The Eswatini PRISM Study on Adolescents Living With HIV
NCT07101458 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2025-12-04
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.
Conditions
- Human Immunodeficiency Virus
- Psychological Stress
Interventions
- BEHAVIORAL
-
Promoting Resilience in Stress Management intervention
PRISM is a manualized, skills-based training program comprised of three 60-minute, one-on-one sessions designed to build resilience resources (stress management, goal-setting, cognitive-reframing, and meaning-making) in adolescents and young adults (AYAs). The sessions are scheduled every 1-2 weeks based on participant preference. In this study, the PRISM sessions will be facilitated by trained nurses who hold bachelor's degrees in Nursing Science with a specialisation in mental health.
Sponsors & Collaborators
-
Baylor Foundation Eswatini
collaborator UNKNOWN - collaborator OTHER
-
University of Eswatini
collaborator UNKNOWN -
Eswatini Nazarene Health Institutions
lead OTHER
Principal Investigators
-
Musa L. Nhlabatsi, MSc · Eswatini Nazarene Health Institutions
-
Mduduzi C. Shongwe, PhD · Department of Midwifery Science, University of Eswatini
-
Debrah Vambe, MD · Baylor Foundation Eswatini
-
Kay Alexander, MD · Baylor Foundation Eswatini
-
Nobuhle Mthethwa, MPH · Eswatini Ministry of Health (MOH)/Eswatini National Health AIDS
-
Joyce Yi-Frazier, PhD · Dana-Farber Cancer Institute (DFCI)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-30
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
Countries
- Eswatini
Study Locations
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