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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD080492-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe) | OTHER |
| Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT). | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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This study evaluates the impact of Zimbabwe's program for the prevention of mother-to-child HIV transmission (PMTCT) on vertical transmission of HIV infection and HIV-free survival among infants exposed to HIV. The study will test the hypothesis that the accelerated PMTCT program in Zimbabwe will result in fewer new HIV infections in infants and will increase infant survival.
The World Health Organization (WHO) recommends that all pregnant women receive antiretroviral therapy (ART) during pregnancy and breastfeeding ("Option B") or ideally throughout their lives regardless of clinical stage ("Option B+"). In February 2013, Zimbabwe's Ministry of Health and Child Welfare (MoHCW) declared that Zimbabwe would begin implementing Option B+ in October of 2013. This impact evaluation utilizes serial population-based, community-level surveys to comprehensively assess the prevention of mother-to-child HIV transmission strategy (PMTCT) 'Option B+' among mother-infant pairs in Zimbabwe. The investigators will assess the population-level impact of Option B+ in Zimbabwe using serial community-based cross-sectional serosurveys with data from three time points: 2012 (pre-Option A standard of care), 2014 (post-Option A / pre-Option B+), and 2017 (post Option B+ implementation) in order to monitor population-level trends in MTCT and HIV-free infant survival.
The investigators will compare outcomes among infants from 2017 to outcomes among mother-infant pairs who participated in similar surveys conducted in 2012 and 2014. These community-level data, along with in-depth facility survey data, will also allow the investigators to examine impact heterogeneity by the extent of integration of PMTCT and ART services at the facility. Together with effectiveness data from the serosurveys, facility-level resource utilization and cost data will allow assessment of Option B+ cost-effectiveness. In addition, this study will also include a population-based, community-level survey conducted in 2017 to assess retention of mothers in ART services after weaning (19-36 months postpartum). These data will allow the investigators to assess HIV-infected mothers' retention in care at the time of the survey, when most mothers will have stopped breastfeeding
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-Infant Pairs | Mothers or caregivers (at least 16 years of age) and their infants who are 9 to 18 months of age at the time of their survey. | ||
| Mothers or caregivers | Mothers or caregivers (at least 16 years of age) who are 19 to 36 months postpartum at the time of the survey. | ||
| Healthcare staff | Healthcare staff (employed staff and volunteers at least 18 years of age) at all participating healthcare facilities. | ||
| Providers | Health care providers (at least 18 years of age) at select participating healthcare facilities. | ||
| Patients | Patients (at least 18 years of age) receiving care at select participating healthcare facilities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Vertical transmission of HIV infection | Proportion of infants born to HIV-infected mothers who were HIV-infected | 9-18 months after birth |
| HIV-free survival among infants exposed to HIV | Proportion of infants born to HIV-infected mothers who were alive and HIV-uninfected | 9-18 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of mothers in antiretroviral therapy services (ART) services after weaning | The proportion of HIV-infected mothers who were initiated on ART and who continued ART after weaning | 19-36 months postpartum |
| Time between weaning and discontinuation of antiretroviral therapy services (ART) among mothers who did not continue ART after weaning |
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Inclusion Criteria Mothers-Infant pairs:
Exclusion Criteria Mothers-Infant pairs:
Inclusion Criteria Mothers/Caregivers:
Exclusion Criteria Mothers/Caregivers:
Inclusion Criteria Healthcare Staff:
Exclusion Criteria Healthcare Staff:
Inclusion Criteria Providers:
Exclusion Criteria Providers:
Inclusion Criteria Patients:
Exclusion Criteria Patients:
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All study participants will be enrolled from 157 health facilities and health facility catchment areas in Harare, Mashonaland West, Mashonaland Central, Manicaland, and Matabeleland South provinces in Zimbabwe. In Zimbabwe, the catchment area of a health facility has a radius of approximately 10 km (allowing for variation due to geography).
Healthcare staff, providers, and patients will be sampled from health facilities, while mother-infant pairs and mothers/caregivers will be sampled from health facility catchment areas.
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| Name | Affiliation | Role |
|---|---|---|
| Frances Cowan, MSc, MD | Liverpool School of Tropical Medicine, The Centre for Sexual Health and HIV/AIDS Research Zimbabwe | Principal Investigator |
| Nancy Padian, MPH, Ph.D | University of California, Berkeley | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30621615 | Derived | Koyuncu A, Dufour MK, McCoy SI, Bautista-Arredondo S, Buzdugan R, Watadzaushe C, Dirawo J, Mushavi A, Mahomva A, Cowan F, Padian N. Protocol for the evaluation of the population-level impact of Zimbabwe's prevention of mother-to-child HIV transmission program option B+: a community based serial cross-sectional study. BMC Pregnancy Childbirth. 2019 Jan 8;19(1):15. doi: 10.1186/s12884-018-2146-x. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Liverpool School of Tropical Medicine | OTHER |
| Ministry of Health and Child Welfare, Zimbabwe | OTHER |
| Elizabeth Glaser Pediatric AIDS Foundation | OTHER |
| Children's Investment Fund Foundation | OTHER |
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Dried blood spot samples
Average time between delivery and discontinuation of ART among those mothers who did not continue ART |
| 19-36 months postpartum |
| Heterogeneity of the impact of Option B+ on HIV-free survival among infants 9-18 months of age by the extent of integration of PMTCT and anti-retroviral therapy (ART) services at health facilities | HIV-free survival in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility | Baseline |
| Heterogeneity of the impact of Option B+ on mother-to-child transmission of HIV (MTCT) among infants 9-18 months of age by the extent of integration of PMTCT and anti-retroviral therapy (ART) services at health facilities | MTCT in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility | Baseline |
| Cost-effectiveness of Option B+ compared to the standard of care before Option A | Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2017 | Baseline |
| Cost-effectiveness of Option B+ compared to Option A | Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2014 | Baseline |
| Variability in health facility accesibility | Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities | Baseline |
| Variability in health facility quality of available services | Quality of available services at health facilities assessed using exit interviews with patients receiving care at health facilities, and clinical vignettes and time and motion studies with healthcare providers at health facilities | Baseline |
| Variability in health facility appropriateness of available services | Appropriateness of available HIV testing and counseling (HTC), prevention of mother-to-child transmission of HIV (PMTCT) and male circumcision (MC) services assessed using clinical vignettes with healthcare providers at health facilities | Baseline |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |