Clincosm LogoSign in Get a demo

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

Sponsor
HIV Prevention Trials Network (Other)
Overall Status
Completed
CT.gov ID
NCT01264185
Collaborator
(none)
751
Enrollment
3
Locations
52
Duration (Months)
250.3
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    751 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Aug 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Asia--Thailand; S. America--Brazil
    Africa--Zambia

    Outcome Measures

    Primary Outcome Measures

    1. Establish baseline rates of sexual HIV transmission risk [1 year]

      To establish baseline rates of sexual HIV transmission risk behavior in high risk HIV-infected individuals, and to observe the rates and patterns of behavior change over time

    2. Structure and content of a behavioral intervention for individuals with HIV [1 year]

      To gather formative data on the potential structure and content of a behavioral intervention for individuals with HIV in care in international settings and to determine the best, culturally appropriate model for the intervention that will link prevention to care for HIV-infected individuals.

    3. Identify psychosocial and sociodemographic correlates of sexual risk-taking [1 year]

      To examine potential psychosocial and sociodemographic correlates of sexual risk-taking in these individuals in order to help shape the content of an individualized behavioral intervention

    Secondary Outcome Measures

    1. Determine sexually transmitted infection(STI)prevalence and incidence [1 year]

      Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Pesquisa Clinicaq Evandro Chagas CRS Manguinhos RJ Brazil 221045-900
    2 Chiang Mai University AIDS CRS Chiang Mai Thailand
    3 Matero Reference Clinic Lusaka Zambia

    Sponsors and Collaborators

    • HIV Prevention Trials Network

    Investigators

    • Study Chair: Steve Safren, PhD, Fenway Community Health Center
    • Study Chair: Ken Mayer, MD, Fenway Community Health Center
    • Principal Investigator: Stewart Reid, MD, MPH, Centre for Infectious Disease Research in Zambia (CIDRZ)
    • Principal Investigator: Ruth Friedman, MD, Instituto de Pesquisa Clincia Evandro Chagas (IPEC) Clinical Research Site (CRS)
    • Principal Investigator: Kriengkrai Srithanaviboonchai, MD, MPH, Chiang Mai University AIDS CRS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HIV Prevention Trials Network
    ClinicalTrials.gov Identifier:
    NCT01264185
    Other Study ID Numbers:
    • HPTN 063
    First Posted:
    Dec 21, 2010
    Last Update Posted:
    Aug 19, 2014
    Last Verified:
    Aug 1, 2014

    Study Results

    No Results Posted as of Aug 19, 2014