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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201507001178614 |
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Date of registration:
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22/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Integration of EPI and Pediatric HIV Services for Improved ART Initiation
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Scientific title:
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Integration of EPI and Pediatric HIV Services for Improved ART Initiation |
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Date of first enrolment:
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27/07/2015 |
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Target sample size:
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15160 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1178 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Allocation will be done using a program in Stata with a random seed to improve reproducibility. Randomization will be stratified according to the first primary outcome, and will use the minimum maximum t-statistic method to ensure maximum balance on covariates,All allocations to intervention and control will be done simultaneously in Stata
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Phase:
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Not Applicable
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Brett
Keller |
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Address:
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Skyways Building, 3rd Floor. Ohio and Sokoine Drive
Dar es Salaam
Tanzania |
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Telephone:
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+18579390304 |
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Email:
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bkeller@clintonhealthaccess.org |
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Affiliation:
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Technical Advisor, Clinton Health Access Initaitive |
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Name:
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Brett
Keller |
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Address:
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Skyways Building, 3rd Floor. Ohio and Sokoine Drive
Dar es Salaam
Tanzania |
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Telephone:
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+18579390304 |
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Email:
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bkeller@clintonhealthaccess.org |
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Affiliation:
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Technical Advisor, Clinton Health Access Initaitive |
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Key inclusion & exclusion criteria
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Inclusion criteria: All public health facilities across Zimbabwe that provide ART and EPI services will be eligible for the study, provided they do not have active relevant research ongoing at the site; site has provided Penta1 services to at least 500 infants in the previous eight months; and site is reasonably accessible for study
staff to visit.
Exclusion criteria: Sites within ten kilometers of another eligible facility will be excluded, as will facilities with active research related to EPI services, ART initiation, or other subjects that could directly impact
this study.
Age minimum:
0 Year(s)
Age maximum:
2 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
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HIV/AIDS
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Intervention(s)
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Control (standard of care) group
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Intervention group
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Primary Outcome(s)
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The proportion of infants coming for Penta1 visit who initiate ART by age 16 weeks
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The average age of infants initiating on ART for all infants who initiate ART by age 2 years
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Secondary Outcome(s)
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the total number of infants less than two years of age tested for HIV
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the proportion of infants less than two years testing HIV positive who initiate on ART
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the proportion of infants coming for a Penta1 visit who are tested for HIV by age 12 weeks
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the turnaround time between testing and receiving HIV results for infants less than two years
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the total number of infants less than two years of age initiating on ART during the study period;
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the total number of infants receiving Penta1 immunizations
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the cost per additional ART initiation by age 16 weeks
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the proportion of HIV testing results from Penta1 visits available at Penta2 visits
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the cost per additional HIV test for children under 12 weeks
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Source(s) of Monetary Support
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International Initiative for Impact Evaluation
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Ethics review
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Status: Approved
Approval date: 29/05/2015
Contact:
Chesapeake Institutional Review Board
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Status: Not approved
Approval date:
Contact:
Medical Research Council of Zimbabwe
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Status: Not approved
Approval date:
Contact:
Research Council of Zimbabwe
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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