Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
Phase: NA
Conditions: Mother to Child Transmission, Pregnancy in Adolescence, Social Stigma, Self Disclosure, HIV
Sponsor: Pacific Institute for Research and Evaluation

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Development of a digital intervention to address stigma among 
pregnant unmarried adolescents living with HIV 
 
 
NCT05383755 
 
 
August 15, 2023 
 

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Study Protocol (Version 1.5, 15th August 2023) 
 
1. TITLE OF THE PROJECT:  
Development of a digital intervention to address stigma among pregnant unmarried adolescents living 
with HIV 
 
2. INVESTIGATORS AND INSTITUTIONAL AFFILIATIONS:  
Principal Investigator (PI) – Dr. Winfred Luseno 
Pacific Institute for Research and Evaluation (PIRE) 
101 Conner Dr., Suite 200 
Chapel Hill, North Carolina 
Postal code: 27514-7038 
United States  
 
Co-Investigator (Co-I) – Dr. Daniel Kwaro 
KEMRI- Centre for Global Health Research 
Busia Road 
P.O. Box 1578, 40100, Kisumu  
 
Co-Investigator (Co-I) – Dr. Adam Gilbertson 
Pacific Institute for Research and Evaluation (PIRE) 
101 Conner Dr., Suite 200 
Chapel Hill, North Carolina 
Postal code: 27514-7038 
United States 
 
Co-Investigator (Co-I) – Dr. Melissa DeRosier 
3-C Institute for Social Development 
4364 S. Alston Ave., Suite 300 
Durham, North Carolina  
Postal code: 27713-2565 
United States 
 
Acronyms and Abbreviations 
ALHIV  
Adolescents living with HIV 
ART 
 
Antiretroviral therapy 
Co-I 
 
Co-investigator 
Co-PI 
 
Co-principal investigator 
COVID-19 
Coronavirus disease 2019 
CV  
 
Curriculum vitae 
DSMP  
Data and Safety Monitoring Plan 
CSQ-8  
8-item Client Satisfaction Questionnaire 
DI  
 
Dyadic interview 
FGD 
 
Focus group discussion 
IDI  
 
Individual in-depth interview 
KEMRI  
Kenya Medical Research Institute 
MCH 
 
Maternal and child health 

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mHealth 
Mobile health 
MTCT  
Mother-to-child transmission 
NASCOP 
National AIDS and STI Control Programme 
NIH 
 
National Institutes of Health (USA) 
PI 
 
Principal investigator 
PIRE  
 
Pacific Institute for Research and Evaluation 
PMTCT  
Prevention of mother-to-child transmission of HIV 
SCT 
 
Social Cognitive Theory 
SMS 
 
Short Message Service (e.g.., text messaging) 
SUS 
 
System Usability Scale 
U.S. 
 
United States 
 
3. ABSTRACT:  
Kenya has high rates of mother-to-child transmission (MTCT) of HIV, large numbers of adolescents living 
with HIV (ALHIV), and elevated adolescent fertility rates. Stigma, undisclosed HIV status, and lack of 
social support may be key barriers to engagement in prevention of MTCT (PMTCT) services. Thus, 
addressing barriers to disclosure and social support may mitigate harmful effects of the intersecting 
stigmas of HIV and pregnancy on health outcomes. Growing evidence highlights the promise of digital 
interventions as important tools for improving HIV outcomes and communication with parents. 
However, digital interventions to address effects of stigma have not been explored among pregnant 
ALHIV. This study’s specific aims are to: (1) Develop and evaluate a digital intervention for pregnant 
unmarried ALHIV aged 15-19 to increase awareness of stigma and its consequences; improve disclosure 
self-efficacy and skills; and facilitate enlistment of family caregivers as social support allies to enhance 
uptake of PMTCT services; and (2) Identify acceptable approaches to increase awareness about stigma 
and enhance skills in communication and provision of social support among family caregivers. We will 
use data from individual interviews with pregnant ALHIV and joint interviews with pregnant 
ALHIV/caregiver dyads to develop initial intervention specifications and mock-ups. We will conduct 
focus groups to obtain feedback on sample materials to develop an intervention prototype. We will then 
conduct a pilot to evaluate the prototype. We will conduct focus groups with caregivers to identify 
acceptable approaches to involve them. Data will be used to finalize content and specifications of the 
digital intervention for pregnant ALHIV and will provide the framework for a future intervention for 
caregivers, which will both be tested in a larger trial. 
 
4. LAY SUMMARY:  
Kenya is one of few countries that has a combination of high rates of mother-to-child transmission 
(MTCT) of HIV, large numbers of adolescents living with HIV (ALHIV), and elevated adolescent fertility 
rates. Kenya’s comprehensive strategy to address MTCT includes HIV testing for all pregnant women, 
lifelong antiretroviral therapy (ART) for all pregnant women living with HIV, and counseling on HIV care, 
symptoms, linkage to treatment and support, and positive living. The strategy promotes at least four 
antenatal care (ANC) visits to obtain the necessary prevention of MTCT (PMTCT) services. 
  
Pregnant ALHIV are less likely than adults to receive PMTCT services, thereby contributing to the high 
MTCT rate. Research among 15-19-year-old Kenyan ALHIV, including some who were pregnant, suggests 
that stigma, undisclosed HIV status, and lack of social support may be key barriers to engagement in HIV 
services, including PMTCT. Moreover, ALHIV often find out that they are HIV-infected and pregnant at 
the same time. Often, these adolescents delay disclosing their pregnancies and HIV status to parents 
due to fear of their reactions, which in turn delays engagement in ANC/PMTCT services. 

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Reducing barriers to disclosure and improving social support may lessen harmful effects of the 
intersecting stigmas of HIV and pregnancy on the health outcomes of pregnant ALHIV. Growing evidence 
highlights the promise smartphone-delivered digital interventions hold for facilitating HIV disclosure, 
improving treatment adherence among youth living with HIV, and preventing HIV and improving 
communication with parents among Kenyan youth. However, digital interventions to address the effects 
of stigma have not been explored among pregnant ALHIV. 
 
