Clinical trial NCT02295800: The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
Official title: The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mother-to-child HIV Transmission
Keywords: HIV
PMTCT
Antenatal Care
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Rwanda
name: University of Rwanda
First posted: 2014-11-20
Enrollment: 1216
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women identified as HIV infected during antenatal care and receiving PMTCT services (regardless of ARV regimen received) in the selected antenatal clinics in Kigali, Rwanda are eligible for study enrollment. The infants born to enrolled study women during the study pregnancy will also be study participants up to the age of 18 - 24 months.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
timeFrame: 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
timeFrame: 18 - 24 months
measure: Infants and young children breastfed (exclusive or any breastfeeding) at various ages
timeFrame: 18 - 24 months
measure: 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
timeFrame: 18 - 24 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Emily A. Bobrow, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: