Actively Recruiting

Phase Not Applicable
Age: 10Years - 19Years
All Genders
NCT07101458

The Eswatini PRISM Study on Adolescents Living With HIV

Led by Eswatini Nazarene Health Institutions · Updated on 2025-12-04

140

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

E

Eswatini Nazarene Health Institutions

Lead Sponsor

B

Baylor College of Medicine Children's Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Eswatini PRISM Study on Adolescents Living With HIV

Who Can Participate

Age: 10Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents living with HIV aged 10-19 years
  • Cognitively able to participate in interviews based on medical history
  • Score greater than 13 on the Kessler Screening Scale for Psychological Distress (K6)
Not Eligible

You will not qualify if you...

  • Adolescents who refuse to participate
  • Adolescents under 18 whose parents or caretakers do not consent
  • Adolescents reporting suicidal thoughts in the last 30 days
  • Parents or caretakers refusing to participate when invited
  • Participants or PRISM coaches unwilling to provide informed consent for interviews

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic

Manzini, Manzini Region, Eswatini, M200

Actively Recruiting

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Research Team

M

Musa L. Nhlabatsi, MSc

CONTACT

M

Mduduzi C. Shongwe, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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