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Can a buddy system keep young women HIV-Free? new study aims to find out

NCT ID NCT07666139

Prevention Sponsor: RTI International 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 adapts a program called CARES to help 2,100 adolescent girls and young women (ages 16-24) in South Africa and Zimbabwe consistently use HIV prevention methods like pills, rings, or injections. The program includes counseling, text reminders, and peer support. Researchers will see if it helps them get their PrEP refills on time and use it correctly.

What this could mean

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

Active substance
Comprehensive Adherence Resource and Empowerment Support (CARES) intervention
What this could lead to
If successful, this could provide a practical, low-cost way to help young women consistently use HIV prevention methods, reducing new infections.
What could go wrong
This is an early-stage adaptation study, not a test of a new drug. The intervention may not improve adherence in real-world clinics, and results may vary by location.

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 2,100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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

16 to 24 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Aim 2: Inclusion (AGYW): * age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible) * has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and * willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable * fluent in one of the study languages (English, isiXhosa, Shona, Ndebele) * target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

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

HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Desmond Tutu Health Foundation

    Cape Town, South Africa

  • Pangaea Zimbabwe

    Harare, Zimbabwe

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