Clinical trial NCT00720733: Intervention for (Those) Recently Informed of Seropositive Status (IRISS)
Official title: A Positive Affect Intervention for Those Recently Diagnosed With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Mood
Emotion
Coping
Aids
Affect
Adults
Diagnosed
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: During the intervention and at 5- 10- and 15-months after diagnosis.
Secondary outcomes:
measure: 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.
timeFrame: At 15 months post diagnosis
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith T Moskowitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. J Consult Clin Psychol. 2017 May;85(5):409-423. doi: 10.1037/ccp0000188. Epub 2017 Mar 23.