Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Zimbabwe
Harare, Zimbabwe
Actively Recruiting
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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