- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175250
Translation of Basic Research in Cognitive Science to HIV Risk
June 2, 2017 updated by: Alan Stacy, Claremont Graduate University
Action Plans & Memory Consolidation: Reducing HIV Risk in Drug Users
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
343
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled in drug diversion education program
- Minimum age 18
- Understand English
Exclusion Criteria:
- Under 18
- Do not understand English
- Obviously intoxicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Health Education
This condition included live health education followed by health education videos on HIV risks, testing, and condom use.
The videos were presented over laptop.
|
Videos (AIDSvideos.org)
were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing
|
|
Active Comparator: Action Plan
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.
|
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.
|
|
Experimental: Memory Practice
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV and other infection testing
Time Frame: Past 3 months
|
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).
|
Past 3 months
|
|
Condom use
Time Frame: Past 3 months
|
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.
|
Past 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2013
Primary Completion (Actual)
March 31, 2016
Study Completion (Actual)
March 31, 2016
Study Registration Dates
First Submitted
June 1, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1R01DA033871 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pretest and outcome data will be made available after publication.
Data can be obtained from the PI at alan.stacy@cgu.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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