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RECRUITING

NCT07101458

The Eswatini PRISM Study on Adolescents Living With HIV

Sponsor: Eswatini Nazarene Health Institutions

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-12-30

Completion Date

2026-12-30

Last Updated

2025-12-04

Healthy Volunteers

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.

Inclusion Criteria for the Clinical Trial: * 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). Exclusion Criteria for the Clinical Trial: * Adolescents who refuse to participate. * Adolescents whose parents/caretakers (for \<18 years) will not consent to their participation. * Adolescents who will report having suicidal thoughts (i.e., who will respond yes to one item asking if they thought of killing themselves in the last 30days). This exclusion is based on the understanding that the PRISM intervention was not designed to address suicidal ideation, as confirmed by its developers. Such individuals will be referred to a licensed psychologist following the study's established referral plan, thereby ensuring they receive the appropriate care and support. Inclusion criteria for a support person: 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. Exclusion criteria for a support person: • A parent or caretaker who refuses to participate. Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention Inclusion criteria for participants: * 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. Exclusion criteria for participants: • Participants who meet the inclusion criteria but are unwilling to provide informed consent or assent and/or parental consent. Inclusion criteria for implementers: • PRISM coaches who offered all sessions of the PRISM intervention and who will be willing to be audio-taped. Exclusion criteria for implementers: • PRISM coaches who meet the inclusion criteria but are unwilling to provide informed consent to participate.

Locations (1)

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

Manzini, Manzini Region, Eswatini