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

Overview

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.

Interventions

• Behavioral PAC-Man
  PAC-Man represents an integrated DSD model for mothers and infants that brings the following three evidence-based practices into the community for EMTCT: 1) pediatric active case finding using novel POC EID technology; 2) same-day ART initiation for infants newly diagnosed with HIV infection; and 3) 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. Delivering the PAC-Man model will be done under the auspices
• Behavioral Standard of Care
  Routine care as provided by Ministry of Health.

Primary outcome measures

• Proportion of infants who receive EID testing by age 6 months [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]

Secondary outcome measures (12)

• Proportion of infants who receive EID testing by age 2 months [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants who receive EID testing by age 12 months [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of high-risk infants who receive EID testing by age 6 months [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants who initiate ART [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Median infant results return time [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants newly diagnosed with HIV [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Median age at ART initiation among infants [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Median time to ART initiation among infants [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants who initiate ART the same day as diagnosis [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants with HIV retained in care at 3 months post-ART initiation [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of infants with HIV retained in care at 6 months post-ART initiation [Time frame: Within 12 months of MIP enrollment in the national EMTCT program]
• Proportion of MIPs reached with viral load testing [Time frame: Within 12 months of MIP enrollment in the national 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Malawi · 3 centers

• Bwaila Hospital — Lilongwe
• Area 18 Health Centre — Lilongwe
• Monkey Bay Community Hospital — Monkey Bay

Publications

• Herce ME, Cassidy C, Munson A, Edwards JK, Rutstein SE, Matoga M, Kumwenda C, Simon KR, van Oosterhout JJ, Cox CM, Kamanga F, Kumwenda W, Phiri S, Rambiki E, Thawani A, Huwa J, Malewezi B, Mvalo T, Bula A, Chinula L, Hoffman I, Squibb MA, Nyirenda RK, Saidi F, Hosseinipour MC, Chagomerana MB. Study design and procedures for a hybrid effectiveness-implementation incomplete stepped-wedge cluster-ran PMID 40721832

Identifiers

NCT: NCT06493357 · 24-0561 · 1P01HD112215

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