The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV

Completed

• Conditions: Mother-to-child HIV Transmission
• Interventions: Other: Standard of care; Other: Semi-structured interviews

• Registration Number: NCT02295800
• Lead Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

Brief Summary

The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed until the infants reach the age of 18 - 24 months and semi-structure interviews with a sub-set of these women. A second study component involves semi-structured interviews with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the selected study facilities.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-10-15
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1216

Inclusion Criteria

• Documented HIV infection
• Pregnant, in the last trimester of pregnancy or within two weeks post-delivery.
• Participation in the PMTCT program during antenatal care at one of the study sites
• Planning on remaining in the Kigali area after delivery
• Able and willing to give informed consent for study participation for herself and her infant(s).

If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents

Exclusion Criteria

• Women not willing to provide informed consent to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mothers	Standard of care	HIV Infected mothers
Mothers	Semi-structured interviews	HIV Infected mothers
Infants	Standard of care	HIV exposed infants
Healthcare workers	Semi-structured interviews	Facility based healthcare workers

Primary Outcome Measures

Name	Time	Method
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women	18 - 24 months

Secondary Outcome Measures

Name	Time	Method
Infants and young children breastfed (exclusive or any breastfeeding) at various ages	18 - 24 months
HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages	18 - 24 months
Adherence to the universal antiretroviral therapy (ARV) regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children, including the proportion of study women with HIV RNA < 1000 copies/ml or > 2 log10 copies/mL decrease in viral	18 - 24 months

Trial Locations

Locations (1)

Elizabeth Glaser Pediatric AIDS Foundation; 🇷🇼 Kigali, Rwanda