Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants

NCT ID: NCT06629753

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-13
• Study Completion Date: 2025-11-04

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.

Conditions

Hiv; Transmission Vertical; Viremia; Health Care Acceptability; Health Care Utilization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DSD arm for stable clients

PPHIV who meet the following criteria will be considered stable clients: on current antiretroviral therapy ≥6 months; no active illness in the past 6 months; retained in care; viral load \<50 copies/mL within the last 6 months; age ≥18 years; not primigravida; not high-risk pregnancy. PPHIV meeting these criteria will be offered postnatal clinic visits monthly for the first 6 months followed by visits every 2-3 months, flexible ART refills, and encounters with a clinician at each visit and mentor mother as needed. Clients who do not meet these criteria will continue to receive standard-of-care services which include monthly visits and ART refills during pregnancy through 18 months postpartum.

Group Type: EXPERIMENTAL

Differentiated service delivery model

Intervention Type: BEHAVIORAL

The differentiated service delivery (DSD) intervention is a clinic-level intervention in which PMTCT clients are differentiated into those who are clinically stable or unstable, with each group offered a different package of services to meet their needs. The DSD model that is being tested in this study is an individual-focused, facility-based model designed for implementation within maternal-child health clinics offering integrated HIV services.

Interventions

Differentiated service delivery model

The differentiated service delivery (DSD) intervention is a clinic-level intervention in which PMTCT clients are differentiated into those who are clinically stable or unstable, with each group offered a different package of services to meet their needs. The DSD model that is being tested in this study is an individual-focused, facility-based model designed for implementation within maternal-child health clinics offering integrated HIV services.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ≥18 years of age

2. Able to understand English or Kiswahili

3. Works as a clinician, nurse, peer counsellor, social worker, pharmacist, or clinic supervisor involved in providing PMTCT services in the maternal-child health clinic at Huruma Sub-District Hospital

5. Woman is ≥15 years of age 6. Woman is enrolled in maternal-child health services at HSDH 7. Woman is living with HIV 8. Woman is able to understand English or Kiswahili

Exclusion Criteria

none

Eligibility criteria for PPHIV and their infants enrolled prospectively (n=500)*

Cognitive impairment that would impair participation in the study

*All infants born to enrolled women during the study will be included.

• Minimum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

John Moore Humphrey

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huruma Sub-District Hospital

Eldoret, Uasin Gishu County, Kenya

Countries

Kenya

Other Identifiers

K23HD105495

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23897

Identifier Type: -

Identifier Source: org_study_id