The Eswatini PRISM Study on Adolescents Living With HIV

NCT07101458 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-04

No results posted yet for this study

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
  • Dana-Farber Cancer Institute

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101458 on ClinicalTrials.gov