Emory School of Medicine
Atlanta, Georgia, 30307, United States
NCT Number: NCT07769580
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 opening soon.
Get Notified18 year–30 year
Male
Interventional
Not applicable
Atlanta, Georgia, 30307, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
Contact information is provided by the study sponsor or research team.
Emory University
Other
Project SPACE (Study Pilot on Alcohol Construals Everyday)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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