An interventional study of Digital intervention for pregnant adolescents living with HIV in Mother to Child Transmission, Pregnancy in Adolescence and Social Stigma, sponsored by Pacific Institute for Research and Evaluation. Completed at 1 site in Kenya. Open to female participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Pacific Institute for Research and Evaluation · Not applicable, Interventional, and Supportive care
Pregnant adolescents living with HIV (ALHIV) in Kenya frequently experience stigma and difficulty telling a family member about their HIV and pregnancy status. This study will develop and evaluate a digital intervention for pregnant unmarried ALHIV to address the effects of stigma and strengthen communication skills. Family caregivers are an important yet underappreciated and understudied source of social support for pregnant unmarried ALHIV. The study will also identify acceptable approaches to involve family caregivers in addressing the detrimental effects of the intersecting stigmas faced by pregnant ALHIV. Together, these approaches are expected to improve engagement in PMTCT services among pregnant ALHIV. The study 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 then conduct focus groups to obtain feedback on sample materials in order to refine the materials and develop an intervention prototype. We will then conduct a pilot to evaluate acceptability, usability, and preliminary efficacy of the prototype. All participating adolescents will receive a session in using the digital intervention with a mobile phone or tablet. The research team will ask questions both before the session and two weeks after the session in order to assess the intervention's usability and acceptability and preliminary improvements in the adolescents regarding stigma, disclosure, and social support. 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 complementary intervention for caregivers, which will both be tested in a larger R34 or R01 trial.
Our two-year study consisted of qualitative approaches for intervention development, and a single arm pre/post pilot study to assess the newly developed intervention's acceptability, usability, and preliminary efficacy (Aim 1). We also conducted focus group discussions (FGDs) with family caregivers to identify acceptable approaches to strengthen their supportive roles (Aim 2). For Aim 1, multi-methods were used spanning three phases: (1) in-depth interviews (IDIs) with pregnant adolescents living with HIV (ALHIV) and dyadic interviews (DIs) with ALHIV/caregiver pairs; (2) FGDs with ALHIV and (3) a pilot study with ALHIV. In the pilot study, we evaluated our newly developed digital intervention for pregnant adolescents living with HIV (ALHIV) in Kenya (N = 30). The intervention was designed to increase awareness of stigma regarding HIV and pregnancy, improve disclosure self-efficacy skills, and facilitate enlistment of family members as social support allies. The goal of the intervention was to enhance uptake of services for prevention of mother-to-child transmission of HIV (PMTCT). Using a single pre-post intervention group quasi-experimental design, the study assessed usability, acceptability, and preliminary improvements in stigma, disclosure, and social support measures. All participants received the intervention. The adolescents included in the pilot study were female, living with HIV, pregnant, unmarried, ages 15-19 years old. We included both rural and urban youth. There were two contacts with study participants. At the first contact, all participants were consented, completed a baseline quantitative survey, and received the intervention. During the intervention session, they were provided with a mobile phone/tablet with internet access, guided on how to access the digital intervention, received a guided tour of the website, and had their questions answered. After the tour, they were asked to review the intervention content. After reviewing the intervention content, participants completed a quantitative survey assessing the intervention's acceptability and usability. At the second contact, two weeks after the intervention session, follow up survey data was collected to assess maintenance/persistence of intervention effects after a short duration exposure. Survey measures at baseline and two-week follow up included demographics, stigma about HIV and pregnancy, disclosure self-efficacy for HIV and pregnancy, and disclosure of HIV and pregnancy to caregivers. Descriptive analyses were conducted of the quantitative data to describe time-related patterns and assess clinically meaningful improvements in our measures.
266 studies on the registry are indexed under Social Stigma; 66 are open to participants now.
This study's enrollment of 169 is above the median of 139 across 217 interventional studies indexed under Social Stigma.
Browse Social Stigma studies →Pacific Institute for Research and Evaluation is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria for all participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Digital intervention for pregnant adolescents living with HIV.
Behavioral: Digital intervention for pregnant adolescents living with HIV
The newly developed digital intervention uses illustrative characters to deliver didactic content to (1) raise awareness about stigma and its effects and understanding of disclosure and social support's importance, (2) increase self-efficacy and communication skills for disclosure and enlistment of caregivers as social support allies, and (3) tell stories to demonstrate how peers in similar situations have successfully coped with stigma, disclosed their pregnancies and/or HIV, and sought support from caregivers. Each module takes 20-30 minutes to complete.
