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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: |
PACTR201804003064160 |
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Date of registration:
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08/02/2018 |
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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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Cluster randomized trial of VMMC demand creation strategies
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Scientific title:
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A cluster randomized controlled trial of innovative demand creation strategies to increase voluntary medical male circumcision uptake in Zimbabwe |
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Date of first enrolment:
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15/02/2018 |
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Target sample size:
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140 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3064 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Randomization was restricted by age and sex of IPC agent, and mobilization experience.,Allocation was determined by the holder of the sequence who is situated off site.
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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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Webster
Mavhu |
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Address:
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9 Monmouth Road, Avondale
Harare
Zimbabwe |
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Telephone:
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+263 4 333393 |
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Email:
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webster@ceshhar.co.zw |
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Affiliation:
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co-investigator |
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Name:
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Stephen
Buzuzi |
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Address:
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9 Monmouth Road Avondale
Harare
Zimbabwe |
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Telephone:
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+263 4 333393 |
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Email:
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sbuzuzi@gmail.com |
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Affiliation:
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Study Coordinator |
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Key inclusion & exclusion criteria
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Inclusion criteria: Willing and able to provide written informed consent for participation.
Mobilizes men for VMMC
Mobilized for VMMC using one of 4 approaches
Exclusion criteria: Unwillingness to provide written informed consent
Too physically or psychologically unwell
Does not mobilize men for VMMC
Was not mobilized for VMMC using one of 4 approaches
Age minimum:
13 Year(s)
Age maximum:
60 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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New IPC demand creation approach plus offer of HIVST
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New IPC demand creation approach
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Standard community mobilization plus offer of HIVST
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Standard community mobilization
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Primary Outcome(s)
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comparison of the absolute number of men circumcised over period of trial by trial arm
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Secondary Outcome(s)
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¿ Proportion of men who were offered HIV self test kits and accepted/declined (and reasons)
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¿ The number of men booked for VMMC
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¿ Proportion of men with a reactive HIV self test result who link to post test services
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¿ The mean conversion rate by trial arm (conversion rate defined as number of men who are circumcised divided by the number of men reached by IPC agent per month)
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¿ The number of men actually reached (and number of times subsequently contacted)
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¿ Proportion of men who obtain HIV self test kits and go on to self-test
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¿ The number of men spoken to by IPC agents
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¿ The number of men who present for VMMC (by trial arm)
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Source(s) of Monetary Support
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BMGF through PSI Zimbabwe
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Ethics review
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Status: Approved
Approval date: 29/11/2017
Contact:
Medical Research Council of Zimbabwe
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Status: Approved
Approval date: 01/12/2017
Contact:
LSHTM Observational / Interventions Research Ethics Committee
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Status: Approved
Approval date: 15/12/2017
Contact:
LSTM Research Ethics Committee
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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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