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Sustainable HIV Risk Reduction Strategies for CJ Systems (DRR)

2013年7月11日 更新者:Wayne Lehman

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.

調査の概要

状態

完了

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

1396

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

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

Exclusion Criteria:

  • Sex offenders or those convicted of a violent crime.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:WaySafe
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.
介入なし:Treatment as usual
Participants in this arm completed pre- and post-surveys and attended normal substance abuse programming.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
HIV Knowledge Confidence (change from pre-test to post-test)
時間枠: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."
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)
時間枠: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."
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)
時間枠: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'."
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)
時間枠: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."
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)
時間枠: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."
One week prior to the intervention start (for both experiemental and control arms) and one week after the intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Wayne E Lehman, Ph.D.、Institute of Behavioral Research, Texas Christian University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年8月1日

一次修了 (実際)

2011年8月1日

研究の完了 (実際)

2011年11月1日

試験登録日

最初に提出

2013年7月2日

QC基準を満たした最初の提出物

2013年7月11日

最初の投稿 (見積もり)

2013年7月16日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年7月16日

QC基準を満たした最後の更新が送信されました

2013年7月11日

最終確認日

2013年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • DA25885-Sum08-13

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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