Validation of a Community Survey Methodology for Measuring PMTCT Program Impact

NCT01951794 | Completed

• 2 other identifiers: CIDRZ 1225R01HD075131-01
• Study Type: observational
• Target: 827
• Locations: 1 country
• Sites: 1

Brief Summary

Validate a promising community survey methodology for evaluating the Prevention of Mother to Child Transmission (PMTCT) program effectiveness against a "gold standard" cohort design and to identify individual- and facility-level characteristics associated with HIV-free survival among HIV-exposed infants.

Conditions

HIV

Keywords

HIV infected; HIV exposed; HIV-free

Outcome Measures

Primary Outcomes (1)

• HIV-free survival among HIV-exposed infants.

  Our primary outcome will be HIV-free survival at 18 months among HIV-exposed infants. HIV-free survival has been proposed as a more comprehensive measure of PMTCT program effectiveness than HIV infections alone, since health services may have a broader health impact outside of interrupted transmission. We have chosen the 18-month time point for several reasons. Because the vast majority of HIV-exposed infants will have stopped breastfeeding by this age, this will provide more complete ascertainment of mother-to-child transmission compared to earlier measurements. This time point has also been endorsed by the WHO as one of two priority outcomes for PMTCT impact evaluations. Since both methodologies will sample and recruit participants from within the community, our measures will be population-based (vs. facility-based).

  18 months

Eligibility Criteria

• Age: Up to 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected women and their HIV-exposed infants / children

Eligibility criteria for community cohort: * We will use facility- and community-based reporting systems from BHOMA to identify all recent births and, within the first 4 weeks of life, approach mothers at their homes to explain the study. Mothers are screened for HIV status, by on-site test and by medical record review (if available) Eligibility criteria for community survey: * We will enrollment HIV-infected women who report a delivery of an infant in the past 24 months

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Centre for Infectious Disease Reseach in Zambia

Lusaka, 34681, Zambia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect Dried Blood Specimens (DBS) from both mother and infant and link them using pre-printed bar codes. For a mother who refuses real-time testing, but agrees to collection of this maternal DBS specimen, she will be provided a card with a unique study-generated identification number that can be used pick-up results at the community's designated health facility. For those who agreed to on-site HIV testing, we will retain the DBS specimens for quality assurance purposes. As part of the informed consent process, participants will also be asked whether leftover specimens may be used for future use, pending local and international ethical approvals for specified substudies.

Study Officials

• Benjamin Chi, MD

  UNC at Chapel Hill, Center for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: June 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

ZA (1)