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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT01264185
First received: December 14, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings

Resource links provided by NLM:


Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Blood, genital fluids


Enrollment: 751
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asia--Thailand; S. America--Brazil
Africa--Zambia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264185

Locations
Brazil
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, RJ, Brazil, 221045-900
Thailand
Chiang Mai University AIDS CRS
Chiang Mai, Thailand
Zambia
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
  More Information

No publications provided

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT01264185     History of Changes
Other Study ID Numbers: HPTN 063
Study First Received: December 14, 2010
Last Updated: March 27, 2014
Health Authority: Brazil: Ethics Committee
Zambia: Ethics Committee
Thailand: Ethics Committee

ClinicalTrials.gov processed this record on July 29, 2014