HIVNCT07769580
Project SPACE: Testing Daily Text Messages to Reduce Alcohol Use and HIV Risk Behavior
A study testing CLT- Concrete text messages, CLT- Abstract text messages and No messages in people with HIV and Risk Behavior, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- HIV, Risk Behavior, Alcohol Abuse
- What is being tested?
- CLT- Concrete text messages, CLT- Abstract text messages and No messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Emory School of Medicine
Atlanta, Georgia, 30307
Neo Gebru, PhD, 404-778-3771, neo_gebru@emory.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- HIV, Risk Behavior, Alcohol Abuse
- Being tested
- CLT- Concrete text messages, CLT- Abstract text messages, Control messages, No messages, GamePlan Online Program
- Keywords
- Men who have sex with men, Micro-randomized trial, Construal level theory, Text messaging, Mobile health, Alcohol use, HIV prevention, Young adults, Intervention optimization
- Medical subject headings
- Risk-Taking, Alcoholism, Homosexuality, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLT- Concrete text messagesBehavioural
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 messagesBehavioural
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 messagesBehavioural
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 messagesBehavioural
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 ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CLT- Concrete text messages; Behavioral: CLT- Abstract text messages; Behavioral: Control messages; Behavioral: No messages; Behavioral: GamePlan Online Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Daily during the 8-week intervention period (Days 1-56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Neo Gebru, Emory University
- Investigators
- Neo Gebru, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769580
- Sponsor's protocol ID
- 2026P000846
- Other IDs
- 4R00AA031443-03
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SPACE (Study Pilot on Alcohol Construals Everyday)
- ClinicalTrials.gov ID
- NCT07769580
- Acronym / sponsor ID
- 2026P000846
- Conditions
- HIV, Risk Behavior, Alcohol Abuse
- Keywords
- Men who have sex with men, Micro-randomized trial, Construal level theory, Text messaging, Mobile health, Alcohol use, HIV prevention, Young adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm | Experimental | Behavioral: CLT- Concrete text messages, Behavioral: CLT- Abstract text messages, Behavioral: Control messages, Behavioral: No messages, Behavioral: GamePlan Online ProgramAll 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLT- Concrete text messagesOn 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. | Behavioural | GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm |
| CLT- Abstract text messagesOn 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. | Behavioural | GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm |
| Control messagesOn 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. | Behavioural | GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm |
| No messagesOn 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. | Behavioural | GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm |
| GamePlan Online ProgramFollowing 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. | Behavioural | GamePlan and Daily Micro-Randomized Texts for 8 weeks Arm |
Primary outcome
Daily number of standard alcoholic drinks
Time frame: 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 sexual HIV Risk Indicator
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neo Gebru, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLT- Concrete text messages, CLT- Abstract text messages and No messages in people with HIV and Risk Behavior, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neo Gebru, PhD (404-778-3771, neo_gebru@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily number of standard alcoholic drinks (time frame: Daily during the 8-week intervention period (Days 1-56)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.