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

Completed

• Conditions: HIV Infection; Death
• Interventions: Other: Community-based Survey

• Registration Number: NCT00753428
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2008-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4129

Inclusion Criteria

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

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Exclusion Criteria

• Household where there no child has been born in the past two years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Following implementation	Community-based Survey	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. \[Note: At time of implementation, we used the same sampling frame for each community. Because of the population increased observed in parts of Kafue, the final number of households significantly exceeded the minimum threshold.\]
Baseline evaluation	Community-based Survey	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.

Primary Outcome Measures

Name	Time	Method
Population HIV-free survival	2 years

Trial Locations

Locations (1)

Centre for Infectious Disease Reseach in Zambia; 🇿🇲 Lusaka, Zambia