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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00720733
First received: July 21, 2008
Last updated: August 15, 2014
Last verified: August 2014

July 21, 2008
August 15, 2014
September 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00720733 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intervention for (Those) Recently Informed of Seropositive Status (IRISS)
A Positive Affect Intervention for Those Recently Diagnosed With HIV

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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.
  • 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.
  • Experimental: 1
    Skills Building Group
    Intervention: Behavioral: Skills-Building Intervention
  • Active Comparator: 2
    Personal Interview Group
    Intervention: Behavioral: Personal Interview Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720733
RMH084723A, 1RO1MHO84723-01
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Judith T Moskowitz, PhD, MPH University of California, San Francisco
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP