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Implementing an Evidence-based Alcohol Use and Sexual Risk Intervention in Young Adult Homeless Service Settings

2026年11月6日 更新者:Graham DiGuiseppi、RAND

The goal of this clinical trial is to learn if AWARE-a brief, 4-session group program based on motivational interviewing-reduces alcohol and other drug use and sexual risk behavior among young adults experiencing homelessness (ages 18-25). The study will also learn how well AWARE can be delivered in real-world drop-in center settings and what it would take to keep the program running long-term.

The main questions it aims to answer are:

  • Does AWARE reduce the frequency, quantity, and consequences of alcohol use more than services as usual?
  • Does AWARE reduce sexual risk behavior (condomless sex with primary and casual partners, number of sexual partners, and alcohol or other drug use during sexual activity)?
  • How consistently and well can AWARE be delivered at community drop-in centers?

Researchers will compare AWARE to services as usual at three drop-in centers in Los Angeles and Pittsburgh to see if AWARE works to better.

Participants will:

  • Attend up to 4 group sessions of AWARE or continue receiving usual services at their drop-in center
  • Complete surveys about their alcohol and drug use, sexual behavior, and health at study enrollment, and 3 and 6 month follow-ups.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Young adults experiencing homelessness (YAEH) are disproportionately affected by alcohol and other drug (AOD) use and sexual risk behavior, yet drop-in centers serving this population have limited access to brief, evidence-based programs that address both. AWARE is a 4-session group intervention grounded in motivational interviewing (MI) that targets AOD use and sexual risk behavior among 18-25 year olds experiencing homelessness. The program integrates education, skills building, and normative feedback in an interactive group format, incorporating components shown to be effective with homeless youth and other at-risk populations: enhancing protective factors, targeting multiple risk behaviors together, using active learning techniques, reinforcing skills, and delivering information in a non-judgmental manner. Sessions address HIV/STI knowledge and partner risk evaluation (Session 1), identifying and managing triggers for sexual risk behavior (Session 2), weighing the pros and cons of substance use and building strategies to reduce harm (Session 3), and understanding how AOD use affects brain functioning and behavior (Session 4). The brief format and group delivery model were designed to fit the service realities of drop-in centers, where YAEH may engage sporadically and staff capacity is limited.

The study design is a hybrid type 1 effectiveness-implementation study in which we will test the effectiveness of AWARE on young adult health outcomes, while collecting contextual data on implementation and sustainability of the intervention. The effectiveness study will follow a group-randomized design in which young adults receiving services at three drop-in centers will either be in the intervention condition (N = 180) or a services as usual control condition (N = 180). Young adult participants will complete surveys measuring primary and secondary outcomes at baseline, and follow-up surveys at 3- and 6-months post-baseline. The group-randomized trial will have crossover conditions and groups to avoid problems of power reduction and contamination associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on where they receive services at a given time. The field period in each condition will be divided into four 22-week phases. The three drop-in centers will alternate serving as the "intervention site" or the "control site," with each center having two intervention phases and two control phases. The first 16 weeks of each phase involves delivering AWARE (intervention sites) or surveying participants at the control sites. Sixteen weeks was chosen to repeat the four-session AWARE program four times, allowing YAEH several opportunities to attend all sessions. The remaining six weeks of each phase is an inactive "wash out" period to allow for the recruitment of a new cohort and reduce the likelihood of contamination across conditions.

In addition to testing effectiveness, this study will assess how consistently and with what quality AWARE is delivered across sites and phases (implementation outcomes), and what organizational and fiscal conditions would support long-term sustainment. Fidelity to the AWARE protocol and MI will be assessed by audio recording sessions and rating them using an adherence checklist. Participant perspectives on intervention quality will be captured at the 3-month follow-up via item measuring therapeutic alliance and MI-consistent facilitator behaviors. Sustainment will be examined through interviews with policy actors and site leaders to identify barriers and facilitators to continued adoption beyond the study period.

研究の種類

介入

入学 (推定)

360

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Marylou Gilbert
  • 電話番号:6007 310-393-0411
  • メール:marylou@rand.org

研究場所

    • California
      • Los Angeles、California、アメリカ、90028
      • Venice、California、アメリカ、90291
    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15222
        • 412 Youth Zone
        • コンタクト:

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~25年 (大人)

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:

  • aged 18-25 years
  • receiving services at the drop-in center
  • plans to stay in the geographic area for the next month
  • English speaking

Exclusion Criteria:

  • Observed cognitive impairment during enrollment

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:AWARE condition

AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback. Participants will have access to all usual care services while receiving AWARE.

AWARE is a brief (four-session) group counseling intervention that uses motivational interviewing and psychoeducation to address hazardous alcohol use and sexual risk behaviors. AWARE was developed with input from young adults experiencing homelessness and service providers and has shown to be feasible, acceptable, and efficacious when delivered in young adult homeless service settings. AWARE sessions are 45-minutes in length and delivered by one to two facilitators who receive training on the AWARE protocol and motivational interviewing. AWARE sessions provide normative feedback about alcohol use, and education about sexual risk behaviors and sexually transmitted infections. AWARE is designed to be collaborative and strengths-based, helping young adults identify and plan for high-risk situations and develop effective coping strategies to reduce the likelihood of alcohol-related negative consequences and sexual risk behaviors.

