BEing Safe in Treatment

Substance Use Clinical Trial

— BEST  

Official title:

Maximizing the Patient-counselor Relationship to Reduce Sexual Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575585
• Other study ID #: 48767
• Secondary ID: 5R01HD078163
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Risk Behavior
• Risk Reduction
• Sex, Unsafe
• Substance Use

Intervention

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.
• 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.
• Standard Counselor Training
2 hours of training on how to use the BEST patient feedback report
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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