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Family planning visits could double as HIV prevention for young women

NCT ID NCT04666792

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether offering HIV prevention services, including PrEP medication, in family planning clinics helps more young women get tested for HIV and start PrEP. Over 25,000 sexually active, HIV-negative young women in Kenya took part. The goal was to see if integrating these services into routine care is practical and effective.

What this could mean

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

Active substance
PrEP (emtricitabine/tenofovir disoproxil fumarate)
What this could lead to
If successful, this approach could make it easier for young women to access HIV prevention during routine family planning visits, potentially reducing new HIV infections.
What could go wrong
This is an implementation study, not a test of PrEP's effectiveness. Results may depend on clinic resources and patient adherence, and may not apply to other 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

25,457 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2024

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Female of reproductive age * Sexually active * Able and willing to provide informed consent * HIV negative, according to national HIV testing algorithm * Has at least one risk factor for HIV as defined by the Kenya National AIDS and STI Control Program Exclusion Criteria: \- Otherwise not eligible based on the above inclusion criteria

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Conditions

The condition(s) this trial relates to.

sexually transmitted disease HIV infectious disease prevention target

As listed by the trial registrant

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

Contraception HIV infections STI

Contacts and locations

Locations

  • Kenyatta National Hospital

    Kisumu, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.