were used. Most participants with 
988 
primary sexual partners distributed self-tests to partners: 53 (91%) of 58participants in antenatal 
989 
care and 91 (86%) of 106 in post-partum care. Among self-tests distributed to and used by 
990 
primary sexual partners of participants, women reported that couples testing occurred in 27 
991 
(51%) of 53 in antenatal care and 62 (68%) of 91 from post-partum care. In this study, two 
992 
postpartum participants reported intimate partner violence as a result of self-test distribution. No 
993 
other adverse events were reported. In a subsequent randomized controlled trial of HIV self-test 
994 

 
 
 
 
23 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
kit distribution with antenatal and postpartum women in Kisumu, the researchers found that this 
995 
strategy was successful in promoting both partner testing and couple testing. Among570 
996 
participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%,258/284) 
997 
than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4%to 45.8%, p 
998 
<0.001). Couples testing was also more likely in the HIVST group than the comparison group 
999 
(75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p <0.001). No participants 
1000 
reported intimate partner violence due to HIV testing in this study. 
1001 
• 
Risk related to the new Corona Virus Disease (COVID-19): COVID-19  is primarily transmitted 
1002 
from person to person, among those who are in close contact through respiratory droplets. 
1003 
Transmission can occur by direct contact with infected persons, or by contact with contaminated 
1004 
objects and surfaces. There are potential risks of exposure and contracting the disease to 
1005 
participants during movement from their home to the facility or any other location they choose to 
1006 
meet with study staff for participation in the study. They may interact with other people whose 
1007 
COVID-19 status is unknown and potentially may be exposed or contract the disease in the 
1008 
process.  Additionally, there is risk of disclosure of participants’ information to the Ministry of 
1009 
Health designated officials in the event that the study learns that a participant is potentially 
1010 
infected with COVID-19 for purposes of treatment. Participants will be informed during 
1011 
consenting of potential disclosure to health officials if they have COVID-19.The study will 
1012 
provide 3ply face masks, handwashing facilities, and sanitizers to participants and will observe 
1013 
Ministry of Health directives during all interactions with participants, in order to mitigate the 
1014 
potential for infection as much as possible.  
1015 
 
1016 
Adequacy of Protection against Risks:  
1017 
Any risks to subjects that stem from participation in assessments or intervention activities will be 
1018 
minimized by: 1) training of staff in the ethical conduct of research 2) training of staff in issues 
1019 
specifically pertaining to couples in this setting (e.g., potential for coercion for women participating, 
1020 
potential for partner violence) 3) close monitoring of any adverse events with appropriate IRB reporting 
1021 
and 4) referral to professionals or community agencies with mental health training or other appropriate 
1022 
services, when necessary. For those participants who engage in HIV testing during a couple home visit 
1023 
(Study Arm 1) or at the clinic (standard care, Study Arm 3)a separate consent procedure will be 
1024 
conducted for HIV testing, and all procedures will be conducted by trained HIV testing counselors.  
1025 
 
1026 
In the case of any adverse event, including episodes of partner violence, we will have an established 
1027 
protocol describing our response to these events. These procedures will include having back-up 
1028 
systems in place for staff and possible referrals in the event of after-hours or weekend events. Our back 
1029 
up system will include the use of cell phones or pagers and designated staff that can directly assess the 
1030 
severity of the situation and determine a plan of response (e.g., immediate medical or psychological 
1031 
attention, referral to community-based services). All procedures will be documented in the study 
1032 
protocols and manuals, and discussed in staff trainings. These procedures are based on our previous 
1033 
experience with couples-based interventions, including with couples in the proposed setting. In our prior 
1034 
work in the pilot R34 trial in Kenya, adverse events included adverse maternal and pregnancy 
1035 
outcomes not related to participation in the study (1 miscarriage, 5 stillbirths, 3 infant deaths, and 2 
1036 
maternal deaths) and two cases of relationship dissolution that were also not attributed to study 
1037 
participation and in South Africa, our only adverse events had to do with couples breaking up and 
1038 
attributing the break-up to participation in the intervention (N=1).  
1039 
 
1040 
Recruitment and Informed Consent 
1041 
Pregnant female participants will be recruited from ANC clinics, using methodologies from our previous 
1042 
studies with pregnant women. Potential participants will be asked if they would like to hear about the 
1043 
study, and the nature of the study will be explained to them using standardized recruitment scripts. 
1044 
Study descriptions will indicate that there is a possibility of different experiences due to the presence of 
1045 
three study groups. Male partners will be contacted, informed about the study, and consented 
1046 
subsequently, with the express permission of the pregnant woman. If the female partner is eligible for 
1047 
the study and willing to connect the study team with her male partner for potential inclusion in the study 
1048 

 
 
 
 
24 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
as well, research staff will obtain contact information for the woman and the male partner. Those 
1049 
interested but not comfortable with face- to- face contact due to COVID -19 pandemic will be asked to 
1050 
participate remotely through phone after safety and privacy has been ascertained. 
1051 
 
1052 
We will include screening for intimate partner violence in our eligibility questionnaires, in which each 
1053 
partner will be interviewed separately. We will ask participants questions based on our prior studies 
1054 
with couples used in this location. The questions will screen for physical violence (e.g., “My partner 
1055 
pushed, grabbed, or slapped me” “My partner hit me with his fist or something else that could hurt”) and 
1056 
sexual violence (“My partner physically forced me to have sex when I did not want to.”). Potentially 
1057 
controlling behaviors by a partner will be assessed during the intervention and assessments, but will 
1058 
not be used as screening questions. If participants report severe physical or sexual violence in the past 
1059 
6 months, they will be informed at the end of the screening/eligibility interview that they are not eligible 
1060 
to participate, (e.g., “This intervention is not helpful for everybody, and we believe it may not be helpful 
1061 
for you and your partner at this time.”). All couples who are deemed ineligible, regardless of reason of 
1062 
ineligibility will be provided with a list of couples-oriented services in the community—including those 
1063 
agencies which provide services pertaining to intimate violence and HIV.  
1064 
 
