Self-Regulation Intervention for Unprotected Sex Decision-Making

Overseen By Maya Kratzer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must not be taking: PrEP

Disqualifiers: HIV, Monogamous, Bipolar, Schizophrenia, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

354 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the risk of HIV transmission by helping men who have sex with men make safer sexual choices when drinking heavily. The research explores how heavy drinking affects decisions about unprotected sex and tests a brief intervention, the Self-Regulation Intervention, to encourage safer behaviors. Participants will receive either a motivational session with follow-up text support or educational advice about drinking and safe sex. Ideal candidates for this trial are cisgender men who have had unprotected anal sex with another man in the past three months, drink heavily, and own a smartphone. As an unphased trial, this study offers participants the chance to contribute to important research that could improve health outcomes for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently using PrEP or receiving treatment for alcohol or substance use disorder, you would not be eligible to participate.

What prior data suggests that these interventions are safe for reducing sexual risk behavior?

Research has shown that self-regulation programs can be safe and effective. These programs significantly reduce heavy drinking and risky sexual behavior. For instance, a short motivational program led to a noticeable drop in both alcohol use and unprotected sex among participants.

Self-regulation strategies help individuals manage their actions and make healthier choices. These programs often include motivational sessions and follow-up support, such as text messages, to reinforce goals related to safe sex and reduced drinking.

Overall, research suggests that self-regulation programs are well-received. Participants report positive results, with very few negative effects. This indicates that these programs are generally considered safe for groups at risk for HIV, such as men who have sex with men. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they tackle risky sexual behavior and heavy drinking with a fresh, motivational approach. The Self-Regulation Intervention goes beyond traditional advice by using a single motivational session to directly address both drinking habits and sexual risk, combined with four weeks of personalized text message support. This offers a continuous, personalized touch to reinforce healthier choices. On the other hand, the Brief Advice and Information session provides a more traditional approach, focusing on education about the risks and barriers to safe sex. These interventions aim to show that empowering individuals with tailored motivation and education can lead to better decision-making and potentially reduce risky behavior.

What evidence suggests that this trial's interventions could be effective for reducing sexual risk behavior among heavy drinkers?

Research shows that a self-control program can help reduce risky sexual behavior and heavy drinking. In this trial, participants may receive a Self-Regulation Intervention, which includes a single-session motivational program aimed at reducing heavy drinking and sexual risk behavior, followed by four weeks of supportive text messages. One study found that just one session of a motivational program, similar to the one under testing, led to less heavy drinking and fewer instances of unprotected sex among participants. Another study suggests that people with strong self-control skills are less likely to drink heavily or engage in risky sexual behavior. Additionally, reviews of similar programs show effectiveness for teenagers and young adults, helping to lower alcohol use and risky sexual activities. These findings support the idea that self-control programs can reduce behaviors that increase the risk of HIV transmission. ^{1 5 6 7 8}

Who Is on the Research Team?

Tibor Palfai, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for cisgender men who drink heavily (more than 14 drinks weekly or more than 4 on one occasion), are at least 18 years old, have had unprotected sex with another man recently, and own a smartphone. It's not for those with certain mental health conditions, current suicidal intent, HIV infection, those on PrEP or in a monogamous relationship, or undergoing substance abuse treatment.

Inclusion Criteria

Engaged in heavy drinking (assessed by either weekly National Institute on Alcohol Abuse and Alcoholism guidelines [> 14 for men], and/or a heavy drinking episode in the past month [> 4 drinks on an occasion])

I am a cisgender man who has had unprotected sex with another man recently.

Has a smartphone

Exclusion Criteria

I have a history of severe mental health issues or currently feel suicidal.

I am in a committed relationship with one partner only.