介入なし:Standard care condition

Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.

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
Alcohol use frequency
時間枠:Baseline, 3 months, and 6 months follow-up

The number of alcohol use days (any alcohol use) and the number of binge drinking days (5+ drinks) in the past 30 days

Baseline, 3 months, and 6 months follow-up
Alcohol use quantity
時間枠:Baseline, 3 months, and 6 months follow-up

The typical number of drinks consumed on drinking days, and the maximum number of drinks consumed on drinking days in the past 30 days

Baseline, 3 months, and 6 months follow-up
Alcohol use consequences
時間枠:Baseline, 3 months, and 6 months follow-up

Number of alcohol consequences in the past 30 days, assessed by the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

Baseline, 3 months, and 6 months follow-up

二次結果の測定

結果測定
メジャーの説明
時間枠
Other drug use frequency
時間枠:Baseline, 3 months, and 6 months follow-up

Number of days of other drug use besides alcohol (cannabis, stimulants, opioids, sedatives/barbiturates, hallucinogens, cigarette and vape use) in the past 30 days.

Baseline, 3 months, and 6 months follow-up
Cannabis use quantity
時間枠:Baseline, 3 months, and 6 months follow-up

Amount of flower/bud consumed (in grams) on a typical cannabis use day

Baseline, 3 months, and 6 months follow-up
Cannabis use consequences
時間枠:Baseline, 3 months, and 6 months follow-up

Number of cannabis use consequences in the past 30 days, measured by the Brief-Marijuana Consequences Questionnaire (B-MACQ)

Baseline, 3 months, and 6 months follow-up
Substance use disorder
時間枠:Baseline, 3 months, and 6 months follow-up

Probable substance use disorder, measured with the Global Appraisal of Individual Needs Short Screener (GAIN-SS)

Baseline, 3 months, and 6 months follow-up
Number of sexual partners
時間枠:Baseline, 3 months, and 6 months follow-up

Number of oral, vaginal and anal sex partners in the past 3 months. Primary and casual sex partners will be reported separately.

Baseline, 3 months, and 6 months follow-up
Condom use
時間枠:Baseline, 3 months, and 6 months follow-up

Percentage of oral, vaginal, and anal sex events in which a condom was used in the past 3 months, assessed separately for primary and casual partners

Baseline, 3 months, and 6 months follow-up
Alcohol or other drug use during sexual activity
時間枠:Baseline, 3 months, and 6 months follow-up

Frequency of alcohol or other drug use before or during sex in the past 3 months (0=Never to 4=Every time), with primary and casual partners

Baseline, 3 months, and 6 months follow-up
Perceived importance of condom use
時間枠:Baseline, 3 months, and 6 months follow-up

Importance of increasing condom use during sex, or remaining a consistent condom user, measured on a scale from 0 (not at all important) to 10 (extremely important).

Baseline, 3 months, and 6 months follow-up
Condom use self-efficacy
時間枠:Baseline, 3 months, and 6 months follow-up

Self-efficacy to use a condom correctly and consistently and to discuss condom use with partners (from "not at all sure" to "very sure"), assessed using 8-items from a scale by Brafford and Beck (1991)

Baseline, 3 months, and 6 months follow-up

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

協力者

捜査官

  • 主任研究者:Graham DiGuiseppi、RAND
  • 主任研究者:Ariella Korn、RAND

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (推定)

2027年4月15日

一次修了 (推定)

2029年9月30日

研究の完了 (推定)

2029年9月30日

試験登録日

最初に提出

2026年11月6日

QC基準を満たした最初の提出物

2026年11月6日

最初の投稿 (実際)

2026年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年9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

  • R01AA033407 (米国 NIH グラント/契約)
  • HLPHL029 (その他の識別子:RAND)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Qualitative data to be shared include de-identified transcripts generated from staff focus groups and interviews with policy actors. Data will be made available to researchers for secondary analysis or replication of study findings. Transcripts will be de-identified, and sites will be referred to as Site 1, Site 2, and Site 3.

Quantitative data to be shared include de-identified, aggregate survey data to be made available for secondary analysis or replication of study findings. A separate ASCII (csv) data file will be created for young adult demographic and health outcomes (Aim 1), cost and cost-effectiveness data (Aim 1), participant reach and acceptability (Aim 2), AWARE fidelity ratings (Aim 2), and implementation outcomes (Aim 2).

IPD 共有時間枠

We will deposit study data in the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) repository starting 12 months after the award begins. Study protocols, metadata, and de-identified data sets that are ready for public use will be submitted semi-annually (twice per year). Clinical trial data will be shared after the clinical trial is completed. Final project data will be made available at time of manuscript publication, or within 12 months following the project end date, whichever comes first.

IPD 共有アクセス基準

Data will be findable for the research community through the NIAAADA. The study will be findable and identifiable using unique URL links. Links to public access files will be shared in all peer-reviewed publications.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。