We are conducting this study to (1) develop a smartphone-delivered digital intervention for pregnant 
unmarried ALHIV in Kenya and (2) identify acceptable approaches to improve the involvement of their 
caregiving family members. The goal of the digital intervention is to improve stigma awareness, 
disclosure of HIV and pregnancy, and social support to enhance adolescents’ use of PMTCT services. We 
will answer the following questions in the study: (1) What are pregnant unmarried ALHIV’s strategies for 
and experiences with disclosing their HIV and/or pregnancy status to their family caregivers? (2) What 
are pregnant unmarried ALHIV’s strategies for and experiences with enlisting social support from their 
family caregivers? (3) What are pregnant unmarried ALHIV’s experiences and strategies for coping with 
HIV and pregnancy stigma? and (4) What are acceptable approaches to increase awareness about 
stigma and improve skills in communication and provision of social support among family caregivers? 
 
The study will take place in Kisumu and Siaya counties. It will involve about 198 participants who are 
pregnant, unmarried ALHIV (n=110) or caregivers of pregnant ALHIV (n=88). Depending on the study 
activity, we will select adolescents who have disclosed and not disclosed their pregnancy and/or HIV 
status to a caregiver. We will recruit participants from maternal and child health clinics in public health 
facilities in rural and urban sites. We will also use snowball sampling methods to recruit participants. 
Study participation will consist of one of the following activities  (1) answer questions in an individual 
interview, (2) answer questions in a joint interview of a girl or young woman and her caregiver, (3) 
answer questions in a focus group discussion, or (4) test and evaluate a prototype digital intervention.  
 
The risks of participation in the research are that (1) an ALHIV’s HIV and/or pregnancy status could 
accidentally be revealed to family or community members and result in her experiencing stigma, and (2) 
a participant could feel emotional distress while participating in an interview because the topic of HIV 
and pregnancy are personal and sensitive. The benefits are that a participant may experience personal 
satisfaction from communicating with researchers about topics relevant to pregnant girls and young 
women living with HIV and being part of a study that could potentially help people in similar 
circumstances. The study will benefit society in that it will involve end users as partners in the 
development of a culturally-acceptable, feasible and effective digital intervention to lessen the harmful 
effects of stigma and enhance engagement in PMTCT services, thereby promoting the health of a 
vulnerable population of young mothers and their babies. The study will start on 1 February 2022 and 
finish on 31 May, 2023.  
 
5. INTRODUCTION/BACKGROUND:  
The Nyanza region in Kenya is a nexus for adolescent pregnancy and HIV infection. Kenya is among 
countries with the highest adolescent fertility rates (96 per 1,000 women aged 15-19 vs. 44 
worldwide).1-3 At 22% compared to 18% nationally, adolescent pregnancy is highest in Kenya’s Nyanza 
region.4,5 Kenya is also among four sub-Saharan African countries with the highest numbers of ALHIV 
aged 10-19 in the world.6 In 2019, Kenyan females aged 15-24 comprised 110,000 persons living with 
HIV and 10,000 new infections.6 Nyanza accounted for 41% of infected female youth and 46% of new 

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infections among female youth in the nation.6 Nyanza counties most afflicted by HIV are Siaya, Kisumu, 
Migori, and Homa Bay.7   
 
PMTCT engagement is sub-optimal among youth, leading to poor outcomes. Kenya is also among 7 
countries that accounted for half of all new pediatric HIV infections in 2019.6 MTCT incidence in the 
Nyanza counties most afflicted by HIV is 8-12%; they account for 34% of the nation’s gap in PMTCT 
coverage.7 Higher rates of MTCT to infants aged 4-8 weeks have been found among adolescent mothers 
(6.9%) compared to adult mothers (2.4%).8 Other data show that youth are less likely than adults to 
adhere to PMTCT tenets.5,8-13 A Kenya study found 8% of adult vs. 33% of adolescent mothers were not 
using ART, and 2% of adults’ infants vs. 14% of adolescents’ infants were not being given ARTs by their 
parents for PMTCT.10   
 
Stigma has a detrimental effect on outcomes among pregnant adolescents.14 Common fears among 
pregnant unmarried ALHIV include being seen while attending PMTCT clinics and the gossip that would 
follow.15 Uninfected adolescents have also reported feeling stigmatized by their pregnancies, feelings of 
social isolation and loneliness, fear of family reaction, and experiences with derision and shaming meted 
out by ANC providers.16-20 While HIV stigma is associated with a health condition, pregnancy stigma may 
be associated with perceived moral corruption via premarital sex.21,22 Although the convergence of HIV 
and pregnancy-related stigmas may be understood implicitly, a lens of intersectionality has not been 
applied to address their potential combined effects on disclosure, social support, and PMTCT outcomes 
among pregnant ALHIV.21,23 
 
Disclosure and social support improve uptake of PMTCT services. Disclosure of HIV and pregnancy to 
family members increases social support and is important for PMTCT engagement.24 25-28 However, 
adolescents who receive their diagnoses alone may delay disclosure of their HIV status and/or 
pregnancy to family members, and thus do not receive needed support to engage in timely PMTCT 
care.8,15,29 Family members (often a mother, grandmother, sister, or aunt) are a crucial source of support 
for pregnant adolescents.16,29 Unmarried pregnant women are more likely to rely on support from family 
members than from a male partner.30 Research is needed to identify effective strategies to promote and 
facilitate communication between pregnant ALHIV and their caregivers to improve their engagement in 
PMTCT care. 
 
Few interventions exist to address stigma outcomes among pregnant ALHIV.31,32 Only one study in 
South Africa has evaluated an intervention to address stigma among pregnant adult women living with 
HIV.33 The intervention comprised of six group sessions (four antenatal, two postnatal) led by lay health 
workers. Two sessions focused on stigma by addressing communication with partners, HIV status 
disclosure, and ART adherence. While the intervention reduced HIV stigma,33 it did not reduce MTCT or 
increase ART adherence or ART/PMTCT knowledge.34 The limited impacts were attributed to the 
intervention’s focus on individual factors rather than a multilevel approach that involved partners.22,34 
 
Use of mobile health (mHealth) tools improves PMTCT uptake. Among pregnant adult women, SMS 
and phone calls have been found to increase PMTCT outcomes.35-37 SMS approaches have also shown 
promise in lowering pregnancy rates among adolescents.38 Studies show that SMS works well for 
reminders, 39-41 but if used alone they are limited in their ability to facilitate behavior change via support 
mechanisms or skills development.42 Thus, in addition to SMS, other mHealth tools are needed to 
achieve desired outcomes. 
 

