RecruitingNot ApplicableNCT06506188

Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi

UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi


Sponsor

University of North Carolina, Chapel Hill

Enrollment

5,000 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 15 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether integrating HIV prevention medication (PrEP) into routine infant vaccination visits can help breastfeeding mothers in Malawi stay protected from HIV after giving birth. **You may be eligible if...** - You are a female 15 years or older living without HIV - You are currently breastfeeding and enrolled in a PrEP program at a participating site in Malawi - For the survey sub-study: you have been on PrEP for approximately 6 months **You may NOT be eligible if...** - There are no formal exclusion criteria for the main PrEP user cohort - For the survey sub-study: you do not meet the above criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLINK model

The LINK model includes four elements: (1) linking postpartum HIV testing and PrEP services to early infant vaccination, (2) screening for HIV risk among those who test negative for HIV at the early infant vaccination visit, (3) male partner engagement to support status awareness within couples and PrEP persistence, and (4) community-facility linkage (CFL) peer mom for ongoing support of breastfeeding women using PrEP and follow-up of breastfeeding women who disengage from PrEP care.


Locations(1)

University of North Carolina Project Malawi (UNCPM)

Lilongwe, Malawi

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NCT06506188


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