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

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ClinicalTrials.gov Identifier: NCT00753428
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
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%.


Condition or disease Intervention/treatment
Death HIV Infection Other: Community-based Survey

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 Type : Observational
Actual Enrollment : 4129 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : November 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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.
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.


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.]
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.





Primary Outcome Measures :
  1. Population HIV-free survival [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Finger/Heel pricks will be performed for Dried Blood Spot Cards.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Households will be eligible for the full survey if they report that a child was born to a household member within the past two years. If the answer to this question is "yes," an attempt will be made to speak with the mother of the child. If the mother of the child is not available, then the primary care-taker of the child will be interviewed at that time.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753428


Locations
Zambia
Centre for Infectious Disease Reseach in Zambia
Lusaka, Zambia, 34681
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Benjamin Chi, M.D. Centre for Infectious Disease Research in Zambia

Additional Information:
Publications of Results:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00753428     History of Changes
Other Study ID Numbers: 12-0399
X080331005 ( Other Identifier: UNC )
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by University of North Carolina, Chapel Hill:
HIV-free survival
Community based evaluation
Pregnancy
Under 2 child survival
PMTCT
Pediatric HIV infection
HAART
Routine ART
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases