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

May 30, 2023 updated by: University of California, Berkeley

Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.
Healthcare staff
Healthcare staff (employed staff and volunteers at least 18 years of age) at all participating healthcare facilities.
Providers
Health care providers (at least 18 years of age) at select participating healthcare facilities.
Patients
Patients (at least 18 years of age) receiving care at select participating healthcare facilities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vertical transmission of HIV infection
Time Frame: 9-18 months after birth
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
Time Frame: 9-18 months after birth
Proportion of infants born to HIV-infected mothers who were alive and HIV-uninfected
9-18 months after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
19-36 months postpartum
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
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
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
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities
Baseline
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
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Elizabeth Glaser Pediatric AIDS Foundation
Liverpool School of Tropical Medicine
Ministry of Health and Child Welfare, Zimbabwe
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
Children's Investment Fund Foundation
Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frances Cowan, MSc, MD, Liverpool School of Tropical Medicine, The Centre for Sexual Health and HIV/AIDS Research Zimbabwe
  • Principal Investigator: Nancy Padian, MPH, Ph.D, University of California, Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HD080492-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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