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Feasibility and Acceptability of the Promoting Resilience in Stress Management (PRISM) Intervention Among Adolescents (10 - 19 Years) Living With HIV in Eswatini: A Single Site, Single-Blind, Randomized Controlled Pilot Clinical Trial

Status: Recruiting
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• Adolescents living with HIV aged 10-19 years.

• Adolescents living with HIV who are cognitively able to participate in interviews (based on their medical history).

• Adolescents living with HIV who will have a score \> 13 on the Kessler Screening Scale for Psychological Distress (K6).

⁃ The PRISM intervention requires a caretaker or parent to be invited by the study participant to join the third session.

⁃ • Parent or caretaker should be ≥ 18 years of age and consent to participation.

• Adolescents who have been in the treatment arm of the PRISM intervention pilot clinical trial.

• Adolescents who completed all sessions of the PRISM intervention.

• Adolescents who are willing to be audio taped.

⁃ • PRISM coaches who offered all sessions of the PRISM intervention and who will be willing to be audio-taped.

Contact Information
Primary
Musa L. Nhlabatsi, MSc
lewienhlabatsi@gmail.com
+26876115197
Backup
Mduduzi C. Shongwe, PhD
mduyaye@gmail.com
+26876180806/+26879280047
Time Frame
Start Date: 2025-12-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 140
Treatments
Experimental: Treatment Arm
Promoting Resilience in Stress Management (PRISM)~Individual, 1:1 version of the Promoting Resilience in Stress Management intervention.
No_intervention: Standard Psychosocial Care
Standard psychosocial care includes comprehensive psychosocial evaluations and referrals to behavioural health services, financial assistance, and various social support resources available at the health facility.
Related Therapeutic Areas
Sponsors
Leads: Eswatini Nazarene Health Institutions
Collaborators: Dana-Farber Cancer Institute, University of Eswatini, Baylor College of Medicine Children's Foundation

This content was sourced from clinicaltrials.gov