Actively Recruiting
TENDAI4PrEP: Adapted Problem-solving Intervention to Improve PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
Led by Massachusetts General Hospital · Updated on 2026-03-31
132
Participants Needed
1
Research Sites
12 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
This research aims to develop a multi-level intervention called TENDAI4PrEP, adapted from the TENDAI program, to improve uptake and persistence of oral pre-exposure prophylaxis (PrEP) among pregnant persons in Zimbabwe. The study addresses the urgent public health need due to Zimbabwe's high HIV prevalence, especially among cisgender women of reproductive age, and aims to overcome barriers such as psychological distress, stigma, low partner support, and limited provider knowledge. The intervention involves 4-5 problem-solving sessions including one with a partner and an optional postpartum booster, incorporating PrEP education, psychoeducation, and a culturally adapted Life Steps approach. Participants are randomized to either the TENDAI4PrEP intervention or enhanced treatment as usual (ETAU), which includes monthly antenatal care visits and educational pamphlets. Providers at the clinics also receive training to improve PrEP knowledge and reduce stigma. Participants will be involved in assessments over approximately five months post-baseline, including evaluations of feasibility and acceptability of the intervention and provider training. Measurements include self-reported PrEP adherence, psychological distress, PrEP persistence, and changes in provider knowledge and stigma. Qualitative interviews with providers and administrators will explore implementation outcomes to prepare for larger-scale testing.
CONDITIONS
Brief 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
- Attending Chitungwiza Central Hospital antenatal clinic
- Aged 15 years or older
- Willing to provide informed consent or assent
- HIV negative status
- At risk for HIV (e.g., partner of unknown HIV status, suspected partner infidelity, multiple partners, history of STI, or recent condomless sex)
- Score above 5 on the Shona Symptom Questionnaire
- Willing to start PrEP before randomization
- Able to bring pregnancy partner if safe to do so
You will not qualify if you...
- Unable to give informed consent or complete study procedures in Shona or English
- Have an untreated or unstable mental health condition that prevents participation (e.g., active psychosis, untreated bipolar disorder)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 months post-baseline
Participants randomized to the TENDAI4PrEP intervention will attend approximately 4 to 5 problem-solving sessions, including one dyadic session with a partner, plus an optional postpartum booster session focused on PrEP education and adherence support during pregnancy and postpartum.
4 to 5 sessions plus 1 optional booster session
Duration - Up to 5 months post-baseline
Participants randomized to enhanced treatment as usual (ETAU) will have monthly antenatal care visits and receive informational pamphlets about PrEP efficacy, safety in pregnancy/postpartum, and availability, along with referrals for psychological services as needed.
Monthly visits to antenatal clinic
Duration - Up to 5 months post-baseline
All antenatal care providers will receive approximately 2 training sessions addressing PrEP knowledge, stigma, and barriers to prescribing PrEP during pregnancy.
2 training sessions
Trial Site Locations
Total: 1 location
1
University of Zimbabwe
Harare, Zimbabwe
Actively Recruiting
Research Team
C
Conall O'Cleirigh
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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