An interventional study of PAC-Man and Standard of Care in HIV Prevention, sponsored by University of North Carolina, Chapel Hill. Recruiting at 3 sites in Malawi. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:
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.
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.
University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria for Enumerated MIP Cohort is as follows:
Inclusion Criteria:
Exclusion Criteria:
The criteria for Enumerated MIP Field Survey is as follows:
Inclusion Criteria:
Exclusion Criteria:
The criteria for In-Depth Interviews is as follows:
Inclusion criteria:
Exclusion criteria:
The criteria for Focus Group Discussions is as follows:
Inclusion criteria:
Exclusion criteria:
The criteria for Key Informant Interviews is as follows:
Inclusion criteria:
Exclusion criteria:
The criteria for Implementation Actor Questionnaires is as follows:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
Behavioral: PAC-Man
Routine care as provided by the Ministry of Health.
Behavioral: Standard of Care
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 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.
Routine care as provided by Ministry of Health.
Proportion of infants who receive EID testing by age 6 months
Proportion of infants exposed to HIV who receive EID testing by age 6 months among the enumerated cohort of MIPs with infants at least 6 weeks old at all study sites.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who receive EID testing by age 2 months
Proportion of infants exposed to HIV who receive EID testing by age 2 months among the enumerated cohort of all MIPs with infants at least 6 weeks old at all study sites.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who receive EID testing by age 12 months
Proportion of infants exposed to HIV who receive EID testing by age 12 months among the enumerated cohort of all MIPs with infants at least 6 weeks old at all study sites.
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
Proportion of infants with high-risk mothers exposed to HIV who receive EID testing by age 6 months among all high-risk MIPs with infants at least 6 weeks old at all study sites.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART
Proportion of infants newly diagnosed with HIV who initiate ART ≤60 days from EID sample collection among the enumerated cohort of all infants.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Median infant results return time
Median number of days from infant EID sample collection to results returned to caregivers.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants newly diagnosed with HIV
Proportion of infants newly diagnosed with HIV among the enumerated cohort of all infants.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Median age at ART initiation among infants
Median age in months at ART initiation among infants who test positive for HIV.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Median time to ART initiation among infants
Median number of days to ART initiation among infants who test positive for HIV.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART the same day as diagnosis
Proportion of infants newly diagnosed with HIV who initiate ART on the same day as EID results received among the enumerated cohort of all infants.
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
Proportion of infants with HIV who are 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
Proportion of infants with HIV who are 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
Proportion of mothers living with HIV who received MOH-recommended 6-monthly VL testing during pregnancy and breastfeeding among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs reached with viral load testing
Proportion of high-risk MIPs living with HIV who received MOH-recommended 6-monthly VL testing during pregnancy and breastfeeding among all high-risk MIPs from the enumerated cohort.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 6 months
Proportion of mothers with viral suppression (\<1,000 copies of HIV per ml.) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 6 months
Proportion of high-risk mothers with viral suppression (\<1,000 copies of HIV per ml.) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 12 months
Proportion of mothers with viral suppression (\<1,000 copies of HIV per ml.) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 12 months
Proportion of high-risk mothers with viral suppression (\<1,000 copies of HIV per ml.) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 6 months
Proportion of mothers who are retained in care (≥1 clinic encounter within the last 180 days) at 6 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 12 months
Proportion of mothers who are retained in care (≥1 clinic encounter within the last 180 days) at 12 months after EMTCT enrollment among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who resumed ART
Proportion of mothers who had documented treatment interruption (i.e., a treatment gap ≥28 days) who later resumed ART among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who received enhanced adherence counseling
Proportion of MIPs who had unsuppressed viral load and then completed enhanced adherence counselling among the enumerated cohort of all MIPs.
Time frame: Within 12 months of MIP enrollment in the national EMTCT program
Adoption - proportion of sites that adopt the PAC-Man model
Number of trained sites that deliver the PAC-Man intervention divided by the total number of trained sites. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
Time frame: 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)
Adoption - proportion of providers who adopt the PAC-Man model
Number of trained providers who deliver the PAC-Man intervention divided by the total number of trained providers. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
Time frame: 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)
Implementation - cost per pediatric case
Incremental cost of PAC-Man implementation per pediatric HIV case identified, compared to standard of care. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
Time frame: 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)
Implementation - cost per unsuppressed MIP
Incremental cost of PAC-Man implementation per pregnant and breastfeeding woman with unsuppressed viral load identified, compared to standard of care. Study endline sustainability survey is conducted at the end of the trial once all study sites have been randomized to receive the intervention.
Time frame: 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)
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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