We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Validation of a Community Survey Methodology for Measuring PMTCT Program Impact

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01951794
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : April 19, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 827 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: CIDRZ 1225 - Validation of a Community Survey Methodology for Measuring PMTCT Program Impact
Actual Study Start Date : June 2014
Primary Completion Date : November 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

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.

Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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): NCT01951794

Centre for Infectious Disease Reseach in Zambia
Lusaka, Zambia, 34681
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Benjamin Chi, MD UNC at Chapel Hill, Center for Infectious Disease Research in Zambia
More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01951794     History of Changes
Other Study ID Numbers: CIDRZ 1225
R01HD075131-01 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by University of North Carolina, Chapel Hill:
HIV infected
HIV exposed