Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV
NCT05383755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169
Last updated 2026-02-12
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.
Conditions
- Mother to Child Transmission
- Pregnancy in Adolescence
- Social Stigma
- Self Disclosure
- HIV
Interventions
- 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.
Sponsors & Collaborators
-
Kenya Medical Research Institute
collaborator OTHER -
3-C Institute for Social Development
collaborator INDUSTRY -
Fogarty International Center of the National Institute of Health
collaborator NIH -
Pacific Institute for Research and Evaluation
lead OTHER
Principal Investigators
-
Winfred (Winnie) K. Luseno, PhD · Pacific Institute for Research and Evaluation
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-30
- Primary Completion
- 2023-12-14
- Completion
- 2023-12-14
Countries
- Kenya
Study Locations
More Related Trials
-
Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children
NCT00429546 ·Status: COMPLETED ·Phase: PHASE1
-
A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
NCT03600142 ·Status: COMPLETED ·Phase: NA
-
A Social Media Intervention to Improve Retention in Care for Adolescents and Young Adults With HIV in Uganda
NCT06545968 ·Status: RECRUITING ·Phase: NA
-
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
NCT05841797 ·Status: COMPLETED ·Phase: NA
-
Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
NCT00931216 ·Status: COMPLETED ·Phase: NA
-
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
NCT06117163 ·Status: RECRUITING ·Phase: NA
-
Peer Mentors for Adolescents in HIV Affected Families
NCT00056953 ·Status: COMPLETED ·Phase: PHASE2
-
Determining Characteristics and Behaviors of Adolescent Women Regarding HIV Risk and Microbicide Trial Participation
NCT00872261 ·Status: COMPLETED
-
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
NCT05110963 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
HIV-Related Stigma Intervention for Malaysian Clinicians
NCT05597787 ·Status: COMPLETED ·Phase: NA
-
Readiness to Disclose Mother's HIV Diagnosis to Their Children in Beijing, China
NCT03248778 ·Status: COMPLETED ·Phase: NA
-
Self-management of HIV Among Adolescents
NCT05073705 ·Status: COMPLETED ·Phase: NA
-
Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
NCT02888288 ·Status: COMPLETED ·Phase: NA
-
Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
NCT05634265 ·Status: COMPLETED ·Phase: NA
-
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
NCT07064928 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Safer Conception Intervention for HIV-1 Serodiscordant Couples
NCT03030768 ·Status: COMPLETED
-
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pilot Phase
NCT07225894 ·Status: RECRUITING ·Phase: NA
-
Intervention for Newly Diagnosed Youth With HIV
NCT00510237 ·Status: COMPLETED ·Phase: NA
-
Community Home-based Care Intervention and Its Health Outcome in HIV-positive People
NCT03505866 ·Status: COMPLETED ·Phase: NA
-
Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan
NCT05107401 ·Status: COMPLETED ·Phase: NA
-
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania
NCT05033002 ·Status: COMPLETED ·Phase: NA
-
Jamii Bora: A Home-Based Couples Intervention
NCT02403583 ·Status: COMPLETED ·Phase: NA
-
HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings
NCT01256463 ·Status: COMPLETED ·Phase: NA
-
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
NCT06501885 ·Status: COMPLETED ·Phase: NA
-
Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda
NCT05516602 ·Status: COMPLETED ·Phase: NA