이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Project SPACE: Testing Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior

2026년 8월 17일 업데이트: Neo Gebru, Emory University

Project SPACE (Study Pilot on Alcohol Construals Everyday)

Project SPACE is a micro-randomized trial evaluating the proximal effects theory-based text messages on alcohol use and sexual HIV risk behaviors among HIV-negative young adult men at the day-level.

At baseline, all participants will complete GamePlan, an existing brief online sexual health program. During the subsequent 8-week intervention period, participants will complete a brief morning assessment of the preceding day and will be randomized each afternoon, with equal probability, to receive concrete ("how"), abstract ("why"), neutral control, or no afternoon intervention messages. Participants will also complete pre- and post-intervention measures. The effects of GamePlan are not being separately evaluated in this study.

연구 개요

상세 설명

Project SPACE will evaluate the proximal effects of different types of text messages on heavy drinking and HIV risk among young adult men. The study will evaluate the effects of the text messages on alcohol use and sexual HIV risk behaviors among young adult men. The study will evaluate the effectiveness of the text messages using responses obtained via online surveys and text messaging responses.

The study will enroll up to 240 young adult men aged 18-30 who report heavy drinking and HIV risk behaviors. No minors or other vulnerable populations are targeted. Recruitment will occur online nationwide through targeted digital outreach.

Participants will complete online pre- and post-intervention surveys. Following the baseline assessment, all participants will complete GamePlan, a brief online sexual-health program designed to help users reflect on their sexual and drinking choices, receive personalized feedback, and consider whether they wish to make changes. GamePlan is provided to all participants as a common baseline program and is not a randomized intervention component. The study is not designed to estimate the independent effect of GamePlan.

After completing the baseline assessment and GamePlan, participants will begin the 8-week daily text-messaging protocol. Each morning, participants will receive a brief assessment concerning alcohol use, sexual behavior, and related behaviors on the preceding day. At each afternoon decision point, participants will be independently randomized, with equal probability, to one of four conditions: CLT-concrete messages, CLT-abstract messages, neutral control messages, or no afternoon intervention messages.

In a small initial tech-check, up to 8 participants will participate to ensure surveys and text messages are functioning correctly and verify randomization procedures and data capture before full recruitment begins. The technical run-in is intended to permit operational refinements that do not alter the eligibility criteria, intervention content, randomization probabilities, outcome definitions, or assessment schedule.

Then, participants enrolled in the clinical trial will be involved for approximately 8 weeks, completing pre- and post-surveys alongside the texting intervention period.

No biological specimens will be collected. De-identified survey and intervention data may be stored securely and used for future research consistent with IRB approval.

The study team will protect participants' privacy and ensure the confidentiality of all data in accordance with Emory University's Office of Information Technology (OIT) data and security requirements. All study data will be stored on secure, password-protected servers, and access will be limited to authorized research personnel.

연구 유형

중재적

등록 (추정된)

240

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

    • Georgia
      • Atlanta, Georgia, 미국, 30307
        • Emory School Of Medicine
        • 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

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Male sex at birth and currently identify with male gender
  • Own and use a smartphone that can receive text messages daily
  • Have tested negative for HIV in the past 24 months
  • Be willing to consider a change in their drinking behavior
  • Not currently in a sexually exclusive relationship
  • In the past three months, the subject must have had at least 3 condomless sexual encounters with men and consumes ≥5 standard alcoholic drinks at least once a week.

Exclusion Criteria:

  • Involved in previous Project SPACE research (i.e., members of the Phase 1 community advisory board or Phase 2 pilot tests)
  • Participants that have sought treatment for substance use in the past month.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm

All participants will complete a baseline assessment followed by GamePlan, an online sexual-health program. Participants will then complete an 8-week daily text-messaging protocol. Texts will be delivered from an automated computerized system.

Each day of the 8-week texting intervention period, there will be 2 sets of texts: morning and afternoon.

Each morning, participants will receive questions about their behaviors the preceding day, including alcohol use, sexual behaviors (e.g., type of sexual activity, partner type).

In the afternoons, participants will be micro-randomized every day for 8 weeks to receive a series of (1) CLT-concrete text messages; (2) CLT-abstract text messages; (3) control messages; or (4) no messages.

Each afternoon, there will be a 25% chance of receiving one of the 4 afternoon conditions. Randomization on any given day will be independent of previous texts.

Participants will complete baseline and post-intervention assessments.

On participant-days assigned to this condition, participants will receive interactive CLT-concrete ('how'-based) text messages will involve asking participants questions about their alcohol use and sexual behaviors.

Participants will receive 3 how-based questions related to alcohol and 3 how-based questions related to sexual behaviors (for a total of 6 questions).

The messages will prompt participants to think concretely about actions and strategies related to reducing alcohol-related and sexual health risks.

On participant-days assigned to this condition, participants will receive interactive CLT-abstract ('why'-based) text messages will involve asking participants questions about their alcohol use and sexual behaviors. Participants will receive 3 why-based questions related to alcohol and 3 why-based questions related to sexual behaviors (for a total of 6 questions). The messages will prompt participants to think abstractly about their reasons, values, and broader goals related to reducing alcohol-related and sexual-health risks.
On participant-days assigned to this condition, participants will receive interactive neutral messages will follow the same structure as intervention texts (CLT-texts), daily for 8 weeks, with having an initial question with 2 follow-up questions (i.e., 3 total questions). Control texts will be neutral (e.g., fun fact). Control messages will help enhance study rigor and rule out confounding due to any potential assessment reactivity to texts.
On participant-days assigned to this condition, no afternoon intervention message will be delivered. Participants will continue to receive the regularly scheduled morning assessment. Participants in this condition will previously have received the common baseline GamePlan program, as will all other participants.
Following the baseline assessment and before beginning the 8-week text-messaging period, all participants will complete GamePlan, a brief online sexual-health program lasting approximately 15-20 minutes. GamePlan provides personalized feedback and activities intended to help participants reflect on their sexual choices and consider whether they wish to make changes. GamePlan is administered to all participants and is not a randomized intervention component in this study. Its independent effect will not be evaluated.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Daily number of standard alcoholic drinks
기간: Daily during the 8-week intervention period (Days 1-56)
Each morning, participants will report the total number of standard alcoholic drinks consumed on the preceding calendar day. Days without alcohol use will be assigned a value of zero. This day-level outcome will be examined in relation to the afternoon message condition assigned on the corresponding calendar day
Daily during the 8-week intervention period (Days 1-56)
Daily sexual HIV Risk Indicator
기간: Daily during the 8-week intervention period (Days 1-56)
Each morning, participants will report sexual behaviors occurring on the preceding calendar day. A prespecified binary day-level indicator will be coded as yes when at least one behavior meets the study's sexual HIV-risk definition and no when none is reported. This outcome will be examined in relation to the afternoon message condition assigned on the corresponding calendar day.
Daily during the 8-week intervention period (Days 1-56)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Neo Gebru, PhD, Emory University

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 2월 1일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 13일

QC 기준을 충족하는 최초 제출

2026년 8월 13일

처음 게시됨 (실제)

2026년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 17일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data will be shared.

IPD 공유 기간

Final submission and release of the study data will occur within 6 months following the end of fieldwork and within the award period. Study data deposited in the NDA will be available to the research community in perpetuity.

IPD 공유 액세스 기준

Given the sensitivity of the human subject behavioral data, access to data will be controlled and will be made available only after there is a demonstrated valid research need and users meet conditions of use.

Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA).

Data sets in the NDA will be findable and identifiable through a study-specific Digital Object Identifier (DOI) number.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • CSR

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. .

구독하다