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

NCT ID: NCT00753428

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-11-30

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.

Conditions

Death; HIV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Baseline evaluation

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.

Community-based Survey

Intervention Type: 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.

Following implementation

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

Community-based Survey

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Chi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Infectious Disease Research in Zambia

Locations

Centre for Infectious Disease Reseach in Zambia

Lusaka, , Zambia

Countries

Zambia

References

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.

Reference Type: RESULT

PMID: 21470348 (View on PubMed)

Related Links

http://www.cidrz.org/

Website for organisation implementing research study

Other Identifiers

X080331005

Identifier Type: OTHER

Identifier Source: secondary_id

12-0399

Identifier Type: -

Identifier Source: org_study_id