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CompletedNCT00720733IRISSUpdated Mar 6, 2015

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

An interventional study of Skills-Building Intervention and Personal Interview Group in HIV Infections, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • HIV Infections

Keywords

  • HIV
  • Mood
  • Emotion
  • Coping
  • Aids
  • Affect
  • Adults
  • Diagnosed
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In context

HIV Infections

4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 160 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    1

    Skills Building Group

    Behavioral: Skills-Building Intervention

  • Active comparator
    2

    Personal Interview Group

    Behavioral: Personal Interview Group

Interventions

  • BehavioralSkills-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.

  • BehavioralPersonal 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.

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

1 site
  • UCSF
    San Francisco, California 94115, United States
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References and documents

Publications

  • 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. PubMed 28333512 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2008
First posted
Jul 23, 2008
Start
Sep 2008
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Mar 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00720733
Responsible party
Sponsor
First posted
Jul 23, 2008
Start date
Sep 2008
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Mar 6, 2015

Study contacts

Judith T Moskowitz, PhD, MPH
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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