Mother-to-child HIV Transmission Clinical Trial
Official title:
The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
| Verified date | November 2014 |
| Source | Elizabeth Glaser Pediatric AIDS Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1216 |
| Est. completion date | December 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Rwanda | Elizabeth Glaser Pediatric AIDS Foundation | Kigali |
| Lead Sponsor | Collaborator |
|---|---|
| Elizabeth Glaser Pediatric AIDS Foundation | Ministry of Health, Rwanda, University of Rwanda |
Rwanda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women | 18 - 24 months | ||
| Secondary | HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages | 18 - 24 months | ||
| Secondary | Infants and young children breastfed (exclusive or any breastfeeding) at various ages | 18 - 24 months | ||
| Secondary | 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 |