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Could STI testing be the key to getting more women on HIV prevention?

NCT ID NCT06743204

Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study in Uganda tests whether adding lab tests for common sexually transmitted infections (STIs) to standard HIV risk screening helps more women start and stick with PrEP, a daily pill that prevents HIV. About 4,500 HIV-negative women aged 15-39 will be randomly assigned to either standard screening or standard screening plus STI testing. Researchers will track PrEP use, adherence, and persistence over six months to see if the extra testing makes a difference.

What this could mean

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

Active substance
STI diagnostic testing for chlamydia, gonorrhea, trichomonas, and syphilis
What this could lead to
If it works, this could show that routine STI testing helps identify more women at risk for HIV and encourages them to use PrEP consistently, potentially reducing new HIV infections in Africa.
What could go wrong
This is a large trial, but it's testing a screening strategy, not a new drug. The benefit depends on whether women act on the test results, and results may not apply outside Uganda.

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 5,560 people

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

Started

Sep 2025

Expected to finish

Jan 2029

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 39 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: * Sexually active females aged 15-39 years, * resident in Rakai Community Cohort Study (RCCS) communities and who have participated in the most recent RCCS survey will be eligible to participate irrespective of their HIV serostatus. * Pregnant women will be included in this study * Additionally, eligibility criteria include participation in the most recent RCCS with consent to store and test plasma specimens collected during the RCCS visit, * consent to be re-contacted for future studies, and * willingness to be randomized in IN-STEP. Exclusion criteria: * Individuals incapable of providing consent or * not meeting the above criteria will be excluded from the study.

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Conditions

The condition(s) this trial relates to.

chlamydia infectious disease chlamydia trachomatis infectious disease gonorrhea HIV infectious disease sexually transmitted disease syphilis Trichomonas vaginitis urogenital infection trichomoniasis

As listed by the trial registrant

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

Chlamydia females Gonorrhea female HIV Prep uptake Syphilis female Trichomonas vaginalis

How to take part

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

  1. The places running it

    1 site. 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

  • Rakai Health Sciences Program

    RECRUITING

    Kalisizo, Uganda

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