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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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ClinicalTrials.gov |
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Last refreshed on:
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17 January 2022 |
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Main ID: |
NCT03235518 |
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Date of registration:
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28/07/2017 |
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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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A Combination HIV Prevention Strategy for Young Women at Risk for HIV
IPrEP |
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Scientific title:
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A Combination HIV Prevention Strategy for Young Women at Risk for HIV |
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Date of first enrolment:
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June 28, 2017 |
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Target sample size:
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329 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03235518 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Wafaa M. El-Sadr, MD, MPH, MPA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
FSW. Inclusion criteria for the structured interviews, FGDs and IDI are identical.
- Report being female or transgender women born make who have sex with men
- Report being HIV-negative or unknown status
- Report being between 18-24 years of age
- Report residing or working in study community
- Reports exchange sex for goods, money, flavors or other services in past 3 months
- Willing to allow audio-recording of FGDs or IDI
- Able to complete study procedures in English, Kiswahili or Dhuluo
Male Clients
- Male
- Report being >=18 years of age
- Report exchanging goods, money, favors or other services for sex in past 3 months
- Willing to allow audio-recording of IDI
- Able to complete study procedures in English, Kiswahili or Dhuluo
Health Care Providers
- Currently working as nurse or clinical officer at a clinic or other facility likely to
offer PrEP
- Report being >= 18 years of age
- Willing to allow audio-recording of IDI
- Able to complete study procedures in English
Exclusion Criteria:
- Individuals who do not meet the inclusion criteria
- Individuals who in the opinion of the investigators would interfere with adherence to
study study requirements
- FSW participating in FGD are not eligible for participation in IDI
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Immunodeficiency Virus
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Primary Outcome(s)
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Percentage of FSW participants who would be willing to participate in HIV prevention research
[Time Frame: 6 months]
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Secondary Outcome(s)
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Percentage of MC participants who would be willing to participate in HIV prevention research
[Time Frame: 6 months]
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Secondary ID(s)
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AAAR0256
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R01MH110051
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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