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

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ClinicalTrials.gov Identifier: NCT03388398
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2018
Last Update Posted : August 27, 2018
Sponsor:
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
Information provided by (Responsible Party):
University of California, Berkeley

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.

Condition or disease
HIV Infections

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


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Study Type : Observational
Estimated Enrollment : 30642 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Population-level Impact of Prevention of Mother-to-Child HIV Transmission Program Option B+ in Zimbabwe
Actual Study Start Date : January 2012
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Dried blood spot samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388398


Sponsors and Collaborators
University of California, Berkeley
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
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03388398     History of Changes
Other Study ID Numbers: 1R01HD080492-01 ( U.S. NIH Grant/Contract )
1R01HD080492-01 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Berkeley:
Mother-to-child transmission of HIV (MTCT)
Prevention of mother-to-child HIV transmission (PMTCT)
Antiretroviral therapy (ART)
Antenatal care (ANC)
Pediatric infections
Pregnancy

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases