Clinical Trial

The Eswatini PRISM Study on Adolescents Living With HIV

Study acronym: PRISM
Active, Not Recruiting
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Summary
Adolescents living with Human Immunodeficiency Virus (ALHIV) are at an increased risk of experiencing psychological distress and adverse mental health outcomes, particularly in low- to middle-income countries (LMICs). Although interventions aimed at promoting resilience have demonstrated potential in enhancing psychosocial outcomes among adolescents with chronic illnesses in high-income settings, there is a paucity of evidence from LMICs. This study protocol aims to outline a comprehensive framework for evaluating the feasibility, acceptability, and effectiveness of the Promoting Resilience in Stress Management (PRISM) intervention in comparison to standard psychosocial care among ALHIV in a LMIC, such as Eswatini (formerly known as Swaziland). Additionally, it seeks to gather qualitative insights from both participants and PRISM coaches regarding the PRISM program. Exploratory outcomes under investigation are psychological distress, resilience, and HIV health-related quality of life. We hypothesise that: 1. Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm. 2. Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group. 3. Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-07-28; most recent amendment 2026-06-26.
Status change: Recruiting → Active, Not Recruiting 2026-06-26
Status change: Not Yet Recruiting → Recruiting 2025-11-26
Trial Details
NCT Number NCT07101458
Lead Sponsor Eswatini Nazarene Health Institutions
Collaborators: Baylor College of Medicine Children's Foundation, Dana-Farber Cancer Institute, University of Eswatini
Conditions Human Immunodeficiency Virus, Psychological Stress
Enrollment 140 participants
Start Date 2025-12-30
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30