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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA030461-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Syracuse University | OTHER |
| University of South Dakota | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
Despite prevention efforts over the past two decades, HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Approximately 65% of new HIV diagnoses in the United States are due to male-to-male sexual contact. 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 risk factors that underlie HIV acquisition and transmission and develop behavioral strategies that modify them directly or reduce the influence of these factors on behavior. Alcohol use, particularly heavy episodic drinking, is a central modifiable risk factor that may increase CAI in conjunction with other contextual variables. Although there have been a limited number of HIV prevention interventions that incorporate alcohol in sexual risk reduction efforts, relatively little is known about how such interventions impact sexual decision-making in "heat-of the-moment", particularly while intoxicated and in high arousal states that commonly are proximal to sexual behavior.
The goals of this study are to: (1) better understand the within-person mechanisms linking alcohol and arousal with CAI and (2) test the efficacy of an HIV prevention intervention approach that both reduces alcohol consumption and mitigate the influence of intoxication and arousal on CAI. These complementary objectives are addressed through an experience sampling method study (ESM) that examines the impact of an HIV prevention intervention that targets sexual risk and alcohol use. This study will examine whether mechanisms that underlie sexual risk in the natural environment and can be modified by intervention.
In the proposed study, non-monogamous adult MSM who engage in heavy drinking and CAI will be randomly assigned to an intervention condition that addresses alcohol use and sexual decision-making in "heat-of-the-moment" situations. The intervention will be preceded and followed by 3-week ESM bursts of intensive longitudinal assessment of alcohol use, arousal, sexual delay discounting, working memory, and CAI. 4-month follow-up data will be collected. Results will contribute to the long-term goal of enhancing effectiveness of behavioral HIV prevention interventions that address alcohol use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Regulation Intervention | Experimental | 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 |
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| Brief Advice and Information | Active Comparator | Single session to provide psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Regulation Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Count of number of times engaged in Condomless Anal Intercourse (CAI) from Sexual Behavior Survey | Self-reported number of times engaged in CAI | Past 90 days |
| Heavy Drinking Episodes from the Quick Drinking Screen | Self-reported number of days consumed 5 or more standard drinks | Past 90 days |
| Average number of drinks per week from the Quick Drinking Screen | Self-reported average number of drinks per week multiplied by frequency of drinking per week | Past 90 days |
| Condomless Anal Intercourse: Experience Sampling | Self-reported frequency of CAI from experience sampling questions | ESM assessments over a 3 week period |
| Alcohol Use: Experience Sampling | Self-reported number of drinks and perceived intoxication (composite variable) | ESM assessments over 3 week period |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tibor Palfai, PhD | Contact | 6173539345 | palfai@bu.edu | |
| Maya Kratzer | Contact | mkratzer@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tibor Palfai, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Department of Psychological and Brain Sciences | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14743950 | Background | Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003 Nov;64(6):858-61. doi: 10.15288/jsa.2003.64.858. | |
| 9302547 | Background | Gordon CM, Carey MP, Carey KB. Effects of a drinking event on behavioral skills and condom attitudes in men: implications for HIV risk from a controlled experiment. Health Psychol. 1997 Sep;16(5):490-5. doi: 10.1037//0278-6133.16.5.490. |
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Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review.
In addition, data will be shared according to the guidelines for the National Institute of Mental Health Data Archive (NDA)
Data will be available one year after the end of the study. Support will be provided for data access for up to 5 years.
Based on review of data plan from the Multiple Principal Investigators of the study
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D047568 | Unsafe Sex |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
| D015658 | HIV Infections |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants randomly assigned to either intervention or control
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Trial procedures designed so that the post-intervention assessor is blind to condition
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| Brief Advice and Information | Behavioral | Psychoeducation about heavy drinking risks, discussion of barriers to safe sex, information about pre-exposure prophylaxis (PrEP) |
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| D000086982 |
| Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |