The Eswatini PRISM Study on Adolescents Living With HIV (NCT07101458) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Eswatini PRISM Study on Adolescents Living With HIV
Eswatini140 participantsStarted 2025-12-30
Plain-language 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.
Who can participate
Age range
10 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.