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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00720733 |
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 |
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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 |
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 |
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1: Experimental
Skills Building Group
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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.
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2: Active Comparator
Personal Interview Group
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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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Step[hanie Maurer, MA | 415/353-7795 | maurers@ocim.ucsf.edu |
Contact: Jen Hult, MPH | 415/353-7701 | hultj@ocim.ucsf.edu |
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 |
Principal Investigator: | Judith T Moskowitz, PhD, MPH | University of California, San Francisco |
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 |
HIV Mood Emotion Coping |
Aids Affect Adults Diagnosed |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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 |