What is TENDAI4PrEP studying for pregnant women in Zimbabwe?

TENDAI4PrEP is being studied to improve the use and persistence of HIV prevention medicine called PrEP among pregnant women in Zimbabwe. The study aims to address challenges like psychological distress and stigma that affect PrEP use. Massachusetts General Hospital is leading this research to help reduce HIV risk during pregnancy.

Who may be eligible for this HIV prevention clinical trial?

Individuals aged 15 to 55 who are pregnant, HIV negative, at risk of HIV infection, and able to consent are eligible. Participants should be willing to start PrEP and bring a pregnancy partner if safe. The study is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV prevention clinical trial?

Study-related care, including the study treatment and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase Not Applicable

Age: 15Years - 55Years

All Genders

ID06226155

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

Research Sites

12 weeks

Total Duration

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 Zimbabwes 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

Age: 15Years - 55Years

All Genders

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)

Research Team

Conall O'Cleirigh

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