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Kenya aims to slash HIV in Moms-to-Be with massive PrEP rollout

NCT ID NCT06526507

Prevention Sponsor: University of Washington 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a package of tools—training for healthcare workers, quality improvement methods, and a community of practice—to help clinics in Kenya offer HIV prevention pills (PrEP) to pregnant and postpartum women. The goal is to screen more women and start them on PrEP if they want it. Over 17,000 women and healthcare workers will take part across multiple clinics.

What this could mean

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

Active substance
Implementation strategy package (training, quality improvement, community of practice)
What this could lead to
If successful, this could make HIV prevention pills more accessible to pregnant and postpartum women in Kenya, reducing new infections.
What could go wrong
This is a large-scale implementation study, not a test of a new drug. Success depends on real-world factors like staff training and clinic resources, so results may vary across settings.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 17,000 people

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

Started

Jan 2025

Expected to finish

Dec 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

15 to 50 years

Sex

Female participants only

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: Health Care Workers: * work at a facility involved in study * involved in PrEP service delivery * \>=18 years Clients: * female clients seeking health services at study facilities * pregnant or postpartum * \>15 years (includes emancipated minors) Exclusion Criteria: * N/A

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Conditions

The condition(s) this trial relates to.

AIDS 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

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Busia County Referral Hospital

    Busia, Kenya

  • Kapsabet County Referral Hospital

    Kapsabet, Nandi, Kenya

  • Kenyatta National Hospital

    Nairobi, MRX5 + 53, Kenya

  • Kitale County Referral Hospital

    Kitale, Trans Nzoia, Kenya

  • Uasin Gishu District Hospital

    Eldoret, Uasin Gishu County, Kenya

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