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Alcohol and Implicit Process in Sexual Risk Behavior in MSM

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clinicaltrials.gov/study/NCT03361384
Is a
‌
Clinical study
1

Clinical Study attributes

NCT Number
NCT033613841
Trial Recruitment Size
2601
Trial Sponsor
Syracuse University
Syracuse University
1
Trial Collaborator
Boston University
Boston University
1
University of South Dakota
University of South Dakota
1
Clinical Trial Start Date
2016
1
Primary Completion Date
June 30, 2020
1
Study Completion Date
June 30, 2020
1
Clinical Trial Study Type
Interventional1
Interventional Trial Purpose
Basic Science1
Intervention Type
Other1
Drug1
Intervention Name
Placebo (non-alcoholic beverage)1
Alcohol1
Interventional Trial Phase
Phase 11
Participating Facility
University of South Dakota
University of South Dakota
1
Boston University
Boston University
1
Syracuse University
Syracuse University
1
Official Name
Alcohol and Implicit Process in Sexual Risk Behavior in MSM1
Last Updated
July 23, 2021
1
Allocation Type
Randomized1
Intervention Model
Parallel Assignment1
Masking Type
Double1
Masked Party
Outcomes Assessor1
Participant1
Study summary

The current study is the first empirical investigation that directly addresses the correspondence between responses regarding indicators of risky sexual behavior while under the influence of alcohol in the laboratory and the occurrence of sexually risky behavior while under the influence of alcohol in the natural environment, by use of Ecological Sampling Methodology (ESM). The study will allow us to compare and contrast implicit and explicit assessments of sexual risk in respect to future behavior in the natural environment. The data obtained will thus provide new information regarding the external validity of alcohol administration studies of sexual risk behavior and will provide information to optimize the selection of dependent measures. The current study also represents the first attempt to test a causal model linking alcohol intoxication and risky sexual behavior as a function of both automatic, reflexive, approach tendencies and effortful, deliberative, self-control (operationalized by executive working memory in this application). The ESM study will augment the findings of the experiment by providing a detailed assessment of contextual factors that affect sexual risk behavior as well as replicating and extending the findings of the experiment to sexual risk situations in the natural environment. Finally, to our knowledge there has been only one experimental study of alcohol and sexual risk in MSM (Maisto, Palfai, Vanable, Heath, \& Woolf-King, 2012), which is remarkable given that MSM have been identified as the population at highest risk to contract the HIV in the U.S. since the virus was identified in the early 1980s. Thus the proposed research is only the second attempt to add to an understanding of the connections among alcohol, cognitive processes, and sexual risk behaviors in MSM.

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