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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
343

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Health Education
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claremont Graduate University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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