Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01264185
First received: December 14, 2010
Last updated: August 18, 2014
Last verified: August 2014

December 14, 2010
August 18, 2014
April 2010
August 2014   (final data collection date for primary outcome measure)
  • Establish baseline rates of sexual HIV transmission risk [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
  • Structure and content of a behavioral intervention for individuals with HIV [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.
  • Identify psychosocial and sociodemographic correlates of sexual risk-taking [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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
  • Establish baseline rates of sexual HIV transmission risk [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
  • Structure and content of a behavioral intervention for individuals with HIV [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • Identify psychosocial and sociodemographic correlates of sexual risk-taking [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
Complete list of historical versions of study NCT01264185 on ClinicalTrials.gov Archive Site
Determine sexually transmitted infection(STI)prevalence and incidence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks
Determine sexually transmitted infection(STI)prevalence and incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks
Not Provided
Not Provided
 
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, genital fluids

Non-Probability Sample

Asia (Thailand) and South America (Brazil)

  • 100 heterosexual men,
  • 100 heterosexual women,
  • 100 Men having sex with men (MSM), and
  • ~40 community members and stakeholders

Africa (Zambia)

  • 100 heterosexual men,
  • 100 heterosexual women,
  • ~40 community members and stakeholders
HIV
Not Provided
  • Asia--Thailand; S. America--Brazil
  • Africa--Zambia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
751
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Thailand,   Zambia
 
NCT01264185
HPTN 063
No
HIV Prevention Trials Network
HIV Prevention Trials Network
Not Provided
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
HIV Prevention Trials Network
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP