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

NCT ID: NCT01264185

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 751 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-08-31

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

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Asia--Thailand; S. America--Brazil

No interventions assigned to this group

Africa--Zambia

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HIV Prevention Trials Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Safren, PhD

Role: STUDY_CHAIR

Fenway Community Health Center

Ken Mayer, MD

Role: STUDY_CHAIR

Fenway Community Health Center

Stewart Reid, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centre for Infectious Disease Research in Zambia (CIDRZ)

Ruth Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Pesquisa Clincia Evandro Chagas (IPEC) Clinical Research Site (CRS)

Kriengkrai Srithanaviboonchai, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University AIDS CRS

Locations

Instituto de Pesquisa Clinicaq Evandro Chagas CRS

Manguinhos, Rio de Janeiro, Brazil

Chiang Mai University AIDS CRS

Chiang Mai, , Thailand

Matero Reference Clinic

Lusaka, , Zambia

Countries

Brazil; Thailand; Zambia

Other Identifiers

HPTN 063

Identifier Type: -

Identifier Source: org_study_id