HIV Risk BehaviorsDRRNCT01900210
Sustainable HIV Risk Reduction Strategies for CJ Systems
A study testing WaySafe in people with HIV Risk Behaviors, run by Wayne Lehman.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Risk Behaviors
- What is being tested?
- WaySafe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,396 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Incarcerated offenders in eight participating facilities in two states entering the last phase of their prison-based substance abuse treatment.
Who cannot join
- Sex offenders or those convicted of a violent crime.
About this study
Official title: Sustainable Disease Risk Reduction Strategies for CJ Systems
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.
Read the detailed description
The purpose of the TCU 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. This project focuses on risky sexual and drug use behaviors during re-entry, including problem recognition, commitment to change, and strategies for avoiding behavioral risks of infections. Motivational and planning sessions will be delivered near the end of criminal justice (CJ) institution-based substance abuse treatment, and they will also bridge into re-entry care services during community transitional treatment by using a self-study toolkit for released offenders that emphasize applications of DRR principles. This 5-year project has been funded by the National Institute on Drug Abuse.
The intervention has two components - an in-prison and a post-release component.
- The in-prison component, WaySafe, is a six session, manual-based training on decision-making skills that occurs during the last several months of treatment before release from incarceration. It is a group-based, interactive curriculum based on TCU Mapping Enhanced Counseling strategies, which are used to visually enhance communication between clients and counselors. Homework assignments are given to be completed between the weekly sessions. The six hour-long WaySafe sessions are conducted by current counselors at the facility who have been trained in the curriculum.
For comparison purposes, some offenders who voluntarily agree to participate in the DRR study are randomly assigned to attend "treatment as usual." All participants in the study first sign an Informed Consent document indicating that their participation is voluntary and that they have been informed about their rights as research participants. They are also asked to complete a brief pre-test at the beginning of the study and a brief post-test at the end of the six-week period. A signed Certificate of Completion is given to all participants who complete the study.
- The post-release component, Keep It Safe, is a self-study toolkit given to offenders when they are released from incarceration, using mapping principles similar to those in the WaySafe sessions. It is designed to reinforce decision-making skills during this transition period and includes multiple assignments on topics such as risk taking, making better decisions regarding risky behaviors, and decisions regarding HIV testing.
For comparison purposes, some offenders are randomly selected to receive a booklet that includes readings on HIV and Hepatitis B\&C derived from National Institutes of Health (NIH) and Center for Disease Control (CDC) materials, with short quizzes after each section. Both the Keep It Safe and CDC Readings booklets are designed to take about five hours to complete including a final follow-up survey in each booklet. Offenders are asked to mail their completed booklets directly to TCU in a provided pre-addressed, franked envelope. A Certificate of Completion is mailed directly to the participant when the completed workbook and follow-up survey is received at TCU project offices.
- Conditions
- HIV Risk Behaviors
- Being tested
- WaySafe
- Keywords
- Criminal justice, substance abuse treatment, HIV risk behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaySafeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: WaySafe |
| Treatment as usual | No intervention | Participants in this arm completed pre- and post-surveys and attended normal substance abuse programming. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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."
Measured: 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'."
Measured: 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."
Measured: 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."
Measured: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Risk BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne Lehman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wayne Lehman, Texas Christian University
- Investigators
- Wayne E Lehman, Ph.D., Principal investigator, Institute of Behavioral Research, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900210
- Sponsor's protocol ID
- DA25885-Sum08-13
- Acronym
- DRR
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Disease Risk Reduction Strategies for CJ Systems
- ClinicalTrials.gov ID
- NCT01900210
- Acronym / sponsor ID
- DRR / DA25885-Sum08-13
- Conditions
- HIV Risk Behaviors
- Keywords
- Criminal justice, substance abuse treatment, HIV risk behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,396 participants (actual)
- Lead sponsor
- Wayne LehmanUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the TCU 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. This project focuses on risky sexual and drug use behaviors during re-entry, including problem recognition, commitment to change, and strategies for avoiding behavioral risks of infections. Motivational and planning sessions will be delivered near the end of criminal justice (CJ) institution-based substance abuse treatment, and they will also bridge into re-entry care services during community transitional treatment by using a self-study toolkit for released offenders that emphasize applications of DRR principles. This 5-year project has been funded by the National Institute on Drug Abuse.
The intervention has two components - an in-prison and a post-release component.
- The in-prison component, WaySafe, is a six session, manual-based training on decision-making skills that occurs during the last several months of treatment before release from incarceration. It is a group-based, interactive curriculum based on TCU Mapping Enhanced Counseling strategies, which are used to visually enhance communication between clients and counselors. Homework assignments are given to be completed between the weekly sessions. The six hour-long WaySafe sessions are conducted by current counselors at the facility who have been trained in the curriculum.
For comparison purposes, some offenders who voluntarily agree to participate in the DRR study are randomly assigned to attend "treatment as usual." All participants in the study first sign an Informed Consent document indicating that their participation is voluntary and that they have been informed about their rights as research participants. They are also asked to complete a brief pre-test at the beginning of the study and a brief post-test at the end of the six-week period. A signed Certificate of Completion is given to all participants who complete the study.
- The post-release component, Keep It Safe, is a self-study toolkit given to offenders when they are released from incarceration, using mapping principles similar to those in the WaySafe sessions. It is designed to reinforce decision-making skills during this transition period and includes multiple assignments on topics such as risk taking, making better decisions regarding risky behaviors, and decisions regarding HIV testing.
For comparison purposes, some offenders are randomly selected to receive a booklet that includes readings on HIV and Hepatitis B\&C derived from National Institutes of Health (NIH) and Center for Disease Control (CDC) materials, with short quizzes after each section. Both the Keep It Safe and CDC Readings booklets are designed to take about five hours to complete including a final follow-up survey in each booklet. Offenders are asked to mail their completed booklets directly to TCU in a provided pre-addressed, franked envelope. A Certificate of Completion is mailed directly to the participant when the completed workbook and follow-up survey is received at TCU project offices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WaySafe | Experimental | Behavioral: WaySafeWaySafe -- 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. |
| Treatment as usual | No intervention | –Participants in this arm completed pre- and post-surveys and attended normal substance abuse programming. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Incarcerated offenders in eight participating facilities in two states entering the last phase of their prison-based substance abuse treatment.
Key exclusion criteria (1 listed)
- Sex offenders or those convicted of a violent crime.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaySafe | Behavioural | WaySafe |
Primary outcome
HIV Knowledge Confidence (change from pre-test to post-test)
Time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
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."
Avoiding Risky Sex (change from pre-test to post-test)
Time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
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."
Avoiding Risky Drug Use (change from pre-test to post-test)
Time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
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'."
HIV Testing Awareness (change from pre-test to post-test)
Time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
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."
Risk Reduction Skills (change from pre-test to post-test)
Time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention
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."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne E Lehman, Ph.D. principal investigator
Institute of Behavioral Research, Texas Christian University
Questions about this trial
What is this clinical trial studying?
A study testing WaySafe in people with HIV Risk Behaviors, run by Wayne Lehman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Knowledge Confidence (change from pre-test to post-test) (time frame: One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.