Alcohol ConsumptionNCT06624514
mHealth Behavior Study
A study testing Training Group in people with Alcohol Consumption and Condom Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Alcohol Consumption, Condom Use
- What is being tested?
- Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 9 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women who report lifetime experience sexual assault,
- Consume alcohol at least moderately (e.g., at least seven drinks per week; NIAAA, 2015),
- Have engaged in sexual intercourse with a casual, non-committed male partner without a condom at least three times during the three months prior to data collection.
Who cannot join
- Active homicidal or suicidal ideation;
- History of or current psychotic disorders as the study protocol may be therapeutically insufficient;
- Previously identified as having a Pervasive Developmental Disability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Mobile Health Reaction Time and Behavior Study
The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. The main questions it aims to answer are:
- Does the smartphone task change approach biases for alcohol and condom-related images?
- Does the smartphone task reduce alcohol use and risky sexual behavior?
Read more
Researchers will compare the smartphone task to a sham control to see if the smartphone task changes biases and behavior.
Participants will:
- Complete a baseline assessment battery of questionnaires
- Complete either the intervention smartphone task or the sham smartphone task on four consecutive days.
- Complete a follow-up assessment one week after finishing the four tasks
- Complete a three-month follow-up
- Conditions
- Alcohol Consumption, Condom Use
- Being tested
- Training Group, Sham Training Group
- Keywords
- Alcohol, condoms, Sexual Assault, Risky Sex
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training GroupBehavioural
Implicit approach bias is the behavioral action tendency to be faster to approach rather than avoid cues for a stimulus category. The Approach-Avoidance Task (AAT)is a computerized program in which participants make approach or avoidance movements in response to an irrelevant feature of an image presented on a computer screen (e.g., push when in portrait, pull when in landscape). The intervention in this study is a treatment version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull).
Sham Training GroupBehavioural
A sham-training control condition
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | This arm receives a version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull). Receives: Behavioral: Training Group |
| Control | Sham comparator | No treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group. Receives: Behavioral: Sham Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Approach Bias
At one-week and three-months following the completion of the final study interventional session, participants will complete the AAT Assessment Procedure and complete the baseline questionnaire battery to assess alcohol and condom use since the previous appointment.
Measured: 3-months post final intervention session
Condom Use
Condom use over the past three months will be measured via the NIDA HIV Risk Measure (HRM).
Measured: Three-Months
Alcohol Use
Alcohol use will be assessed at a three-month follow-up using the Daily Drinking Questionnaire - Revised (DDQ-R).
Measured: Three-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start29 Jan 2025
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Austin Hahn, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624514
- Sponsor's protocol ID
- Pro00138757
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Reaction Time and Behavior Study
- ClinicalTrials.gov ID
- NCT06624514
- Acronym / sponsor ID
- Pro00138757
- Conditions
- Alcohol Consumption, Condom Use
- Keywords
- Alcohol, condoms, Sexual Assault, Risky Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 3 Oct 2024 (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.
The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. The main questions it aims to answer are:
- Does the smartphone task change approach biases for alcohol and condom-related images?
- Does the smartphone task reduce alcohol use and risky sexual behavior?
Researchers will compare the smartphone task to a sham control to see if the smartphone task changes biases and behavior.
Participants will:
- Complete a baseline assessment battery of questionnaires
- Complete either the intervention smartphone task or the sham smartphone task on four consecutive days.
- Complete a follow-up assessment one week after finishing the four tasks
- Complete a three-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Training GroupThis arm receives a version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull). |
| Control | Sham comparator | Behavioral: Sham Training GroupNo treatment version of the AAT used as an Approach Bias Modification (ABM) intervention will be used in this group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women who report lifetime experience sexual assault,
- Consume alcohol at least moderately (e.g., at least seven drinks per week; NIAAA, 2015),
- Have engaged in sexual intercourse with a casual, non-committed male partner without a condom at least three times during the three months prior to data collection.
Key exclusion criteria (3 listed)
- Active homicidal or suicidal ideation;
- History of or current psychotic disorders as the study protocol may be therapeutically insufficient;
- Previously identified as having a Pervasive Developmental Disability.
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 |
|---|---|---|
| Training GroupImplicit approach bias is the behavioral action tendency to be faster to approach rather than avoid cues for a stimulus category. The Approach-Avoidance Task (AAT)is a computerized program in which participants make approach or avoidance movements in response to an irrelevant feature of an image presented on a computer screen (e.g., push when in portrait, pull when in landscape). The intervention in this study is a treatment version of the AAT used as an Approach Bias Modification (ABM) intervention, to retrain participants' implicit biases toward or away from stimuli by presenting the target stimuli predominantly in one format (e.g., push or pull). | Behavioural | Training Group |
| Sham Training GroupA sham-training control condition | Behavioural | Control |
Primary outcome
Approach Bias
Time frame: 3-months post final intervention session
At one-week and three-months following the completion of the final study interventional session, participants will complete the AAT Assessment Procedure and complete the baseline questionnaire battery to assess alcohol and condom use since the previous appointment.
Condom Use
Time frame: Three-Months
Condom use over the past three months will be measured via the NIDA HIV Risk Measure (HRM).
Alcohol Use
Time frame: Three-Months
Alcohol use will be assessed at a three-month follow-up using the Daily Drinking Questionnaire - Revised (DDQ-R).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Austin Hahn, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training Group in people with Alcohol Consumption and Condom Use, run by Medical University of South Carolina 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Approach Bias (time frame: 3-months post final intervention session). The study lists 3 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 Mar 2026.