Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new program called TENDAI4PrEP, which aims to help pregnant women in Zimbabwe use and stick with PrEP, a medicine that can prevent HIV. The program is an adaptation of an existing approach designed to support people living with HIV, focusing on reducing feelings of depression and anxiety that can make it hard to stay on treatment. Researchers want to see if this new program is easy to use, accepted by the participants, and effective in helping pregnant women who are at risk of getting HIV.

To be eligible for the trial, participants need to be pregnant, aged 15 or older, and attending a specific hospital in Chitungwiza. They should also have a negative HIV status and be at risk of HIV infection, which might include having a partner whose HIV status is unknown or experiencing certain risky situations. Participants will have the opportunity to start PrEP and may also involve their partner in the program. This study is important because it addresses a significant health issue for pregnant women in Zimbabwe, helping to prevent the spread of HIV during a critical time in their lives.

Gender

ALL

Eligibility 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)