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

NCT03388398 | Completed

• 1 other identifier: 1R01HD080492-01
• Study Type: observational
• Target: 30,642
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Vertical transmission of HIV infection

  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

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

  9-18 months after birth

Secondary Outcomes (9)

• Retention of mothers in antiretroviral therapy services (ART) services 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

  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

  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

  Baseline

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

  Baseline

Study Arms (5)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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
• 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
• 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
• 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)

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 30621615 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spot samples

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share