Improving HIV prevention for pregnant women in Zimbabwe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to adapt the TENDAI program to create TENDAI4PrEP, a multi-level intervention designed to enhance adherence to pre-exposure prophylaxis (PrEP) among pregnant women in Zimbabwe. By addressing various barriers such as psychological distress, stigma, and provider knowledge, the intervention seeks to improve PrEP uptake and persistence during pregnancy and the postpartum period. The study will involve individual interviews with HIV-negative pregnant women and their partners, as well as antenatal care providers, to explore the challenges faced in accessing and using PrEP. If successful, this intervention could pave the way for larger-scale effectiveness testing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Across all aims participants must be

1. Pregnant
2. Presenting at the Chitungwiza Central Hospital ANC
3. Aged 15+
4. Willing to provide informed consent or assent
5. Have HIV negative status
6. At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and/or recent condomless sexual activity)
7. Score \>5 on the Shona Symptom Questionnaire

   For the RCT, eligible participants must also be willing to
8. Initiate PrEP prior to randomization
9. Bring their pregnancy partner (if they are safe doing so).

Exclusion Criteria:

1. Inability to provide informed consent/assent and/or complete procedures in Shona or English
2. Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)

Where it's running

• University of Zimbabwe
  Harare, Zimbabwe Recruiting

Study contacts

• Principal investigator: Amelia M Stanton, PhD — Boston University
• Study coordinator: Conall O'Cleirigh
• Email: cocleirigh@mgh.harvard.edu
• Phone: 617-643-0385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.