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Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

NCT06226155 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-03-31

No results posted yet for this study

Summary

The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.

Conditions

  • HIV Infections
  • Pregnancy Related
  • Depression, Anxiety

Interventions

BEHAVIORAL

TENDAI4PrEP

An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.

OTHER

Enhanced treatment as usual

Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy. safety during pregnancy/postpartum, and PrEP availability at the ANC.

Sponsors & Collaborators

  • University of Zimbabwe

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Amelia M Stanton, PhD · Boston University

  • Walter Mangezi, MD · University of Zimbabwe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2027-01-01
Completion
2027-03-31

Countries

  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226155 on ClinicalTrials.gov