Can a simple stress program help teens with HIV in eswatini?

NCT ID NCT07101458

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

10 to 19 years

Sex

Anyone

Healthy volunteers

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

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.

AIDS HIV infectious disease Stress, Psychological

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Manzini, Manzini Region, M200, Eswatini

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