Skip to main content
OpenTrials
Completed

NCT Number: NCT03388398

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Vertical transmission of HIV infection

    Time frame: 9-18 months after birth

    Proportion of infants born to HIV-infected mothers who were HIV-infected

  2. HIV-free survival among infants exposed to HIV

    Time frame: 9-18 months after birth

    Proportion of infants born to HIV-infected mothers who were alive and HIV-uninfected

Secondary outcomes

  1. Retention of mothers in antiretroviral therapy services (ART) services after weaning

    Time frame: 19-36 months postpartum

    The proportion of HIV-infected mothers who were initiated on ART and who continued ART after weaning

  2. Time between weaning and discontinuation of antiretroviral therapy services (ART) among mothers who did not continue 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

  3. 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

    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

  4. 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

    Time frame: Baseline

    MTCT in health facility catchment areas stratified by the extent of integration of PMTCT and ART services at the health facility

  5. Cost-effectiveness of Option B+ compared to the standard of care before Option A

    Time frame: Baseline

    Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2017

  6. Cost-effectiveness of Option B+ compared to Option A

    Time frame: Baseline

    Facility costing data and HIV-free survival and MTCT in health facility catchment areas in 2012 compared to 2014

  7. Variability in health facility accesibility

    Time frame: Baseline

    Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities

  8. Variability in health facility quality of available services

    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

  9. Variability in health facility appropriateness of available services

    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

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
  • Children's Investment Fund Foundation
  • Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
  • Elizabeth Glaser Pediatric AIDS Foundation
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Liverpool School of Tropical Medicine
  • Ministry of Health and Child Welfare, Zimbabwe

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.