NCT01900210

Brief Summary

The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR) Project is to develop and test an intervention designed to increase positive decision-making skills among offenders for healthy living, including skills for making decisions for reducing disease risk behaviors, particularly those involving HIV and Hepatitis B \& C. This project focuses on the critical transition time between incarceration and return to the community.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,396

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 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

August 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

3 years

First QC Date

July 2, 2013

Last Update Submit

July 11, 2013

Conditions

Keywords

Criminal justicesubstance abuse treatmentHIV risk behaviors

Outcome Measures

Primary Outcomes (5)

  • HIV Knowledge Confidence (change from pre-test to post-test)

    13 item scale comprised of items assessing knowledge, confidence and motivation regarding HIV knowledge (alpha = .89. Responses on a 5-point "strongly disagree" to "strongly agree" scale. Sample item -- "You should know enough to teach others what they should do if they have been exposed to HIV."

    One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

  • Avoiding Risky Sex (change from pre-test to post-test)

    13 item scale comprised of items assessing knowledge, confidence and motivation regarding avoiding risky sex behaviors (alpha = .91. Responses on a 5-point "strongly disagree" to "strongly agree" scale. Sample item -- "You have learned to think ahead in order to make less risky decisions about sex."

    One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

  • Avoiding Risky Drug Use (change from pre-test to post-test)

    12 item scale comprised of items assessing knowledge, confidence and motivation regarding avoiding risky drug use behaviors (alpha = .85. Responses on a 5-point "strongly disagree" to "strongly agree" scale. Sample item -- "If you decide to inject drugs, you will always use a 'clean needle'."

    One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

  • HIV Testing Awareness (change from pre-test to post-test)

    7 item scale comprised of items assessing knowledge and motivation regarding getting tested for HIV (alpha = .76). Responses on a 5-point "strongly disagree" to "strongly agree" scale. Sample item -- "You plan on being tested regularly for HIV."

    One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

  • Risk Reduction Skills (change from pre-test to post-test)

    14 item scale comprised of items assessing knowledge, confidence and motivation regarding identifying, planning for, and avoiding risk situations (alpha = .85). Responses on a 5-point "strongly disagree" to "strongly agree" scale. Sample item -- "You know how to stand up for yourself when pressured to take a risk."

    One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

Study Arms (2)

WaySafe

EXPERIMENTAL

WaySafe -- Participants in this arm received a curriculum titled WaySafe that focused on identifying, planning for, and avoiding HIV risk behaviors after release from prison. WaySafe included 6 hour-long, group-based, highly interactive sessions normally held weekly with homework assignments given between sessions.

Behavioral: WaySafe

Treatment as usual

NO INTERVENTION

Participants in this arm completed pre- and post-surveys and attended normal substance abuse programming.

Interventions

WaySafeBEHAVIORAL
WaySafe

Eligibility Criteria

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

You may qualify if:

  • Incarcerated offenders in eight participating facilities in two states entering the last phase of their prison-based substance abuse treatment.

You may not qualify if:

  • Sex offenders or those convicted of a violent crime.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wayne E Lehman, Ph.D.

    Institute of Behavioral Research, Texas Christian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 16, 2013

Study Start

August 1, 2008

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

July 16, 2013

Record last verified: 2013-07