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There are no digital interventions to address PMTCT outcomes among pregnant ALHIV. Digital 
interventions include ehealth approaches, which use information and communication technologies for 
health-related purposes, and mhealth approaches, which use mobile devices for health-related 
purposes. They include interventions delivered via SMS, the web, social media, and smartphone apps. 
More recent approaches include gaming principles, interactive elements, simulations, and virtual reality. 
No studies have tested the impact of digital interventions on PMTCT behaviors/outcomes or HIV stigma 
among pregnant ALHIV. However, a growing number of studies highlight the promise of such 
interventions in supporting HIV-status disclosure,43 engagement in care, and adherence to ART.44-46 Most 
studies have been conducted in the U.S. among young men who have sex with men (MSM),43-45,47,48 with 
only one conducted in Kenya that showed preliminary efficacy in reducing HIV risk and improving 
communication with parents among 
adolescents aged 11-14.49,50 While 
youth access to mobile and smart 
phones continues to grow in many 
African countries, including 
Kenya,51-53 breach of privacy via 
phone sharing is a key concern that 
threatens the viability of SMS and 
app interventions.54 Still, recent 
studies indicate that adolescents 
are amenable to mHealth 
approaches to improve health. 55,56 
Digital interventions with web-
based components for knowledge 
and skills development, and SMS for 
reminders (coded for privacy), may offer an alternative, more ethically sound approach to facilitate 
behavior change.39-41 
 
Conceptual Framework. Intervention development is informed by an integrated framework, with 
adaptations from The Health Stigma and Discrimination Framework;22 Turan’s framework for the effects 
of stigma on maternal and child health;14 the social ecological model (SEM);57,58 Heaney and Israel’s 
social networks and social support model,59 and Bandura’s Social Cognitive Theory (SCT).60 In this study, 
we posit that intersecting HIV and pregnancy stigmas increase non-disclosure and inhibit social support, 
which, in turn, intensifies the negative direct effect of these stigmas on use of services to prevent MTCT 
and improve health outcomes. We propose to develop an intervention that will (1) raise awareness 
about these intersecting stigmas; (2) increase self-efficacy and communication skills for disclosure and 
enlistment of family caregivers as social support allies; and (3) counteract the effect of stigma on 
disclosure and social support among pregnant ALHIV. Ultimately, these improvements are expected to 
enhance PMTCT engagement and outcomes.  Previous studies have shown that social support buffers 
the negative effects of stigma61,62 and improving self-efficacy improves health among youth.60 
 
Team’s Prior Experience. The PI, Dr. Luseno, was the PI of a recently completed R01 that examined 
ethical issues in the conduct of adolescent HIV research in sub-Saharan Africa (R01MH102125) and a 
supplement to the R01 examining ethical issues in the implementation of medical male circumcision for 
HIV prevention among adolescents in Kenya (R01MH102125-S1). Dr. Luseno was also the PI on a 
previous R21 study to examine adolescent HIV prevalence, use of HIV health-related services, and 
barriers and facilitators to accessing care in Kenya (R21MH099923). The R01, supplement, and R21 were 

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all conducted in the Nyanza region. Co-Investigators (Co-Is) include Dr. Gilbertson, who led the 
qualitative component of Dr. Luseno’s supplement. He also co-led a study in the U.S. to examine 
experiences among patients diagnosed during acute HIV infection and the ethical issues to consider 
when involving this population in clinical research (R21AI120549). Dr. Kwaro is based at KEMRI and was 
a Co-I on the ethics parent R01 and supplement. He has extensive knowledge about the local Kenyan 
health system and has led several HIV prevention/control, care, and treatment programs as a clinician 
and program manager. Currently, he leads a Gates Foundation funded ANC surveillance project in one 
sub-county within Siaya County. There are 1,263 pregnant adolescents aged 15-19 in this project. Of 
these, 63 (5%) are HIV-infected; half (32/63) are single. Dr. DeRosier is Chief Executive Officer at 3C 
Institute. She has extensive experience with development and implementation of both universal and 
targeted positive behavioral interventions for adolescents. Her recent research focused on developing 
and implementing evidence-based interventions via emergent technology and intelligent tutoring 
systems. She has served as PI and co-PI on several NIH-funded projects to develop culturally specific 
digital interventions. See Appendices B1-B3 for additional information about Drs. Luseno, Gilbertson, 
and DeRosier, including publications.   
 
6. PROBLEM STATEMENT:  
Nyanza has high rates of pregnancy among ALHIV and MTCT and youth are less likely to receive PMTCT 
services than adults. HIV- and pregnancy-related stigmas, non-disclosure, and lack of social support are 
key barriers to PMTCT engagement. In this study, we will develop and conduct a preliminary evaluation 
of a digital intervention to address the effects of the intersecting HIV and pregnancy stigmas on self-
disclosure and social support among unmarried adolescents. We will also identify acceptable 
approaches to involve family caregivers. Our goal is to improve PMTCT outcomes among ALHIV.  
 
7. JUSTIFICATION FOR THE STUDY:  
First, we will develop a novel theory-informed digital intervention to mitigate the effects of two 
intersecting stigmas (HIV and pregnancy) on PMTCT behaviors among pregnant ALHIV, a vulnerable yet 
understudied population. Our intervention will include SMS, which has been found to work well for 
reminders,51-53 and web-based elements to engage users and enhance the degree and depth of their 
interaction with the intervention content to increase learning and skills-building. Second, we propose a 
rigorous phased approach with end-user involvement to develop and evaluate the intervention. Third, 
we will explore with family caregivers of pregnant ALHIV acceptable approaches to involve them in 
providing support and to strengthen their communication skills. Although family caregivers are an 
important source of support for these young women, there is a dearth of research on strategies to help 
them build skills to effectively communicate with and provide needed support to their loved ones during 
this tumultuous time in the family unit. Fourth, we include bidirectional capacity building across our 
study team to strengthen skills in stigma research, qualitative analysis and manuscript development 
among Kenyan team members (KEMRI) and cultural competence and understanding with respect to 
digital intervention development among US team members (PIRE and 3C Institute).  
 
