Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe
- Conditions
- HIV Infections
- Registration Number
- NCT03388398
- Lead Sponsor
- University of California, Berkeley
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30642
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vertical transmission of HIV infection 9-18 months after birth Proportion of infants born to HIV-infected mothers who were HIV-infected
HIV-free survival among infants exposed to HIV 9-18 months after birth Proportion of infants born to HIV-infected mothers who were alive and HIV-uninfected
- Secondary Outcome Measures
Name Time Method Retention of mothers in antiretroviral therapy services (ART) services after weaning 19-36 months postpartum The proportion of HIV-infected mothers who were initiated on ART and who continued ART after weaning
Time between weaning and discontinuation of antiretroviral therapy services (ART) among mothers who did not continue ART after weaning 19-36 months postpartum Average time between delivery and discontinuation of ART among those mothers who did not continue ART
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 Baseline HIV-free survival in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility
Variability in health facility appropriateness of available services Baseline 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
Cost-effectiveness of Option B+ compared to the standard of care before Option A Baseline Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2017
Variability in health facility quality of available services Baseline 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
Cost-effectiveness of Option B+ compared to Option A Baseline Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2014
Variability in health facility accesibility Baseline Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities
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 Baseline MTCT in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility