Actively Recruiting
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Led by University of North Carolina, Chapel Hill · Updated on 2025-08-24
5000
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of the Leveraging Infant Visit PrEP INtegration \& tasK Shifting to Improve Postpartum HIV Prevention in Malawi (LINK) study is to evaluate both the effectiveness of a postpartum prevention package ("LINK model") among post-partum women and its implementation into existing clinical care models in Lilongwe, Malawi. The main question the study seeks to answer is: Do women at clinics implementing the LINK model have improved Pre-exposure Prophylaxis (PrEP) persistence compared to women at clinics receiving the standard of care? Researchers will compare the LINK model to standard of care by randomizing twelve sites to either the LINK model or the standard of care. Then researchers will review existing medical record and health surveillance data, and qualitative and quantitative data collected from intervention and control sites.
CONDITIONS
Official Title
Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female enrolled in PrEP care at a study site
- Breastfeeding documented while on PrEP
- Living without HIV
- Female who has presented for PrEP visit at a participating clinical site at least ~6 months after initiating PrEP
- Aged 15 years or older (assent with parental/guardian consent for ages 15-17)
- Female presenting with infant under 3 years for under-five visit to participating clinical site
- Female presenting for child vaccination to participating clinical site
- Aged 18 years or older for non-patient key stakeholders involved in PrEP or HIV prevention activities
You will not qualify if you...
- Decline informed consent for participation in surveys or interviews
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina Project Malawi (UNCPM)
Lilongwe, Malawi
Actively Recruiting
Research Team
R
Rutstein E Sarah, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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