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| Sponsors and Collaborators: |
University of Alabama at Birmingham Doris Duke Charitable Foundation |
|---|---|
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00753428 |
Purpose
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 | Intervention |
|---|---|
|
HIV-Free Survival HIV Infections |
Other: Community-based Survey |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Community-Based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia. |
Finger/Heel pricks will be performed for Dried Blood Spot Cards.
| Estimated Enrollment: | 1548 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Prior to the implementation of the pilot project of giving routine HAART as a method of PMTCT, 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households each 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. |
|
2
After two years, Following the implementation of the pilot project of giving routine HAART as a method of PMTCT, 387 households with children under the age of two will be sampled within each community, for a total of 1,548 households each 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. |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Benjamin Chi, M.D. | 00260 966 859179 | Benjamin.Chi@cidrz.org |
| Zambia | |
| Centre for Infectious Disease Reseach in Zambia | |
| Lusaka, Zambia, 34681 | |
| Principal Investigator: | Benjamin Chi, M.D. | CIDRZ |
More Information
| Responsible Party: | CIDRZ ( Benjamin Chi, MD ) |
| Study ID Numbers: | X080331005 |
| Study First Received: | September 15, 2008 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00753428 |
| Health Authority: | Zambia: Ministry of Health |
|
HIV-free survival Community based evaluation Pregnancy Under 2 child survival PMTCT |
Pediatric HIV infection HAART Routine ART HIV Seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |
