Validation of a Community Survey Methodology for Measuring PMTCT Program Impact
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ClinicalTrials.gov Identifier: NCT01951794
Recruitment Status :
First Posted : September 27, 2013
Last Update Posted : April 19, 2017
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
HIV-free survival among HIV-exposed infants. [ Time Frame: 18 months ]
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).
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.
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Ages Eligible for Study:
up to 49 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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