Unable to provide one or more individuals who can serve as an alternate contact

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a single session motivational intervention on reducing heavy drinking and sexual risk behavior, followed by 4 weeks of text messages on content relevant to drinking goals and support for healthy sexual choices

4 weeks

1 visit (in-person), 4 weeks of text messages

Experience Sampling Method (ESM) Assessment

Intensive longitudinal assessment of alcohol use, arousal, sexual delay discounting, working memory, and CAI

3 weeks

Follow-up

4-month follow-up data collection to assess long-term effects of the intervention

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief Advice and Information
• Self-Regulation Intervention

Trial Overview The study aims to understand how heavy drinking affects sexual decision-making among men who have sex with men and to test an intervention designed to reduce risky sexual behavior related to alcohol use. Participants will receive either self-regulation strategies or brief advice and information.

How Is the Trial Designed?

Group I: Self-Regulation Intervention Experimental Treatment 1 Intervention

Single session motivational intervention on reducing heavy drinking and sexual risk behavior, encouraging consideration of pre-exposure prophylaxis (PrEP), followed by 4 weeks of text messages on content relevant to drinking goals and support for healthy sexual choices

Group II: Brief Advice and Information Active Control 1 Intervention

Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP)

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Syracuse University

Collaborator

Trials

54

Recruited

118,000+

University of South Dakota

Collaborator

Trials

16

Recruited

2,000+

Published Research Related to This Trial

Brief interventions for hazardous and harmful drinking are effective in encouraging individuals to change their alcohol use patterns, even when they do not meet the criteria for alcohol abuse or dependence.

Innovative delivery methods, like online platforms and interactive multimedia, can enhance the implementation of these interventions, making them more accessible and easier to disseminate to a wider audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief interventions for alcohol problems: factors that facilitate implementation. Moyer, A., Finney, JW.[2021]

The HIV epidemic in the US, particularly in the southeast, has increasingly impacted women and minorities, highlighting the need for tailored interventions in diverse patient populations.

The Start Talking About Risks (STAR) program utilizes Motivational Interviewing (MI) to provide a client-centered approach to safer sex counseling for people living with HIV/AIDS, aiming to effectively reduce risky behaviors by addressing individual circumstances rather than using standardized prevention messages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Start Talking About Risks: development of a Motivational Interviewing-based safer sex program for people living with HIV. Golin, CE., Patel, S., Tiller, K., et al.[2022]

In a study of 287 unmarried heterosexual young adults aged 18 to 26, high long-term self-regulation was linked to safer sexual behaviors, such as later initiation of oral sex and coitus, fewer lifetime partners, and increased contraceptive use.

Conversely, high short-term self-regulation was associated with a lower likelihood of condom use and higher overall coital risk, suggesting that immediate decision-making may lead to riskier sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and Long-Term Self-Regulation and Sexual Risk-Taking Behaviors in Unmarried Heterosexual Young Adults. Moilanen, KL.[2016]

Brief interventions (BIs) for hazardous alcohol use show efficacy in primary health care, but their effectiveness in broader settings is less promising, indicating a need to explore the content and mechanisms of BIs to improve outcomes.

Research on the active components of BIs, particularly in brief motivational interviewing (BMI), suggests that personalized feedback and certain motivational techniques may enhance effectiveness, but overall evidence on mechanisms remains limited and inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of action of brief alcohol interventions remain largely unknown - a narrative review. Gaume, J., McCambridge, J., Bertholet, N., et al.[2022]

In a study of 274 never-married young adults aged 18 to 24, high self-regulation was found to indirectly reduce sexual risk-taking by promoting sexual self-restraint and reducing substance use.

Interestingly, while high self-regulation generally limits risky sexual behaviors, it was also associated with having multiple sexual partners and engaging in high-risk practices, potentially due to increased romantic competence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms Linking Self-Regulation and Sexual Behaviors in Never-Married Young Adults. Moilanen, KL., Manuel, ML.[2018]

A behavioral self-control training intervention for 93 problem drinkers led to significant reductions in alcohol consumption and improvements in various life problems over a 24-month follow-up period.

