Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

Sponsor
Pacific Institute for Research and Evaluation
Study ID
NCT05383755
Status
Completed

Conditions

  • HIV
  • Mother to Child Transmission
  • Pregnancy in Adolescence
  • Self Disclosure
  • Social Stigma

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • Digital intervention for pregnant adolescents living with HIV — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Mar 30, 2022
Status verified
Jan 2026
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023

Study Design

Enrollment
169 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Digital intervention
    Digital intervention for pregnant adolescents living with HIV.

Primary Outcome Measure

User Version Mobile Application Rating Scale (uMARS) - Objective Quality Measure [ Time Frame: Immediately post-intervention approximately 10 minutes ]

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