User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure
Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative measure adapted for this study; overall objective quality (engagement, functionality, aesthetics, information); self-report survey items assessing overall objective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App objective quality mean scores Min=4.25, Max=5.00. Higher scores mean perception of higher quality.
Time frame: Immediately post-intervention approximately 10 minutes
User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure)
Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative data; overall subjective quality; self-report survey items assessing overall subjective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App subjective quality mean scores: Min=3.67, Max=5.00. Higher scores indicate perception of higher quality.
Time frame: Immediately post-intervention approximately 10 minutes
HIV/AIDS Stigma Instrument - People Living With HIV (PWLA)
Aim 1 Phase 3. Change in perception of experienced stigma (e.g., "Someone stopped being my friend.") (Never, Once or twice, Several times, Most of the time)(14 summed items; scale score range 0-42 with higher values indicating more stigma)
Time frame: Two weeks post-intervention
Internalized Pregnancy-Related Stigma Scale
Aim 1 Phase 3. Change in internalized pregnancy-related stigma among adolescents. Example item:"Becoming pregnant and having a baby as a teen makes me feel ashamed and bad about myself;" Response Options: Agree, Disagree) (4 summed items; scale score range 0-4 with higher values indicating more stigma). Adapted for pregnancy-related stigma from the Internalized AIDS-Related Stigma Scale.
Time frame: Two weeks post-intervention
Self-efficacy to Make an Effective Decision to Disclose HIV Status
Aim 1 Phase 3. Change in the respondent's confidence in making an effective decision to disclose HIV status to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.
Time frame: Two weeks post-intervention
Self-efficacy to Make an Effective Decision to Disclose Pregnancy
Aim 1 Phase 3. Change in respondent's confidence in making an effective decision to disclose pregnancy to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are pregnant?" (1 item, 11-pt scale: 0-10; 0=cannot do, 10=certain can do; higher scores mean higher confidence). Adapted from self-efficacy to make an effective decision to disclose HIV status.
Time frame: Two weeks post-intervention
Self-efficacy for Knowing it is Safe to Disclose HIV Status
Measures respondent's confidence in knowing when it is safe to disclose HIV status to a family member. Question Item: "How confident are you that you could know whether it was safe to tell a family member parent that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.
Time frame: Two weeks post-intervention
Internalized AIDS-Related Stigma Scale
Change in internalized HIV-related stigma (or self-stigma) among adolescents (e.g., "You feel guilty that you are HIV positive;" Response Options: Agree, Disagree). (4 summed items; scale score range 0-4 with higher values indicating more stigma)
Time frame: Two weeks post-intervention
Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale
Change in respondent's use of avoidance, denial, and wishful thinking to cope with the stigma of HIV/AIDS (e.g. "I try not to think about the stigma of living with HIV. I try to forget all about it;" Response Options: Not at all, A little, Some, A lot). (4 summed items; score range 4-16 with higher values indicating poorer coping)
Time frame: Two weeks post-intervention
Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent directly informs her caregiver that she is pregnant and/or living with HIV.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Disclosure Experiences. Sub-Theme: Indirect Disclosure
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent makes no direct effort to reveal her status.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Disclosure Experiences. Sub-Theme: Caregiver Initiated Disclosure
Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Disclosure Experiences. Sub-Theme: Mediated Disclosure
Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Disclosure Experiences. Sub-Theme: Accidental Disclosure
Data were collected during Aim 1 Phase 1. Measure Definition: The disclosure occurs though it was unintended by the adolescent.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Stigma. Sub-Theme: HIV-Related Stigma Worse Than Pregnancy-Related Stigma
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV-related stigma is worse than stigma associated with pregnancy.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Stigma. Sub-Theme: Pregnancy-Related Stigma is Worse Than HIV-Related Stigma
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that pregnancy-related stigma is worse than stigma associated with HIV.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perspectives About Stigma. Sub-Theme: HIV-Related and Pregnancy-Related Stigma Equally Bad
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV- and pregnancy-related stigma are equally bad.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Support Received
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who noted having not received support (e.g., money, food, clothing, encouragement, emotional support, etc.) that they needed.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After Pregnancy Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing their pregnancies.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After Pregnancy Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing their pregnancies.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After HIV Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing HIV.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After HIV Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing HIV.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After Pregnancy Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed their pregnancy.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After HIV Disclosure
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed HIV.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their Pregnancy at Time of Their Interview.