8. STATE THE NULL HYPOTHESIS:  
Not applicable. Consistent with the National Institutes of Health (NIH) R21 funding mechanism, our 
study is exploratory and developmental. Thus, no formal hypothesis testing will be conducted. 
 
9. (a) GENERAL OBJECTIVES:  

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The main goal of our study is to collect data to understand the lived experiences of pregnant unmarried 
ALHIV, how to strengthen the supportive role of their family caregivers, and to use these data to 
develop a digital intervention to improve health outcomes for this vulnerable population.  
 
(b) SPECIFIC OBJECTIVES:  
Aim 1: To develop and evaluate a digital intervention for pregnant unmarried ALHIV aged 15-19 to 
increase awareness of stigma and its consequences; improve disclosure self-efficacy and skills; and 
facilitate enlistment of family caregivers as social support allies to enhance uptake of PMTCT services. 
 
Aim 2: To identify acceptable approaches to increase awareness about stigma and enhance skills in 
communication and provision of social support among family caregivers.  
 
10. METHODOLOGY: 
(a) Study site (Geographical): The study will be conducted in Nyanza’s Siaya and Kisumu Counties. Siaya 
is rural with a population of roughly 841,746.63 Kisumu County is urban, consists of Kisumu City, and 
has a population of about 968,451.64 Including urban and rural participants will ensure our approach 
is robust and unbiased, and broaden the applicability and relevance of our intervention.  
 
(b) Study design: Our two-year study will consist of qualitative approaches for intervention 
development, and a mixed methods pilot study to assess the newly developed intervention’s 
acceptability, usability, and preliminary efficacy (Aim 1). We will also conduct focus group 
discussions (FGDs) with family caregivers to identify acceptable approaches to strengthen their 
supportive roles (Aim 2). This formative work, done in partnership with the end users, is critical for 
the development of a feasible and effective digital intervention.   
 
(c) Study populations 
The study components and populations are as follows: 
1. Individual interviews with pregnant ALHIV participants and joint interviews with pregnant 
ALHIV/caregiver dyads to inform initial digital intervention planning and development (Aim 1). 
2. Focus groups with pregnant ALHIV participants to obtain feedback on sample digital intervention 
materials (Aim 1).  
3. Pilot study with pregnant ALHIV participants who will test and evaluate the prototype (Aim 1). 
4. Focus groups with ALHIV caregivers to identify ways to involve them (Aim 2). 
 
Each type of participant group will be half from a rural area and half from an urban area. All participants 
will participate in only one research component. 
 
Aim 1 adolescent participants:  N=24 adolescents will participate in an IDI and N=24 adolescents will 
participate in a dyadic interview with a family caregiver (Component 1), N=32 adolescents will 
participate in an FGD (4 FGDs comprised of 8 participants each, Component 2), and N=30 adolescents 
will participate in the pilot study (Component 3). Inclusion criteria: All adolescent participants will be 
female, currently pregnant, unmarried, 15-19 years old and have been diagnosed with HIV and aware of 
this diagnosis. They will collectively have a range of disclosure experiences (disclosed pregnancy and HIV 
status to a caregiving family member, disclosed one of the two conditions, has not disclosed either 
condition). Exclusion criteria: An adolescent will be excluded if she: (1) does not meet all inclusion 
criteria, (2) already participated in a study activity, or (3) does not show understanding of consent based 
on our consent assessment. 

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Aim 1 caregiving family member participants (N = 24, Component 1): They will be the family member 
who participates in the dyadic interview with an ALHIV. Inclusion criteria: Caregiving family member 
(e.g., parent, guardian, grandparent, sibling or other relative) of a pregnant unmarried ALHIV who is 
aged 15-19. They will be age 20 or older and may be female or male. Exclusion criteria: Caregivers will be 
excluded if they: (1) do not meet all inclusion criteria, (2) already participated in a study activity, or (3) 
are a romantic/sexual partner or a family member of a romantic/sexual partner of a pregnant ALHIV 
(rather than a member of her family). 
 
Aim 2 caregiving family member participants (N = 64, Component 4): Inclusion criteria: Like the Aim 1 
caregivers, they will be a caregiving family member of a pregnant unmarried ALHIV who is aged 15-19, 
aged 20 or older, and may be female or male. They may or may not be the family member of an Aim 1 
participant. They will participate in one FGD session. Exclusion criteria: Caregivers will be excluded if 
they: (1) do not meet all inclusion criteria, (2) already participated in a study activity, or (3) are a 
romantic/sexual partner or a family member of a romantic/sexual partner of a pregnant ALHIV (rather 
than a member of her family). 
 
(d) Sampling 
Sample size determination: Sample sizes for our qualitative research activities (IDIs, DIs, and FGDs) are 
consistent with guidance to reach saturation and previous experience.65,66 Our study is not powered to 
detect statistically significant intervention effects on our behavioral outcomes. Rather, our focus is to 
assess the intervention’s acceptability, usability, and whether it produces clinically meaningful 
improvements on our primary outcomes. Positive findings, even if not statistically significant, will 
provide preliminary evidence in support of conducting a larger pilot trial of this novel intervention. 
Nonetheless, based on enrolling 30 subjects, 80% power, and 10% two-sided type I error rate 
(Bonferroni corrected), the minimum detectable effect size in a pre-post comparison (paired t-test) of 
each subject's scores on our primary outcomes of 1) anticipated HIV stigma from family members, 2) 
internalized pregnancy stigma, 3) HIV disclosure self-efficacy, and 4) pregnancy disclosure self-efficacy is 
a Cohen's dz (standardized difference scores) of .59. This is considered a "medium" effect size. As a 
secondary outcome, we will assess safe disclosure behaviors to determine whether we can obtain valid 
and reliable measures of the incidence and timing of disclosure since this would be a primary outcome 
in a scaled-up trial of the intervention. Our proposed sample size and single pre-post intervention group 
design is appropriate for this pilot study’s purpose of assessing time-related patterns and consistent 
with guidelines for assessing clinically meaningful improvements in outcomes. 
 
