Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program Option B+ in Zimbabwe

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Mothers-Infant pairs: Mother or caregiver is 16 years of age or older Delivered or provides care for an infant (alive or deceased) who is or who would have been 9-18 months of age at the time of the survey Able and willing to provide written informed consent Exclusion Criteria Mothers-Infant pairs: Mother or caregiver is younger than 16 years of age Infant (alive or deceased) is not/would not have been 9-18 months of age at the time of the survey Inclusion Criteria Mothers/Caregivers: At least 16 years of age or older Delivered an infant (alive or deceased) who is or who would have been 19-36 months of age at the time of the survey Able and willing to provide written informed consent Exclusion Criteria Mothers/Caregivers: Mother or caregiver is younger than 16 years of age Infant (alive or deceased) is not/would not have been 19-36 months of age at the time of the survey Inclusion Criteria Healthcare Staff: At least 18 years of age or older Currently providing PMTCT services at one of the 157 selected facilities Able and willing to provide written informed consent Exclusion Criteria Healthcare Staff: Health care staff is younger than 18 years of age Health care staff is not currently providing PMTCT services at one of the 157 selected facilities Inclusion Criteria Providers: At least 18 years of age or older Currently providing ANC or ART care directly to clients at one of the 20 purposefully selected facilities Splitting time as a provider between one or more of the following HIV services: HIV testing and counseling (HTC), prevention of mother-to-child transmission (PMTCT), and male circumcision (MC) Able and willing to provide written informed consent Exclusion Criteria Providers: Provider is younger than 18 years of age Currently not providing ART care directly to clients at one of the 20 purposefully selected facilities Does not split time as a provider between one or more of the following HIV services: HIV testing and counseling (HTC), prevention of mother-to-child HIV transmission (PMTCT), and male circumcision (MC) Inclusion Criteria Patients: At least 18 years of age or older Received HIV testing and counseling (HTC), prevention of mother-to-child HIV transmission (PMTCT), or male circumcision (MC) services at one of the 20 purposefully selected facilities on the day of the interview Able and willing to provide verbal consent Exclusion Criteria Patients: Patient is younger than 18 years of age Did not receive HIV testing and counseling (HTC), prevention of mother-to-child HIV transmission (PMTCT), or male circumcision (MC) services at one of the 20 purposefully selected facilities on day of interview

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother-Infant Pairs<br>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<br>Mothers or caregivers (at least 16 years of age) who are 19 to 36 months postpartum at the time of the survey. | |
| Healthcare staff<br>Healthcare staff (employed staff and volunteers at least 18 years of age) at all participating healthcare facilities. | |
| Providers<br>Health care providers (at least 18 years of age) at select participating healthcare facilities. | |
| Patients<br>Patients (at least 18 years of age) receiving care at select participating healthcare facilities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mother-to-child transmission of HIV (MTCT), Prevention of mother-to-child HIV transmission (PMTCT), Antiretroviral therapy (ART), Antenatal care (ANC), Pediatric infections, Pregnancy