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Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi

NCT06493357

RecruitingNA

Sponsor: University of North Carolina, Chapel Hill

Conditions: HIV Prevention

Interventions: PAC-Man, Standard of Care

Countries: Malawi

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (3)

Lilongwe, Central Region, Malawi
Lilongwe, Malawi
Monkey Bay, Malawi