Mother to Child TransmissionNCT05383755
Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV
A study testing Digital intervention for pregnant adolescents living with HIV in people with Mother to Child Transmission and Pregnancy in Adolescence, run by Pacific Institute for Research and Evaluation at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother to Child Transmission, Pregnancy in Adolescence, Social Stigma
- What is being tested?
- Digital intervention for pregnant adolescents living with HIV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteKenya
- Study dates
- 30 Mar 2022to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Living with HIV
- Pregnant
- Unmarried
- 15-19 years old
Who cannot join
- Does not meet all inclusion criteria
- Participated in a prior study activity
- Does not show adequate understanding of consent
Trial locations and contacts
1 site in 1 country.
Kenya1 site
The Kenya Medical Research Institute - Centre for Global Health Research
Kisumu, 40100
About this study
Official title: Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
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.
Read the detailed description
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.
- Conditions
- Mother to Child Transmission, Pregnancy in Adolescence, Social Stigma, Self Disclosure, HIV
- Being tested
- Digital intervention for pregnant adolescents living with HIV
- Keywords
- HIV, Adolescent, Social Stigma, Mother-to-Child Transmission, Pregnancy in Adolescence, Software, Parents, Caregivers, Prevention, Self Disclosure, Cell Phone, Self Efficacy
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention for pregnant adolescents living with HIVBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention | Experimental | Digital intervention for pregnant adolescents living with HIV. Receives: Behavioral: Digital intervention for pregnant adolescents living with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks post-intervention
Secondary outcomes (36)
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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start30 Mar 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mother to Child TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, 3-C Institute for Social Development, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Winfred K. Luseno, Pacific Institute for Research and Evaluation
- Investigators
- Winfred (Winnie) K. Luseno, PhD, Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383755
- Sponsor's protocol ID
- R21TW011788
- Other IDs
- 1805399, R21TW011788
- Status last verified
- Jan 2026
- First submitted
- 12 May 2022
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Gilbertson A, Iritani BJ, Agot IA, Odongo FS, Luseno WK. Adolescents' Experiences of HIV and Pregnancy Disclosure to Family Caregivers. J Adolesc. 2026 Aug 3. doi: 10.1002/jad.70242. Online ahead of print.
PubMed 42544751Luseno WK, Iritani B, Gilbertson A, Odongo F, Agot I. Development and Preliminary Evaluation of a Digital Intervention to Improve Disclosure to Family Caregivers, Stigma Coping, and Social Support Among Pregnant Adolescents Living with HIV. AIDS Behav. 2026 Jul 28. doi: 10.1007/s10461-026-05257-5. Online ahead of print.
PubMed 42509417
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Intervention to Address Stigma Among Pregnant Unmarried Adolescents Living With HIV
- ClinicalTrials.gov ID
- NCT05383755
- Acronym / sponsor ID
- R21TW011788
- Conditions
- Mother to Child Transmission, Pregnancy in Adolescence, Social Stigma, Self Disclosure, HIV
- Keywords
- HIV, Adolescent, Social Stigma, Mother-to-Child Transmission, Pregnancy in Adolescence, Software, Parents, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, 3-C Institute for Social Development, Fogarty International Center of the National Institute of Health
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Experimental | Behavioral: Digital intervention for pregnant adolescents living with HIVDigital intervention for pregnant adolescents living with HIV. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female
- Living with HIV
- Pregnant
- Unmarried
- 15-19 years old
Key exclusion criteria (3 listed)
- Does not meet all inclusion criteria
- Participated in a prior study activity
- Does not show adequate understanding of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention for pregnant adolescents living with HIVThe 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. | Behavioural | Digital intervention |
Primary outcome
User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure
Time frame: Immediately post-intervention approximately 10 minutes
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.
User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure)
Time frame: Immediately post-intervention approximately 10 minutes
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.
HIV/AIDS Stigma Instrument - People Living With HIV (PWLA)
Time frame: Two weeks post-intervention
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)
Internalized Pregnancy-Related Stigma Scale
Time frame: Two weeks post-intervention
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.
Self-efficacy to Make an Effective Decision to Disclose HIV Status
Time frame: Two weeks post-intervention
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.
Self-efficacy to Make an Effective Decision to Disclose Pregnancy
Time frame: Two weeks post-intervention
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.
36 secondary outcomes
Self-efficacy for Knowing it is Safe to Disclose HIV Status
Time frame: Two weeks post-intervention
Internalized AIDS-Related Stigma Scale
Time frame: Two weeks post-intervention
Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale
Time frame: Two weeks post-intervention
Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42544751Gilbertson A, Iritani BJ, Agot IA, Odongo FS, Luseno WK. Adolescents' Experiences of HIV and Pregnancy Disclosure to Family Caregivers. J Adolesc. 2026 Aug 3. doi: 10.1002/jad.70242. Online ahead of print.
- Derived from this study: PubMed 42509417Luseno WK, Iritani B, Gilbertson A, Odongo F, Agot I. Development and Preliminary Evaluation of a Digital Intervention to Improve Disclosure to Family Caregivers, Stigma Coping, and Social Support Among Pregnant Adolescents Living with HIV. AIDS Behav. 2026 Jul 28. doi: 10.1007/s10461-026-05257-5. Online ahead of print.
- Individual participant dataSharing planned: 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.
Related trials for Mother to Child Transmission
Active, not recruitingPhase 4
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Hepatitis B Virus - Chronic Active
Recruiting
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
Human Immunodeficiency Virus, Mental Disorder
Recruiting
"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"
HBV Infection, Pregnancy
Not yet recruitingObservational study
Prospective Registry of Exposure to Gepotidacin (PREG)
Sexually Transmitted Diseases
Recruiting
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
HIV Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfred (Winnie) K. Luseno, PhD principal investigator
Pacific Institute for Research and Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention for pregnant adolescents living with HIV in people with Mother to Child Transmission and Pregnancy in Adolescence, run by Pacific Institute for Research and Evaluation at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure (time frame: Immediately post-intervention approximately 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.