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

NCT01264185 | Completed

• 1 other identifier: HPTN 063
• Study Type: observational
• Target: 751
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• Establish baseline rates of sexual HIV transmission risk

  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

  1 year

• Structure and content of a behavioral intervention for individuals with HIV

  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.

  1 year

• Identify psychosocial and sociodemographic correlates of sexual risk-taking

  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

  1 year

Secondary Outcomes (1)

• Determine sexually transmitted infection(STI)prevalence and incidence

  1 year

Study Arms (2)

Asia--Thailand; S. America--Brazil

Africa--Zambia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HIV Prevention Trials Network: lead

Study Sites (3)

Instituto de Pesquisa Clinicaq Evandro Chagas CRS

Manguinhos, Rio de Janeiro, 221045-900, Brazil

Location

Chiang Mai University AIDS CRS

Chiang Mai, Thailand

Location

Matero Reference Clinic

Lusaka, Zambia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, genital fluids

Study Officials

• Steve Safren, PhD

  Fenway Community Health Center

  STUDY CHAIR

• Ken Mayer, MD

  Fenway Community Health Center

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 21, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

ZA (1); BR (1); TH (1)