Project SPACE: A Micro-Randomized Trial of Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07769580
Status
Not Yet Recruiting

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Conditions

  • Alcohol Abuse
  • HIV
  • Risk Behavior

Eligibility Criteria

Sex
MALE
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • CLT- Concrete text messages — BEHAVIORAL
    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.
  • CLT- Abstract text messages — BEHAVIORAL
    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.
  • Control messages — BEHAVIORAL
    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.
  • No messages — BEHAVIORAL
    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.
  • GamePlan Online Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Feb 28, 2027
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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.

Primary Outcome Measure

Daily number of standard alcoholic drinks [ Time Frame: Daily during the 8-week intervention period (Days 1-56) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory School of MedicineAtlantaGeorgia30307
Neo Gebru, PhD
404-778-3771

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