Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe
NCT ID: NCT03388398
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30642 participants
OBSERVATIONAL
2012-01-31
2019-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Healthcare staff
Healthcare staff (employed staff and volunteers at least 18 years of age) at all participating healthcare facilities.
No interventions assigned to this group
Providers
Health care providers (at least 18 years of age) at select participating healthcare facilities.
No interventions assigned to this group
Patients
Patients (at least 18 years of age) receiving care at select participating healthcare facilities.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* Infant (alive or deceased) is not/would not have been 9-18 months of age at the time of the survey
* 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
* 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
* 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)
* 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
16 Years
ALL
No
Sponsors
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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)
NIH
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
University of California, Berkeley
OTHER
Responsible Party
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Principal Investigators
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Frances Cowan, MSc, MD
Role: PRINCIPAL_INVESTIGATOR
Liverpool School of Tropical Medicine, The Centre for Sexual Health and HIV/AIDS Research Zimbabwe
Nancy Padian, MPH, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
References
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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.
Other Identifiers
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