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Hodnocení diferencovaného modelu aktivního vyhledávání případů a řízení v místě péče k eliminaci přenosu HIV z matky na dítě v Malawi (PAC-Man)

17. září 2026 aktualizováno: University of North Carolina, Chapel Hill

UNCPM 22401 – Vyhodnocení diferencovaného modelu aktivního vyhledávání případů a řízení v místě péče pro eliminaci přenosu HIV z matky na dítě v Lilongwe a Mangochi, 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

2426

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Malawi
      • Lilongwe, Malawi
        • Nábor
        • Area 18 Health Centre
        • Kontakt:
      • Monkey Bay, Malawi
        • Nábor
        • Monkey Bay Community Hospital
        • Kontakt:
    • Central Region
      • Lilongwe, Central Region, Malawi
        • Zatím nenabíráme
        • Bwaila Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

16 let a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PAC-Man Model

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.
Behaviorální: 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 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.
Aktivní komparátor: Standard of care (control arm)

Routine care as provided by the Ministry of Health.
Behaviorální: Standard of Care

Routine care as provided by Ministry of Health.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of infants who receive EID testing by age 6 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of infants who receive EID testing by age 2 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who receive EID testing by age 12 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk infants who receive EID testing by age 6 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants newly diagnosed with HIV who initiate ART ≤60 days from EID sample collection among the enumerated cohort of all infants.
Within 12 months of MIP enrollment in the national EMTCT program
Median infant results return time
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Median number of days from infant EID sample collection to results returned to caregivers.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants newly diagnosed with HIV
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants newly diagnosed with HIV among the enumerated cohort of all infants.
Within 12 months of MIP enrollment in the national EMTCT program
Median age at ART initiation among infants
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Median age in months at ART initiation among infants who test positive for HIV.
Within 12 months of MIP enrollment in the national EMTCT program
Median time to ART initiation among infants
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Median number of days to ART initiation among infants who test positive for HIV.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of infants who initiate ART the same day as diagnosis
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
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
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants with HIV who are retained in care at 3-months post-ART initiation.
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
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of infants with HIV who are retained in care at 6-months post-ART initiation.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs reached with viral load testing
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs reached with viral load testing
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 6 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 6 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs virally suppressed at 12 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of high-risk MIPs virally suppressed at 12 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 6 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs retained in care at 12 months
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who resumed ART
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

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.
Within 12 months of MIP enrollment in the national EMTCT program
Proportion of MIPs who received enhanced adherence counseling
Časové okno: Within 12 months of MIP enrollment in the national EMTCT program

Proportion of MIPs who had unsuppressed viral load and then completed enhanced adherence counselling among the enumerated cohort of all MIPs.
Within 12 months of MIP enrollment in the national EMTCT program
Adoption - proportion of sites that adopt the PAC-Man model
Časové okno: 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)

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.
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
Časové okno: 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)

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.
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
Časové okno: 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)

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.
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
Časové okno: 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)

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.
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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of North Carolina, Chapel Hill

Spolupracovníci

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Michael Herce, MD, MPH, University of North Carolina, Chapel Hill

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. března 2025

Primární dokončení (Odhadovaný)

31. března 2028

Dokončení studie (Odhadovaný)

31. března 2028

Termíny zápisu do studia

První předloženo

26. června 2024

První předloženo, které splnilo kritéria kontroly kvality

8. července 2024

První zveřejněno (Aktuální)

10. července 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 24-0561
  • 1P01HD112215 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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).

Časový rámec sdílení IPD

Beginning 9 and continuing for 36 months following publication

Kritéria přístupu pro sdílení IPD

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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