1065 
Process of obtaining informed consent: Following initial contact, and screening for eligibility, informed 
1066 
consent will be obtained. If both members of the couple are eligible and willing to participate, each 
1067 
member of the couple will be consented individually.  The study’s consent form will be read and 
1068 
explained to them by an interviewer, and if they agree, they will be asked to sign the consent form.For 
1069 
participants who wish to enroll in the study but prefer virtual/remote participation, we will conduct 
1070 
consenting process on the phone.  The study staff shall read the consent word for word and verify the 
1071 
participant’s understanding before obtaining verbal consent. Verbal consent shall be taken by asking 
1072 
the participant to repeat the participant declaration statement written in the tail end of the consent as 
1073 
the staff audio records. All participants choosing to be consented remotely will be informed of recording 
1074 
their declaration to participate and the consent form will be kept safely for signing by the participant 
1075 
when COVID-19 spread is brought under controlVersions of the consent form will be available in 
1076 
English, Luo, and Swahili. A detailed description of the study procedures will be included. The consent 
1077 
form will include the information that they have the right to refuse or withdraw from participation at any 
1078 
time. The consent form will provide detailed descriptions of the expectations of being a participant in 
1079 
any of the study groups, along with the accompanying potential risks and benefits of each. Information 
1080 
will be presented on randomization, following procedures used to describe randomization in prior 
1081 
studies in the community.  An information sheet will be provided with the goals of the research, the 
1082 
study procedures, and the names and contact info for the principal investigators will also be provided, 
1083 
and a contact number for the chair of the Ethics Committee of the Kenyan IRB. We will ask for 
1084 
signatures, but should participants be more comfortable, they can mark the form with an “x”. We will 
1085 
confirm that participants understand the material covered in the consent form by asking questions prior 
1086 
to their signature, e.g. “could you tell me what will happen if you participate in the study?”. If 
1087 
interviewers assess that the participant’s level of understanding is insufficient and cannot be addressed 
1088 
by additional clarification the participant will be excluded from the study and provided with appropriate 
1089 
referrals. We have had experience obtaining consent from couples in prior studies in this context, and 
1090 
similar consent procedures will be followed. All consent forms will be approved by the IRBs of both UAB 
1091 
and U-Michigan and KEMRI in Kenya.  
1092 
For receiving CHTC similar procedures will be followed, with a separate consent process and consent 
1093 
form.  Consent will also be obtained for audio files to be digitally recorded of the home-based 
1094 
intervention couples’ counseling sessions, but this material will only be used for quality control  
1095 
procedures.  
1096 
 
1097 
For the in-depth qualitative interviews, similar procedures will be followed, with a separate consent 
1098 
process and consent form. Consent will also be obtained for digital audio recording of the interviews so 
1099 
that verbatim transcriptions may be made. 
1100 
 
1101 
Protections against Risk: 
1102 

 
 
 
 
25 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
In general, any potential risks from participation will be minimized by ensuring that study staff is well 
1103 
trained in ethical research standards and by developing detailed protocols to limit the likelihood of any 
1104 
risk. However, we have identified the following potential risks associated with participation in this study: 
1105 
1) discomfort/distress 2) loss of confidentiality, and 3) conflict, or tension between partners 4) risks 
1106 
associated with HIVST distribution, and 5) risks associated with home visits. In addition, there are risks 
1107 
associated with individual testing for HIV and CHTC. 
1108 
Participant distress/discomfort: Our research team has a significant amount of experience 
1109 
conducting behavioral surveys and interviews within the field of HIV prevention, PMTCT, and with 
1110 
couples, including in the proposed setting. It has been our experience that it is rare for a participant to 
1111 
find the interview upsetting. We have infrequently encountered episodes of mild embarrassment or 
1112 
awkwardness, which quickly dissipate. Interviewers and study staff will be trained to minimize 
1113 
distress/discomfort to participants, to recognize any signs of symptoms of distress, and to make 
1114 
appropriate referrals to appropriate community-based services, if necessary. Experienced mental 
1115 
health counselors will be on the study staff, and can be consulted or referred to should a participant 
1116 
exhibit severe symptom of mental distress. Should a participant experience distress after-hours or on 
1117 
weekends a back-up system will be in place in the event a mental health or medical professional is 
1118 
needed for assessment or immediate referral. All couples’ counseling sessions will be conducted by lay 
1119 
counselors, but who have received significant training pertaining to couples, so any distress during an 
1120 
intervention session will be able to be processed and dealt with appropriately. All staff will be trained in 
1121 
the proper referral procedures, and will be provided with ongoing supervision of such issues by the 
1122 
Study Coordinator, who will be an experienced couples counselor. Through our prior work in the 
1123 
community, we have compiled a list of community-based resources for couples, including mental health 
1124 
counseling, general health services, mental health counseling, intimate partner violence, substance 
1125 
use, and other issues. These lists will continue to be updated, and a copy will systematically be 
1126 
provided to every couple during baseline questionnaires, and then during follow-up assessments. 
1127 
Providing them to all couples will reduce the likelihood that any one couple would be identified as 
1128 
needing a particular service, and implying that they have a particular need for a type of service. In 
1129 
addition, it could ameliorate tension between partners, as one partner could become distressed if a 
1130 
partner were given referrals following disclosure of information in an interview.  
1131 
Loss of confidentiality: To protect participants’ confidentiality the following steps will be taken: 1) all 
1132 
staff will receive training at the initiation of the study (all staff receive GCP training at the KEMRI study 
1133 
site), and ongoing supervision to ensure their understanding of any and all confidentiality-protecting 
1134 
procedures; 2) participants’ names will not be associated with any research instruments; 3) only 
1135 
research identification numbers will be used on data; 4) any tracing or other contact information 
1136 
obtained in locator form (see Appendix R), including signed consent forms will be stored separately 
1137 
from survey data; 5) all records will be stored in locked file cabinets in study offices at KEMRI study 
1138 
office; 6) the files linking research identification numbers and names will be stored in a separate locked 
1139 
file cabinet, and a computer file only accessible by the Study Coordinator, MPIs and Co-Is; 7) all 
1140 
computers on which any data are stored will be password protected.  
1141 
 
1142 
As this is a study involving couples, additional measures are needed to protect each participant’s 
1143 
confidentiality from their partner. From our prior work, we have developed procedures to minimize risk. 
1144 
For the ongoing assessment questionnaires, all participants will be interviewed by a gender-matched 
1145 
interviewer who will conduct the assessment in a private room, or privately. Couples will typically be 
1146 
interviewed in their homes, but will be consented and interviewed separately. Prior to their separation, 
1147 
study staff will inform them that they may contact the staff member who interviewed them, but they will 
1148 
not be permitted to have contact with the interviewer who administered the survey to their partner. This 
1149 
procedure will enhance the participants’ confidence that the information they disclose will be kept 
1150 
confidential and not disclosed to their partner. 
1151 
 
1152 
Each interviewer will only interact with one participant of the couple, and the interviewers will be 
1153 
instructed not to compare answers between them regarding a couple’s answers. Thus, it will not be 
1154 
possible for interviewers to become aware that one member of a couple is unaware of potential HIV risk 
1155 
posed to them by the other member of the couple. However, it is possible when analyzing the data that 
1156 
the investigators will be able to identify a condition of unrecognized HIV risk, such as non-disclosure of 
1157 

 
 
 
 
26 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
HIV status. Should the situation arise where we identify that one partner has not disclosed their HIV-
1158 
positive status to their partner, we will have protocols in place to first work with the participant to 
1159 
facilitate disclosure to their partner.  We will have several resources (e.g., our own couples counselors 
1160 
and couples testing counselors) and referral pathways in place for this situation. Should, after 
1161 
counseling a participant still refuse to disclose their status, we would, in consult with the local IRB and 
1162 
our DSMB about next steps.  
1163 
 
1164 
The consent form will include specific language regarding the confidentiality of the partner’s study data: 
1165 
“Please be aware that you will not be told any information that your partner says in his or her interview. 
1166 
This includes any information your partner might say about his or her sexual health, including HIV 
1167 
status, even if we think you do not know this information. Likewise, no information you say in your 
1168 
interview will be told to your partner, even if we think your partner might not know this information.” 
1169 
Interviewers will be trained to ensure that participants understand this condition during the informed 
1170 
consent process, including information about the confidentiality of their own and their partner’s data. As 
1171 
mentioned above, systematically providing this information will eliminate partner’s surmising that it is 
1172 
being provided due to information disclosed during the interview. 
1173 
 
