HIV PreventionPAC-ManNCT06493357
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
A study testing PAC-Man in people with HIV Prevention, run by University of North Carolina, Chapel Hill at 3 sites in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- PAC-Man
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,426 participants
- Where
- 3 sitesMalawi
- Study dates
- 27 Mar 2025to 31 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.
- Age 16 years or older.
- Enrolled in the national EMTCT program at a study site in the 12 months preceding a survey.
- Age 16 years or older.
- Met high-risk criteria for PAC-Man model.
- Participated in a field survey.
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- 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.
- 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.
- 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.
Who cannot join
- None.
- The criteria for Enumerated MIP Field Survey is as follows:
- 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:
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- Decline informed consent.
- The criteria for Focus Group Discussions is as follows:
- Decline informed consent.
- The criteria for Key Informant Interviews is as follows:
- Decline informed consent.
- The criteria for Implementation Actor Questionnaires is as follows:
- Decline informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi3 sites, 3 recruiting
- Not yet recruiting
Bwaila Hospital
Lilongwe, Central Region
Michael Herce, MD, MPH, 9198435996, michael_herce@med.unc.edu
- Recruiting
Area 18 Health Centre
Lilongwe
Chimwemwe Kumwenda, +265-999-265626, ckumwenda@unclilongwe.org
- Recruiting
Monkey Bay Community Hospital
Monkey Bay
Chimwemwe Kumwenda, +265-999-265626, ckumwenda@unclilongwe.org
About this study
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
Purpose: To conduct a hybrid effectiveness-implementation stepped-wedge trial to:
- Estimate the effect of the PAC-Man model, compared to SOC, on the proportion of infants who receive timely EID testing.
- 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.
- Compare implementation outcomes between the PAC-Man model and SOC.
Read more
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.
Read the 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.
- Conditions
- HIV Prevention
- Being tested
- PAC-Man, Standard of Care
- Keywords
- HIV Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-ManBehavioural
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.
Standard of CareBehavioural
Routine care as provided by Ministry of Health.
| Study group | Role | What they receive |
|---|---|---|
| PAC-Man Model | Experimental | 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. Receives: Behavioral: PAC-Man |
| Standard of care (control arm) | Active comparator | Routine care as provided by the Ministry of Health. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months of MIP enrollment in the national EMTCT program
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start27 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michael Herce, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493357
- Sponsor's protocol ID
- 24-0561
- Other IDs
- 1P01HD112215
- Acronym
- PAC-Man
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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-randomized trial to evaluate a differentiated point-of-care HIV diagnosis and management model for the prevention of vertical transmission of HIV in Malawi: The PAC-Man trial protocol. Implement Sci Commun. 2025 Jul 28;6(1):78. doi: 10.1186/s43058-025-00762-5.
PubMed 40721832