Sampling procedure: We will use purposive sampling techniques to select ALHIV and caregivers from 
our urban and rural study settings based on inclusion criteria. Recruitment of pregnant ALHIV 
(Components 1, 2, and 3): For individual in-depth interviews (IDIs) and focus group discussions (FGDs), 
we will select adolescents who have disclosed and not disclosed their pregnancy and/or HIV status to a 
caregiver. For dyadic interviews (DIs), we will purposively select adolescents who have disclosed both 
conditions to their caregiver. Pilot study participants will not have disclosed at least one of the two 
conditions to a caregiver. In both our urban and rural sites, we will recruit participants from maternal 
and child health (MCH) clinics in public health facilities. Kisumu and Siaya County Directors of Health will 
assist us to identify public health facilities serving large numbers of pregnant ALHIV. As in our previous 
research, we will visit the facilities to seek assistance from MCH providers in referring potential 
participants to our study staff. To protect their privacy, MCH staff will inform potential participants (i.e., 
pregnant unmarried ALHIV aged 15-19) about our study and ask if they are interested in participating. 

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MCH providers will give interested individuals the following options: (1) give verbal consent to the MCH 
provider to allow their contact information to be shared securely with study staff, (2) be given contact 
information of the study staff so that the adolescent can call at her convenience, and/or (3) give verbal 
consent for the MCH provider to call study staff in their presence to schedule a meeting. Providers 
assisting with recruitment will be trained in human subjects protections and given a script to use when 
informing potential participants about the study. We will adjust our recruitment procedures based on 
any new clinic/hospital protocols that have been implemented to mitigate the spread of COVID-19. 
Providers will receive financial support to assist with recruitment (e.g., for cell phone airtime and 
transport).  
 
We will also use snowball sampling techniques to recruit participants. We will ask ALHIV and caregivers 
who participate in study activities if they are willing to assist with recruitment. To ensure the privacy of 
potential participants, we will provide participants who are willing to assist with recruitment with up to 
two flyers each to pass on to potentially eligible ALHIV and caregivers in their communities. The flyer will 
include instructions for individuals who are interested in participating in the study. We may also 
advertise the study to pregnant ALHIV by placing posters with a brief study description and contact 
information in health facilities and other public venues that interested pregnant ALHIV may use to 
contact research staff. We used this procedure in our previous study.  
 
Our staff will be trained on COVID-19 protective measures (i.e., wearing masks, washing hands, and 
keeping a safe distance) and on how to explain these measures to potential participants using culturally 
appropriate terms. They will be provided with surgical masks and hand sanitizer for themselves and to 
offer to participants they interact with. Staff will meet participants at a location that is comfortable, 
convenient, and private for the potential participants. The staff will use a script to provide potential 
participants with information about the study, answer questions, and use a screening questionnaire to 
confirm eligibility for the research activity. They will enroll eligible participants while meeting our 
purposive sampling goals of (1) having equal numbers of participants from the rural (Siaya) and urban 
(Kisumu) counties, and (2) having the HIV and pregnancy disclosure experience appropriate to the 
research activity. For the DIs, we will not recruit ALHIV who decline to identify a caregiver to invite for 
the DI. Participants will participate in one study activity. Regular meetings during the recruitment period 
will be held by research staff and clinicians assisting with recruitment to identify and overcome 
difficulties during this phase. These strategies worked well for the team in a previous study.15,66 
 
Recruitment of caregivers (Components 1 and 4): Caregiving family members will be a parent, guardian, 
grandparent, sibling, or other relative of a pregnant ALHIV who is responsible for the adolescent’s care, 
food, and/or shelter.  Study staff will ask adolescents who have disclosed their HIV status and pregnancy 
to family member(s) if there is a caregiver whom they recommend being invited to participate in the 
dyadic interview or focus groups. ALHIV will be informed that recommending a caregiver for a dyadic 
interview or focus group is optional and not required for study participation. ALHIV will give their 
permission for their caregivers to be recruited for the study (either for a dyadic interview or for the Aim 
2 FGD). We expect that some pregnant ALHIV who have disclosed both conditions will decline to 
nominate a caregiver and for their safety we will not ask those who have not disclosed either or both 
conditions to nominate a caregiver. Only ALHIV who have disclosed their conditions and the caregiver to 
whom they have disclosed their conditions will be invited to participate in dyadic interviews. 
 
As needed, in order to achieve our Aim 2 sample targets (Component 4), we will recruit additional 
family member caregivers of pregnant unmarried ALHIV aged 15-19 from the community and clinics. For 

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example, we will seek assistance from providers to recruit eligible caregivers in their catchment areas. 
We also will place posters with a brief study description and contact information for study staff in the 
health facilities and other public venues that interested caregivers of pregnant ALHIV may use to contact 
research staff. We will recruit only caregivers who already are aware they are caring for an adolescent 
who is both pregnant and living with HIV.  We will conduct eight FGDs in Aim 2 (4 rural, 4 urban; 8 
participants per FGD; n=64) in two rounds. In round 1, we will present Aim 1 findings, obtain caregivers’ 
perceptions about whether the findings resonate with their experiences, and explore acceptable 
approaches to strengthen caregivers’ skills. In round 2, we will present the final Aim 1 prototype and 
obtain caregivers’ views, including about the acceptability of a complementary digital intervention for 
caregivers. 
 
Retention of participants: Adolescents and caregivers who participate in individual in-depth interviews 
(IDIs), dyadic interviews (Dis), and focus groups (FGs) will participate in one research activity; thus, we 
will not have a retention plan for them. Adolescents who participate in the pilot study will take a follow-
up survey two weeks after exposure to the intervention. The short time interval of two weeks will help 
to ensure participants are not lost to follow-up. In addition, to help us retain these participants, we will 
obtain participant locator information, including contact information, and set up the two-week 
appointment in advance. One week before their appointment, study staff will send an SMS to remind 
participants about their upcoming appointment. A day before their appointment, staff will place a 
phone call to participants to arrange a time and place to meet for the follow-up appointment. All 
participants, including caregivers, will be given an incentive of USD $10 for each session.  
 
