Community-based Evaluation of a Pilot PMTCT Project in Kafue District
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%.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||CIDRZ 1236 - Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia.|
- Population HIV-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Finger/Heel pricks will be performed for Dried Blood Spot Cards.
|Study Start Date:||November 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
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.
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.]
Other: Community-based Survey
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753428
|Centre for Infectious Disease Reseach in Zambia|
|Lusaka, Zambia, 34681|
|Principal Investigator:||Benjamin Chi, M.D.||Centre for Infectious Disease Research in Zambia|