Clinical trial NCT00753428: Community-based Evaluation of a Pilot PMTCT Project in Kafue District
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
HIV Infection
Keywords: HIV-free survival
Community based evaluation
Pregnancy
Under 2 child survival
PMTCT
Pediatric HIV infection
HAART
Routine ART
HIV Seronegativity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2008-09-16
Enrollment: 4129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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%.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Population HIV-free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Reseach in Zambia
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Benjamin Chi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.