NCT06226155 Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe
| NCT ID | NCT06226155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2024-10-21 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.
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)
Contact & Investigator
Amelia M Stanton, PhD
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT06226155 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 55 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226155 currently recruiting?
Yes, NCT06226155 is actively recruiting participants. Contact the research team at cocleirigh@mgh.harvard.edu for enrollment information.
Where is the NCT06226155 trial being conducted?
This trial is being conducted at Harare, Zimbabwe.
Who is sponsoring the NCT06226155 clinical trial?
NCT06226155 is sponsored by Massachusetts General Hospital. The principal investigator is Amelia M Stanton, PhD at Boston University. The trial plans to enroll 132 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.