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New program aims to tackle HIV stigma and depression in teens

NCT ID NCT07221201

Disease control Sponsor: Johns Hopkins Bloomberg School of Public Health Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study tests a program called Project YES+ for youth aged 15-21 living with HIV in Zambia. The program combines peer mentoring with mental health support to reduce stigma, violence, and depression. Researchers will enroll 400 participants to see if the program is feasible and acceptable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Project YES+ behavioral intervention (peer mentoring and WHO-endorsed mental health approaches)
What this could lead to
If successful, this could provide a scalable way to improve HIV medication adherence and viral suppression among young people by addressing stigma and mental health.
What could go wrong
This is a small pilot study focused on feasibility, not effectiveness. Results may not apply to other regions or populations, and the intervention requires significant community support.

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

323 people

The number who actually took part.

Started

Oct 2025

Finished

Jun 2026

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

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 * 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 Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

AIDS anxiety anxiety disorder HIV infectious disease Psychological Well-Being Social Stigma

As listed by the trial registrant

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

Anxiety Depression in adolescence HIV (human immunodeficiency virus) Mental health STIGMA

Contacts and locations

Locations

  • Arthur Davison Children's Hospital

    Ndola, Copperbelt, Zambia

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