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%.

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Key information

Conditions

Death Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Infectious Disease Reseach in Zambia

Lusaka, 34681, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community-based Survey

Other

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.

Primary outcomes

Population HIV-free survival

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

Doris Duke Charitable Foundation

Registry information

Official study title

CIDRZ 1236 - Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia.

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Sep 16, 2008
Registry last updated: Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed