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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02295800
Acronym
Kabeho
Enrollment
1216
Registered
2014-11-20
Start date
2013-04-01
Completion date
2016-12-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-to-child HIV Transmission

Keywords

HIV, PMTCT, Antenatal Care

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.

Interventions

OTHERStandard of care
OTHERSemi-structured interviews

Sponsors

Elizabeth Glaser Pediatric AIDS Foundation
Lead SponsorOTHER
Ministry of Health, Rwanda
CollaboratorOTHER_GOV
University of Rwanda
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women18 - 24 months

Secondary

MeasureTime frame
HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages18 - 24 months
Infants and young children breastfed (exclusive or any breastfeeding) at various ages18 - 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 viral18 - 24 months

Countries

Rwanda

Contacts

PRINCIPAL_INVESTIGATOREmily A. Bobrow, PhD, MPH

Elizabeth Glaser Pediatric AIDS Foundation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026