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

HIV Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753428
• Other study ID #: 12-0399
• Secondary ID: X080331005
• Status: Completed
• First received: September 15, 2008
• Last updated: April 17, 2018
• Start date: November 2008
• Est. completion date: November 2011

Study information

• Verified date: April 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4129
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• HIV Infection
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Reseach in Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Doris Duke Charitable Foundation

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population HIV-free survival		2 years

External Links

•   Website for organisation implementing research study