1174 
Possibility of intra-couple tension, conflict, or violence: It will be clear in the consent form that each 
1175 
partner completes that, while study staff members will not reveal their information to their partner, it is 
1176 
possible that their partners might ask them about their responses to certain questions or issues they 
1177 
discussed. Interviewers will be trained to discuss with participants ways of coping with this situation if 
1178 
the participant they are consenting expresses concern or distress about this matter either during 
1179 
consent, the administration of the survey, or after it is completed. Interviewers and other intervention 
1180 
staff will also be trained in the identification of, and proper response to, issues of coercion or abuse, 
1181 
and will be familiar with how to facilitate referrals for intimate partner violence assistance (either for the 
1182 
violent partner or the victimized partner). For example, staff will assess the degree of threat, whether 
1183 
the participant’s life is currently at risk, or whether the crisis is not of an imminent nature. Depending on 
1184 
the degree of threat, the participant could be referred immediately to a crisis center in the nearest town, 
1185 
or, in lesser threat situation could be provided with referrals for community-based services. As stated in 
1186 
the inclusion criteria, couples will be excluded if they report a history of severe intimate partner violence 
1187 
in the past three months. The 2014 Kenya Demographic and Health Survey found a lifetime prevalence 
1188 
for spousal violence (physical, sexual, or emotional) of 47% of women of reproductive age, and 33% for 
1189 
the past year.[179] We do not wish to exclude a lifetime experience of domestic violence from our 
1190 
sample, as that would potentially exclude those women most at risk for HIV. By screening out recent 
1191 
episodes (past three months) of intimate partner violence, we aim to have a sample that balances 
1192 
potential benefit with relatively low risk from a couples-based intervention. In our prior studies, we have 
1193 
had very few instances where couples presenting for our couples-focused studies reported any history 
1194 
of domestic violence with their current/study partner. In our prior RCT with couples in South Africa, less 
1195 
than 5 couples were excluded for reporting severe violence. In the R34 pilot study in Kenya, 10 women 
1196 
were excluded from the randomized part of the study at baseline using the same criteria (and their 
1197 
partners were not subsequently contacted for study participation).  
1198 
 
1199 
Studies of voluntary counseling and testing (VCT) in sub-Saharan Africa have not found significant 
1200 
differences in adverse events when comparing women who participated with their partner compared to 
1201 
women who participated alone. A study in Zambia found that women participating in antenatal couple 
1202 
counseling did not experience more adverse social events associated with HIV disclosure 
1203 
(separation/divorce, forced to leave the home, violence) than women counseled alone.[180] In a 
1204 
randomized study in Tanzania, HIV-positive women in the couples voluntary testing and counseling arm 
1205 
had lower levels of marital dissolution and violence after testing than HIV-positive women in the 
1206 
individual counseling and testing arm.[84]Never-the-less, due to the potential risks of HIV status 
1207 
disclosure it is clear that home-based strategies need to be carefully designed. 
1208 
 
1209 
Although we have not had problems in the past in our studies with couples in Nyanza, Kenya with 
1210 
participants reporting being there under coercion, staff members will be trained to be sensitive to the 
1211 
possibility that one member of the couple was pressured or coerced by the other partner to participate 
1212 

 
 
 
 
27 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
in the study. Questions may be posed such as “Did you come here freely?” or “Will something bad 
1213 
happen to you if you say no?”Should the staff member have this suspicion, s/he will be trained to 
1214 
immediately terminate the survey or session and provide the participant with appropriate referrals and 
1215 
the study incentive. Any data collected will be destroyed. The staff member will also be trained to offer 
1216 
the participant the opportunity to remain in the interview room for the appropriate amount of time that it 
1217 
would have taken to complete the survey or interview so that the study partner would not be alerted to 
1218 
the fact that the interview was terminated. If necessary, back-up staff members who are clinicians can 
1219 
be contacted to assess the appropriate immediate steps, should intervention be needed.  
1220 
 
1221 
Should evidence of coercion arise in a couples’ counseling session, the counselor will provide the 
1222 
appropriate clinical intervention regarding participation of the couple and provide community referrals. 
1223 
Should a participant specifically request an intimate partner violence referral, the staff member will 
1224 
immediately terminate the interview, provide the participant with the study incentive, offer to let the 
1225 
participant remain in the interview room for the approximate time of completion, and assist the 
1226 
participant in contacting an appropriate service agency. In addition, our resource list given to all 
1227 
participants will include intimate partner violence programs, clinicians, and support groups specializing 
1228 
in relationship abuse and violence. 
1229 
Risks associated with HIVST kit distribution:  Our study will use procedures developed and utilized by 
1230 
co-investigators Thirumurthy and Agot to minimize probability of violence associated with participants’ 
1231 
offering HIV testing to male partners and to minimize probability of adverse reactions to test results and 
1232 
ensuring receipt of appropriate services. To minimize the likelihood of violence against study 
1233 
participants, participants will be encouraged to distribute a test kit to their male partner or to use both 
1234 
test kits to undertake couples testing if they feel comfortable doing so; they will also be counseled 
1235 
on how to talk to their partners about HIV testing, the possibility of adverse reactions associated with 
1236 
suggesting HIV testing, learning their partner’s HIV status, and disclosing their own HIV status. 
1237 
Study staff will be trained to talk to female participants at the time of enrollment about the importance of 
1238 
using their discretion and assessing the risk of IPV when deciding whether to introduce self-tests to 
1239 
their male partners. It will be emphasized to study participants that they are not obligated to distribute 
1240 
self-tests to their male partners. Participants will be counseled to never offer a self-test to someone who 
1241 
they will believe will become violent due to the introduction. Following Kenya’s 2015 HIV testing 
1242 
services guidelines, participants will be informed about the need to seek clinic-based confirmatory 
1243 
testing if a reactive self-test result is obtained, and an invitation for confirmatory testing at a clinic 
1244 
will be included with each test. Information will also be provided on clinics in the area where free HIV 
1245 
care and treatment is available. Additionally, we will inform study participants on where they can seek 
1246 
help if experience mental distress, experience violence, or need other counseling or advice. The 
1247 
proposed study will utilize the training materials for study staff that were implemented during Drs. 
1248 
Thirumurthy and Agot’s studies on HIV self-testing with pregnant/postpartum women in this part of 
1249 
Kenya. Additionally, in our home-based couple visit pilot study, we set up intensive procedures and 
1250 
referral systems for participants experiencing IPV and mental distress. 
1251 
 
