Clinical trial NCT06506188: Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Official title: UNCPM 22402 - Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
HIV Prevention
Keywords: Breastfeeding
HIV
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-17
Enrollment: 5000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Study Design Overview:

The LINK study is an effectiveness-implementation type I hybrid cluster randomized trial. Prospective data collection and existing medical record and health surveillance data will be used to evaluate the effectiveness and implementation of the LINK model. The LINK model is a clinical intervention aiming to improve PrEP persistence among postpartum women. Outcomes from this trial will be used to assess its potential for implementation outside of the trial setting.

The study will take place in Lilongwe district in Malawi, a priority district for HIV prevention services given high HIV incidence. Twelve sites in Lilongwe will be randomized 1:1 to the LINK model or the standard of care.

The LINK model includes:

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
4. Community facility-linkage (CFL) peer mom for ongoing support of breastfeeding moms using PrEP, and follow-up of breastfeeding women who disengage from PrEP care

Components #1-3 are directly integrated into the Expanded Programme on Immunization (EPI) infant vaccination visit and will be carried out by a mix of existing staff and study-hired HIV diagnostic assistants (HDA). HDAs are a lower healthcare worker cadre that Malawi has successfully deployed to expand HIV testing services. Component #4 will take place outside of the infant immunization clinic, integrated into existing PrEP clinics and clinic flow at each site. Component #4 will shift the tasks of engaging women, exploring strategies to facilitate ongoing PrEP care attendance, and tracing persons who disengage from care from the the PrEP prescriber (typically a nurse) to the CFL "PrEP peer" mother. The study anticipates supporting placement of one PrEP-trained HDA and at least one CFL "PrEP peer" at each intervention site. All PrEP services, including clinical evaluation and medication refill or administration, will be provided by Malawi Ministry of Health (MoH) and/or local implementing partners tasked with PrEP delivery.

Data collection methods will include structured observation, medical record review, surveys, and in-depth interviews (IDI) with patients in each of the twelve clinics. The primary outcome, PrEP persistence, will be assessed by PrEP medical record review of patients at intervention and control clinics. Additionally, there will be study-specific data collection tools including surveys, IDI, and dried blood spots (DBS) administered to participants consented and enrolled into the study at intervention and control clinics. Participants will not be followed longitudinally. Study data assistants will administer surveys at each participating site for women receiving services related to infant vaccines and PrEP care. These surveys will collect demographic information, HIV risks, and PrEP utilization (if applicable). Researchers will collect DBS from a subset of women who initiated PrEP to measure oral PrEP adherence.

A subset of women in intervention clinics, including those receiving services at the PrEP and/or EPI clinics, as well as clinical providers, implementing partners, and members of the Malawi Ministry of Health will be asked to participate in an IDI focused on acceptability and feasibility of the intervention. For women, interviews will focus on experiences with each component of the intervention and partner support for HIV testing and PrEP usage during the postpartum period. Non-patient stakeholders' interviews will focus on context and feasibility of implementation, scale, and sustainability of the LINK model.

Eligibility criteria: PrEP user cohort:

PrEP user cohort includes all adolescent and adult women \>=15 years old who are on PrEP and breastfeeding, enrolled in PrEP at each of the participating 12 sites during the study follow-up period. PrEP provision and clinical management will be at the discretion of the non-study PrEP providers according to Malawi PrEP guidelines and eligibility. Data for these women are abstracted from PrEP records. We are seeking a waiver of informed consent for all health record abstraction for the LINK study.

Inclusion criteria:

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

Exclusion criteria:

- None

PrEP user survey and dried blood spot sub-group Breastfeeding women \>=15 years old who are presenting to 6- and 12-month PrEP visits 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.

Inclusion criteria:

* Female presenting for \~6-month or \~12 month oral PrEP visit at participating clinical site
* Aged \>=15 years (assent with parental/guardian consent for women aged 15-17)
* Living without HIV

Exclusion criteria:

- 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.

Inclusion criteria:

- Female presenting with infant under 3 for under-five visit to participating clinical site

Exclusion criteria:

- None

Postpartum women - surveys Postpartum women \>=15 years old 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.

Inclusion criteria:

* Female presenting for child vaccination to participating clinical site
* Aged \>=15 years (assent with parental/guardian consent for women aged 15-17)

Exclusion criteria:

- 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.

Inclusion criteria:

* Aged \>= 18 years
* Involved in relevant activities pertinent to integration or provision of PrEP services such as PrEP providers, peer mothers, HIV diagnostic assistants, or clinic managers, OR policy and implementing partner stakeholders such as 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

Exclusion criteria:

- Decline informed consent

Primary outcomes:
measure: PrEP persistence: Proportion of patients on PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
measure: PrEP uptake: Proportion of patients initiating PrEP while breastfeeding among HIV-negative deliveries at the clinic in the past year
timeFrame: Study start to study end (approximately 3.5 years)
measure: 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
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
Secondary outcomes:
measure: Oral PrEP persistence: Proportion of patients on oral PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
measure: Injectable PrEP persistence: Proportion of patients on injectable PrEP for 6 months after initiation with no lapse of PrEP coverage exceeding 14 days
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 6 months
measure: PrEP persistence: Proportion of patients on PrEP for 12 months after initiation with no lapse of PrEP coverage exceeding 14 days
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
measure: 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
timeFrame: PrEP initiation or initiation of breastfeeding while on PrEP through 12 months
measure: Adoption: Number of referrals from all sources to CFL peer mothers
timeFrame: From study start through study end (approximately 3.5 years)
measure: Adoption: Number of referrals from PrEP providers to CFL peer mothers
timeFrame: From study start through study end (approximately 3.5 years)
measure: Cost-effectiveness: Intervention cost-effectiveness for patient persistent on PrEP at 6 months
timeFrame: From study start through study end (approximately 3.5 years)
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: University of North Carolina Project Malawi (UNCPM)
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sarah E Rutstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: