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

Trial Summary

What is the purpose of this trial?

HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking.

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 data supports the effectiveness of this treatment for unprotected sex decision-making?

Research shows that behavioral self-control training, which is part of the treatment, has been effective in reducing alcohol consumption and improving related life problems. This suggests that similar approaches could help in managing risky behaviors like unprotected sex. ^{1 2 3 4 5}

Is the Self-Regulation Intervention for Unprotected Sex Decision-Making safe for humans?

Research on similar interventions, like brief motivational interventions for reducing HIV/STI risk, suggests they are safe to implement even in individuals with significant substance use issues. These interventions focus on enhancing motivation and planning for safer behaviors without causing harm. ^{3 6 7 8 9}

How does the self-regulation intervention treatment differ from other treatments for unprotected sex decision-making?

This treatment is unique because it focuses on enhancing self-regulation skills, which can help individuals manage their impulses and make safer sexual decisions. Unlike other treatments that might focus solely on providing information or using medication, this approach uses techniques like counseling, stress management, and skills training to empower individuals to control their behaviors and reduce risk-taking. ^{7 10 11 12 13}

Research Team

Tibor Palfai, PhD

Principal Investigator

Boston University

Eligibility Criteria

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.

I am HIV-positive.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Addictive behaviors and life problems before and after behavioral treatment of problem drinkers. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a self-control manual for problem drinkers with and without therapist contact. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Brief interventions for alcohol problems: factors that facilitate implementation. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Group behavior therapy for problem drinkers. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanisms of action of brief alcohol interventions remain largely unknown - a narrative review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Brief motivational interventions for HIV/STI risk reduction among individuals receiving alcohol detoxification. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Brief intervention for female heavy drinkers in routine general practice: a 3-year randomized, controlled study. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Start Talking About Risks: development of a Motivational Interviewing-based safer sex program for people living with HIV. [2022]

10. England 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Self-regulation as a protective factor against risky drinking and sexual behavior. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mechanisms Linking Self-Regulation and Sexual Behaviors in Never-Married Young Adults. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

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