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BEing Safe in Treatment (BEST)

Primary Purpose

Risk Behavior, Sex, Unsafe, Substance Use

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BEST assessment only
BEST assessment plus feedback report
Standard Counselor Training
Enhanced Counselor Training
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Risk Behavior focused on measuring HIV, Counselor Skills Training, Behavioral Intervention, Personalized Feedback Report

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Admitted to substance use disorder treatment in the prior 45 days,
  • Age 18 years or older
  • Plan to remain in the local area for the next three months
  • Assigned to a treatment counselor enrolled in the study.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Comparator: No Feedback, Standard Counselor

    Active1: Feedback, Standard Counselor

    Active2: No feedback, Enhanced Counselor

    Active3: Feedback, Enhanced Counselor

    Arm Description

    Patient assigned to a Standard Training counselor, completed the BEST assessment, but did NOT receive a feedback report.

    Patient assigned to a Standard Training counselor, completed the BEST assessment, and received a personalized feedback report.

    Patient assigned to a Enhanced Training counselor, completed the BEST assessment, but did NOT receive a feedback report.

    Patient assigned to a Enhanced Training counselor, completed the BEST assessment, and received a personalized feedback report.

    Outcomes

    Primary Outcome Measures

    Patient unprotected sexual occasions
    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days
    Patient unprotected sexual occasions
    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days
    Discussions of sex during counseling session
    Patient report of number of counseling sessions in past 90 days in which sexual risk was discussed with patients

    Secondary Outcome Measures

    Patient sexual partners
    Self-reported number of sexual partners in the 90 days prior to 3- and 6-month follow-up.
    Patient unprotected sexual occasions with a casual partner
    Self-reported number of unprotected sexual occasions with a partner who is not a committed monogamous partner, in the 90 days prior to 3- and 6-month follow-up.
    Combining sex and drugs
    Patient self-report of number of occasions combining drug use and sex in the 90 days prior to 3- and 6-month follow-up.
    Patient attitudes toward condoms
    The Condom Barriers Scale (CBS) (Doyle, Calsyn & Ball, 2009; St. Lawrence et al., 1999) completed by patient participants is a self-report instrument consisting of 29 items worded as short statements and rated by participants on a 5-point Likert-type scale from 1 (strongly agree) to 5 (strongly disagree). Items reflect attitudes about condoms, which may act as barriers towards condom use. Scores are obtained on four conceptual domains: Partner Barriers (8 items), Effects on Sexual Experience (7 items), Access/Availability (8 items), and Motivational Barriers (6 items) and Total Score.
    Patient HIV transmission knowledge
    Patients' HIV knowledge was assessed via self-report using the 18-item HIV Knowledge Questionnaire (HIV-KQ-18: Carey & Schroder, 2002). Items, such as "A woman can get HIV if she has anal sex with a man," are answered "true," "false," or "don't know." Scores range from zero to 18.
    Patient risk reduction activities
    Self-report of engagement in lifestyle risk reduction activities in the 90 days prior to 3- and 6-month follow-up, assessed via the Lifestyle Enhancement Survey. The Lifestyle Enhancement Survey (Calsyn, unpublished), was designed to assess the degree to which patient participants were using strategies to avoid sexual risk and to disentangle their sexual behavior from substance use. Originally designed for a prior pilot study, the version used for this study was modified to align with suggestions included in the Personalized Feedback Report.
    Counselor sexual attitudes
    To assess change in counselor sexual attitudes, we used 20 items of the 25-item Sexual Attitude Scale (Hudson, Murphy & Nurius, 1983), an instrument intended to measure the extent to which a participant "adheres to a liberal or a conservative orientation toward human sexual expression" (Hudson et al., 1983, pp. 258). On a 5-point scales, ranging from "Strongly Disagree" to "Strongly Agree," participants rate items, such as "I think there is too much sexual freedom given to adults these days." To reduce participant burden, we abbreviated the scale, removing 5 of 20 items. Two additional items were slightly revised to update language.
    Counselor self-efficacy for discussing sex
    The Sexual Intervention Self-Efficacy Scale (Miller & Byers, 2008) used 16 items via 4 subscales: Comfort/Bias Self-Efficacy (4 items; e.g., I will be able to treat clients with sexual problems even when I don't necessarily agree with their decisions/actions), Skill Self-Efficacy (5 items; e.g., I am unfamiliar with the techniques used to intervene with individuals who have sexual concerns/problems), and Confidence in Ability to Relay Accurate Information (7 items; e.g., I am confident that I can relay accurate information to clients about sexual orientation/identity issues). We also included 3 of 4 items from Miller & Byers (2008; 2012) Willingness to Treat Sexual Issues Scale (e.g., If a couple told me that they were having a sexual problem I would refer them to another clinician). Items were on a 6-point scale ("Strongly Disagree" to "Strongly Agree"). Total scale score equaled the mean of all items. Scoring (after some item reversal) is toward greater self-efficacy.
    Counselor skill for discussing sexual issues in counseling sessions
    Demonstrated skills in reviewing a personalized feedback report with a Standardized Patient, as coded by independent coders.
    Counselor HIV transmission knowledge
    Counselors' HIV knowledge was assessed via self-report using the 18-item HIV Knowledge Questionnaire (HIV-KQ-18: Carey & Schroder, 2002). Items, such as "A woman can get HIV if she has anal sex with a man," are answered "true," "false," or "don't know." Scores range from zero to 18.