The study found that while body weight initially increased after treatment, it generally returned to baseline levels, and successful smoking cessation was linked to better control of alcohol use, highlighting the interconnectedness of these behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addictive behaviors and life problems before and after behavioral treatment of problem drinkers. Miller, WR., Hedrick, KE., Taylor, CA.[2019]

In a study involving 31 self-referred problem drinkers, both minimal therapist contact and therapist-directed training led to significant reductions in alcohol consumption and peak blood alcohol concentration.

Surprisingly, there were no significant differences in outcomes between the two training modalities, suggesting that even minimal support can be effective for achieving moderation in drinking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a self-control manual for problem drinkers with and without therapist contact. Miller, WR., Gribskov, CJ., Mortell, RL.[2019]

In a study involving 28 problem drinkers, 70% achieved success in reducing their alcohol consumption and peak blood alcohol levels after participating in behavioral training groups focused on moderate drinking.

The severity of problem drinking was identified as a key predictor of success, supporting the effectiveness of behavioral self-control training as a treatment for early-stage problem drinkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group behavior therapy for problem drinkers. Miller, WR., Pechacek, TF., Hamburg, S.[2019]

In a 1-year study of 1,136 college students, high self-regulation was found to significantly reduce heavy episodic drinking, alcohol-related problems, and unprotected sex, highlighting its protective role in risky behaviors during early adulthood.

Self-regulation was particularly effective in preventing risky behaviors among individuals with low sensation seeking, suggesting that interventions aimed at enhancing self-regulation could be beneficial, especially for those at higher risk due to their personality traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation as a protective factor against risky drinking and sexual behavior. Quinn, PD., Fromme, K.[2022]

The brief motivational intervention (BMI) was successfully implemented during short-term alcohol detoxification, showing potential to enhance motivation for safer sexual behaviors among individuals with substance impairment.

While BMI increased motivation for STI protection, it did not lead to significant changes in sexual risk behavior, and negative biological feedback may have inadvertently increased sexual activity, counteracting the intended risk reduction effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief motivational interventions for HIV/STI risk reduction among individuals receiving alcohol detoxification. Brems, C., Dewane, SL., Johnson, ME., et al.[2021]

This study reviewed 21 evidence syntheses involving over 650,000 participants to evaluate self-regulation interventions aimed at reducing risk-taking behaviors in areas like smoking, alcohol use, and unhealthy eating.

Effective interventions often included multiple delivery methods (group, individual, or computer-based), targeted specific behaviors, and provided personalized feedback and support, highlighting the importance of tailored approaches in promoting health behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How best to reduce unhealthy risk-taking behaviours? A meta-review of evidence syntheses of interventions using self-regulation principles. Protogerou, C., McHugh, RK., Johnson, BT.[2021]

In a study involving 118 female heavy drinkers in Finnish primary care clinics, brief alcohol intervention counseling led to a clinically meaningful reduction in drinking for 27% to 75% of participants, regardless of the number of sessions attended.

However, there were no significant differences in drinking reduction between those receiving varying levels of intervention and those given minimal advice, suggesting that even simple advice can be effective in a routine healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief intervention for female heavy drinkers in routine general practice: a 3-year randomized, controlled study. Aalto, M., Saksanen, R., Laine, P., et al.[2015]

In a study involving 4,198 patients with unhealthy alcohol use, 71% had documented use of an electronic clinical reminder for brief alcohol counseling, indicating high implementation rates in routine care.

Patients who received the counseling reminder showed a slightly higher resolution rate of unhealthy alcohol use at follow-up (31%) compared to those who did not receive the reminder (28%), suggesting that the reminder may contribute to improved outcomes in alcohol use management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an electronic clinical reminder for brief alcohol counseling is associated with resolution of unhealthy alcohol use at follow-up screening. Williams, EC., Lapham, G., Achtmeyer, CE., et al.[2022]

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