Community-based Evaluation of a Pilot PMTCT Project in Kafue District
| Tracking Information | |||||
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| First Received Date ICMJE | September 15, 2008 | ||||
| Last Updated Date | May 30, 2012 | ||||
| Start Date ICMJE | November 2008 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Population HIV-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00753428 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Community-based Evaluation of a Pilot PMTCT Project in Kafue District | ||||
| Official Title ICMJE | Community-based Evaluation of a Pilot PMTCT Project in Kafue District: Impact of HAART to Prevent Pediatric AIDS in Rural Zambia. | ||||
| 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%. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Finger/Heel pricks will be performed for Dried Blood Spot Cards. |
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| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) |
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| Publications * | Turnbull E, Lembalemba MK, Brad Guffey M, 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 Apr 7. doi: 10.1111/j.1365-3156.2011.02776.x. [Epub ahead of print] | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4129 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Zambia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00753428 | ||||
| Other Study ID Numbers ICMJE | X080331005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill | ||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | Doris Duke Charitable Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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