Youth HIV study tests talking circles for better mental health
NCT ID NCT04024488
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.
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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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484 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Jun 2025
- Lead sponsor
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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
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15 years and older
- 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 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.
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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College of Medicine CRS 30301
Blantyre, Malawi
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Gaborone Prevention/Treatment Trials CRS 12701
Gaborone, Botswana
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Harare Family Care CRS 31890
Harare, Zimbabwe
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Molepolole Prevention/Treatment Trials CRS 12702
Molepolole, Botswana
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Seke North CRS 30306
Harare, Zimbabwe
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Soweto IMPAACT CRS 8052
Soweto, South Africa
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St. Mary's CRS 30303
Chitungwiza, Zimbabwe
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University of North Carolina Lilongwe CRS 12001
Lilongwe, Malawi
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