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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: |
PACTR201711002697316 |
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Date of registration:
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16/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners
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Scientific title:
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Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners |
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Date of first enrolment:
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25/09/2017 |
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Target sample size:
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22500 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2697 |
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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,Stratified allocation by facility,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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Malawi
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Contacts
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Name:
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Kathryn
Dovel |
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Address:
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Area 36, Plot 8, M1 Road South
3
Lilongwe
Malawi |
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Telephone:
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265-99-764-5317 |
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Email:
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kdovel@mednet.ucla.edu |
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Affiliation:
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Adjunct Assistant Professor |
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Name:
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Frackson
Shaba |
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Address:
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Area 36, Plot 8, M1 Road South
3
Lilongwe
Malawi |
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Telephone:
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265-88-853-1006 |
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Email:
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fraxonnuka@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: 15 years or older
Willing and able to provide informed consent
Being seen for OPD or STI services at the time of the study (Aim 1)
HIV-positive (Aim 2)
Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)
Exclusion criteria: Currently enrolled in the INTERVAL study
Guardians attending clinics with OPD or STI clients (Aim 1)
History of intimate partner violence in the past 12 months (Aim 2)
Fear of intimate partner violence as a consequence of participating in the study (Aim 2)
Age minimum:
15 Year(s)
Age maximum:
100 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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Standard of care (SOC)
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HIV self-testing (HIVST)
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Optimized standard of care (OSOC)
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Primary Outcome(s)
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Cost-effectiveness of HIV self-testing in OPD and STI clinics and distributing HIV self-test kits for index partner testing
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Number of patients and partners tested for HIV in OPD and STI clinics
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Secondary Outcome(s)
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Rate of linkage to care (ART services) for HIV positive index clients and index partners
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Testing yield of HIV-positive individuals from OPD and STI clinics and index partners
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Acceptability of HIV self-testing in waiting areas of OPD and STI clinics and for index partner testing
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Secondary ID(s)
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NCT03271307
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Source(s) of Monetary Support
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U.S. Agency for International Development (USAID)
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Ethics review
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Status: Approved
Approval date: 31/01/2017
Contact:
Malawi National Health Sciences Research Committee
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Status: Approved
Approval date: 17/05/2017
Contact:
UCLA Office of the Human Research Protection Program
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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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