Can a simple stress program help teens with HIV in eswatini?
NCT ID NCT07101458
First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 3 times
Summary
This study tests a program called PRISM that teaches teens with HIV how to manage stress, set goals, and build resilience. It involves three one-on-one sessions with a nurse. The goal is to see if the program is feasible and acceptable, and whether it reduces psychological distress and improves quality of life. The trial includes 140 adolescents aged 10-19 in Eswatini.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Promoting Resilience in Stress Management (PRISM) behavioral intervention
- What this could lead to
- If it works, this could provide a simple, low-cost way to help teens with HIV manage stress and improve their mental health.
- What could go wrong
- This is a small pilot study (140 participants) testing feasibility, not effectiveness. The program may not reduce distress or be acceptable to all teens.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Raleigh Fitkin Memorial Hospital-Baylor College of Medicine Children's Foundation Clinic
Manzini, Manzini Region, M200, Eswatini
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