NCT00720733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

6.3 years

First QC Date

July 21, 2008

Last Update Submit

March 5, 2015

Conditions

HIV Infections

Keywords

HIVMoodEmotionCopingAidsAffectAdultsDiagnosed

Outcome Measures

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.

    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.

    At 15 months post diagnosis

Study Arms (2)

1

EXPERIMENTAL

Skills Building Group

Behavioral: Skills-Building Intervention

2

ACTIVE COMPARATOR

Personal Interview Group

Behavioral: Personal Interview Group

Interventions

Skills-Building InterventionBEHAVIORAL

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.

1
Personal Interview GroupBEHAVIORAL

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • 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.

    PMID: 28333512DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeDisease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith T Moskowitz, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)