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

NCT06506188 | Recruiting

• 2 other identifiers: 24-03231P01HD112215
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breastfeeding; HIV Prevention

Keywords

Breastfeeding; HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Oral PrEP persistence: Proportion of patients on oral PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days

  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

  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

  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

  PrEP initiation or initiation of breastfeeding while on PrEP through 12 months

• Adoption: Number of referrals from all sources to CFL peer mothers

  From study start through study end (approximately 3.5 years)

Study Arms (2)

LINK model

EXPERIMENTAL

Women at these sites receive the LINK model, which includes integrated EPI/HIV testing, screening for HIV risk, support for male partner engagement, and community-facility linkage (CFL) peer moms for breastfeeding women using PrEP for ongoing support and follow-up for breastfeeding women who disengage from PrEP care. This model is integrated into the SOC and does not replace SOC activities.

Behavioral: LINK model

Standard of Care

NO INTERVENTION

Women at these sites continue to receive the current standard of care (SOC) for postpartum HIV testing, PrEP screening, and PrEP care in Malawi.

Interventions

LINK model BEHAVIORAL

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.

LINK model

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female enrolled in PrEP care at a study site
• Breastfeeding documented while on PrEP
• Living without HIV

You may not qualify if:

• \- None
• PrEP user survey and dried blood spot sub-group Breastfeeding women 15 years and older who are presenting \~6 months after initiating PrEP are eligible participation in study surveys and dried blood spot using fingerstick specimen collection. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
• Female who has presented for PrEP visit at a participating clinical site at least \~6 months after initiating PrEP
• Aged 15 years (assent with parental/guardian consent for women aged 15-17)
• Living without HIV
• \- Decline informed consent
• Postpartum women - health passport review We review use existing health records (Health passports) of postpartum women presenting to infant immunization appointments with their child. No identifying information will be collected from this group.
• \- Female presenting with infant under 3 for under-five visit to participating clinical site
• \- None
• Postpartum women - surveys Postpartum women 15 years and older who are presenting to under-five visits with their child under 3 will be eligible for participation in study surveys. Women aged 15-17 will be asked to provide assent with parental/guardian consent. Every woman who is consented for the survey will also be asked about their willingness to participate in in-depth interviews. Only a subset of consenting participants, purposively sampled to reflect variety in key demographics and clinical metrics, will complete interviews.
• Female presenting for child vaccination to participating clinical site
• Aged15 years and older (assent with parental/guardian consent for women aged 15-17)
• \- Decline informed consent
• Non-patient key stakeholder Non-patient stakeholders relevant to intervention implementation at the clinic and national level, including clinical and policy stakeholders. Examples of clinical stakeholders may include key clinic staff working in PrEP, HIV testing, EPI, and CFL peer support mothers. Policy and implementing partner stakeholders may include officials from the Malawi Ministry of Health, donors in HIV prevention (e.g. PEPFAR, the Global Fund), members of community advocacy groups, the Lilongwe DHO, and other persons involved in infant vaccine and HIV prevention program and policy development and implementation in HIV prevention in Lilongwe.
• Aged 18 years and older

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of North Carolina Project Malawi (UNCPM)

Lilongwe, Malawi

RECRUITING

Related Publications (1)

• Rutstein SE, Lucas VA, Hosseinipour MC, Herce ME, Edwards J, Cassidy C, Villiera J, Kamanga F, Chagomerana M, van Oosterhout JJ, Chikuse E, Rambiki E, Thawani A, Malewezi B, Makhupula L, Udedi C, Mbulaje P, Matoga M, Kumwenda W, Mvalo T, Bula A, Nkhalamba L, Mofolo I, Chinula L, Thonyiwa V, Kumwenda O, Chisema MN, Hoffman IF, Miller WC, Go VF, Pence B, Squibb MA, Saidi F. Leveraging infant visit PrEP screening INtegration & tasK shifting to improve post-partum HIV prevention in Malawi (LINK): a cluster-randomized trial evaluation of a postpartum HIV prevention package among breastfeeding women in Malawi. BMC Health Serv Res. 2025 Aug 19;25(1):1107. doi: 10.1186/s12913-025-13133-6.

  PMID: 40830473 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sarah E Rutstein, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutstein E Sarah, MD, PhD

CONTACT

(919) 966-2537; srutstein@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an effectiveness-implementation type I hybrid cluster randomized trial which includes prospective data collection (both quantitative and qualitative) as well as use of existing surveillance data to inform pre-defined effectiveness and implementation outcomes of interest. Randomization and implementation of the LINK model occurs at the clinic level, and individuals are considered exposed or unexposed based on their attendance at intervention or control clinics.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 17, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (1)