Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the acceptability and feasibility of an enhanced, individual-level counseling intervention for individuals in the acute and early phase of HIV infection aimed at reducing risk behaviors.

Official Title
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Feasibility and Acceptability Study of an Individual-Level Behavioral Intervention for Individuals With Acute and Early HIV-Infection

Conditions
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Acute HIV Infection

Intervention / Treatment
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* Behavioral: Standard counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be enrolled in CHAVI 001 Note: The inclusion and exclusion criteria for CHAVI 001 are provided below. The criteria will not be reassessed prior to enrollment in HPTN 062. Inclusion Criteria from CHAVI 001 Men and women aged ≥ 18 years at the time of screening. Able and willing to provide adequate information for locator purposes. Hemoglobin > 10.0 g/dL. Willing to receive HIV test results. Not intending to relocate out of the area for the duration of study participation and does not have a job or other obligations that may require long absences from the area. Has acute HIV infection. (See Section 2.3 for definition). Exclusion Criteria: Any prior or current use of antiretroviral therapy (ART). This does not apply to individuals screening for Group 1A. ART use for the prevention of perinatal transmission may be waived after prior consultation with the protocol team. Previous or current participation in a HIV vaccine study. HPTN 062 Version 3.0 Final 03 August 2010 Any condition that, in the opinion of the Investigator of Record, 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced counseling<br>5 intensive counseling sessions following acute HIV infection | Behavioral: Standard counseling<br>* Standard HIV counseling<br>|
| Active Comparator: Standard counseling<br>Standard HIV counseling following acute HIV infection | Behavioral: Standard counseling<br>* Standard HIV counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants in the experimental arm who receive the first four intervention sessions between enrollment and week 2 visit |  | Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of self-reported unprotected sex acts |  | 6 months |