(e) Procedures 
Overview of Procedures 
Summary of data collection: Aim 1 will consist of three phases. In Aim 1 Phase 1, we will conduct 
individual in-depth interviews (IDIs) with pregnant ALHIV and dyadic interviews (DI) with pairs of 
pregnant ALHIV and their family member caregiver. In Aim 1 Phase 2 we will conduct focus group 
discussions (FGDs) with pregnant ALHIV. In Aim 1 Phase 3 we will carry out a pilot study with pregnant 
ALHIV serving as prototype testers and will collect survey data (baseline and two-weeks post-
intervention) and qualitative data (participant thoughts and field staff notes). In Aim 2, we will conduct 
two rounds of FGDs with family member caregivers of an ALHIV. 
 
What Participants Will Do 
Individual in-depth interviews (IDIs) of adolescents (Aim 1 Phase 1, Component 1): All IDIs will be 
conducted by trained, experienced interviewers able to speak fluently in the local languages (Luo, 
Swahili, and English). The research team will develop a semi-structured interview guide. Questions asked 
of the pregnant ALHIV will include ones pertaining to their experiences disclosing their HIV and/or 
pregnancy status to caregiving family members, receiving support from caregivers, with stigma due to 
their HIV and/or pregnancy status, and perspectives about SMS and digital intervention features, 
images, and preferences. IDIs will be conducted at venues that offer privacy and are quiet, convenient, 
and comfortable for participants. Each interview will take about 60-90 minutes.  
 
Dyadic Interviews with adolescents and caregivers (Aim 1 Phase 1, Component 1): Research staff will use 
the same procedures for conducting the DIs as described above for the IDIs (i.e., semi-structured 
interview guide, private and convenient venues for the interviews, 90-minute sessions). However, in 
these interviews, the adolescent and their caregiver will be interviewed together. Research staff will ask 

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them about their disclosure experiences, what could have improved the experience, the best ways to 
involve caregivers, and advice they have for people in a similar circumstance.  
 
The research team will use the IDI and DI findings, led by our 3C Institute collaborators, to develop initial 
specifications and mock-ups of the digital intervention.  
 
FGDs with adolescents (Aim 1 Phase 2, Component 2) and caregivers (Aim 2, Component 4): For Aim 1 
there will be 4 FGDs (8 participants each) conducted with pregnant ALHIV (2 rural and 2 urban). For Aim 
2, there will be 4 FGDs (8 participants each) conducted with caregiving family members (2 rural and 2 
urban) in Round 1 and 4 FGDs in Round 2 (2 rural, 2 urban). FGD sessions will be facilitated by a trained 
KEMRI moderator fluent in the local languages who will use a semi-structured guide. Each session will 
last up to two hours. The adolescents will be asked for feedback on the content and flow of the 
intervention module and their opinion on the mock-ups (e.g., appropriateness, realism, appeal, and 
plans for using text messaging). Caregivers in Round 1 will be asked about our plans for developing a 
digital intervention for ALHIV and approaches for involving family caregivers. Caregivers in Round 2 will 
be asked for feedback about the final Aim 1 intervention prototype and views on a potential 
complementary digital intervention for caregivers. All FGDs will be conducted in a location providing 
privacy and confidentiality. 
 
Using Aim 1 findings, the research team will develop an intervention prototype. As part of this process, 
PIRE and KEMRI staff will test versions in order to finalize the prototype. 
 
Pilot study with adolescents (Aim 1, Component 3): The pregnant ALHIV participants will complete a 40-
50-minutes baseline survey that includes questions about demographics, HIV and pregnancy stigmas, 
and disclosure. All participants will receive a one-on-one intervention session in which they will be 
provided with a study mobile phone with internet access, guided on how to access the prototype 
intervention, and instructed to go through the intervention. Research staff will take notes of 
observations made while participants are using the app. Immediately after participating in the 
intervention, the adolescents will complete a questionnaire asking about the intervention’s acceptability 
and usability.  Intervention sessions may last up to two hours.  Altogether, the baseline data collection 
and intervention session will last approximately 3 hours. Participants will take a follow-up survey two 
weeks after the intervention session, which will last about 40-50 minutes. 
 
All participants (Aims 1 and 2, Components 1 through 4): The study will collect private identifiable 
information from all participants. Socio-demographic data (e.g., age, gender, educational attainment) 
and written consent forms (containing participant names) will be collected from all participants. 
Participants in the interviews and pilot study will be asked questions about their own lives and 
experiences. 
 
COVID-19 Prevention Protocols (all participants):  Dr. Kwaro (KEMRI co-investigator) is overseeing 
operations of a research project monitoring HIV infections among pregnant women in Siaya County. We 
will follow his study’s protocols (adapted as needed), which are compliant with Kenya’s Ministry of 
Health guidelines for COVID-19 prevention. Study staff and research participants will be screened for 
COVID-19 symptoms before engaging in study procedures (taking temperature, screening for symptoms, 
and compulsory handwashing/sanitizing). Staff or participants who screen positive will be directed to 
appropriate testing and health care resources. Study staff will receive training on COVID-19 mitigation 
measures. Staff and participants will be required to wear face masks during all face-to-face interactions, 

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follow hand hygiene protocols, and adhere to physical distancing rules. Staff will sanitize data collection 
tools. Data collection activities will be conducted in open outdoor spaces whenever feasible and when 
privacy can be ensured. When that is not possible, the activities will be conducted indoors with 
adequate ventilation. 
 
