Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Community-based Evaluation of a Pilot PMTCT Project in Kafue District

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00753428
First received: September 15, 2008
Last updated: September 16, 2014
Last verified: September 2014

September 15, 2008
September 16, 2014
November 2008
November 2011   (final data collection date for primary outcome measure)
Population HIV-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Community-based Evaluation of a Pilot PMTCT Project in Kafue District
CIDRZ 1236 - Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia.

In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate population HIV-free survival among infants born in each target community.

The investigators hypothesize that incorporation of routine ART into PMTCT will increase the HIV-free survival of exposed infants to 75%.

The primary objective is to determine the incremental benefit of a routine ART strategy for PMTCT on a population basis, when compared to short-course Zidovudine and single-dose Nevirapine (the current PMTCT standard of care).

We will take advantage of planned implementation of a pilot project for routine ART across four primary care centres in rural Zambia (Kafue District). Using a community-based survey modeled after the Demographic and Health Survey, we will measure HIV-free survival among children under two years of age in the catchment areas surrounding these pilot sites, both before and after implementation of services. We will use before-after comparisons in each of these four communities to better understand the incremental benefit of providing these services.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Finger/Heel pricks will be performed for Dried Blood Spot Cards.

Probability Sample

Households will be eligible for the full survey if they report that a child was born to a household member within the past two years. If the answer to this question is "yes," an attempt will be made to speak with the mother of the child. If the mother of the child is not available, then the primary care-taker of the child will be interviewed at that time.

  • Death
  • HIV Infection
Other: Community-based Survey

Questionnaires will be used to record detailed information regarding demographic and socioeconomic characteristics, maternal medical history, recent obstetrical history (including access to preventive services for mother-to-child HIV transmission), and infant medical history. Infant deaths will also be recorded as part of the survey. In cases where either the mother or infant has died, we will perform verbal autopsy interviews (Appendix 5) with surviving family members to determine cause of death and gather information regarding HIV infection and/or exposure.

Heel/finger pricks will be taken so as to perform dried blood spot cards, and test for HIV in children and adults.

  • Baseline evaluation
    Prior to the implementation of the pilot project of giving routine HAART as a method of PMTCT, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households for the first round.
    Intervention: Other: Community-based Survey
  • Following implementation
    Two years after full implementation of the pilot project of giving routine HAART for PMTCT across all sites, a minimum of 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households. [Note: At time of implementation, we used the same sampling frame for each community. Because of the population increased observed in parts of Kafue, the final number of households significantly exceeded the minimum threshold.]
    Intervention: Other: Community-based Survey
Turnbull E, Lembalemba MK, Guffey MB, Bolton-Moore C, Mubiana-Mbewe M, Chintu N, Giganti MJ, Nalubamba-Phiri M, Stringer EM, Stringer JS, Chi BH. Causes of stillbirth, neonatal death and early childhood death in rural Zambia by verbal autopsy assessments. Trop Med Int Health. 2011 Jul;16(7):894-901. doi: 10.1111/j.1365-3156.2011.02776.x. Epub 2011 Apr 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4129
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Household where a child has been born in the past two years.

Exclusion Criteria:

  • Household where there no child has been born in the past two years.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00753428
X080331005
No
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Principal Investigator: Benjamin Chi, M.D. Centre for Infectious Disease Research in Zambia
University of North Carolina, Chapel Hill
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP