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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03175250
Other study ID # 1R01DA033871
Secondary ID 1R01DA033871
Status Completed
Phase N/A
First received June 1, 2017
Last updated June 2, 2017
Start date October 15, 2013
Est. completion date March 31, 2016

Study information

Verified date June 2017
Source Claremont Graduate University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 343
Est. completion date March 31, 2016
Est. primary completion date March 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Enrolled in drug diversion education program

- Minimum age 18

- Understand English

Exclusion Criteria:

- Under 18

- Do not understand English

- Obviously intoxicated

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Education
Videos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing
Action Plan
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.
Memory Practice
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Claremont Graduate University National Institute on Drug Abuse (NIDA)

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Past 3 months
Primary Condom use Condom use was assessed with three condom use frequency items from the HIV Risk-taking Behavior Scale (Darke et al., 1991; a =.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
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