PRISM program for adolescents living with HIV in Eswatini
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
This trial will test whether a brief PRISM resilience program helps adolescents (ages 10–19) living with HIV in Eswatini who have high psychological distress do better than standard psychosocial care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | Eswatini Nazarene Health Institutions Academic / other |
| Locations | 1 site (Manzini, Manzini Region) |
| Trial ID | NCT07101458 on ClinicalTrials.gov |
What this trial studies
This is an explanatory sequential mixed-methods project that begins with a single-site, single-blind pilot randomized controlled trial enrolling 140 adolescents living with HIV. Participants are randomized to an adapted PRISM intervention (three 60-minute one-on-one sessions delivered 1–2 weeks apart) or to standard psychosocial care, with outcomes measured at baseline and 3, 6, 9, and 12 months. Primary exploratory outcomes include psychological distress, resilience, and HIV-related health quality of life, and the trial will measure feasibility and acceptability in addition to signals of effectiveness. A second qualitative phase uses interviews with participants and PRISM coaches to gather in-depth feedback on program experience and implementation.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10–19 living with HIV in Eswatini who are cognitively able to participate and who screen with elevated psychological distress (K6 score > 13), and who do not report recent suicidal thoughts.
Not a fit: Patients with current suicidal ideation, severe cognitive impairment, those outside the 10–19 age range, or those requiring more intensive psychiatric care are not expected to benefit from this program and are excluded or referred for other services.
Why it matters
Potential benefit: If successful, PRISM could reduce psychological distress and strengthen resilience and HIV-related quality of life for adolescents living with HIV in low-resource settings.
How similar studies have performed: PRISM-style resilience interventions have shown promise improving psychosocial outcomes among adolescents with chronic illness in high-income settings, but this adapted PRISM has limited prior testing in low- and middle-income countries like Eswatini.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manzini, Manzini Region
- Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic — Manzini, Manzini Region, Eswatini (Recruiting)
Study contacts
- Principal investigator: Musa L. Nhlabatsi, MSc — Eswatini Nazarene Health Institutions
- Study coordinator: Musa L. Nhlabatsi, MSc
- Email: lewienhlabatsi@gmail.com
- Phone: +26876115197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.