Validation of a Community Survey Methodology for Measuring PMTCT Program Impact

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by University of North Carolina, Chapel Hill

Sponsor:

Collaborator:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01951794

First received: September 24, 2013

Last updated: December 2, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition
HIV


Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Cross-Sectional
Official Title:	CIDRZ 1225 - Validation of a Community Survey Methodology for Measuring PMTCT Program Impact

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

HIV-free survival among HIV-exposed infants. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	1680
Study Start Date:	June 2014
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility


Ages Eligible for Study:	up to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951794

Contacts


Contact: Benjamin Chi, MD		Benjamin.Chi@cidrz.org

Locations


Zambia
Centre for Infectious Disease Reseach in Zambia	Recruiting
Lusaka, Zambia, 34681
Contact: Benjamin Chi, M.D. +260 977 859179 Benjamin.Chi@cidrz.org
Principal Investigator: Benjamin Chi, M.D.

Sponsors and Collaborators

Benjamin Chi, MD, MSc

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Benjamin Chi, MD	UNC at Chapel Hill, Center for Infectious Disease Research in Zambia

More Information

No publications provided


Responsible Party:	Benjamin Chi, MD, MSc, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01951794 History of Changes
Other Study ID Numbers:	CIDRZ 1225
Study First Received:	September 24, 2013
Last Updated:	December 2, 2014
Health Authority:	United States: Institutional Review Board Zambia: Research Ethics Committee Zambia: Ministry of Health

Keywords provided by University of North Carolina, Chapel Hill:


HIV infected HIV exposed HIV-free

ClinicalTrials.gov processed this record on February 27, 2015

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