Intervention for (Those) Recently Informed of Seropositive Status (IRISS)

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Skills-Building Intervention; Behavioral: Personal Interview Group

• Registration Number: NCT00720733
• Lead Sponsor: University of California, San Francisco

Brief Summary

An intervention designed to increase positive affect in a population newly diagnosed with HIV will be effective at improving affect and HIV-related outcomes such as mental and physical health, coping and coping resources.

Detailed Description

The study is a randomized controlled trial of a 5-session positive affect skills intervention compared to an attention-matched control condition. Participants will be 200 men and women who have tested positive for HIV within the past 12 weeks. Both intervention and control sessions will be approximately one hour long and will be administered one-on-one by trained facilitators. Both groups will have daily home practice over the 5 weeks of the intervention. At the end of the assessment period, participants in the control condition will have the opportunity to attend a ½ day group session that provides a condensed version of the positive affect skills taught in the intervention condition. Participants will complete assessments at four points and CD4 and viral load assays will be run at 3 time points.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-22
• Study First Posted: 2008-07-23
• Study Start: 2008-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• have been informed they were HIV positive within the past 12 weeks
• speak English or Spanish
• be 18 years or older
• have the ability to provide informed consent to be a research participant.

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Exclusion Criteria

• inability to provide informed consent, as evidenced by cognitive impairment as assessed by trained interviewers and confirmed by a licensed clinical psychologist
• active psychosis as assessed by trained interviewers and confirmed by clinical psychologist

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Skills-Building Intervention	Skills Building Group
2	Personal Interview Group	Personal Interview Group

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of the Intervention for those Recently Informed of their Seropositive Status (IRISS) for increasing the frequency and intensity of positive affect in men and women newly diagnosed with HIV.	During the intervention and at 5- 10- and 15-months after diagnosis.

Secondary Outcome Measures

Name	Time	Method
Effects on outcomes and if increases in positive affect are responsible for improvements; effects of individual facets on affect and outcomes; and, evaluate extent to which personality, se status, race/ethn, & stress level, moderate effects on outcomes.	At 15 months post diagnosis

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States