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New program aims to protect young kenyan women from both HIV and partner violence

NCT ID NCT05599581

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 2 times

Summary

This study tests a program called Tu'Washindi, designed by and for young women in Kenya. It combines support clubs and community sessions to help girls ages 15-24 reduce intimate partner violence and consistently use HIV prevention pills (PrEP). About 1,562 participants will be followed for a year to see if the program works better than standard care alone.

What this could mean

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

Active substance
behavioral intervention (support clubs and community sessions)
What this could lead to
If successful, this program could offer a practical way to both lower intimate partner violence and improve HIV prevention among young women in high-risk settings.
What could go wrong
This is a behavioral study, not a drug trial, so results depend on participation and community factors. It may not work in other regions or cultures.

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

1,562 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 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 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.

Inclusion Criteria: To join the study potential AGYW participants must be: * Age 15-24 years * Female * Currently in a sexual relationship with a male partner for at least 1 month * Susceptible to HIV per modified Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) eligibility score * (a) Taking PrEP or (b) interested in PrEP (i.e., thinks she would benefit from PrEP but is not currently taking it) * Resident of applicable ward * Willing and able to attend support clubs for over 6 months * Willing and able to provide adequate contact information for retention * Fluent in one of the study languages (English, Dholuo, or Kiswahili) * (a) If aged 18 and above: Willing and able to provide informed consent; or (b) if non-mature minor aged 15-17: willing and able to provide assent and parent or guardian willing and able to provide parental consent; or (c) if mature minor aged 15-17: willing and able to provide informed consent or to provide assent and parent or guardian consent, per participant choice.

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Conditions

The condition(s) this trial relates to.

AIDS incontinentia pigmenti posterior leukoencephalopathy syndrome HIV infectious disease prevention target

As listed by the trial registrant

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

HIV IPV PREP

Contacts and locations

Locations

  • Impact Research and Development Organization (IRDO)

    Kisumu, Kenya

  • RTI International Africa Regional Office

    Nairobi, Kenya

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