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Youth HIV study tests talking circles for better mental health

NCT ID NCT04024488

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a group therapy program, led by trained youth leaders, could improve mental health and help young people with HIV stick to their medication. About 484 youth in low-resource settings took part. The program used trauma-informed counseling adapted to local cultures. The study was stopped early, so results are limited.

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

484 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

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 Youth Participants: * If of legal age to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site IRB/EC policies and procedures: potential youth participant is willing and able to provide written informed consent for study participation. * If not of legal age to provide independent informed consent: Parent or guardian is willing and able to provide written informed consent for study participation and potential youth participant is willing and able to provide written informed assent for study participation. * Confirmed HIV-infection based on documented testing of two samples collected at different time points as documented in medical records or by confirmatory testing. * Age limit 15-19 years * At screening, aware of his or her HIV infection, as confirmed by Investigator of Record or designee. * At screening, has been prescribed ART for a minimum of 24 weeks prior to screening based on medical record documentation. * At screening, meets at least one of the following indicators of moderate to severe mental health symptomology: * Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 * General Anxiety Disorder-7 (GAD-7) score ≥ 10 * UCLA Post-Traumatic Stress Disorder-Reaction Index (UCLA PTSD-RI) score \>= 35 Inclusion Criteria - For Caregiver Participants: * Caregiver, defined as a biological parent, legal guardian, or person who provides emotional, psychological and/or informational care to a youth taking part in the Randomized Trial, as identified by the youth, and for whom the youth has provided written permission to participate in the study. * Of legal age to provide independent consent and willing and able to provide written informed consent for study participation. Exclusion Criteria - For Youth Participants: * At entry, participating in a study delivering a mental health or ART adherence intervention. * Prior participation in an IMPAACT 2016 Focus Group or Pilot Test * Any other condition, adverse social situation or cognitive impairment that, in the opinion of the site investigator, would preclude informed assent and informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. Exclusion Criteria - For Caregiver Participants: Prior participation in an IMPAACT 2016 Focus Group or Pilot Test.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Psychological Well-Being

As listed by the trial registrant

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

Contacts and locations

Locations

  • College of Medicine CRS 30301

    Blantyre, Malawi

  • Gaborone Prevention/Treatment Trials CRS 12701

    Gaborone, Botswana

  • Harare Family Care CRS 31890

    Harare, Zimbabwe

  • Molepolole Prevention/Treatment Trials CRS 12702

    Molepolole, Botswana

  • Seke North CRS 30306

    Harare, Zimbabwe

  • Soweto IMPAACT CRS 8052

    Soweto, South Africa

  • St. Mary's CRS 30303

    Chitungwiza, Zimbabwe

  • University of North Carolina Lilongwe CRS 12001

    Lilongwe, Malawi

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