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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: |
PACTR201607001701788 |
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Date of registration:
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29/06/2016 |
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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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A trial of interventions to improve linkage to care after HIV self-testing
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Scientific title:
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A cluster randomised trial of interventions to improve linkage to care following community-based distribution of HIV self-test kits in rural Zimbabwean communities |
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Date of first enrolment:
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15/07/2016 |
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Target sample size:
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44 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1701 |
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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,Stratified randomisation of clusters,stratified by district, with restriction on proximity to a health facility,This is a cluster-randomised trial, randomisation of clusters will be done before the intervention begins.
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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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Frances
Cowan |
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Address:
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CeSHHAR Zimbabwe, 9 Monmouth Rd, Avondale
Harare
Zimbabwe |
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Telephone:
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002634333393 |
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Email:
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f.cowan@ucl.ac.uk |
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Affiliation:
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Principal Investigator |
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Name:
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Euphemia
Sibanda |
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Address:
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CeSHHAR Zimbabwe
Harare
Zimbabwe |
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Telephone:
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002634333393 |
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Email:
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euphemia@ceshhar.co.zw |
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Affiliation:
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Project Director |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Living in the study communities (clusters)
2. Aged at least 16 years old (Ministry of Health age for independent consent to test for HIV)
3. Willing to self-test for HIV
Exclusion criteria: None
Age minimum:
16 Year(s)
Age maximum:
120 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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Incentives for HIV positive patients who are referred for HIV care
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Both incentives for CBDs and for HIV positive participants
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Incentives for community-based distributors of HIV self-test kits
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No incentives for CBDs; no incentives for HIV positive participants who are referred
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Primary Outcome(s)
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Proportion of HIV positives initiated on ART
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Proportion of HIV positives assessed for ART
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Proportion of people who linked to PSI outreach services
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Proportion of men taking up VMMC in each community
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Proportion of individuals who have self-tested in each community
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Proportion of women accessing contraception consultations in each community
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Source(s) of Monetary Support
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UNITAID
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Ethics review
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Status: Approved
Approval date:
Contact:
University College London Ethics Committe
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Status: Not approved
Approval date:
Contact:
London School of Hygiene & Tropical Medicine
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Status: Not approved
Approval date:
Contact:
Medical 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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