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

2026년 11월 6일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

360

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Marylou Gilbert
  • 전화번호: 6007 310-393-0411
  • 이메일: marylou@rand.org

연구 장소

    • California
      • Los Angeles, California, 미국, 90028
      • Venice, California, 미국, 90291
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15222
        • 412 Youth Zone
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Alcohol use frequency
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Other drug use frequency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Graham DiGuiseppi, RAND
  • 수석 연구원: Ariella Korn, RAND

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 4월 15일

기본 완료 (추정된)

2029년 9월 30일

연구 완료 (추정된)

2029년 9월 30일

연구 등록 날짜

최초 제출

2026년 11월 6일

QC 기준을 충족하는 최초 제출

2026년 11월 6일

처음 게시됨 (실제)

2026년 11월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 6일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R01AA033407 (미국 NIH 보조금/계약)
  • HLPHL029 (기타 식별자: RAND)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .