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

University of North Carolina (UNC)

Status: Completed

Conditions: Death; HIV Infection

Treatments: Other: Community-based Survey

Study type: Observational

Funder types: Other

Identifiers

NCT00753428

12-0399

X080331005 (Other Identifier)

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 4,129 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

4,129 participants in 2 patient groups

Baseline evaluation

Description:

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.

Treatment:

Other: Community-based Survey

Following implementation

Description:

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. \[Note: At time of implementation, we used the same sampling frame for each community. Because of the population increased observed in parts of Kafue, the final number of households significantly exceeded the minimum threshold.\]

Treatment:

Other: Community-based Survey