BEing Safe in Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Maximizing the Patient-counselor Relationship to Reduce Sexual Risk

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

Intervention / Treatment
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* Behavioral: BEST assessment only
* Behavioral: BEST assessment plus feedback report
* Behavioral: Standard Counselor Training
* Behavioral: Enhanced Counselor Training


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Counselor Skills Training, Behavioral Intervention, Personalized Feedback Report