Study Among People Living With HIV and Their Health Professionals of Associated Factors of Resilience to Self-stigma
NCT05149001
Behavior, Blood-Borne Infections
Aix-en-Provence, France
View Trial DetailsNCT Number: NCT03388398
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.
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Notify Me16 year and older
All sexes
Observational
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
Only the study team can determine whether someone qualifies for participation.
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:
Time frame: 9-18 months after birth
Proportion of infants born to HIV-infected mothers who were HIV-infected
Time frame: 9-18 months after birth
Proportion of infants born to HIV-infected mothers who were alive and HIV-uninfected
Time frame: 19-36 months postpartum
The proportion of HIV-infected mothers who were initiated on ART and who continued ART after weaning
Time frame: 19-36 months postpartum
Average time between delivery and discontinuation of ART among those mothers who did not continue ART
Time frame: Baseline
HIV-free survival in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility
Time frame: Baseline
MTCT in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility
Time frame: Baseline
Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2017
Time frame: Baseline
Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2014
Time frame: Baseline
Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities
Time frame: 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
Time frame: 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
University of California, Berkeley
Other
Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program Option B+ in Zimbabwe
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