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OpenTrials
Completed

NCT Number: NCT03575585

BEing Safe in Treatment

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

BEST assessment only

Behavioral

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

BEST assessment plus feedback report

Behavioral

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

Standard Counselor Training

Behavioral

2 hours of training on how to use the BEST patient feedback report

Other names: Standard Training

Enhanced Counselor Training

Behavioral

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

Primary outcomes

  1. Patient unprotected sexual occasions

    Time frame: 3-month follow-up

    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days

  2. Patient unprotected sexual occasions

    Time frame: 6-month follow-up

    Number of unprotected sexual occasions, measured via self-report on the BEST assessment for the prior 90 days

  3. Discussions of sex during counseling session

    Time frame: 3-month follow-up

    Patient report of number of counseling sessions in past 90 days in which sexual risk was discussed with patients

Secondary outcomes

  1. Patient sexual partners

    Time frame: 3- and 6-month follow-up

    Self-reported number of sexual partners in the 90 days prior to 3- and 6-month follow-up.

  2. Patient unprotected sexual occasions with a casual partner

    Time frame: 3- and 6-month follow-up

    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. Combining sex and drugs

    Time frame: 3- and 6-month follow-up

    Patient self-report of number of occasions combining drug use and sex in the 90 days prior to 3- and 6-month follow-up.

  4. Patient attitudes toward condoms

    Time frame: 3- and 6-month follow-up

    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.

  5. Patient HIV transmission knowledge

    Time frame: 3- and 6-month follow-up

    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.

  6. Patient risk reduction activities

    Time frame: 3- and 6-month follow-up

    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.

  7. Counselor sexual attitudes

    Time frame: Baseline to 1-week post-training and 3-months

    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.

  8. Counselor self-efficacy for discussing sex

    Time frame: Baseline to 1-week post-training and 3-month follow-up

    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.

  9. Counselor skill for discussing sexual issues in counseling sessions

    Time frame: 1-week post-training and 3-month follow-up

    Demonstrated skills in reviewing a personalized feedback report with a Standardized Patient, as coded by independent coders.

  10. Counselor HIV transmission knowledge

    Time frame: Baseline to 1-week post-training and 3-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Maximizing the Patient-counselor Relationship to Reduce Sexual Risk

Acronym: BEST

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2018
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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