1252 
Risks related to couple home visits:  Home visits for those randomized to the home-based couples 
1253 
intervention arm of the study will be conducted in a manner such that we uphold the highest standards 
1254 
of confidentiality and prevent unwanted disclosure of HIV status in the community and the family. Prior 
1255 
to starting this phase of the study, community announcements will be made through the community 
1256 
partners, stating that the health facility will be starting home visits for pregnant women and male 
1257 
partners to support maternal and child health. Lay health workers conducting home visits will use 
1258 
unmarked vehicles and will not wear any garments that identify them as working on HIV/AIDS. When 
1259 
visiting the household, the lay health workers will request to speak to the couple alone in a private room 
1260 
in the household, or at a nearby location in the community, and will not begin the study explanations 
1261 
and informed consent process for the man until they have obtained this privacy. In each community, we 
1262 
will identify a location for couple sessions that participants may choose if privacy cannot be maintained 
1263 
in the home (such as the home of the local community health worker). The lay health worker will offer 
1264 
HIV counseling and testing to the couple together, as if the woman had not already tested for HIV at the 
1265 
ANC clinic. Our experiences with couple/family HIV counseling and testing in Uganda and South Africa 
1266 

 
 
 
 
28 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
reveal that most “index clients” (persons who initially tested HIV-positive in the clinic) prefer this 
1267 
approach. 
1268 
 
1269 
Risks associated with testing for HIV: Engaging in voluntary counseling and testing for HIV, CHTC, will 
1270 
have a separate informed consent process, which will detail the potential risks, procedures involved, 
1271 
and any benefits. The risks associated with testing could include pain or complications from the finger 
1272 
prick in order to obtain serum for the rapid test. Testing will be conducted by trained HIV counselors, 
1273 
who are trained in phlebotomy and GCP in order to minimize the likelihood of any complications. There 
1274 
is a risk that participants could learn that they or their partner are HIV-positive. The testing counselors 
1275 
will be trained in all aspects of aiding participants through the testing process to alleviate as much 
1276 
distress as possible and to help them come to terms with this information. Additional referrals for 
1277 
couples’ counseling, services for HIV care and treatment, and other relevant services will also be 
1278 
provided as part of the intervention.  
1279 
 
1280 
Potential benefits of the proposed research to the subjects and others: 
1281 
There are no direct benefits to the study participants. However, they may learn information regarding 
1282 
HIV treatment and prevention, pregnancy, and infant health, and may learn skills for communicating 
1283 
better with their partner, and potentially reduce their risk for HIV. The larger public health community 
1284 
could benefit if the intervention demonstrates efficacy, as improving rates of treatment and reducing 
1285 
levels of HIV viral load in individuals can potentially lower the burden of HIV in the community. There 
1286 
could be benefits to the mother and child with regard to increased likelihood of health care facility 
1287 
delivery, preventive healthcare utilization, and/or ART treatment for the pregnant women. While there 
1288 
are some risks to participating in the study, based on prior experience, we feel that the likelihood of 
1289 
participants experiencing negative events due to participation is low. It is our aim that participation in 
1290 
the intervention could serve to improve treatment and prevention for HIV, including the reduction of viral 
1291 
load levels, and possibly learn skills to improve relationships with one’s partner. The risk to individual 
1292 
participants is small, and the potential to provide information that could benefit the target population 
1293 
outweighs the risk.  
1294 
Reimbursement of participants: Each participant will be reimbursed for each assessment visit 
1295 
(questionnaires), but not for brief phone assessments and intervention activities. Each participant will 
1296 
receive approximately 500Kenyan Shillings (roughly 5 US dollars) per assessment. This reimbursement 
1297 
is in accordance with other studies being conducted through KEMRI, and will be approved by the local 
1298 
Kenyan IRB. Reimbursements will be paid in cash following the completion of each visit. Participants in 
1299 
the home visit study arm will also receive a small gift (such as a bar of soap or a bag of sugar) of 
1300 
approximately 200 KSh value ($2.66 US) at each home visit, which is a cultural expectation for persons 
1301 
visiting the home of pregnant/postpartum couples. 
1302 
 
1303 
Participants in the in-depth qualitative interviews will be reimbursed 500 Kenyan Shillings (KSh) for their 
1304 
transportation expenses related to participation in the interview, which is equivalent to around $5 US 
1305 
dollars, which is approximately the cost of round-trip minibus fare from a long-range location. 
1306 
 
1307 
 
1308 
EXPECTED APPLICATION OF RESULTS 
1309 
This study could improve our ability to improve HIV prevention behaviors, identification of pregnant 
1310 
women and male partners infected with HIV, treatment engagement, and reduce viral load for pregnant 
1311 
women and their male partners, thereby reducing the likelihood of vertical and horizontal HIV 
1312 
transmission, among couples in western Kenya, a population at high risk for HIV. Most HIV infections in 
1313 
sub-Saharan Africa are occurring within primary partnerships.2 Intervening with couples also increases 
1314 
the participation of men in HIV prevention activities, which have previously focused on women, and 
1315 
could contribute to a shift in community norms regarding gender and couple relations. The ability to 
1316 
reduce the likelihood of transmission with partnerships, as well as mother-to-child transmission of HIV, 
1317 
has the potential for high public health impact. Thus, through this study, we will gain evidence of the 
1318 
comparative effectiveness of these three different approaches to engaging couples on health 
1319 
behaviors and outcomes. Following completion of the study, we will be able to present to the 
1320 

 
 
 
 
29 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
Kenyan MOH and partners, for potential expansion of effective strategies to more sites across the 
1321 
country.  If found to be effective, these strategies can also be adapted to other similar settings in 
1322 
sub-Saharan Africa, with important potential benefits for maternal, paternal, and infant health. 
1323 
 
1324 
LIMITATIONS  
1325 
In the case that we are not able to recruit enough couples in a timely manner, due to decreasing HIV 
1326 
prevalence in the study counties or other factors, we have the ability to add additional study sites 
1327 
due to our strong relationships with Ministry of Health County teams (see Letters of Support). 
1328 
Contamination across study arms due to availability of HIV self-test kits in the study communities 
1329 
may also be a challenge. However HIV self-test kits are not widely available or accessible, and we 
1330 
will assess use of HIV self-test kits in all three arms and account for this in analyses. There are 
1331 
potential risks of couple conflict related to HIV testing and disclosure. We have demonstrated that 
1332 
we can mitigate these risks through careful training of lay counselors in the home visit arm, special 
1333 
counseling for women in the HIV self-test kit arm, and a free number to text study staff (see Human 
1334 
Subjects section).  Neither the R34 pilot in Kenya (PI: Turan), nor the couple R01 in South Africa (PI: 
1335 
Darbes) found any increased couple conflict or violence related to the couple interventions.  
1336 
 
 
1337 

 
 
 
 
30 
Jamii Bora Study protocol: version: 9.0; Date:  February 14, 2022   
 
1338 
REFERENCES 
1339 
 
1340 
1. 
Bispo, S., et al., Postnatal HIV transmission in breastfed infants of HIV-infected women on ART: a 
1341 
systematic review and meta-analysis. Journal of the International AIDS Society, 2017. 20(1): p. 1-8. 
1342 
2. 
Chikhungu, L., et al., HIV-free survival at 12-24 months in breastfed infants of HIV-infected women on 
1343 
antiretroviral treatment. Tropical Medicine and International Health, 2016. 21(7): p. 820-828. 
1344 
3. 
Ashiono, E., et al., Vertical HIV transmission in perinatally-exposed infants in South-Rift region of 
1345 
Kenya: a retrospective cross sectional study. BMC Public Health, 2017. 17(207). 
1346 
4. 
Sirengo, M., et al., Mother-to-child transmission of HIV in Kenya: results from a nationally 
1347 
representative study. Journal of Acquired Immune Deficiency Syndrome, 2014. 66(Suppl 1): p. S66-S74. 
1348 
5. 
UNAIDS, Kenya AIDS Response Progress Report. Available at:  
1349 
http://www.unaids.org/sites/default/files/country/documents/KEN_narrative_report_2014.pdf, 2014. 
1350 
Accessed April 1, 2017. 
1351 
6. 
WHO, UNAIDS, and UNICEF, Global HIV/AIDS response: epidemic update and health sector progress 
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1755 

