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New study aims to boost HIV prevention in vulnerable women

NCT ID NCT06835751

Prevention Sponsor: Johns Hopkins Bloomberg School of Public Health 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 2 times

Summary

This study tests two counseling programs to help women who use drugs in Tanzania start and stay on PrEP, an HIV prevention pill. 200 women will be randomly assigned to receive either brief motivational counseling, the same plus extra mental health support, or standard information. The goal is to see which approach works best to overcome barriers like stigma and mental health challenges.

What this could mean

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

Active substance
Motivational Interviewing for PrEP and Common Elements Treatment Approach (CETA) plus MI-PrEP
What this could lead to
If successful, this could point toward effective ways to support PrEP use among women who use drugs, reducing their HIV risk.
What could go wrong
This is a small pilot study with 200 participants, so results may not apply to all women. The interventions may not improve PrEP adherence or mental health as hoped.

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 200 people

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

Started

Jul 2025

Expected to finish

Sep 2026

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

18 years and older

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: * Female sex * 18 years or older * Non-reactive or negative HIV test result * Self-reported drug- or sex-related HIV risk behaviors in the past six months * Hazardous or harmful opioid use in the past six months * Meets criteria for at least one of the following co-occurring mental health conditions: symptoms of depression (PHQ-9 \>= 9), anxiety (GAD-7 \>= 10), and/or PTSD (HTQ \>= 40) Exclusion Criteria: * Reactive or positive HIV test result * Currently taking PrEP * Actively suicidal, homicidal, or psychotic, and needing immediate hospitalization based on safety assessments * Unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

anxiety depressive disorder opiate dependence post-traumatic stress disorder psychiatric disorder Psychological Well-Being substance abuse substance-related disorder HIV infectious disease prevention target

As listed by the trial registrant

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

HIV Mental health Substance use (drugs, alcohol)

Contacts and locations

Locations

  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam, Tanzania

More trials for these conditions

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