NCT07101458Active, not recruiting
The Eswatini PRISM Study on Adolescents Living With HIV
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 28 Jul 2025
- Start date
- 30 Oct 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Eswatini Nazarene Health Institutions
- Diseases
- HIV
- NCT number
- NCT07101458
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 30 Oct 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Adolescents whose parents/caretakers (for \<18 years) will not consent to their participation.
Other
- Adolescents who refuse to participate.
- 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.
- A parent or caretaker who refuses to participate.
- Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention
- Participants who meet the inclusion criteria but are unwilling to provide informed consent or assent and/or parental consent.
- PRISM coaches who meet the inclusion criteria but are unwilling to provide informed consent to participate.
Who the study is looking for
- 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.
Age in the registry: 10 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic Coordinator of this site? Confirm its status | Manzini | Eswatini | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.