Jamii Bora R01; Woman informed consent form; Version 4.0  20 April, 2019
Page 1 of 5
ENROLLMENT INFORMED CONSENT TO BE A RESEARCH PARTICIPANT 
(Pregnant women)
Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Conducted by the Kenya Medical Research Institute, the University of Alabama at Birmingham
(USA), the University of Michigan (USA), University of Pennsylvania (USA), and University of the 
Witwatersrand (South Africa).
Name
Institution
Contact
Janet M. Turan
University of Alabama at Birmingham (UAB)
000-1-205-934-6780
Zachary Kwena
Kenya Medical Research Institute (KEMRI)
0733 333 005
Elizabeth Bukusi
Kenya Medical Research Institute (KEMRI)
0733 617 503
Lynae Darbes
University of Michigan (UM)
000-1-734-763-7265
Thomas Braun
University of Michigan (UM)
000-1-734-936-9844
Abigail Hatcher
University of the Witwatersrand, South Africa
000-27-84-406-7773
Harsha Thirumurthy University of Pennsylvania (UPenn)
001-1-215-898-7136
Maria Pisu
University of Alabama at Birmingham (UAB)
000-1205-972-7366
24-hour Emergency contact number 0718441874
I would like to tell you about a study being conducted by researchers from the Kenya Medical 
Research Institute (KEMRI), the University of Alabama at Birmingham (UAB), the University of 
Michigan (UM), and the University of Pennsylvania (UPenn) in the United States, and the 
University of the Witwatersrand in South Africa. The study is funded by the United States 
National Institutes of Health. The purpose of this consent form is to give you the information 
you will need to help you decide whether to be in this study or not.  You may ask questions 
about the purpose of the research, what happens if you participate in the research, the 
possible risks and benefits, your rights as a volunteer, and anything else about the research or 
this form that is not clear. 
When we have answered all your questions, you can decide if you want to be in the study or 
not. This process is called „informed consent.‟ We will give you a copy of this form to take 
home if you wish to.  If you do not wish to take a copy, we will keep your copy in a locked 
cabinet in the research office.
Why is this study being done?
We are learning how to promote family health. We are trying three ways. The first way is 
healthcare workers teach women and their husbands about family health topics during a home 
visit. Two health workers talk about HIV testing during pregnancy. The second way is women 
and their husbands get HIV self-test kits. They can choose to use the self-test kits to test on 
their own. The last way is normal health care at the clinic around the time of pregnancy. 
Why are you being asked to take part?
You are being asked to take part in this study because you said that you would like to learn 
about participating in a study together with your husband. I am speaking with you because you 
come to antenatal care at one of the clinics where the study is being conducted. We are inviting 
women who are pregnant and are interested. You and your husband may benefit from 

Jamii Bora R01; Woman informed consent form; Version 4.0  20 April, 2019
Page 2 of 5
  
participating in this study if you decide to take part.
How many people will take part in the study?
A total of around 1080 pregnant women like you will be asked to take part in the study. If your 
husband and you both agree, you will be assigned to one of three groups. We will draw from 
an envelope (like a lottery) and you will be able to: 1) get home visits with your husband from 
two health workers, 2) get multiple oral fluid-based HIV self-testing kits for you and your 
husband to use if you choose, or 3) go to normal ANC services at the clinic by yourself or with 
your husband. Anyone in group 1 2 or 3 can get normal services at the clinic. The group you 
will be in with your husband will be decided randomly, like a lottery.
What will happen if I take part in this study?
If you agree to take part in the study, the following things will happen:

Once you agree to participate in the study, we will ask you to sign this form to show that you 
understand and agree to participate.

We will ask you questions in a survey that takes about an hour. 

We will contact your husband by phone to find a time to give him information about the 
study, sign a form, and answer questions that take about an hour.

We will ask you and your husband to come together to the clinic or for us to visit your house 
or other convenient location, so that you can find out which group you are in. 

If you are in the home visit group, we will ask locator information (including cell phone 
contacts) for you and your husband and ask about good times visit you at home.  You will 
receive up to 5 home visits from a pair of counselors during pregnancy and after the birth.

If you are in the HIV self-testing group, when you come to the ANC clinic we will give 
you self-test kits and show you how to use the tests if you want to use them. With self-
testing, individuals collect their own sample and perform an HIV test in the absence of 
a care provider by swabbing inside of their mouths. You will be given two self-test kits 
to take home to distribute to your husband or use yourself.  The staff will explain how 
these tests are to be used so that you can use the tests correctly later or that you can 
explain how to use the tests when giving them to other people. Even though the self-
tests are highly accurate, it is important to have HIV-positive test results confirmed at a 
clinic where HIV testing services are available. Each self-test kit will include a referral 
voucher for clinic-based confirmatory testing in case an HIV-positive result is obtained. 
Each self-test kit will include instructions on how to perform the test and a phone 
number to call in case you or another user has questions. You will receive additional 
self-test kits during the study.

Participants in all three groups can continue to come to clinic like normal.
We will ask both you and your husband to answer questions at a few more clinic or home 
visits: before baby’s birth, when the baby is 3 months old, 12 months old, and 18 months 
old. Also, we will ask both you and your husband a few questions by phone during late 
pregnancy, when the baby is 6 months old, and when the baby is 18 months old.  
How long will I be in the study?
If you agree to participate, you will remain in the study until your baby is 18 months old, which 
will be about two years from now, depending on your stage of pregnancy today.
Can I stop being in the study?
Yes.  You can decide to stop at any time. Just tell the study researcher or staff person right 
away if you wish to stop being in the study. Also, the study researcher may stop you from 
taking part in this study at any time if he or she believes it is in your best interest, if you do not 
follow the study rules, or if the study is stopped.

Jamii Bora R01; Woman informed consent form; Version 4.0  20 April, 2019
Page 3 of 5
  
What side effects or risks can I expect from being in the study?

Study researchers will ask sensitive questions about sexual behavior and HIV testing and 
will be trained not to share the information with anyone.

Some of the questions may make you feel uncomfortable or upset, so if you do not wish to 
answer a question you can skip. You can ask to take a break or stop the interview at any 
time.

Some people may experience bleeding from the gums when using the oral swab used in 
the HIV self-test kit; this risk is similar to that when brushing your teeth. You or your 
husband may also test HIV-positive during the study. Knowing your status or the status of 
your husband may make you feel worried. If you test HIV-positive using an HIV self-test, 
we encourage you to seek confirmation of the result at a health facility. If clinic-based HIV 
tests indicate you or one of your sexual partners is HIV-positive, you or he will receive 
counseling at the facility on how to cope with an HIV-positive result and also be linked to 
appropriate care.

