Overview

This trial is active, not recruiting.

Condition mother-to-child hiv transmission
Treatments standard of care, semi-structured interviews
Sponsor Elizabeth Glaser Pediatric AIDS Foundation
Collaborator Ministry of Health, Rwanda
Start date April 2013
End date May 2016
Trial size 1216 participants
Trial identifier NCT02295800, EGPAF0098

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
HIV Infected mothers
standard of care
semi-structured interviews
HIV exposed infants
standard of care
Facility based healthcare workers
semi-structured interviews

Primary Outcomes

Measure
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
time frame: 18 - 24 months

Secondary Outcomes

Measure
HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages
time frame: 18 - 24 months
Infants and young children breastfed (exclusive or any breastfeeding) at various ages
time frame: 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
time frame: 18 - 24 months

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
Principal investigator Emily A. Bobrow, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Elizabeth Glaser Pediatric AIDS Foundation.