Eriytetyn hoitopisteen aktiivisen tapausten etsintä- ja hallintamallin arviointi äidistä lapselle tapahtuvan HIV-tartuntojen poistamiseksi Malawissa (PAC-Man)
UNCPM 22401 - Eriytetyn hoitopisteen aktiivisen tapausten etsintä- ja hallintamallin arviointi äidistä lapseen tapahtuvan HIV-tartunnan eliminoimiseksi Lilongwessa ja Mangochissa, Malawissa
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.
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Michael Herce, MD, MPH
- Puhelinnumero: 9198435996
- Sähköposti: michael_herce@med.unc.edu
Opiskelupaikat
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Lilongwe, Malawi
- Rekrytointi
- Area 18 Health Centre
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Ottaa yhteyttä:
- Chimwemwe Kumwenda
- Puhelinnumero: +265-999-265626
- Sähköposti: ckumwenda@unclilongwe.org
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Monkey Bay, Malawi
- Rekrytointi
- Monkey Bay Community Hospital
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Ottaa yhteyttä:
- Chimwemwe Kumwenda
- Puhelinnumero: +265-999-265626
- Sähköposti: ckumwenda@unclilongwe.org
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Central Region
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Lilongwe, Central Region, Malawi
- Ei vielä rekrytointia
- Bwaila Hospital
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Ottaa yhteyttä:
- Michael Herce, MD, MPH
- Puhelinnumero: 9198435996
- Sähköposti: michael_herce@med.unc.edu
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
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. |
|
Active Comparator: Standard of care (control arm)
Routine care as provided by the Ministry of Health. |
Routine care as provided by Ministry of Health. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of infants who receive EID testing by age 6 months
Aikaikkuna: Within 12 months of MIP enrollment in the national EMTCT program
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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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of infants who receive EID testing by age 2 months
Aikaikkuna: 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
Aikaikkuna: 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
|
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Proportion of high-risk infants who receive EID testing by age 6 months
Aikaikkuna: 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
Aikaikkuna: 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
|
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Median infant results return time
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
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Implementation - cost per unsuppressed MIP
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Michael Herce, MD, MPH, University of North Carolina, Chapel Hill
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 24-0561
- 1P01HD112215 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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-jaon aikakehys
Beginning 9 and continuing for 36 months following publication
IPD-jaon käyttöoikeuskriteerit
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
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