Sometimes, discussions with  your husband about HIV or sensitive topics can cause 
arguments or disagreements. We will never share information you tell us with your 
husband. We are here to offer referrals if you or your husband responds badly or is upset 
by the study.
Are there benefits to taking part in this part of the study?
You and your husband may benefit from home or clinic visits, or HIV self-testing during this 
study. You may learn about being a parent to your new baby. Your answers to study questions 
will help us learn more about better ways to help pregnant women and men with family health. 
If you decide to go through Couples HIV Counseling and Testing (CHCT) together with your 
husband it may improve your relationship or your health.
What other choices do I have if I do not take part in this part of the study?
You can choose to take part in any part of the study or to skip any part of the study. You can 
choose to stop the study at any time. If you decide not to take part in this study, you will still 
receive clinic services like normal.
Will information about me be kept private?
We will do our best to make sure that the personal information gathered for this study is kept 
private. Our team is trained to only talk about the study with other study researchers. However, 
we cannot guarantee total privacy. Your personal information may be given out to university 
review boards or others who are responsible for the laws and ethics of good research. This may 
include people at the United States National Institute of Health (NIH) and the Office for Human 
Research Protections. The information you provide will be entered into a tablet computer but 
WITHOUT your name or other identifying information on you. Your name and locator 
information will be kept in a locked cabinet. The answers you share will be looked at by the 
team conducting this study and will be analyzed and published for scientific purposes without 
naming you or any other participant.
What are the costs of taking part in this part of the study?
There will be no costs to you as a result of taking part in this study.
Will I be paid for taking part in this part of the study?
You will be reimbursed in the amount of 500 KSh for your time or travel expenses each time 

Jamii Bora R01; Woman informed consent form; Version 4.0  20 April, 2019
Page 4 of 5
  
you answer questions for this study in person at the clinic or your home lasting about one hour 
(once during pregnancy, and two times after baby’s birth). Similar to yourself, your husband 
will also be reimbursed in the amount of 500 KSh after answering questions in person in this 
manner. If you are in the home visit group of the study, your family will also receive a small gift 
for each couple home visit that you complete. When answering baseline questions for this 
study at the clinic, you will be offered a packet of milk during the interview of which you are 
free to decline or accept.  We have observed in the past that after a long days antenatal clinic 
process, pregnant women are tired and hungry hence they find it difficult to concentrate during 
the baseline interviews. You will not receive reimbursement for brief questions that we will ask 
you and your husband by phone during late pregnancy, when the baby is 6 months old, and 
when the baby is 18 months old.  
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose to take part or not to take part in this 
study.  If you decide to take part in this study, you may leave the study at any time. No matter 
what decision you make, there will be no penalty to you in any way.  You will still get the same 
medical treatment and can access all health services offered at your clinic.
Who can answer my questions about the study?
If you have any questions or concerns about participating, please call our study staff at
0718441874.  You may also contact any of the investigators listed above. If you have 
questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact Secretary of the Ethical Review Committee, Kenya Medical 
Research Institute at Tel. 020-2722541.  You may also contact the UAB Office of the IRB 
(OIRB) in the United States at by email at IRB@uab.edu or by mail at 701 20th Street South, 
Birmingham, Alabama, 35294-0104, USA; or the University of Michigan Health Sciences and 
Behavioral Sciences Institutional Review Board by email at irbhsbs@umich.edu or by mail at 
2800 Plymouth Rd., Building 520, Room 1170, Ann Arbor, Michigan, 48109-2800, USA. You 
may contact these offices in the event the research staff cannot be reached or you wish to 
communicate with someone else. These committees are concerned with the protection of 
volunteers in research projects.
CONSENT
You will be given a copy of this consent form to keep. If you do not wish to take a copy, we 
will keep your copy in a locked cabinet in the research office.
PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to be in this 
part of the study, or to withdraw from it at any point without penalty or loss of benefits to which 
you are otherwise entitled. You are not waiving any of your legal rights by signing this 
informed consent document.
Participant’s Statement
This study described above has been explained to me. I volunteer to take part in this part of the 
research. I have had a chance to ask questions. If I have future questions about the research, I 
can ask one of the investigators listed above.  If I have questions about my rights as a research 
participant, I can contact those listed above.
If you wish to participate in this study, you should sign below.
Do you provide consent to participate in this study?

Jamii Bora R01; Woman informed consent form; Version 4.0  20 April, 2019
Page 5 of 5
  
Yes  No
DATE CONSENT OBTAINED  
GIVEN BY: 
NAME OF PARTICIPANT
SIGNATURE OF PARTICIPANT
BY:
 
NAME OF PERSON OBTAINING CONSENT
SIGNATURE OF 
PERSON OBTAINING CONSENT
WITNESS SIGNATURE (IF NEEDED):
NAME OF WITNESS
SIGNATURE OF WITNESS
If illiterate
I have witnessed the accurate reading of the consent form to the participant and the 
individual has had the opportunity to ask questions. I confirm that the individual has given 
consent freely.
Name of witness 
 AND   Thumbprint of participant
Signature of witness  
Date  
 Day/month/year
BY:
NAME OF STAFF MEMBER                  SIGNATURE OF STAFF MEMBER

Jamii Bora R01; Man informed consent form; Version 3.0 November 7, 2018
Page 1 of 5
ENROLLMENT INFORMED CONSENT TO BE A RESEARCH PARTICIPANT 
(Male partners)
Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Conducted by the Kenya Medical Research Institute, the University of Alabama at Birmingham
(USA), the University of Michigan (USA), University of Pennsylvania (USA), and University of the 
Witwatersrand (South Africa).
Name
Institution
Contact
Janet M. Turan
University of Alabama at Birmingham (UAB)
000-1-205-934-6780
Zachary Kwena
Kenya Medical Research Institute (KEMRI)
0733 333 005
Elizabeth Bukusi
Kenya Medical Research Institute (KEMRI)
0733 617 503
Lynae Darbes
University of Michigan (UM)
000-1-734-763-7265
Thomas Braun
University of Michigan (UM)
000-1-734-936-9844
Abigail Hatcher
University of the Witwatersrand, South Africa
000-27-84-406-7773
Harsha Thirumurthy University of Pennsylvania (UPenn)
001-1-215-898-7136
24-hour Emergency contact number 0718441874
I would like to tell you about a study being conducted by researchers from the Kenya Medical 
Research Institute (KEMRI), the University of Alabama at Birmingham (UAB), the University of 
Michigan (UM), and the University of Pennsylvania (UPenn) in the United States, and the 
University of the Witwatersrand in South Africa. The study is funded by the United States 
National Institutes of Health. The purpose of this consent form is to give you the information 
you will need to help you decide whether to be in this study or not.  You may ask questions 
about the purpose of the research, what happens if you participate in the research, the 
possible risks and benefits, your rights as a volunteer, and anything else about the research or 
this form that is not clear. 
When we have answered all your questions, you can decide if you want to be in the study or 
not. This process is called „informed consent.‟ We will give you a copy of this form to take 
home if you wish to.  If you do not wish to take a copy, we will keep your copy in a locked 
cabinet in the research office.
Why is this study being done?
We are learning how to promote family health. We are trying three ways. The first way is 
healthcare workers teach women and their husbands about family health topics during a home 
visit. Two health workers talk about HIV testing during pregnancy. The second way is women 
and their husbands get HIV self-test kits. They can choose to use the self-test kits to test on 
their own. The last way is normal health care at the clinic around the time of pregnancy. 
Why are you being asked to take part?
You are being asked to take part in this study because you said that you would like to learn 
about participating in a study together with your pregnant wife. I am speaking with you because 
your pregnant wife comes to antenatal care at one of the clinics where the study is being 
conducted. We are inviting women who are pregnant and their husbands. You and your wife 

