Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-26
Brief Title:
Evaluation of a Differentiated Point-of-care Active Case Finding Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
UNCPM 22401 - Evaluation of a Differentiated Point-of-care Active Case Finding Management Model for the Elimination of Mother-to-Child Transmission of HIV in Lilongwe and Mangochi Malawi
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAC-Man
Brief Summary:
Purpose To conduct a hybrid effectiveness-implementation stepped-wedge trial to
1 Estimate the effect of the PAC-Man model compared to SOC on the proportion of infants who receive timely EID testing
2 Estimate the effect of the PAC-Man model compared to SOC on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing
3 Compare implementation outcomes between the PAC-Man model and SOC
Participants The total study sample size is 2426 including 2304 mother-infant pair MIP survey participants 48 high-risk pregnantbreastfeeding women living with HIV for in-depth interviews from high-risk MIPs who participated in a survey 10 PMTCT policy makers and Ministry of Health MOH Presidents Emergency Plan for AIDS Relief PEPFAR implementing partner senior managers for key informant interviews and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys
To rigorously evaluate the PAC-Man model investigators will use a hybrid type 3 effectiveness-implementation incomplete stepped-wedge trial design The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental rollout of the PAC-Man model and serial measurement of both health outcomes for infants and mothers in Objectives 1 and 2 respectively as well as implementation outcomes Objective 3 The incomplete stepped-wedge design is more efficient than a complete design minimizes costs and reduces participant burden without sacrificing statistical precision Using this design sequential crossover from control ie the SOC to intervention ie SOC plus the PAC-Man model takes place at each step using cluster randomization until all clusters defined as a group of sites or health facilities plus the surrounding communities in its catchment area receive the intervention The 12 sites included in our study will be divided into 4 clusters of 3 sites each
1 Estimate the effect of the PAC-Man model compared to SOC on the proportion of infants who receive timely EID testing
2 Estimate the effect of the PAC-Man model compared to SOC on the proportion of pregnant and breastfeeding women living with HIV who receive guideline-adherent viral load testing
3 Compare implementation outcomes between the PAC-Man model and SOC
Participants The total study sample size is 2426 including 2304 mother-infant pair MIP survey participants 48 high-risk pregnantbreastfeeding women living with HIV for in-depth interviews from high-risk MIPs who participated in a survey 10 PMTCT policy makers and Ministry of Health MOH Presidents Emergency Plan for AIDS Relief PEPFAR implementing partner senior managers for key informant interviews and about 48-64 professional and lay health providers for focus group discussions and implementation actor surveys
To rigorously evaluate the PAC-Man model investigators will use a hybrid type 3 effectiveness-implementation incomplete stepped-wedge trial design The hybrid incomplete stepped-wedge design is a rigorous quasi-experimental design that allows for incremental rollout of the PAC-Man model and serial measurement of both health outcomes for infants and mothers in Objectives 1 and 2 respectively as well as implementation outcomes Objective 3 The incomplete stepped-wedge design is more efficient than a complete design minimizes costs and reduces participant burden without sacrificing statistical precision Using this design sequential crossover from control ie the SOC to intervention ie SOC plus the PAC-Man model takes place at each step using cluster randomization until all clusters defined as a group of sites or health facilities plus the surrounding communities in its catchment area receive the intervention The 12 sites included in our study will be divided into 4 clusters of 3 sites each
Detailed Description:
PAC-Man Model
PAC-Man represents an integrated differentiated services delivery DSD model for mothers and infants that brings the following three evidence-based practices into the community for elimination of mother to child transmission EMTCT 1 pediatric active case finding using novel point-of-care POC early infant diagnosis EID technology 2 same-day antiretroviral therapy ART initiation for infants newly diagnosed with HIV infection and 3 maternal viral load mVL testing and back-to-care services PAC-Man uses a mobile approach to offer EMTCT services in the community and reach high risk MIPs in which the mother living with HIV did not initiate ART started ART late during pregnancy or breastfeeding dropped off treatment following ART initiation was unsuppressed on ART was identified with HIV infection for the first-time during the post-partum period andor did not return with her infant for EID testing Because these evidence-based practices are already recommended by the Ministry of Health and will be functioning at the site and not the individual level delivering the PAC-Man model will be done under the auspices of routine care applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings
PAC-Man Implementation Approaches
The overall implementation strategy being evaluated in this study is the creation of mobile care teams to deploy m-PIMA and provide EMTCT services in the community Complementing this overarching strategy will be two sub-strategies used to enhance PAC-Man adoption 1 task shifting of active case finding EID and mVL testing ART initiation and back-to-care services to community health workers CHWs community nurses and HIV diagnostic assistants and 2 changing service sites to convenient locations in the community to overcome barriers to EID and mVL delivery These strategies are intended to work in concert with the above evidence-based practices to integrate PAC-Man into the EMTCT program
PAC-Man represents an integrated differentiated services delivery DSD model for mothers and infants that brings the following three evidence-based practices into the community for elimination of mother to child transmission EMTCT 1 pediatric active case finding using novel point-of-care POC early infant diagnosis EID technology 2 same-day antiretroviral therapy ART initiation for infants newly diagnosed with HIV infection and 3 maternal viral load mVL testing and back-to-care services PAC-Man uses a mobile approach to offer EMTCT services in the community and reach high risk MIPs in which the mother living with HIV did not initiate ART started ART late during pregnancy or breastfeeding dropped off treatment following ART initiation was unsuppressed on ART was identified with HIV infection for the first-time during the post-partum period andor did not return with her infant for EID testing Because these evidence-based practices are already recommended by the Ministry of Health and will be functioning at the site and not the individual level delivering the PAC-Man model will be done under the auspices of routine care applying an overarching implementation strategy of creating new mobile care teams equipped with new diagnostic technology who deploy the m-PIMA in community settings
PAC-Man Implementation Approaches
The overall implementation strategy being evaluated in this study is the creation of mobile care teams to deploy m-PIMA and provide EMTCT services in the community Complementing this overarching strategy will be two sub-strategies used to enhance PAC-Man adoption 1 task shifting of active case finding EID and mVL testing ART initiation and back-to-care services to community health workers CHWs community nurses and HIV diagnostic assistants and 2 changing service sites to convenient locations in the community to overcome barriers to EID and mVL delivery These strategies are intended to work in concert with the above evidence-based practices to integrate PAC-Man into the EMTCT program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P01HD112215 | NIH | None | None |