NCT06397690Completed
Supporting Oral and Long-acting PrEP Decision Making Among Pregnant Women in Lilongwe, Malawi
UNCPM 22325 - Supporting Oral and Long-acting Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi: a Feasibility Pilot Study
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about Pre-exposure prophylaxis (PrEP) use during pregnancy and breastfeeding. Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period. Investigators will recruit 50 women to participate in the feasibility pilot study. A subset of these participants will participate in qualitative interviews. Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews. Procedures (methods): Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, Long-acting injectable cabotegravir (CAB-LA), and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 19 Apr 2024
- Start date
- 10 Feb 2025
- Primary completion date
- 16 Jul 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV
- NCT number
- NCT06397690
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 10 Feb 2025 to the primary completion date, 16 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Positive HIV test at time of screening
- No identified HIV risk factors per national PrEP guidelines
Other
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
Who the study is looking for
- The criteria for pregnant women participants is as follows:
- Age 18 or older
- Documented pregnancy by urine pregnancy test or physical exam
- Documented negative HIV status within the past three months
- Identified factor(s) for elevated risk for HIV acquisition per PrEP national eligibility guidelines
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
- Investigators will also conduct interviews with male partners and study staff to assess exploratory qualitative outcomes. All study staff will be eligible to participate in an interview. Male partners will be eligible to participate if they meet the following criteria:
- Referred by a study participant as her romantic partner
- Age 18 or older
- Able and willing to provide informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bwaila Hospital Coordinator of this site? Confirm its status | Lilongwe | Malawi | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.