Improving HIV care for pregnant and postpartum women and their infants in Kenya
Pilot Implementation of Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants
This study is testing a new way to provide HIV care for pregnant and new mothers in Kenya to see if it helps them and their babies stay healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 515 (estimated) |
| Ages | 1 Day and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Eldoret, Uasin Gishu) |
| Trial ID | NCT06629753 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates a differentiated service delivery (DSD) model for pregnant and postpartum women living with HIV and their infants at Huruma Sub-District Hospital in Kenya. The DSD model aims to simplify and adapt HIV services for clinically stable clients, enhancing retention in care and viral suppression while preventing mother-to-child transmission of HIV. Over 12 months, the study will recruit participants to assess the effectiveness of this approach in a resource-limited setting. Clinical staff will triage participants based on stability criteria to provide tailored services.
Who should consider this trial
Good fit: Ideal candidates include pregnant and postpartum women aged 15 and older living with HIV who are enrolled in maternal-child health services at the hospital.
Not a fit: Patients with cognitive impairments that would hinder their participation in the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve health outcomes for pregnant and postpartum women living with HIV and their infants by enhancing care retention and reducing transmission rates.
How similar studies have performed: Other studies have shown success with differentiated service delivery models in HIV care, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Eldoret, Uasin Gishu
- Huruma Sub-District Hospital — Eldoret, Uasin Gishu, Kenya (Recruiting)
Study contacts
- Study coordinator: John M Humphrey, MD
- Email: humphrjm@iu.edu
- Phone: (317) 274-8115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.