Clinical trial NCT06629753: Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
Official title: Pilot Implementation of Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-10-08
Enrollment: 515
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Eligibility criteria for providers:

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

Exclusion Criteria:

none

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

Inclusion Criteria:

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:

Cognitive impairment that would impair participation in the study

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

Primary outcomes:
measure: Number of barriers and facilitators to DSD implementation
timeFrame: One month before implementation of the DSD model in the clinic
measure: Median difference in number of minutes of PMTCT appointment duration before versus after DSD implementation
timeFrame: One month before and 6 months after implementation of the DSD model in the clinic
measure: Reach
timeFrame: One month before and 6 months after implementation of the DSD model in the clinic
measure: Effectiveness, clinic operations level
timeFrame: One month before and during the 12-month period of DSD implementation in the clinic
measure: Proportion of participants who are virally suppressed <50 copies/mL
timeFrame: One month before and during the 12-month period of DSD implementation in the clinic
measure: Proportion of children alive and HIV negative
timeFrame: One month before and during the 12-month period of DSD implementation in the clinic
measure: Proportion of participants retained in care
timeFrame: One month before and during the 12-month period of DSD implementation in the clinic
measure: Proportion of healthcare workers who adopt the DSD model
timeFrame: During the 12-month period of DSD implementation in the clinic
measure: Proportion of PMTCT clients triaged correctly according to the DSD model
timeFrame: During the initial 6 months of DSD implementation in the clinic
measure: Proportion of providers affirming the feasibility of the DSD model
timeFrame: During the 12-month period of DSD implementation in the clinic
measure: Proportion of providers who perceive the DSD model to be acceptable
timeFrame: During the 12-month period of DSD implementation in the clinic
measure: Proportion of PMTCT clients triaged correctly according to the DSD model at 12 months
timeFrame: At 12 months following the start of DSD implementation in the clinic
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Huruma Sub-District Hospital
state: Uasin Gishu
Study officials:
References: