Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings (HPTN063)

HIV Prevention Trials Network

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01264185

HPTN 063

Details and patient eligibility

About

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 determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.

Enrollment: 751 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

751 participants in 2 patient groups

Asia--Thailand; S. America--Brazil

Africa--Zambia