11. DATA MANAGEMENT: 
Data Collection and Management: Data sources will include electronic data files, audio-recordings, 
transcripts, and field notes obtained from research activities which will include interviews, focus groups, 
and surveys. Research team members will audio-record the interviews and focus groups and take notes. 
All audio recordings will be transcribed and translated. The research team will develop and use 
codebooks for each qualitative research activity to analyze the data. For the pilot study, the research 
team will analyze the pre- and post-treatment questionnaire data to assess if the intervention produced 
clinically meaningful improvements on outcomes of interest. Participants will complete a survey at 
baseline, immediate post-intervention, and two-week follow-up. We will use an adaptation of the user 
version Mobile Application Rating Scale (uMARS),79 modified for our study, to assess the intervention’s 
acceptability 44,46 and usability.44,67 Other measures, based on our conceptual framework (Fig. 1), will 
include demographics, stigma (HIV: anticipated from family members,68 internalized,69,70 coping;71 
pregnancy: internalized72), disclosure self-efficacy,73 and disclosure to family members.74 Survey data will 
be collected using computer-assisted interviewing (CAI) techniques on secure password-protected 
devices. All study data will be transferred from data collection devices to KEMRI’s secure servers daily. 
Data will be transferred from KEMRI to PIRE as encrypted data files. At PIRE, the data will be stored on 
secure servers. Only research staff authorized by the PI (Dr. Luseno) and Co-PI (Dr. Kwaro) will have 
access to the data. PIRE staff will conduct further data cleaning, coding, and data analysis. 
 
12. ETHICAL CONSIDERATIONS 
(a) Human Subjects 
Informed Consent: All study participation will be voluntary. Informed consent will be obtained from 
participants by trained research staff at each stage of the recruitment and enrollment process. 
Information provided as part of the consent process will include the purpose of the research, study 
procedures, explanation of possible risks and safeguards, and explanation that participation is voluntary. 
 
Potential participants who are identified by MCH providers will be offered options about how to connect 
the individual with study staff (giving verbal consent for providers to share the person’s contact 
information with study staff, receiving contact information of study staff, or allowing the provider to call 
study staff to schedule a meeting). Research staff will contact potential participants to introduce 
themselves and provide information. Individuals who are still interested in participating will be invited to 
meet in private where screening and consent procedures will be administered. Following a script, 
research staff will obtain verbal consent from individuals prior to screening them for study eligibility. 
Study staff then will obtain written informed consent from each eligible individual before the person 
participates in any research activity. Staff will administer an assessment of adequate understanding of 
the consent information, which we have done in previous research. For additional protection of 
participants in this study, all research staff will receive training on protection of human subjects 
including on confidentiality, the ethical conduct of informed consent procedures, administering the 
assessment of consent comprehension, and reviewing assessment answers and consent form 
information with the adolescent. Moreover, research staff will be experienced in conducting HIV-related 
studies with vulnerable youth, and skilled in counseling vulnerable youth, identifying distressed youth, 

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and interacting with the caregivers of vulnerable youth. They will also be knowledgeable about the 
study sites, cultural nuances, and fluent in local languages. 
 
Request for waiver of parental consent and justification:  We are requesting a waiver of parental 
consent to protect the confidentiality of adolescent participants, including those who are 15-17 years 
old, who will not have disclosed their HIV and/or pregnancy to their parents. Involving parents of those 
who have not disclosed their HIV and/or pregnancy status in the consenting process would result in a 
breach of confidentiality. Pregnant unmarried ALHIV is an understudied, underserved, and hard-to-reach 
population. Studies are urgently needed to better understand their lived experiences, the barriers they 
face in, and factors that facilitate, disclosure and uptake of services. The goal of our study is to examine 
these issues and to develop an approach to enhance disclosure to caregivers and thereby uptake of 
critical health services. Our study procedures balance the need to inform caregivers about the study 
without breaching the confidentiality of adolescent study participants.  
 
We are requesting IRB approval to allow youths 15-17 years old to give consent for themselves and to 
not obtain parent/guardian consent for those youths. In Kenya minor adolescents are considered 
emancipated minors if they are pregnant, heading a household or are parents and are thus treated as 
adults [See National AIDS and STI Control Programme (NASCOP) and Kenya Medical Research Institute 
(KEMRI) (2015). Guidelines for Conducting Adolescents Sexual and Reproductive Health Research in 
Kenya. http://icop.or.ke/wp-content/uploads/2016/10/Adolescents-Guidance-on-HIV-SRH-
Research.pdf.] However, as a culturally appropriate courtesy to the families in Kenya, and only with 
permission from the adolescent participant, we will inform parents, guardians, and/or household heads 
about the study and the 15-17-year-old adolescent’s participation. While doing so, research staff will 
describe the study in a very general way that will not reveal undisclosed information about the 
adolescent. Research staff will be trained to ask all participants if they would like the staff to provide this 
information to their parent. The staff will be available to answer any questions from the adolescents and 
parents, and they will be trained to give the adolescent and parent time to consult with each other 
alone if the adolescent seems to want that.  In addition, as stated in the consent form, at any time, a 
participant may change their mind and withdraw from the study. We have successfully used similar 
procedures in previous studies.15,75 
 
Request for waiver of documentation of informed consent: We plan to obtain verbal consent without 
written documentation for participants to be asked screening questions to determine their eligibility to 
participate in the study. The reason is that the only record linking the subject and the research would be 
the consent document the main risk for that person would be a risk of confidentiality. 
 
Risk of inadvertent disclosure of HIV and/or pregnancy status: The young woman’s HIV status or 
pregnancy could be inadvertently revealed to family or community members and result in her 
experiencing stigma. This could happen if someone who does not already know about the adolescent’s 
pregnancy and/or HIV status were to learn that the adolescent or a caregiver is participating in a study 
for pregnant ALHIV and their caregivers. Accidental disclosure also could occur if a bystander were to 
overhear an interview or other data collection session in which HIV and/or pregnancy status is revealed.  
Although participants in the FGDs and pilot study interviews will not be asked personal questions, it is 
possible that some participants could reveal their HIV and pregnancy status when answering questions. 
A potential consequence of inadvertent HIV or pregnancy disclosure is violence from a partner, family 
member, or other person who is upset or who blames the young woman. In addition, adolescent or 

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caregiver participants could worry about such accidental disclosure occurring, which could result in 
them experiencing stress and anxiety.  
 
Risk of emotional distress during data collection sessions: Some of the adolescent and caregiver 
participants in the interviews or pilot study could feel uncomfortable or emotionally distressed 
answering questions about themselves or their family member being pregnant; being HIV-infected; or 
experiencing problems regarding stigma, disclosure or social support. It also is possible that some 
participants may think about and disclose upsetting events (e.g., sexual abuse, intimate partner 
violence, or interpersonal conflict) during the data collection session. FGD participants will not be asked 
personal questions, but some individuals could potentially think about personal and sensitive thoughts 
during the research activity. 
 
