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

NCT06629753 | Completed DMC

• 2 other identifiers: 23897K23HD105495
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

prevention of mother-to-child transmission; retention; service delivery; maternal-child health; Kenya

Outcome Measures

Primary Outcomes (12)

• Number of barriers and facilitators to DSD implementation

  The primary outcome for the analysis in Aim 1 (i.e., the pre-implementation phase) of this study will be the number of barriers/facilitators to implementation as elicited through rapid qualitative analysis of the pre-implementation workshop transcripts

  One month before implementation of the DSD model in the clinic

• Median difference in number of minutes of PMTCT appointment duration before versus after DSD implementation

  The outcome of interest in this analysis will be the difference in clinic encounter durations (i.e., encounters with clinicians, mentor mother) between clients who are classified as stable versus unstable according to the DSD eligibility criteria, as measured through direct observation and time-motion analysis before an after DSD implementation

  One month before and 6 months after implementation of the DSD model in the clinic

• Reach

  The proportion of eligible WLH who sign consent to participate in the study among the total number of WLH who attend the PMTCT clinic during the recruitment periods.

  One month before and 6 months after implementation of the DSD model in the clinic

• Effectiveness, clinic operations level

  The primary outcome will be a ≥20% median reduction in the total clinic visit duration for stable clients compared to their pre-implementation baseline.

  One month before and during the 12-month period of DSD implementation in the clinic

• Proportion of participants who are virally suppressed <50 copies/mL

  Maternal viral suppression will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.

  One month before and during the 12-month period of DSD implementation in the clinic

• Proportion of children alive and HIV negative

  HIV-free child survival will be assessed among all children of enrolled WLH from birth to 6, 7-12, and 13-18 months postpartum.

  One month before and during the 12-month period of DSD implementation in the clinic

• Proportion of participants retained in care

  Retention in care will be assessed among all WLH after enrollment in the study during pregnancy and from delivery to 6 months postpartum, 7-12, and 13-18 months postpartum.

  One month before and during the 12-month period of DSD implementation in the clinic

• Proportion of healthcare workers who adopt the DSD model

  The degree to which the clinic commits to and takes on the DSDp model, determined through rapid qualitative analysis of audit/feedback workshop transcripts conducted during the implementation phase

  During the 12-month period of DSD implementation in the clinic

• Proportion of PMTCT clients triaged correctly according to the DSD model

  The proportion of PMTCT clients triaged correctly according to the DSD model eligibility criteria.

  During the initial 6 months of DSD implementation in the clinic

• Proportion of patients who perceive the DSD model to be acceptable

  How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.

  During the 12-month period of DSD implementation in the clinic

• Proportion of PMTCT clients triaged correctly according to the DSD model at 12 months

  The extent to which a program is part of routine organizational practice, measured through a final time motion analysis and chart review among enrolled participants, conducted over 10 consecutive working days at 6 months at the end of the implementation phase at 12 months

  At 12 months following the start of DSD implementation in the clinic

• Proportion of providers who perceive the DSD model to be acceptable

  How satisfactory or agreeable the DSD model is perceived by its end-users, assessed through structured questionnaires administered to patients and providers.

  During the 12-month period of DSD implementation in the clinic

Other Outcomes (1)

• Proportion of providers affirming the feasibility of the DSD model

  During the 12-month period of DSD implementation in the clinic

Study Arms (1)

DSD arm for stable clients

EXPERIMENTAL

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.

Behavioral: Differentiated service delivery model

Interventions

Differentiated service delivery model 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.

DSD arm for stable clients

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Able to understand English or Kiswahili
• 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

You may not qualify if:

• none
• Eligibility criteria for PPHIV and their infants enrolled prospectively (n=500)\*
• \. 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
• Cognitive impairment that would impair participation in the study
• \*All infants born to enrolled women during the study will be included.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Indiana University: lead

Study Sites (1)

Huruma Sub-District Hospital

Eldoret, Uasin Gishu County, 30100, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Viremia; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: PPHIV and their children identified who are clinically stable will be differentiated to a care pathway that provides simplified PMTCT services that are adapted to their needs and preferences. PPHIV and their children who are clinically unstable will be differentiated to a care pathway that provides intensified PMTCT services.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: September 13, 2024
• Primary Completion: January 30, 2026
• Study Completion: March 5, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)