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Intervention for (Those) Recently Informed of Seropositive Status (IRISS)
This study is currently recruiting participants.
Verified by University of California, San Francisco, July 2008
First Received: July 21, 2008   Last Updated: October 15, 2008   History of Changes
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00720733
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Skills-Building Intervention
Behavioral: Personal Interview Group

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Positive Affect Intervention for Those Recently Diagnosed With HIV

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. [ Time Frame: During the intervention and at 5- 10- and 15-months after diagnosis. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At 15 months post diagnosis ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Skills Building Group
Behavioral: Skills-Building Intervention
A 5-week intervention including 5 weekly sessions covering 8 varied coping skills with daily home practice. The skills are: 1) noting daily positive events; 2) capitalizing on positive events; 3) gratitude; 4) mindfulness; 5) positive reappraisal; 6) focusing on personal strengths; 7) setting and working toward attainable goals; and 8) small acts of kindness. Sessions are 1 hour long and include approximately 30 minutes per day.
2: Active Comparator
Personal Interview Group
Behavioral: Personal Interview Group

There are 5 weekly sessions which will be approximately one hour long and will consist of personal interview.

The interviews will include both quantitative and qualitative questions. Each session will have a separate theme including: Life 1) History; 2) Health History; 3) Personality; 4) Social Networking; and, 5) Meaning

  • Purpose.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720733

Contacts
Contact: Step[hanie Maurer, MA 415/353-7795 maurers@ocim.ucsf.edu
Contact: Jen Hult, MPH 415/353-7701 hultj@ocim.ucsf.edu

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94115
Contact: Stephanie Maurer, MA     415-353-7795     maurers@ocim.ucsf.edu    
Contact: Jen Hult, MPH     415/353-7701     hultj@ocim.ucsf.edu    
Principal Investigator: Judith T. Moskowitz, PhD, MPH            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Judith T Moskowitz, PhD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco ( Judith T. Moskowitz, PhD )
Study ID Numbers: RMH084723A, 1RO1MHO84723-01
Study First Received: July 21, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00720733     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
Mood
Emotion
Coping
Aids
Affect
Adults
Diagnosed

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 09, 2009