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

NCT ID NCT05624931

Recruiting now Disease control Sponsor: Boston University Charles River Campus Source: ClinicalTrials.gov ↗

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.

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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

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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