BEing Safe in Treatment (BEST)

Maximizing the Patient-counselor Relationship to Reduce Sexual Risk

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.

Study Overview

• Status: Completed
• Conditions: Risk Behavior; Substance Use; Risk Reduction; Sex, Unsafe
• Intervention / Treatment: Behavioral: BEST assessment only; Behavioral: Standard Counselor Training; Behavioral: BEST assessment plus feedback report; Behavioral: Enhanced Counselor Training

• Study Type: Interventional
• Enrollment (Actual): 537
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparator: No Feedback, Standard Counselor; Patient assigned to a Standard Training counselor, completed the BEST assessment, but did NOT receive a feedback report.	Behavioral: BEST assessment only; Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels.; Other Names: No Feedback; Behavioral: Standard Counselor Training; 2 hours of training on how to use the BEST patient feedback report; Other Names: Standard Training
Experimental: Active1: Feedback, Standard Counselor; Patient assigned to a Standard Training counselor, completed the BEST assessment, and received a personalized feedback report.	Behavioral: Standard Counselor Training; 2 hours of training on how to use the BEST patient feedback report; Other Names: Standard Training; Behavioral: BEST assessment plus feedback report; 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.; Other Names: Feedback
Experimental: Active2: No feedback, Enhanced Counselor; Patient assigned to a Enhanced Training counselor, completed the BEST assessment, but did NOT receive a feedback report.	Behavioral: BEST assessment only; Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels.; Other Names: No Feedback; Behavioral: Enhanced Counselor Training; 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.; Other Names: Enhanced Training
Experimental: Active3: Feedback, Enhanced Counselor; Patient assigned to a Enhanced Training counselor, completed the BEST assessment, and received a personalized feedback report.	Behavioral: BEST assessment plus feedback report; 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.; Other Names: Feedback; Behavioral: Enhanced Counselor Training; 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.; Other Names: Enhanced Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient unprotected sexual occasions	Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days	3-month follow-up
Patient unprotected sexual occasions	Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days	6-month follow-up
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	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient sexual partners	Self-reported number of sexual partners in the 90 days prior to 3- and 6-month follow-up.	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.	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.	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.	3- and 6-month follow-up
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.	3- and 6-month follow-up
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.	3- and 6-month follow-up
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.	Baseline to 1-week post-training and 3-months
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.	Baseline to 1-week post-training and 3-month follow-up
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.	1-week post-training and 3-month follow-up
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.	Baseline to 1-week post-training and 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Behavioral Intervention; Counselor Skills Training; Personalized Feedback Report
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 48767; 5R01HD078163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No