이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

말라위에서 모자간 HIV 전파를 근절하기 위한 차별화된 현장 진료 활성 사례 찾기 및 관리 모델 평가 (PAC-Man)

2026년 9월 17일 업데이트: University of North Carolina, Chapel Hill

UNCPM 22401 - 말라위 릴롱웨와 망고치에서 HIV 모자 전파 근절을 위한 차별화된 현장 진료 활성 사례 찾기 및 관리 모델 평가

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

2426

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 말라위
      • Lilongwe, 말라위
        • 모병
        • Area 18 Health Centre
        • 연락하다:
      • Monkey Bay, 말라위
        • 모병
        • Monkey Bay Community Hospital
        • 연락하다:
    • Central Region
      • Lilongwe, Central Region, 말라위
        • 아직 모집하지 않음
        • Bwaila Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
활성 비교기: Standard of care (control arm)

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

Routine care as provided by Ministry of Health.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of infants who receive EID testing by age 6 months
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of infants who receive EID testing by age 2 months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of North Carolina, Chapel Hill

협력자

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

수사관

  • 수석 연구원: Michael Herce, MD, MPH, University of North Carolina, Chapel Hill

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 3월 27일

기본 완료 (추정된)

2028년 3월 31일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2024년 6월 26일

QC 기준을 충족하는 최초 제출

2024년 7월 8일

처음 게시됨 (실제)

2024년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 24-0561
  • 1P01HD112215 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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).

IPD 공유 기간

Beginning 9 and continuing for 36 months following publication

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다