Actively Recruiting

Phase Not Applicable
Age: 15Years - 55Years
All Genders
NCT06226155

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

Led by Massachusetts General Hospital · Updated on 2026-03-31

132

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

U

University of Zimbabwe

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 15Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant
  • Presenting at the Chitungwiza Central Hospital antenatal care clinic
  • Aged 15 years or older
  • Willing to provide informed consent or assent
  • HIV negative status
  • At risk for HIV acquisition (e.g., partner of unknown HIV status, suspicions of partner infidelity, multiple partners, history of STI, or recent condomless sex)
  • Score greater than 5 on the Shona Symptom Questionnaire
  • For the randomized trial: willing to start PrEP before randomization
  • For the randomized trial: willing to bring pregnancy partner if it is safe to do so
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent or assent or complete procedures in Shona or English
  • Having an active, untreated, or unstable mental health condition that interferes with participation (e.g., active psychosis, untreated bipolar disorder)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Zimbabwe

Harare, Zimbabwe

Actively Recruiting

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Research Team

C

Conall O'Cleirigh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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