Safeguards for inadvertent disclosure of HIV or pregnancy status: Interview, FGD, and pilot study 
sessions will be conducted at venues that offer privacy and confidentiality. IDIs and pilot study sessions 
will be conducted individually. Research staff will be sensitive to participants having various disclosure 
circumstances and to the potential risks of accidental disclosure. We will use our experience from 
previous studies15,66,75-78 when entering homes and communicating with household members to ensure 
our participants’ safety and confidentiality. Only caregivers who know both conditions (HIV-positive 
status and pregnancy status) of the adolescent they are caring for will be recruited to participate in the 
dyadic interviews. We will follow procedures to protect data security (described below). We have not 
come across in any of our previous studies15,66,75-78 situations in which an adolescent became exposed to 
violence due to participating in our study. However, we will employ research field staff who are either 
trained as nurses or counselors or experienced in data collection; will be from the local region and 
knowledgeable about cultural nuances; and will have experience with HIV studies and working in rural 
and low-income settings. Like prior studies, staff will receive further training for this study, will have a 
list of resources to help participants in need, and will be prepared to address potential adverse 
situations. 
 
Safeguards for emotional distress during data collection sessions: Participants may choose to not answer 
particular questions and to stop their study participation at any time. Field staff will be trained to offer 
referrals, based on available services within the community, if a young woman were to disclose she has 
been a victim of sexual abuse, violence or other traumatic experience. Staff will be trained to discuss 
sensitively the young woman’s disclosed experience. Field staff also will be trained to monitor for 
emotional upset or anxiety during or as a result of the data collection session among any of the 
participants and to offer support and referrals for services, if they are available. In collaboration with our 
KEMRI partners, we developed a list of available resources and services for referral purposes in our 
previous study for adolescent participants in need of psychological, social and medical services. We will 
update the list and require research staff to distribute a copy to all study participants at the conclusion 
of data collection activities. For adolescents who are identified as distressed, express a need for services, 
or have not disclosed their pregnancy and/or HIV status to a caregiver, research staff will provide active 
referrals to services in the community, e.g., antenatal care (ANC), prevention of mother-to-child HIV 
transmission (PMTCT), HIV treatment and care, counseling, and support with facilitated disclosure. 
 
Data security: Unique ID codes will be attached to data (including transcripts and audio-recording files) 
instead of participant names or other personal identifiers. Data, any lists of names and ID codes, and 
consent forms will be stored in locked cabinets (if paper) or password-protected (if electronic). No 

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reports will link individuals’ names with data; study results will be reported as aggregate data. Research 
staff will have access to data only on a need-to-know basis.  
 
Study monitoring and oversight: The PI will obtain approval for the study from the PIRE and KEMRI IRBs. 
Research staff will receive training in protection of human subjects, research protocols, use of the 
study’s Data Safety and Monitoring Plan (DSMP), and maintaining participant confidentiality. Input will 
be obtained from the Kenyan team to ensure our plans for monitoring participant safety are appropriate 
to the local situation, and staff will be trained on the procedures. The PI, co-investigators, and study 
staff are experienced in conducting research in sub-Saharan Africa, including in the Nyanza region in 
Kenya and in data collection with HIV-infected adolescents, pregnant adolescents, and family member 
caregivers. The PI is experienced in monitoring participant safety of HIV-infected, pregnant, and 
emotionally distressed youth and overseeing field work in Kenya. The study will receive review and 
oversight from the IRBs. Details of our DSMP are provided in an attachment. 
 
Benefits: Participants may experience personal satisfaction from communicating with researchers about 
topics relevant to pregnant ALHIV such as stigma, disclosure and family support; being treated as 
knowledgeable stakeholders; and being part of a study that could potentially help people in similar 
circumstances of need. The adolescents who participate in the pilot study may benefit from receiving 
the digital intervention session which will be designed to help adolescents like them improve stigma 
knowledge and coping skills, HIV and pregnancy disclosure skills, and enlisting support of caregiving 
family members. The study’s risks are reasonable in relation to the potential benefits to participants and 
others. 
 
(b) Animal Subjects. Not applicable. 
 
13. DATA ANALYSIS PLAN 
Qualitative Data. Audio recordings of the sessions will be transcribed and translated. Field notes will 
include detailed notes taken by research staff during sessions. All interview transcripts will be 
deidentified and assigned ID numbers. Transcripts will be read by research staff. Using MAXQDA, 
deductive codes will be applied to segment narratives into a priori conceptual categories (e.g., text 
describing how disclosure occurred). Next, we will apply inductive codes for each conceptual category 
(e.g., reasons ALHIV delay disclosure of pregnancy to caregivers). We will meet virtually bimonthly to 
discuss coding, emerging and overarching themes, and to organize the data into thematic groups. We 
will examine code frequencies across transcripts to identify the most salient themes and create text 
matrices to highlight the co-occurrence of deductive and inductive codes. We will write summary 
reports to describe themes, including illustrative narratives that will be the basis for the intervention 
mock-ups. Analysis will be ongoing to determine whether we are collecting the data we need, if changes 
to interview guides are needed, and data saturation.  
 
Quantitave Data: We will use SAS to summarize the quantitative data. Frequencies and measures of 
central tendency will be calculated for demographics, usability, and acceptability. We will conduct 
descriptive analysis on data collected at two time points to assess time-related patterns and clinically 
meaningful improvements in measures. Our study is not powered to detect statistically significant 
intervention effects. Our goal is to assess maintenance/persistence intervention effects after a short 
duration exposure.  
 
 

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14. EXPECTED APPLICATION OF THE RESULTS:  
The research has a high social value and the potential to benefit adolescents and families in both rural 
and urban areas of a region with high prevalence of HIV and adolescent pregnancy. The study will 
develop a digital intervention that will be designed to address stigma affecting pregnant unmarried 
ALHIV, facilitate skills for disclosure and enlisting family caregiver support, and improve engagement in 
PMTCT services 
 
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