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

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ClinicalTrials.gov Identifier: NCT00720733
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Skills-Building Intervention Behavioral: Personal Interview Group

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Positive Affect Intervention for Those Recently Diagnosed With HIV
Study Start Date : September 2008
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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.
Active Comparator: 2
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.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720733


Locations
United States, California
UCSF
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Judith T Moskowitz, PhD, MPH University of California, San Francisco
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00720733     History of Changes
Other Study ID Numbers: RMH084723A
1RO1MHO84723-01
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

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

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