Clinical trial NCT06493357: Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: HIV Treatment
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: 2024-07-10
Enrollment: 2426
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 2,426, including 2,304 mother-infant pair (MIP) survey participants, 48 high-risk pregnant/breastfeeding 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)/ President's 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 (i.e., the SOC) to intervention (i.e., 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, and/or 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.

Eligibility criteria: The criteria for Enumerated MIP Cohort is as follows:

Inclusion Criteria:

* Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.

Exclusion Criteria:

* None.

The criteria for Enumerated MIP Field Survey is as follows:

Inclusion Criteria:

* Age 16 years or older.
* Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.

Exclusion Criteria:

* Documented transferred out from a site prior to the field survey.
* Participated previously in the field survey.
* Decline informed consent.

The criteria for In-Depth Interviews is as follows:

Inclusion criteria:

* Age 16 years or older.
* Met high-risk criteria for PAC-Man model.
* Participated in a field survey.

Exclusion criteria:

* Decline informed consent.

The criteria for Focus Group Discussions is as follows:

Inclusion criteria:

* Age 18 years or older.
* MOH or implementing partner professional or lay health worker at a study site (such as nurses, community health workers, health surveillance assistants, and HIV diagnostic assistants)
* Generally familiar with the PAC-Man model and/or EMTCT/ EID service delivery at their site.

Exclusion criteria:

* Decline informed consent.

The criteria for Key Informant Interviews is as follows:

Inclusion criteria:

* Age 18 years or older.
* HIV/ EMTCT policy maker OR MOH/ PEPFAR implementing partner senior manager.
* Generally familiar with HIV and/or EMTCT/ EID service delivery.

Exclusion criteria:

* Decline informed consent.

The criteria for Implementation Actor Questionnaires is as follows:

Inclusion criteria:

* Age 18 years or older.
* Professional or lay health provider at a study site.
* Generally familiar with HIV and/or EMTCT/ EID service delivery at their site.
* Participated in a focus group discussion.

Exclusion criteria:

* Decline informed consent.

Primary outcomes:
measure: Proportion of infants who receive EID testing by age 6 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
Secondary outcomes:
measure: Proportion of infants who receive EID testing by age 2 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants who receive EID testing by age 12 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of high-risk infants who receive EID testing by age 6 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants who initiate ART
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Median infant results return time
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants newly diagnosed with HIV
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Median age at ART initiation among infants
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Median time to ART initiation among infants
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants who initiate ART the same day as diagnosis
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants with HIV retained in care at 3 months post-ART initiation
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of infants with HIV retained in care at 6 months post-ART initiation
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs reached with viral load testing
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of high-risk MIPs reached with viral load testing
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs virally suppressed at 6 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of high-risk MIPs virally suppressed at 6 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs virally suppressed at 12 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of high-risk MIPs virally suppressed at 12 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs retained in care at 6 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs retained in care at 12 months
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs who resumed ART
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Proportion of MIPs who received enhanced adherence counseling
timeFrame: Within 12 months of MIP enrollment in the national EMTCT program
measure: Adoption - proportion of sites that adopt the PAC-Man model
timeFrame: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
measure: Adoption - proportion of providers who adopt the PAC-Man model
timeFrame: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
measure: Implementation - cost per pediatric case
timeFrame: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
measure: Implementation - cost per unsuppressed MIP
timeFrame: 6-12 months after sites switch to intervention; study endline (Approximately 12 months from the time that last study sites are switched to the intervention)
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Bwaila Hospital
state: Central Region
city: Lilongwe
country: Malawi
facility: Area 18 Health Centre
city: Monkey Bay
country: Malawi
facility: Monkey Bay Community Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Herce, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: