HIV InfectionsNCT03388398

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

An observational study of HIV Infections, run by University of California, Berkeley.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: HIV Infections
How many people: 30,642 participants
Where: No sites listed yet
Study dates: Jan 2012to Jan 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Child, Adult, Older adult

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.

Who may be able to join

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
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

Show all 16Show fewer

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

Who cannot join

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
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

Show all 11Show fewer

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

About this study

Official title: 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.

Read the 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

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
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03388398
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Vertical transmission of HIV infection
Proportion of infants born to HIV-infected mothers who were HIV-infected
Measured: 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
Measured: 9-18 months after birth

Secondary outcomes (9)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Variability in health facility accesibility
Accessibility of health facilities assessed using exit interviews with patients receiving care at health facilities
Measured: 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
Measured: 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
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jan 2019

First posted3 Jan 2018
Study startJan 2012
Primary completionJul 2018
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 30,642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03388398
Sponsor's protocol ID: 1R01HD080492-01
Other IDs: 1R01HD080492-01
Status last verified: May 2023
First submitted: 15 Dec 2017
Last updated: 1 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30621615

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program Option B+ in Zimbabwe
ClinicalTrials.gov ID: NCT03388398
Acronym / sponsor ID: 1R01HD080492-01
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
Study type: Observational
Recruitment status: Completed
Enrolment: 30,642 participants (actual)
Lead sponsor: University of California, BerkeleyUniversity, hospital or other
Collaborators: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe), Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT)., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Liverpool School of Tropical Medicine, Ministry of Health and Child Welfare, Zimbabwe, Elizabeth Glaser Pediatric AIDS Foundation, Children's Investment Fund Foundation
Study start: Jan 2012 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jan 2019 (actual)
First posted: 3 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 5

Arm	Type	Receives
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.

Who may qualify

Ages: 16 years and older
Sex: All
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (16 listed)

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
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

Key exclusion criteria (11 listed)

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
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Vertical transmission of HIV infection
Time frame: 9-18 months after birth
Proportion of infants born to HIV-infected mothers who were HIV-infected
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 secondary outcomes

Retention of mothers in antiretroviral therapy services (ART) services after weaning
Time frame: 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
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
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
Cost-effectiveness of Option B+ compared to the standard of care before Option A
Time frame: Baseline
Cost-effectiveness of Option B+ compared to Option A
Time frame: Baseline
Variability in health facility accesibility
Time frame: Baseline
Variability in health facility quality of available services
Time frame: Baseline
Variability in health facility appropriateness of available services
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
Derived from this study: PubMed 30621615Koyuncu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frances Cowan, MSc, MD principal investigator

Liverpool School of Tropical Medicine, The Centre for Sexual Health and HIV/AIDS Research Zimbabwe

Nancy Padian, MPH, Ph.D principal investigator

University of California, Berkeley

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by University of California, Berkeley.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertical transmission of HIV infection (time frame: 9-18 months after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03388398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.