Status:
UNKNOWN
IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Impact Research & Development Organization
Research Foundation for Mental Hygiene, Inc.
Conditions:
HIV
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
IPrEP Men's Study is a prospective cohort study enrolling male clients (MC) of female sex workers (FSW) in Kisumu, Kenya. HIV-negative MC participants will be offered oral PrEP (emtricitabine/tenofovi...
Eligibility Criteria
Inclusion
- Report no previous diagnosis of HIV infection
- Report being \>18 years of age
- Report living or working in study area
- Report intention to stay in study area for 6 months
- Report exchanging sex for money, goods or services with a woman in past 3 months
- Report no current or recent (within the past 3 months) PrEP use
- Able to provide informed consent and complete study procedures in English, Kiswahili or Dholuo
- Willingness to participate and adhere to study interventions according to eligibility
Exclusion
- Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
- Unable to provide informed consent for study procedures
- Any medical, psychiatric, or social condition, occupational or other responsibility that, in the judgment of the study team, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04898699
Start Date
October 1 2021
End Date
March 1 2022
Last Update
October 5 2021
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