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of the interview, their primary caregiver knew about their pregnancy.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their HIV Status at Time of Their Interview.
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of their interview, their primary caregiver knew about their HIV status.
Time frame: Single interviews were done during Aim 1 Phase 1 over a 4-month period (April - July 2022). Each interview lasted about 1 hour.
Acceptability of Initial Prototype: Colors Used
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Adolescent Character
Data collected for Aim 1, Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Healthcare Provider Character
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Sister Character
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Mother Character
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Father Character
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Brother Character
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Home Background
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Health Facility Background
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Story
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Acceptability of Initial Prototype: Message
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
Time frame: Focus groups for Aim 1 Phase 2 were done over a 2-month period (May - June 2023). Participants took part in one focus group. Focus groups lasted on average 1 hour and 40 minutes.
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Liked Idea of App for Caregivers
Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who liked the idea of developing a similar digital intervention (i.e., an "App") for caregivers.
Time frame: Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Group Setting
Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.
Time frame: Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Written Media
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.
Time frame: Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Radio Advertisements.
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged via radio advertisements as an alternative to using an App.
Time frame: Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.
Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Healthcare Setting.
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a healthcare setting as an alternative to using an App.
Time frame: Focus groups were done during Aim 2 Rounds 1 and 2 in June and December 2023. Caregivers took part in one focus group. Each focus group lasted 2 hours.
Adolescents and caregivers were recruited with assistance from providers at health clinics.
| Milestone | Digital Intervention |
|---|---|
| Started | 70 |
| Completed | 70 |
| Not completed | 0 |
| Milestone | Digital Intervention |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
| Milestone | Digital Intervention |
|---|---|
| Started | 30 |
| Completed | 29 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Milestone | Digital Intervention |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
| Milestone | Digital Intervention |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative measure adapted for this study; overall objective quality (engagement, functionality, aesthetics, information); self-report survey items assessing overall objective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App objective quality mean scores Min=4.25, Max=5.00. Higher scores mean perception of higher quality.
| score on a scale | Digital Intervention |
|---|---|
| User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure | 4.81 ± 0.22 |
Aim 1 Phase 3 Acceptability of Final Prototype. Quantitative data; overall subjective quality; self-report survey items assessing overall subjective quality of the digital intervention. Scale title: Adapted User version Mobile Application Rating Scale (uMARS; Low quality=1, High quality =5). App subjective quality mean scores: Min=3.67, Max=5.00. Higher scores indicate perception of higher quality.
| score on a scale | Digital Intervention |
|---|---|
| User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure) | 4.67 ± 0.47 |
Aim 1 Phase 3. Change in perception of experienced stigma (e.g., "Someone stopped being my friend.") (Never, Once or twice, Several times, Most of the time)(14 summed items; scale score range 0-42 with higher values indicating more stigma)
| score on a scale | Digital Intervention |
|---|---|
| HIV/AIDS Stigma Instrument - People Living With HIV (PWLA) | 2.31 (0 to 28) |
Aim 1 Phase 3. Change in internalized pregnancy-related stigma among adolescents. Example item:"Becoming pregnant and having a baby as a teen makes me feel ashamed and bad about myself;" Response Options: Agree, Disagree) (4 summed items; scale score range 0-4 with higher values indicating more stigma). Adapted for pregnancy-related stigma from the Internalized AIDS-Related Stigma Scale.
| score on a scale | Digital Intervention |
|---|---|
| Internalized Pregnancy-Related Stigma Scale | 1 (0 to 4) |
Aim 1 Phase 3. Change in the respondent's confidence in making an effective decision to disclose HIV status to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.
| units on a scale | Digital Intervention |
|---|---|
| Self-efficacy to Make an Effective Decision to Disclose HIV Status | 7.66 ± 3.59 |
Aim 1 Phase 3. Change in respondent's confidence in making an effective decision to disclose pregnancy to a family member. Question Item: "How confident are you that you could make an effective decision of whether to tell a family member that you are pregnant?" (1 item, 11-pt scale: 0-10; 0=cannot do, 10=certain can do; higher scores mean higher confidence). Adapted from self-efficacy to make an effective decision to disclose HIV status.
