Clinical trial NCT03388398: Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe
Official title: Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program Option B+ in Zimbabwe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Mother-to-child transmission of HIV (MTCT)
Prevention of mother-to-child HIV transmission (PMTCT)
Antiretroviral therapy (ART)
Antenatal care (ANC)
Pediatric infections
Pregnancy
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
name: Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Liverpool School of Tropical Medicine
name: Ministry of Health and Child Welfare, Zimbabwe
name: Elizabeth Glaser Pediatric AIDS Foundation
name: Children's Investment Fund Foundation
First posted: 2018-01-03
Enrollment: 30642
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Vertical transmission of HIV infection
timeFrame: 9-18 months after birth
measure: HIV-free survival among infants exposed to HIV
timeFrame: 9-18 months after birth
Secondary outcomes:
measure: Retention of mothers in antiretroviral therapy services (ART) services after weaning
timeFrame: 19-36 months postpartum
measure: Time between weaning and discontinuation of antiretroviral therapy services (ART) among mothers who did not continue ART after weaning
timeFrame: 19-36 months postpartum
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Cost-effectiveness of Option B+ compared to the standard of care before Option A
timeFrame: Baseline
measure: Cost-effectiveness of Option B+ compared to Option A
timeFrame: Baseline
measure: Variability in health facility accesibility
timeFrame: Baseline
measure: Variability in health facility quality of available services
timeFrame: Baseline
measure: Variability in health facility appropriateness of available services
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Liverpool School of Tropical Medicine, The Centre for Sexual Health and HIV/AIDS Research Zimbabwe
name: Frances Cowan, MSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Berkeley
name: Nancy Padian, MPH, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.