    Full Information

    First Posted
    April 11, 2018
    Last Updated
    June 28, 2018
    Sponsor
    University of Washington
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03575585
    Brief Title
    BEing Safe in Treatment
    Acronym
    BEST
    Official Title
    Maximizing the Patient-counselor Relationship to Reduce Sexual Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prior research has shown that many individuals with substance use disorders engage in HIV/sexual risk behaviors, and could strongly benefit from HIV prevention interventions that were delivered as part of their substance abuse treatment. However, discussions about sexual risk are not occurring at an appropriate frequency in treatment settings. This project will test the effects of counselor training and coaching, combined with a brief assessment and feedback tool, on counselor-patient communication about sex and on patient sexual risk behavior.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Risk Behavior, Sex, Unsafe, Substance Use, Risk Reduction
    Keywords
    HIV, Counselor Skills Training, Behavioral Intervention, Personalized Feedback Report

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Model Description
    This is a 2 x 2 nested factorial design clinical trial. Counselors were randomized to 1) Standard training [2 hours on using a BEST feedback report] or 2) Enhanced training [Standard + 8 hours on discussing sexual risk with patients + monthly coaching]. Patients of participating counselors completed the BEST assessment and were randomized to receive no feedback or a personalized BEST feedback report, and were followed up at 3-, and 6-months (patients). Counselors were assessed at baseline, post-training and 3-months.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    537 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Comparator: No Feedback, Standard Counselor
    Arm Type
    Experimental
    Arm Description
    Patient assigned to a Standard Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
    Arm Title
    Active1: Feedback, Standard Counselor
    Arm Type
    Experimental
    Arm Description
    Patient assigned to a Standard Training counselor, completed the BEST assessment, and received a personalized feedback report.
    Arm Title
    Active2: No feedback, Enhanced Counselor
    Arm Type
    Experimental
    Arm Description
    Patient assigned to a Enhanced Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
    Arm Title
    Active3: Feedback, Enhanced Counselor
    Arm Type
    Experimental
    Arm Description
    Patient assigned to a Enhanced Training counselor, completed the BEST assessment, and received a personalized feedback report.
    Intervention Type
    Behavioral
    Intervention Name(s)
    BEST assessment only
    Other Intervention Name(s)
    No Feedback
    Intervention Description
    Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels.
    Intervention Type
    Behavioral
    Intervention Name(s)
    BEST assessment plus feedback report
    Other Intervention Name(s)
    Feedback
    Intervention Description
    Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels. Based on their responses they also receive a personalized feedback report that .provides individualized risk levels in five behavior domains: 1) number of partners, 2) riskiness of partners, 3) condom use, 4) riskiness of sex acts, and 5) sex under the influence of drugs or alcohol.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Counselor Training
    Other Intervention Name(s)
    Standard Training
    Intervention Description
    2 hours of training on how to use the BEST patient feedback report
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced Counselor Training
    Other Intervention Name(s)
    Enhanced Training
    Intervention Description
    Standard training (2 hrs) plus 8 additional hours (4 modules) of motivation/skills training on a) talking about sex with patients, b) basics of using Motivational Interviewing techniques to review a feedback report, c) teaching patients problem solving skills, and d) teaching patients relationship communication skills.
    Primary Outcome Measure Information:
    Title
    Patient unprotected sexual occasions
    Description
    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days
    Time Frame
    3-month follow-up
    Title
    Patient unprotected sexual occasions
    Description
    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days
    Time Frame
    6-month follow-up
    Title
    Discussions of sex during counseling session
    Description
    Patient report of number of counseling sessions in past 90 days in which sexual risk was discussed with patients
    Time Frame
    3-month follow-up
    Secondary Outcome Measure Information:
    Title
    Patient sexual partners
    Description
    Self-reported number of sexual partners in the 90 days prior to 3- and 6-month follow-up.
    Time Frame
    3- and 6-month follow-up
    Title
    Patient unprotected sexual occasions with a casual partner
    Description
    Self-reported number of unprotected sexual occasions with a partner who is not a committed monogamous partner, in the 90 days prior to 3- and 6-month follow-up.
    Time Frame
    3- and 6-month follow-up
    Title
    Combining sex and drugs
    Description
    Patient self-report of number of occasions combining drug use and sex in the 90 days prior to 3- and 6-month follow-up.
    Time Frame
    3- and 6-month follow-up
    Title
    Patient attitudes toward condoms
    Description
    The Condom Barriers Scale (CBS) (Doyle, Calsyn & Ball, 2009; St. Lawrence et al., 1999) completed by patient participants is a self-report instrument consisting of 29 items worded as short statements and rated by participants on a 5-point Likert-type scale from 1 (strongly agree) to 5 (strongly disagree). Items reflect attitudes about condoms, which may act as barriers towards condom use. Scores are obtained on four conceptual domains: Partner Barriers (8 items), Effects on Sexual Experience (7 items), Access/Availability (8 items), and Motivational Barriers (6 items) and Total Score.
