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| Name | Class |
|---|---|
| Ministry of Health, Rwanda | OTHER_GOV |
| University of Rwanda | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mothers | HIV Infected mothers |
| |
| Infants | HIV exposed infants |
| |
| Healthcare workers | Facility based healthcare workers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other |
| ||
| Semi-structured interviews |
| Measure | Description | Time Frame |
|---|---|---|
| 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women | 18 - 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages | 18 - 24 months | |
| Infants and young children breastfed (exclusive or any breastfeeding) at various ages | 18 - 24 months |
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Inclusion Criteria:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Emily A. Bobrow, PhD, MPH | Elizabeth Glaser Pediatric AIDS Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elizabeth Glaser Pediatric AIDS Foundation | Kigali | BP 2788 | Rwanda |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Plasma specimens collected from the adult participants at the time of viral load testing and dried blood spot (DBS) specimens drawn from the infant participants.
| Other |
|
| 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 |