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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: Mother-to-child HIV Transmission

Treatments: Other: Semi-structured interviews; Other: Standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT02295800

EGPAF0098

Details and patient eligibility

About

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.

Enrollment: 1,216 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,216 participants in 3 patient groups

Mothers

Description:

HIV Infected mothers

Treatment:

Other: Semi-structured interviews

Other: Standard of care

Infants

Description:

HIV exposed infants

Treatment:

Other: Standard of care

Healthcare workers

Description:

Facility based healthcare workers

Treatment:

Other: Semi-structured interviews