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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asia--Thailand; S. America--Brazil<br> | |
| Africa--Zambia<br> | |

What is the study measuring?
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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 |