NCT07769580

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
10mo left

Started Feb 2027

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 13, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Men who have sex with menMicro-randomized trialConstrual level theoryText messagingMobile healthAlcohol useHIV preventionYoung adultsIntervention optimization

Outcome Measures

Primary Outcomes (2)

  • Daily number of standard alcoholic drinks

    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

    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)

Study Arms (1)

GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm

EXPERIMENTAL

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.

Behavioral: CLT- Concrete text messagesBehavioral: CLT- Abstract text messagesBehavioral: Control messagesBehavioral: No messagesBehavioral: GamePlan Online Program

Interventions

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.

GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm

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.

GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm

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.

GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm
No messagesBEHAVIORAL

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 and Daily Micro-Randomized Texts for 8 weeks Arm

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.

GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale sex at birth and currently identify with male gender
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory School of Medicine

Atlanta, Georgia, 30307, United States

Location

MeSH Terms

Conditions

Risk-TakingAlcoholismHomosexualityAlcohol Drinking

Condition Hierarchy (Ancestors)

BehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSexualitySexual BehaviorDrinking Behavior

Study Officials

  • Neo Gebru, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neo Gebru, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants are enrolled in one study arm. Participants will receive text messages daily for 8 weeks: * 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 with equal probability 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. Assignment occurs repeatedly at the participant-day level rather than once at study enrollment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 18, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be shared.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
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.
Access Criteria
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.

Locations