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Page 1 of 3
HIV TEST INFORMED CONSENT FORM
Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Conducted by the Kenya Medical Research Institute, the University of Alabama at Birmingham
(USA), the University of Michigan (USA), University of Pennsylvania (USA), and University of the 
Witwatersrand (South Africa).
Name
Institution
Contact
Janet M. Turan
University of Alabama at Birmingham (UAB)
000-1-205-934-6780
Zachary Kwena
Kenya Medical Research Institute (KEMRI)
0733 333 005
Elizabeth Bukusi
Kenya Medical Research Institute (KEMRI)
0733 617 503
Lynae Darbes
University of Michigan (UM)
000-1-734-763-7265
Thomas Braun
University of Michigan (UM)
000-1-734-936-9844
Abigail Hatcher
University of the Witwatersrand, South Africa
000-27-84-406-7773
Meredith Kilgore
University of Alabama at Birmingham (UAB)
000-1-205-975-8840
Harsha Thirumurthy University of Pennsylvania (UPenn)
001-1-215-898-7136
24-hour Emergency contact number: 718441874
Introduction
A  virus  called  HIV  (Human  Immunodeficiency  Virus)  causes the  disease  AIDS 
(Acquired Immunodeficiency Syndrome).  Anyone with HIV can spread it to others.  It is 
spread through unsafe sex, sharing needles, or donating blood or other tissues.  Infected 
mothers can spread HIV to their babies.  The test for HIV detects the body's reaction to the 
virus (antibody).  It does not detect the virus itself.  The decision to be tested for antibody to 
the virus that causes AIDS is voluntary; you are not required to have the test.  This test is 
being done for a research study.
You should know the advantages and disadvantages of testing before you decide to take the 
test.  Please read this consent form with care so that you can make an informed choice 
about having the blood test.
What the test means
If you test POSITIVE, you have the HIV virus.  That means you can pass it to others.  The test 
cannot tell how long a person has been infected.  It does not mean that you have AIDS, which is 
the most advanced stage of HIV infection.
If the test is NEGATIVE you probably do not have the HIV virus.  It may mean that you have the 
virus, but your body has not yet made antibody to fight the virus.  It could take up to six months 
after infection for the test to turn positive.  False results are rare.  Unclear results are also rare. 
When a test result does not seem to make sense, we do the test again.  We might do another 
kind of blood test to find out if you are infected or not.
Procedures
This is what will happen if you decide to have the test.  First, you will meet with a 
counselor. The counselor will give you more information about the risks and benefits of the 
test.  They will explain the meaning of test results.  They will teach you how to reduce the 

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chance of spreading HIV.  They will explain the dangers of HIV infection.  A finger prick blood 
will be obtained for the antibody test.  We will test your blood for HIV at the study clinic and 
later in the laboratory in case of invalid results.   For participants with invalid HIV results at 
study clinic, we will make every effort to locate you and give you the definite results. When 
you learn the test results, you will also be counseled to increase your understanding of HIV 
transmission and how to reduce your risks of getting or transmitting sexually transmitted 
diseases by being faithful to one uninfected partner, abstaining from sex if you are 
diagnosed with a sexually transmitted disease while on treatment, and using a condom 
consistently and correctly each time you have sex. You will also be counseled about how to 
notify your sexual partners if your test result is positive
Benefits of being tested
The benefits of being tested are very personal.  If you are worried about AIDS, you might feel 
better if you have a negative test.   Sometimes knowing that the test is positive can relieve 
stress.  You may want to know your test result before you have sex with a partner.  In some 
cases, test results may help diagnose a medical problem or help you make decisions about your 
future or on health care. Those who test positive for HIV will be referred to HIV care clinics for 
further management.  There may be other benefits of testing that we don't know about now.
Risks of being tested
Learning test results may cause you and your partner severe stress, anxiety and depression. 
This may result into blaming each other and even cause separation or divorce. Other people
learning about your HIV status may lead to discrimination in travel, work and insurance. You 
might be tempted to have unsafe sex if the result is negative.  This would increase your risk of
getting AIDS.  If the results of the test get into the wrong hands, prejudice, discrimination, risk to 
employment, travel restrictions, and other adverse effects could result.   There may be other
risks and stresses of being tested that we don't know about now.
You may get a bruise where the needle enters the vein and there is a small risk of infection. You 
may feel some pain as the needle enters your vein.
Information about confidentiality
Your HIV antibody test results will be held in the strictest confidence, and no identifying 
information of any kind will be released to any other person or agency without your specific 
permission in writing. We will not publish or discuss in public anything that could identify you.
Do you have any questions?  Do you agree to participate?
Name of researcher
Signature
Date
Participant’s Statement
I have read this form/this for has been read and explained to me.  I volunteer to take part in 
this research.  I have had a chance to ask questions.  If I have future questions about the 
research, I can ask one of the investigators listed above.  If I have questions about my rights 
as a research subject, I can contact: The Secretary, KEMRI Ethics Review Committee, 
P.O. Box 54840-00200, Nairobi; Telephone numbers: 020-2722541, 0722-205901, 0733-
400003; Email address: ERCadmin@kemri.org.

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Printed name of participant
Signature/thump print
Date
Time
Printed name of witness
Signature of witness
Date
Time
Copies to: Investigator’s files, study participant

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may benefit from participating in this study if you decide to take part.
How many people will take part in the study?
A total of around 1080 couples (pregnant women and their husbands) like you will be asked to 
take part in the study. If your wife and you both agree, you will be assigned to one of three 
groups. We will draw from an envelope (like a lottery) and you will be able to: 1) get home 
visits with your wife from two health workers, 2) get multiple oral fluid-based HIV self-testing 
kits for you and your wife to use if you choose, or 3) your wife will go to normal ANC services 
at the clinic by herself or with you. Anyone in group 1 2 or 3 can get normal services at the 
clinic. The group you will be in with your wife will be decided randomly, like a lottery.
What will happen if I take part in this study?
If you agree to take part in the study, the following things will happen:

Once you agree to participate in the study, we will ask you to sign this form to show that you 
understand and agree to participate.

We will ask you questions in a survey that takes about an hour. 

We will ask you and your wife to come together to the clinic or for us to visit your house or 
other convenient location, so that you can find out which group you are in. 

If you are in the home visit group, we will ask locator information (including cell phone 
contacts) for you and your female partner and ask about good times visit you at home.  You 
will receive up to 5 home visits from a pair of counselors during pregnancy and after the 
birth.

