Improving HIV prevention for pregnant women in Zimbabwe
TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
This study is trying to improve how pregnant women in Zimbabwe can use a medicine to prevent HIV by addressing the challenges they face and getting feedback from them and their healthcare providers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 15 Years to 55 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Harare) |
| Trial ID | NCT06226155 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 15 and older who are HIV-negative and at risk for HIV acquisition.
Not a fit: Patients who are currently experiencing untreated or unstable mental health conditions that interfere with their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce HIV acquisition and transmission among pregnant women in Zimbabwe.
How similar studies have performed: Other studies have shown success in using multi-level interventions to improve health outcomes in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Harare
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.