Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
NCT Number: NCT06506188
Acronym: LINK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breastfeeding|HIV Prevention
Interventions: BEHAVIORAL: LINK model
Sponsor: University of North Carolina, Chapel Hill
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2028-03
Locations: University of North Carolina Project Malawi (UNCPM), Lilongwe, Malawi

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.

Primary Outcome Measures: PrEP persistence: Proportion of patients on PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days, Proportion of breastfeeding patients with health record-reported PrEP use (oral or injectable) who maintain ongoing PrEP usage with no more than a 14-day lapse of expected available pills or timely injections from oral or injectable PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported PrEP use (oral or injectable), PrEP initiation or initiation of breastfeeding while on PrEP through 6 months|PrEP uptake: Proportion of patients initiating PrEP while breastfeeding among HIV-negative deliveries at the clinic in the past year, Proportion of number of breastfeeding patients with record-reported initiation of PrEP (oral or injectable) in the study period, among HIV-negative deliveries in a clinic in the study period, Study start to study end (approximately 3.5 years)|Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 6-month oral PrEP visit, Proportion of breastfeeding patients with record-reported use of PrEP (oral) at 6-month visit consistent with PrEP metabolite levels consistent with \>=4 pills per week among all breastfeeding patients consented to provide samples with record-reported use of PrEP (oral) at 6-month visit and metabolite levels tested, PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Secondary Outcome Measures: Oral PrEP persistence: Proportion of patients on oral PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days, Proportion of breastfeeding patients with health record-reported oral PrEP use who maintain ongoing PrEP usage with no more than a 14-day lapse of expected available pills from oral PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported oral PrEP use, PrEP initiation or initiation of breastfeeding while on PrEP through 6 months|Injectable PrEP persistence: Proportion of patients on injectable PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days, Proportion of breastfeeding patients with health record-reported injectable PrEP use who maintain ongoing PrEP usage with no more than a 14-day lapse of timely injections from injectable PrEP approximately 6 months after PrEP initiation, among the total number of breastfeeding patients with health record-reported injectable PrEP use, PrEP initiation or initiation of breastfeeding while on PrEP through 6 months|PrEP persistence: Proportion of patients on PrEP for 12 months after initiation with no lapse of PrEP coverage exceeding 14 days, Proportion of breastfeeding patients with health record-reported PrEP use (oral or injectable) who maintain ongoing PrEP usage with no more than a 14-day lapse from oral or injectable PrEP at 12 months, among the total number of breastfeeding patients with health record-reported PrEP use (oral or injectable), PrEP initiation or initiation of breastfeeding while on PrEP through 12 months|Oral PrEP adherence: Proportion of patients on oral PrEP with PrEP metabolite levels consistent with >=4 pills per week at a 12-month oral PrEP visit, Proportion of breastfeeding patients with record-reported use of PrEP (oral) at 12-month visit with PrEP metabolite levels consistent with \>=4 pills per week among all breastfeeding patients consented to provide samples with record-reported use of PrEP (oral) at 12-month visit and metabolite levels tested, PrEP initiation or initiation of breastfeeding while on PrEP through 12 months|Adoption: Number of referrals from all sources to CFL peer mothers, Number of referrals to CFL peer moms based on CFL peer mom tracking systems across all intervention sites assessed via repeat cross-sectional surveys from study start to study end, From study start through study end (approximately 3.5 years)|Adoption: Number of referrals from PrEP providers to CFL peer mothers, Number of referrals from PrEP providers to CFL peer mothers based on CFL peer mother tracking systems across all intervention sites assessed via repeat cross-sectional surveys from study start to study end, From study start through study end (approximately 3.5 years)|Cost-effectiveness: Intervention cost-effectiveness for patient persistent on PrEP at 6 months, The Deterministic Incremental Cost Effectiveness Ratio (ICER), the ratio derived from dividing the cost difference between intervention and control groups by the difference in their risk levels of breastfeeding patients remaining persistent on PrEP at 6 months., From study start through study end (approximately 3.5 years)