NCT06493357Toboroz
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 18.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 2426 (tervezett)
- Első benyújtás
- 2024. jún. 26.
- Kezdés
- 2025. márc. 27.
- Elsődleges befejezés
- 2028. márc. 31.
- Fő szponzor
- University of North Carolina, Chapel Hill
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT06493357
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 2426
- 2025. márc. 27. és az elsődleges befejezés (2028. márc. 31.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Documented transferred out from a site prior to the field survey.
- Participated previously in the field survey.
Egyéb
- None.
- The criteria for Enumerated MIP Field Survey is as follows:
- Decline informed consent.
- The criteria for In-Depth Interviews is as follows:
- 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.
Kiket keres a vizsgálat
- 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.
- 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.
A regiszterben nem jelölt feltételek
- The criteria for Enumerated MIP Cohort is as follows:
Életkor a regiszterben: 16 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Area 18 Health Centre | Lilongwe | Malawi | Toboroz |
| Bwaila Hospital | Lilongwe | Malawi | Toborzás még nem indult |
| Monkey Bay Community Hospital | Monkey Bay | Malawi | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.