NCT03175250

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 15, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 1, 2017

Last Update Submit

June 2, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

    Past 3 months

Study Arms (3)

Health Education

ACTIVE COMPARATOR

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

Behavioral: Health Education

Action Plan

ACTIVE COMPARATOR

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.

Behavioral: Action Plan

Memory Practice

EXPERIMENTAL

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.

Behavioral: Memory Practice

Interventions

Videos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing

Health Education
Action PlanBEHAVIORAL

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.

Action Plan
Memory PracticeBEHAVIORAL

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.

Memory Practice

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Under 18
  • Do not understand English
  • Obviously intoxicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1126/science.1439818.

    PMID: 1439818BACKGROUND
  • 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.

    PMID: 11392341BACKGROUND
  • 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.

    PMID: 2031690BACKGROUND

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned at the individual level to one of three different conditions within each drug diversion class.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 5, 2017

Study Start

October 15, 2013

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Pretest and outcome data will be made available after publication. Data can be obtained from the PI at alan.stacy@cgu.edu