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โ† Trials
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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

RecruitingNAAges 16 Years - anyAllUniversity of North Carolina, Chapel Hill
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In plain words

What the trial is, and whether it could suit you

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 prof

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • PAC-Man
  • Standard of Care
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Where

3 sites
Bwaila Hospital
Lilongwe, Malawi
Area 18 Health Centre
Lilongwe, Malawi
Monkey Bay Community Hospital
Monkey Bay, Malawi
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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