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NCT07221201Completed

Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV

Reducing the Intersecting Stigmas of HIV, Violence Victimization, and Mental Health: a Randomized Controlled Pilot Integrating Project YES! Youth Engaging for Success With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV in Ndola, Zambia

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.

Status (registry)
Completed
Study type
Interventional
Enrollment
323 (actual)
First submitted
24 Oct 2025
Start date
25 Oct 2025
Primary completion date
30 Jun 2026
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Diseases
HIV
NCT number
NCT07221201

What you commit to

  • Study type: Interventional
  • Participants enrolled: 323
  • From 25 Oct 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • For youth,
  • only one youth per household may join.
  • Also participants will be excluded from joining the RCT if they are at imminent risk of suicide based on WHO guidance on the Self Help plus program.

Who the study is looking for

  • For youth
  • Be between ages 15-21
  • living within 30-minutes, by personal transportation, of the clinic by self-report,
  • and being available to attend sessions and data collection over a 4-8 month time period On ART for at least 6 months
  • On first-line ART
  • Speaks Bemba
    • For caregivers
  • Being 25 years of age or older
  • Caring for an AYALHIV who meets the study eligibility criteria
  • Speaks Bemba
  • Living within 30-minutes, by personal transportation, of the clinic by self-report
  • Being available to attend sessions and data collection over a 4-8 month time period

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arthur Davison Children's Hospital
Coordinator of this site? Confirm its status
NdolaZambiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.