If you are in the HIV self-testing group, when your wife comes to the ANC clinic we will 
give her self-test kits and show her how to use the tests if she wants to use them. With 
self-testing, individuals collect their own sample and perform an HIV test in the 
absence of a care provider by swabbing inside of their mouths. She will be given two 
self-test kits to take home to distribute to you or use herself. The staff will explain how 
these tests are to be used so that she can use the tests correctly later or so that she 
can explain how to use the tests when giving them to other people. Even though the 
self-tests are highly accurate, it is important to have HIV-positive test results confirmed 
at a clinic where HIV testing services are available. Each self-test kit will include a 
referral voucher for clinic-based confirmatory testing in case an HIV-positive result is 
obtained. Each self-test kit will include instructions on how to perform the test and a 
phone number to call in case you or another user has questions. Your wife will receive 
additional self-test kits from the ANC clinic during the study.

Participants in all three groups can continue to come to clinic like normal.
We will ask both you and your wife to answer questions at a few more clinic or home 
visits: before baby’s birth, when the baby is 3 months old, 12 months old, and 18 months 
old. Also, we will ask both you and your wife a few questions by phone during late 
pregnancy, when the baby is 6 months old, and when the baby is 18 months old.  
How long will I be in the study?
If you agree to participate, you will remain in the study until your baby is 18 months old, which 
will be about two years from now, depending on your wife’s stage of pregnancy today.
Can I stop being in the study?
Yes.  You can decide to stop at any time. Just tell the study researcher or staff person right 
away if you wish to stop being in the study. Also, the study researcher may stop you from 
taking part in this study at any time if he or she believes it is in your best interest, if you do not 
follow the study rules, or if the study is stopped.

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What side effects or risks can I expect from being in the study?

Study researchers will ask sensitive questions about sexual behavior and HIV testing and
will be trained not to share the information with anyone.

Some of the questions may make you feel uncomfortable or upset, so if you do not wish to
answer a question you can skip. You can ask to take a break or stop the interview at any
time.

Some people may experience bleeding from the gums when using the oral swab used in
the HIV self-test kit; this risk is similar to that when brushing your teeth. You or wife may
also test HIV-positive during the study. Knowing your status or the status of your wife may
make you feel worried. If you test HIV-positive using an HIV self-test, we encourage you to
seek confirmation of the result at a health facility. If clinic-based HIV tests indicate you or
one of your sexual partners is HIV-positive, you or he will receive counseling at the facility
on how to cope with an HIV-positive result and also be linked to appropriate care.

Sometimes, discussions with your wife about HIV or sensitive topics can cause arguments
or disagreements. We will never share information you tell us with your partner. We are
here to offer referrals if you or your wife responds badly or is upset by the study.
Are there benefits to taking part in this part of the study?
You and your wife may benefit from home or clinic visits, or HIV self-testing during this study. 
You may learn about being a parent to your new baby. Your answers to study questions will 
help us learn more about better ways to help pregnant women and men with family health. If 
you decide to go through Couples HIV Counseling and Testing (CHCT) together with your wife 
it may improve your relationship or your health.
What other choices do I have if I do not take part in this part of the study?
You can choose to take part in any part of the study or to skip any part of the study. You can 
choose to stop the study at any time. If you decide not to take part in this study, you will still 
receive clinic services like normal.
Will information about me be kept private?
We will do our best to make sure that the personal information gathered for this study is kept 
private. Our team is trained to only talk about the study with other study researchers. However, 
we cannot guarantee total privacy. Your personal information may be given out to university 
review boards or others who are responsible for the laws and ethics of good research. This may 
include people at the United States National Institute of Health (NIH) and the Office for Human 
Research Protections. The information you provide will be entered into a tablet computer but 
WITHOUT your name or other identifying information on you. Your name and locator 
information will be kept in a locked cabinet. The answers you share will be looked at by the 
team conducting this study and will be analyzed and published for scientific purposes without 
naming you or any other participant.
What are the costs of taking part in this part of the study?
There will be no costs to you as a result of taking part in this study.
Will I be paid for taking part in this part of the study?
You will be reimbursed in the amount of 500 KSh for your time or travel expenses each time 
you answer questions for this study in person at the clinic or your home lasting about one hour 
(once during pregnancy, and twice after baby’s birth). Similar to yourself, your wife will also be 
reimbursed in the amount of 500 KSh after answering questions in person in this manner. If 
you are in the home visit group of the study, your family will also receive a small gift for each 

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couple home visit that you complete. You will not receive reimbursement for brief questions 
that we will ask you and your husband by phone during late pregnancy, when the baby is 6 
months old, and when the baby is 18 months old. 
  
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose to take part or not to take part in this 
study.  If you decide to take part in this study, you may leave the study at any time. No matter 
what decision you make, there will be no penalty to you in any way.  You will still get the same 
medical treatment and can access all health services offered at your clinic.
Who can answer my questions about the study?
If you have any questions or concerns about participating, please call our study staff at
0718441874.  You may also contact any of the investigators listed above. If you have 
questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact Secretary of the Ethical Review Committee, Kenya Medical 
Research Institute at Tel. 020-2722541.  You may also contact the UAB Office of the IRB 
(OIRB) in the United States at by email at IRB@uab.edu or by mail at 701 20th Street South, 
Birmingham, Alabama, 35294-0104, USA; or the University of Michigan Health Sciences and 
Behavioral Sciences Institutional Review Board by email at irbhsbs@umich.edu or by mail at 
2800 Plymouth Rd., Building 520, Room 1170, Ann Arbor, Michigan, 48109-2800, USA. You 
may contact these offices in the event the research staff cannot be reached or you wish to 
communicate with someone else. These committees are concerned with the protection of 
volunteers in research projects.
CONSENT
You will be given a copy of this consent form to keep. If you do not wish to take a copy, we 
will keep your copy in a locked cabinet in the research office.
PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to be in this 
part of the study, or to withdraw from it at any point without penalty or loss of benefits to which 
you are otherwise entitled. You are not waiving any of your legal rights by signing this 
informed consent document.
Participant’s Statement
This study described above has been explained to me. I volunteer to take part in this part of the 
research. I have had a chance to ask questions. If I have future questions about the research, I 
can ask one of the investigators listed above.  If I have questions about my rights as a research 
participant, I can contact those listed above.
If you wish to participate in this study, you should sign below.
Do you provide consent to participate in this study?
Yes  No
DATE CONSENT OBTAINED  
GIVEN BY: 
NAME OF PARTICIPANT
SIGNATURE OF PARTICIPANT

Jamii Bora R01; Man informed consent form; Version 3.0 November 7, 2018
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BY:
 
NAME OF PERSON OBTAINING CONSENT
SIGNATURE OF 
PERSON OBTAINING CONSENT
WITNESS SIGNATURE (IF NEEDED):
NAME OF WITNESS
SIGNATURE OF WITNESS
If illiterate
I have witnessed the accurate reading of the consent form to the participant and the 
individual has had the opportunity to ask questions. I confirm that the individual has given 
consent freely.
Name of witness 
 AND   Thumbprint of participant
Signature of witness 
Date 
 Day/month/year
BY:
NAME OF STAFF MEMBER
SIGNATURE OF STAFF MEMBER