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Can therapy help pregnant women stay on HIV prevention? new study aims to find out.

NCT ID NCT05624931

Disease control Sponsor: Boston University Charles River Campus 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests a short counseling program (about 4 sessions) designed to help pregnant and postpartum women in Cape Town, South Africa, keep taking their daily HIV-prevention pill (PrEP). Many women stop PrEP due to depression or trauma from violence. The program uses cognitive behavioral therapy (CBT) to improve coping and build healthy habits. Researchers will enroll 118 women to see if the program is feasible and acceptable, and whether it helps them stay on PrEP during pregnancy and after birth.

What this could mean

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

Active substance
Brief CBT-based behavioral intervention
What this could lead to
If it works, this could point toward a practical, low-cost way to help pregnant women at high HIV risk stay on PrEP by treating underlying depression and trauma.
What could go wrong
This is a small, early-stage pilot study (118 participants) testing feasibility and acceptability, not effectiveness. The intervention is still being developed, so results may not generalize or show clear benefit.

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 118 people

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

Started

Apr 2025

Expected to finish

Jul 2027

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 years and older

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: * For participants across all three aims are: * Female sex * Aged 15+ * Pregnant and presenting antenatal care at the Gugulethu MOU * HIV-negative * Recent PrEP initiation (\<1 month ago) or PrEP adherence challenges, either documented (\>2 weeks late to pick up PrEP refill) or self-reported * Moderate to severe symptoms of posttraumatic stress and/or depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment. Exclusion Criteria: * There are no exclusion criteria with respect to parity or gravidity. * Participants who are unable to provide informed consent or assent in English or Xhosa * Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants. * Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder Medication Adherence post-traumatic stress disorder pregnancy disorder HIV infectious disease prevention target

As listed by the trial registrant

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

Depression Medication adherence Posttraumatic stress disorder Pregnancy related

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Boston University

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Gugulethu Midwife Obstetric Unit (MOU)

    RECRUITING

    Cape Town, Western Cape, 8001, South Africa

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