Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629753
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Implementation of Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Differentiated service delivery DSD is an evidence-based HIV care and treatment model endorsed by the World Health Organization WHO that simplifies HIV services for clients who are clinically stable improving the quality and efficiency of HIV services The goal of this implementation-effectiveness pilot study is to evaluate the implementation of a DSD model for pregnant and postpartum women living with HIV and their infants enrolled in care at Huruma Sub-District Hospital in Kenya
Detailed Description:
For pregnant and postpartum women living with HIV PPHIV in resource-limited settings maintaining retention in care and viral suppression and preventing mother-to-child transmission of HIV are major implementation challenges in the PMTCT cascade The goal of this study is to execute and evaluate the implementation of a differentiated service delivery DSD model for PMTCT to address these challenges Specifically this is a pilot study that will evaluate the implementation of a DSD model for PMTCT in a resource-constrained setting in Kenya The objective of the DSD model is to improve retention in care and viral suppression for PPHIV In the DSD approach clinical services are simplified and adapted to the needs and preferences of clients who are clinically stable allowing the health system to provide intensified services to the clients who unstable according to their needs Set clinical criteria will be used to determine which PPHIV and their HIV-exposed children are clinically stable and which are unstable The DSD model will be implemented at Huruma Sub-District Hospital in western Kenya which offers integrated PMTCT services Over a period of 12 months all PPHIV that attend this clinic will be recruited to participate in the DSD model as part of the study The clinical staff will be responsible for triaging PPHIV and their children as stable or unstable according to the DSD eligibility criteria The implementation success of the DSD model will be determined using the RE-AIM implementation outcomes This will involve semi-structured interviews with PPHIV and focus group discussions with PMTCT providers participating in the model Time-motion analysis and medical record review will also be performed to better understand the implementation process and data needed in preparation a future implementation-effectiveness clinical trial Commensurate with the scope of this pilot implementation study participants will not be randomized and there will not be a required minimum sample size The findings from this study will serve as a foundation for a future large-scale trial to test the effectiveness and implementation of the DSD model for PMTCT in a resource-limited setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None