    Time Frame
    3- and 6-month follow-up
    Title
    Patient HIV transmission knowledge
    Description
    Patients' HIV knowledge was assessed via self-report using the 18-item HIV Knowledge Questionnaire (HIV-KQ-18: Carey & Schroder, 2002). Items, such as "A woman can get HIV if she has anal sex with a man," are answered "true," "false," or "don't know." Scores range from zero to 18.
    Time Frame
    3- and 6-month follow-up
    Title
    Patient risk reduction activities
    Description
    Self-report of engagement in lifestyle risk reduction activities in the 90 days prior to 3- and 6-month follow-up, assessed via the Lifestyle Enhancement Survey. The Lifestyle Enhancement Survey (Calsyn, unpublished), was designed to assess the degree to which patient participants were using strategies to avoid sexual risk and to disentangle their sexual behavior from substance use. Originally designed for a prior pilot study, the version used for this study was modified to align with suggestions included in the Personalized Feedback Report.
    Time Frame
    3- and 6-month follow-up
    Title
    Counselor sexual attitudes
    Description
    To assess change in counselor sexual attitudes, we used 20 items of the 25-item Sexual Attitude Scale (Hudson, Murphy & Nurius, 1983), an instrument intended to measure the extent to which a participant "adheres to a liberal or a conservative orientation toward human sexual expression" (Hudson et al., 1983, pp. 258). On a 5-point scales, ranging from "Strongly Disagree" to "Strongly Agree," participants rate items, such as "I think there is too much sexual freedom given to adults these days." To reduce participant burden, we abbreviated the scale, removing 5 of 20 items. Two additional items were slightly revised to update language.
    Time Frame
    Baseline to 1-week post-training and 3-months
    Title
    Counselor self-efficacy for discussing sex
    Description
    The Sexual Intervention Self-Efficacy Scale (Miller & Byers, 2008) used 16 items via 4 subscales: Comfort/Bias Self-Efficacy (4 items; e.g., I will be able to treat clients with sexual problems even when I don't necessarily agree with their decisions/actions), Skill Self-Efficacy (5 items; e.g., I am unfamiliar with the techniques used to intervene with individuals who have sexual concerns/problems), and Confidence in Ability to Relay Accurate Information (7 items; e.g., I am confident that I can relay accurate information to clients about sexual orientation/identity issues). We also included 3 of 4 items from Miller & Byers (2008; 2012) Willingness to Treat Sexual Issues Scale (e.g., If a couple told me that they were having a sexual problem I would refer them to another clinician). Items were on a 6-point scale ("Strongly Disagree" to "Strongly Agree"). Total scale score equaled the mean of all items. Scoring (after some item reversal) is toward greater self-efficacy.
    Time Frame
    Baseline to 1-week post-training and 3-month follow-up
    Title
    Counselor skill for discussing sexual issues in counseling sessions
    Description
    Demonstrated skills in reviewing a personalized feedback report with a Standardized Patient, as coded by independent coders.
    Time Frame
    1-week post-training and 3-month follow-up
    Title
    Counselor HIV transmission knowledge
    Description
    Counselors' HIV knowledge was assessed via self-report using the 18-item HIV Knowledge Questionnaire (HIV-KQ-18: Carey & Schroder, 2002). Items, such as "A woman can get HIV if she has anal sex with a man," are answered "true," "false," or "don't know." Scores range from zero to 18.
    Time Frame
    Baseline to 1-week post-training and 3-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Admitted to substance use disorder treatment in the prior 45 days, Age 18 years or older Plan to remain in the local area for the next three months Assigned to a treatment counselor enrolled in the study. Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The investigative team will make available copies of the BEST survey items, pseudocode for the BEST feedback report, and the counselor training curriculum to other researchers wanting to evaluate their usefulness. Data for this project will consist of quantitative data from patient and counselor assessments. We plan to make the data available to other researchers using two data sharing methods suggested by the NIH Data Sharing Policy brochure. First, we plan to publish information on processes and findings in a timely manner in appropriate peer- reviewed journals that are available online or through requests for copies made directly to the author(s). We will also respond to data requests made directly to the Principal Investigators by removing all identifying information from the data and making them available on a CD-ROM or by posting them on a secure web site. These data will be available at the end of the project after our primary outcome paper is published.
    IPD Sharing Time Frame
    Data will be available at the end of the project after our primary outcome paper is published.
    IPD Sharing Access Criteria
    Requests can be made to the Principal Investigators.
    Citations:
    PubMed Identifier
    35751944
    Citation
    Hatch MA, Wells EA, Masters T, Beadnell B, Harwick R, Wright L, Peavy M, Ricardo-Bulis E, Wiest K, Shriver C, Baer JS. A randomized clinical trial evaluating the impact of counselor training and patient feedback on substance use disorder patients' sexual risk behavior. J Subst Abuse Treat. 2022 Sep;140:108826. doi: 10.1016/j.jsat.2022.108826. Epub 2022 Jun 16.
    Results Reference
    derived

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