Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506188
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Leveraging Infant Visit PrEP INtegration tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Sponsor:
None
Organization:
None
Study Overview
Official Title:
UNCPM 22402 - Leveraging Infant Visit PrEP INtegration tasK Shifting to Improve Post-partum HIV Prevention in Malawi
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LINK
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
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 11 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 andor 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 andor 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
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 11 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None