| units on a scale | Digital Intervention |
|---|---|
| Self-efficacy to Make an Effective Decision to Disclose Pregnancy | 8.14 ± 3.81 |
Measures respondent's confidence in knowing when it is safe to disclose HIV status to a family member. Question Item: "How confident are you that you could know whether it was safe to tell a family member parent that you are HIV-positive?" (1 item; 11-pt scale: 0-10; 0=cannot do, 10=certain can do). Higher scores mean more confidence.
| units on a scale | Digital Intervention |
|---|---|
| Self-efficacy for Knowing it is Safe to Disclose HIV Status | 7.59 ± 3.79 |
Change in internalized HIV-related stigma (or self-stigma) among adolescents (e.g., "You feel guilty that you are HIV positive;" Response Options: Agree, Disagree). (4 summed items; scale score range 0-4 with higher values indicating more stigma)
| score on a scale | Digital Intervention |
|---|---|
| Internalized AIDS-Related Stigma Scale | .55 (0 to 4) |
Change in respondent's use of avoidance, denial, and wishful thinking to cope with the stigma of HIV/AIDS (e.g. "I try not to think about the stigma of living with HIV. I try to forget all about it;" Response Options: Not at all, A little, Some, A lot). (4 summed items; score range 4-16 with higher values indicating poorer coping)
| score on a scale | Digital Intervention |
|---|---|
| Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale | 6.66 (4 to 16) |
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent directly informs her caregiver that she is pregnant and/or living with HIV.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure | 11 |
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescent makes no direct effort to reveal her status.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Disclosure Experiences. Sub-Theme: Indirect Disclosure | 2 |
Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Disclosure Experiences. Sub-Theme: Caregiver Initiated Disclosure | 20 |
Data were collected for Aim 1 Phase 1. Measure Definition: Caregiver informs the adolescent or otherwise initiates a discussion that reveals the status.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Disclosure Experiences. Sub-Theme: Mediated Disclosure | 18 |
Data were collected during Aim 1 Phase 1. Measure Definition: The disclosure occurs though it was unintended by the adolescent.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Disclosure Experiences. Sub-Theme: Accidental Disclosure | 5 |
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV-related stigma is worse than stigma associated with pregnancy.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Stigma. Sub-Theme: HIV-Related Stigma Worse Than Pregnancy-Related Stigma | 19 |
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that pregnancy-related stigma is worse than stigma associated with HIV.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Stigma. Sub-Theme: Pregnancy-Related Stigma is Worse Than HIV-Related Stigma | 6 |
Data were collected during Aim 1 Phase 1. Measure Definition: Adolescents who made statements suggesting that HIV- and pregnancy-related stigma are equally bad.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perspectives About Stigma. Sub-Theme: HIV-Related and Pregnancy-Related Stigma Equally Bad | 2 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who noted having not received support (e.g., money, food, clothing, encouragement, emotional support, etc.) that they needed.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Support Received | 22 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing their pregnancies.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After Pregnancy Disclosure | 5 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing their pregnancies.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After Pregnancy Disclosure | 12 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received improved after disclosing HIV.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After HIV Disclosure | 0 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who thought the social support they received worsened after disclosing HIV.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After HIV Disclosure | 2 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed their pregnancy.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After Pregnancy Disclosure | 19 |
Data were collected during Aim 1 Phase 1. Responses from adolescents concerning their experiences and thoughts about social support received before and after their disclosure of HIV and/or pregnancy. Measure Definition: Adolescents who reported no change regarding the social support they received after having disclosed HIV.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After HIV Disclosure | 4 |
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of the interview, their primary caregiver knew about their pregnancy.
| Participants | Digital Intervention |
|---|---|
| Caregiver knew about adolescent's pregnancy | 44 |
| Caregiver did not know about pregnancy | 2 |
Data were collected for Aim 1 Phase 1. Measure Definition: Adolescents reported whether, at the time of their interview, their primary caregiver knew about their HIV status.
| Participants | Digital Intervention |
|---|---|
| Caregivers were aware of adolescent's HIV status because they were diagnosed in early life | 32 |
| Caregivers were aware of adolescent's HIV status because adolescent disclosed their status | 12 |
| Caregivers were not aware about adolescent's HIV status because adolescent had not disclosed | 2 |
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Colors Used | 4.45 ± 0.80 |
Data collected for Aim 1, Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Adolescent Character | 4.23 ± 0.97 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Healthcare Provider Character | 4.86 ± 0.47 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Sister Character | 4.23 ± 0.97 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Mother Character | 4.14 ± 0.83 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Father Character | 3.77 ± 0.92 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Brother Character | 3.50 ± 1.06 |
Data collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Home Background | 4.67 ± 0.58 |
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Health Facility Background | 4.68 ± 0.65 |
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Story | 4.73 ± 0.55 |
Data were collected for Aim 1 Phase 2. Four focus groups conducted with N=22 adolescents in total. Participants began by individually reviewing the initial prototype using a tablet and then used a rating form to share their perspectives about various features of the prototype. Intervention features rated by participants included color scheme, characters, backgrounds, story, and message. The rating form provided a star ranking system ranging from 1 (terrible) to 5 (excellent). The rating form was created specifically for this study.
| score on a scale | Digital Intervention |
|---|---|
| Acceptability of Initial Prototype: Message | 4.82 ± 0.39 |
Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who liked the idea of developing a similar digital intervention (i.e., an "App") for caregivers.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Caregivers' Perceptions About Engaging Them: Liked Idea of App for Caregivers | 16 |
Data were collected during Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Group Setting | 5 |
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a group setting as an alternative to using an App.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Written Media | 4 |
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged via radio advertisements as an alternative to using an App.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Radio Advertisements. | 1 |
Data were collected for Aim 2 Rounds 1 and 2. Frequencies of responses from caregivers concerning the intervention prototype and a potential complementary digital intervention for caregivers from four focus groups which included a total of 47 caregivers. Measure Definition: Caregivers who preferred to be engaged in a healthcare setting as an alternative to using an App.
| Participants | Digital Intervention |
|---|---|
| Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Healthcare Setting. | 1 |
Collected over Individuals took part in five different research activities. An individual could only take part in one activity. Adverse event data were monitored as follows: Aim 1 Phase 1 - from enrollment to end of interview, about 1 week. Aim 1 Phase 2 - from enrollment to end of focus group, about 2 weeks . Aim 1 Phase 3 - (Pilot trial) from enrollment to end of follow-up, about 3 weeks. Aim 2 Rounds 1 and 2 - from enrollment to end of the focus group, about 2 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digital Intervention | 0/169 (0%) | 0/169 (0%) | 0/169 (0%) |
Only Aim 1 Phase 3 pilot participants completed baseline, immediate post intervention, and two-week follow-up surveys. For analysis, we used data from 29 Aim 1 Phase 3 pilot participants.
| Age, Continuous(years) | Digital Intervention |
|---|---|
| Mean | 17.9 ± 1.3 |
| Sex: Female, Male(Participants) | Digital Intervention |
|---|---|
| Female | 29 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Digital Intervention |
|---|---|
| Black African (Kenyan) | 29 |
| Internalized AIDS-Related Stigma Scale(scale score) | Digital Intervention |
|---|---|
| Mean | 1 (0 to 4) |
| HIV/AIDS Stigma Instrument - People Living with HIV (PWLA)(scale score) | Digital Intervention |
|---|---|
| Mean | 2.59 (0 to 24) |
| Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale(scale score) | Digital Intervention |
|---|---|
| Mean | 8 (4 to 16) |
| Internalized Pregnancy-Related Stigma Scale(scale score) | Digital Intervention |
|---|---|
| Mean | 1.34 (0 to 4) |
| Pregnancy-Related Experienced Stigma Scale(scale score) | Digital Intervention |
|---|---|
| Mean | 2.14 (0 to 10) |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Because of the sensitive nature of the data and the small sample sizes, we are not planning to share the individual participant data in order to protect the confidentiality of study participants.
Ran from Mar 2022 to primary completion in Dec 2023, 20 months.
Results were first posted in Feb 2026, 2 years 1 month after primary completion.
Of 162 non-industry interventional studies with no phase under Social Stigma, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 20 months is above that.
Counting every sponsor, half of 164 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pacific Institute for Research and Evaluation