Status:
COMPLETED
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
Lead Sponsor:
HIV Prevention Trials Network
Conditions:
HIV
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determ...
Eligibility Criteria
Inclusion
- Men and women at least 18 years of age (Note: Pregnant and breast feeding women are allowed to enroll into the study)
- Documented evidence of HIV infection (HIV diagnosis performed outside of the trial is acceptable so long as local/country guidelines were followed in the testing)
- Receiving HIV/AIDS care (defined as at least two visits within 9 months of enrollment) in a formal health care setting (clinic or hospital)
- Reported history of sexual risk behavior in the previous 12 months, including: acquisition of a sexually transmitted infection, vaginal or anal intercourse without a condom, difficulty negotiating condom use, or non-disclosure of HIV status to an HIV-uninfected partner or partner of unknown HIV serostatus.
- NOTE: For the MSM population, we will enroll men who have sex with men, regardless of whether or not they also have sex with women
Exclusion
- Anyone currently enrolled in another study that involves protocolized HIV risk reduction counseling (e.g. ACTG 5175 or HPTN 052) or any other prevention study
- Anyone having unprotected (i.e. without a condom) sex for the expressed purpose of conceiving
- Planning to relocate out of the area in the next year
- Any condition that, in the opinion of the Investigator of Record or designee, 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 :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT01264185
Start Date
April 1 2010
End Date
August 1 2014
Last Update
August 26 2022
Active Locations (3)
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1
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, Rio de Janeiro, Brazil, 221045-900
2
Chiang Mai University AIDS CRS
Chiang Mai, Thailand
3
Matero Reference Clinic
Lusaka, Zambia