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Translation of Basic Research in Cognitive Science to HIV Risk

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health Education
Action Plan
Memory Practice
Sponsored by
Claremont Graduate University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Enrolled in drug diversion education program
  • Minimum age 18
  • Understand English

Exclusion Criteria:

  • Under 18
  • Do not understand English
  • Obviously intoxicated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Health Education

    Action Plan

    Memory Practice

    Arm Description

    This condition included live health education followed by health education videos on HIV risks, testing, and condom use. The videos were presented over laptop.

    This condition included live health education followed by computerized procedures focusing on action plans for HIV testing and condom use and some of the same health education videos in the Health Education condition.

    This condition included live health education followed by computerized action plan procedures (as in the Action Plan condition), followed by several memory practice procedures also delivered over laptop. The memory practice procedures were designed to help participants more readily retrieve and use action plans in critical situations.

    Outcomes

    Primary Outcome Measures

    HIV and other infection testing
    HIV testing was measured with items from the National Sexual Health Survey (Catania et al., 1992). Hepatitis testing items were assessed in an identical structure. Testing for other sexually transmitted diseases was measured with items from the AIDS Risk Behavior Assessment (Donenberg et al., 2001). These items were tabulated to form a binary variable of whether participants reported testing for HIV, hepatitis, or other sexually transmitted diseases within the past 3 months (3 months following intervention).
    Condom use
    Condom use was assessed with three condom use frequency items from the HIV Risk-taking Behavior Scale (Darke et al., 1991; α =.70; test-retest, r = .86). Response agreement between participants and their sex partners ranged from 88% to 100% in previous research. The questions asked how often participants used condoms in the past 3 months (following the intervention) when having vaginal, oral, or anal sex on a 5-point scale: never, some of the time, about half of the time, most of the time, always.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2017
    Last Updated
    June 2, 2017
    Sponsor
    Claremont Graduate University
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03175250
    Brief Title
    Translation of Basic Research in Cognitive Science to HIV Risk
    Official Title
    Action Plans & Memory Consolidation: Reducing HIV Risk in Drug Users
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2013 (Actual)
    Primary Completion Date
    March 31, 2016 (Actual)
    Study Completion Date
    March 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Claremont Graduate University
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. The trial tested three different interventions on HIV testing and condom use, with a 3 month follow-up. The study translated consistent basic research showing strong effects of memory practice on memory for new material. One of the conditions involved extensive memory practice of action plans involving HIV testing and condom use. Other conditions varied two active control interventions. Results showed that the memory practice condition led to a substantially larger odds of HIV testing than did the two control conditions. Condom use was also significantly more frequent in the memory practice condition than in one of the control conditions but was not significantly different from the second control condition.
    Detailed Description
    This study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce HIV risk and increase screening for HIV and other infections. A randomized trial was conducted (N = 343) to test effects on testing for infection (HIV and hepatitis B/C) and condom use frequency in a sample of drug offenders at risk for infection. Many populations of drug offenders are not currently receiving evidence-based prevention for HIV or hepatitis and are in need of effective interventions that can be used in existing drug programs. At three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. This condition also significantly improved the extent of condom use, compared to a traditional health education condition. The results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. Such procedures can be effectively applied in a complex field setting in existing drug diversion programs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV/AIDS

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomly assigned at the individual level to one of three different conditions within each drug diversion class.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participants were randomly assigned by computer algorithm to three different conditions, and the intervention took place over individually assigned computers with screens that were not observable by the care provider, investigator, or outcome assessor. The two control groups were designed to be "active," that is, designed to have some effects. Thus, there was no indication of which intervention might be more effective.
    Allocation
    Randomized
    Enrollment
    343 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Health Education
    Arm Type
    Active Comparator
    Arm Description
    This condition included live health education followed by health education videos on HIV risks, testing, and condom use. The videos were presented over laptop.
    Arm Title
    Action Plan
    Arm Type
    Active Comparator
    Arm Description
    This condition included live health education followed by computerized procedures focusing on action plans for HIV testing and condom use and some of the same health education videos in the Health Education condition.
    Arm Title
    Memory Practice
    Arm Type
    Experimental
    Arm Description
    This condition included live health education followed by computerized action plan procedures (as in the Action Plan condition), followed by several memory practice procedures also delivered over laptop. The memory practice procedures were designed to help participants more readily retrieve and use action plans in critical situations.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health Education
    Intervention Description
    Videos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing
    Intervention Type
    Behavioral
    Intervention Name(s)
    Action Plan
    Intervention Description
    Participants selected situations for condom use and screening for HIV and hepatitis on individually-assigned laptops. They linked these situations to preventive behaviors regarding screening and condom use.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Memory Practice
    Intervention Description
    Participants engaged in several different types of memory practice procedures on assigned laptops. The procedures focused on memory for action plans for screening and condom use.
    Primary Outcome Measure Information:
    Title
    HIV and other infection testing
    Description
    HIV testing was measured with items from the National Sexual Health Survey (Catania et al., 1992). Hepatitis testing items were assessed in an identical structure. Testing for other sexually transmitted diseases was measured with items from the AIDS Risk Behavior Assessment (Donenberg et al., 2001). These items were tabulated to form a binary variable of whether participants reported testing for HIV, hepatitis, or other sexually transmitted diseases within the past 3 months (3 months following intervention).
    Time Frame
    Past 3 months
    Title
    Condom use
    Description
    Condom use was assessed with three condom use frequency items from the HIV Risk-taking Behavior Scale (Darke et al., 1991; α =.70; test-retest, r = .86). Response agreement between participants and their sex partners ranged from 88% to 100% in previous research. The questions asked how often participants used condoms in the past 3 months (following the intervention) when having vaginal, oral, or anal sex on a 5-point scale: never, some of the time, about half of the time, most of the time, always.
    Time Frame
    Past 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Enrolled in drug diversion education program Minimum age 18 Understand English Exclusion Criteria: Under 18 Do not understand English Obviously intoxicated

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Pretest and outcome data will be made available after publication. Data can be obtained from the PI at alan.stacy@cgu.edu
    Citations:
    PubMed Identifier
    1439818
    Citation
    Catania JA, Coates TJ, Stall R, Turner H, Peterson J, Hearst N, Dolcini MM, Hudes E, Gagnon J, Wiley J, et al. Prevalence of AIDS-related risk factors and condom use in the United States. Science. 1992 Nov 13;258(5085):1101-6. doi: 10.1126/science.1439818.
    Results Reference
    background
    PubMed Identifier
    11392341
    Citation
    Donenberg GR, Emerson E, Bryant FB, Wilson H, Weber-Shifrin E. Understanding AIDS-risk behavior among adolescents in psychiatric care: links to psychopathology and peer relationships. J Am Acad Child Adolesc Psychiatry. 2001 Jun;40(6):642-53. doi: 10.1097/00004583-200106000-00008.
    Results Reference
    background
    PubMed Identifier
    2031690
    Citation
    Darke S, Hall W, Heather N, Ward J, Wodak A. The reliability and validity of a scale to measure HIV risk-taking behaviour among intravenous drug users. AIDS. 1991 Feb;5(2):181-5. doi: 10.1097/00002030-199102000-00008.
    Results Reference
    background
    Links:
    URL
    http://aidsvideos.org/
    Description
    website with HIV related videos used in intervention

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    Translation of Basic Research in Cognitive Science to HIV Risk

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