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

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.

Study Overview

• Status: Completed
• Conditions: HIV

• Study Type: Observational
• Enrollment (Actual): 751

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Manguinhos, RJ, Brazil, 221045-900
      • Instituto de Pesquisa Clinicaq Evandro Chagas CRS
• Thailand
  • Chiang Mai, Thailand
    • Chiang Mai University AIDS CRS
• Zambia
  • Lusaka, Zambia
    • Matero Reference Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Asia--Thailand; S. America--Brazil
Africa--Zambia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine sexually transmitted infection(STI)prevalence and incidence	Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks	1 year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 20, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HPTN 063