N/A
N=70
Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV
Mother to Child Transmission · Pregnancy in Adolescence · Social Stigma · Self Disclosure · HIV
Bottom Line
View on ClinicalTrials.gov: NCT05383755 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure — 4.81 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital intervention for pregnant adolescents living with HIV (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Pacific Institute for Research and Evaluation
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure |
4.81 | — |
| PRIMARY User Version Mobile Application Rating Scale (uMARS) - Subjective Quality Measure (Composite Measure) |
4.67 | — |
| PRIMARY HIV/AIDS Stigma Instrument - People Living With HIV (PWLA) |
2.31 | — |
| PRIMARY Internalized Pregnancy-Related Stigma Scale |
1 | — |
| PRIMARY Self-efficacy to Make an Effective Decision to Disclose HIV Status |
7.66 | — |
| PRIMARY Self-efficacy to Make an Effective Decision to Disclose Pregnancy |
8.14 | — |
| SECONDARY Self-efficacy for Knowing it is Safe to Disclose HIV Status |
7.59 | — |
| SECONDARY Internalized AIDS-Related Stigma Scale |
.55 | — |
| SECONDARY Response to Stress Questionnaire - HIV/AIDS Stigma: Disengaging Coping Subscale |
6.66 | — |
| SECONDARY Qualitative Theme, Disclosure Experiences. Sub-Theme: Direct Disclosure |
11 | — |
| SECONDARY Qualitative Theme, Disclosure Experiences. Sub-Theme: Indirect Disclosure |
2 | — |
| SECONDARY Qualitative Theme, Disclosure Experiences. Sub-Theme: Caregiver Initiated Disclosure |
20 | — |
| SECONDARY Qualitative Theme, Disclosure Experiences. Sub-Theme: Mediated Disclosure |
18 | — |
| SECONDARY Qualitative Theme, Disclosure Experiences. Sub-Theme: Accidental Disclosure |
5 | — |
| SECONDARY Qualitative Theme, Perceptions About Stigma. Sub-Theme: HIV-Related Stigma Worse Than Pregnancy-Related Stigma |
19 | — |
| SECONDARY Qualitative Theme, Perceptions About Stigma. Sub-Theme: Pregnancy-Related Stigma is Worse Than HIV-Related Stigma |
6 | — |
| SECONDARY Qualitative Theme, Perspectives About Stigma. Sub-Theme: HIV-Related and Pregnancy-Related Stigma Equally Bad |
2 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Support Received |
22 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After Pregnancy Disclosure |
5 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After Pregnancy Disclosure |
12 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Improved After HIV Disclosure |
— | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: Support Worsened After HIV Disclosure |
2 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After Pregnancy Disclosure |
19 | — |
| SECONDARY Qualitative Theme, Perceptions About Social Support. Sub-Theme: No Change in Support After HIV Disclosure |
4 | — |
| SECONDARY Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their Pregnancy at Time of Their Interview. |
44; 2 | — |
| SECONDARY Qualitative Theme: Number of Adolescents Who Reported That Their Caregivers Were Aware About Their HIV Status at Time of Their Interview. |
32; 12; 2 | — |
| SECONDARY Acceptability of Initial Prototype: Colors Used |
4.45 | — |
| SECONDARY Acceptability of Initial Prototype: Adolescent Character |
4.23 | — |
| SECONDARY Acceptability of Initial Prototype: Healthcare Provider Character |
4.86 | — |
| SECONDARY Acceptability of Initial Prototype: Sister Character |
4.23 | — |
| SECONDARY Acceptability of Initial Prototype: Mother Character |
4.14 | — |
| SECONDARY Acceptability of Initial Prototype: Father Character |
3.77 | — |
| SECONDARY Acceptability of Initial Prototype: Brother Character |
3.50 | — |
| SECONDARY Acceptability of Initial Prototype: Home Background |
4.67 | — |
| SECONDARY Acceptability of Initial Prototype: Health Facility Background |
4.68 | — |
| SECONDARY Acceptability of Initial Prototype: Story |
4.73 | — |
| SECONDARY Acceptability of Initial Prototype: Message |
4.82 | — |
| SECONDARY Qualitative Theme, Caregivers' Perceptions About Engaging Them: Liked Idea of App for Caregivers |
16 | — |
| SECONDARY Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Group Setting |
5 | — |
| SECONDARY Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Written Media |
4 | — |
| SECONDARY Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement Via Radio Advertisements. |
1 | — |
| SECONDARY Qualitative Theme, Caregivers' Perceptions About Engaging Them: Preferred Engagement in Healthcare Setting. |
1 | — |
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. 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.
Eligibility Criteria
Inclusion criteria for adolescent participants:
- Female
- Living with HIV
- Pregnant
- Unmarried
- 15-19 years old
Exclusion criteria for all participants:
- Does not meet all inclusion criteria
- Participated in a prior study activity
- Does not show adequate understanding of consent
Data sourced from ClinicalTrials.gov (NCT05383755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.