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Risk BehaviorPhase 2BESTNCT03575585

BEing Safe in Treatment

A Phase 2 study testing BEST assessment only, BEST assessment plus feedback report and Standard Counselor Training in people with Risk Behavior and Sex, Unsafe, run by University of Washington.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Risk Behavior, Sex, Unsafe, Substance Use
What is being tested?
BEST assessment only, BEST assessment plus feedback report and Standard Counselor Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
537 participants
Where
No sites listed yet
Study dates
Jun 2015to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -

About this study

Official title: 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.

Being tested
BEST assessment only, BEST assessment plus feedback report, Standard Counselor Training, Enhanced Counselor Training
Keywords
HIV, Counselor Skills Training, Behavioral Intervention, Personalized Feedback Report
Medical subject headings
Risk-Taking, Unsafe Sex, Substance-Related Disorders, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEST assessment onlyBehavioural

    Also called No Feedback

    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 reportBehavioural

    Also called Feedback

    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 TrainingBehavioural

    Also called Standard Training

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

  • Enhanced Counselor TrainingBehavioural

    Also called Enhanced 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.

Study groups in NCT03575585
Study groupRoleWhat they receive
Comparator: No Feedback, Standard CounselorExperimentalPatient assigned to a Standard Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
Receives: Behavioral: BEST assessment only; Behavioral: Standard Counselor Training
Active1: Feedback, Standard CounselorExperimentalPatient assigned to a Standard Training counselor, completed the BEST assessment, and received a personalized feedback report.
Receives: Behavioral: BEST assessment plus feedback report; Behavioral: Standard Counselor Training
Active2: No feedback, Enhanced CounselorExperimentalPatient assigned to a Enhanced Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
Receives: Behavioral: BEST assessment only; Behavioral: Enhanced Counselor Training
Active3: Feedback, Enhanced CounselorExperimentalPatient assigned to a Enhanced Training counselor, completed the BEST assessment, and received a personalized feedback report.
Receives: Behavioral: BEST assessment plus feedback report; Behavioral: Enhanced Counselor Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient unprotected sexual occasions

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

    Measured: 3-month follow-up

  2. Patient unprotected sexual occasions

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

    Measured: 6-month follow-up

  3. 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

    Measured: 3-month follow-up

Secondary outcomes (10)

  1. Patient sexual partners

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

    Measured: 3- and 6-month follow-up

  2. 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.

    Measured: 3- and 6-month follow-up

  3. 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.

    Measured: 3- and 6-month follow-up

  4. 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.

    Measured: 3- and 6-month follow-up

  5. 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.

    Measured: 3- and 6-month follow-up

  6. 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.

    Measured: 3- and 6-month follow-up

  7. 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.

    Measured: Baseline to 1-week post-training and 3-months

  8. 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.

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

  9. 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.

    Measured: 1-week post-training and 3-month follow-up

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study startJun 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575585
Sponsor's protocol ID
48767
Other IDs
5R01HD078163
Acronym
BEST
Status last verified
Jun 2018
First submitted
11 Apr 2018
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35751944

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEST assessment only, BEST assessment plus feedback report and Standard Counselor Training in people with Risk Behavior and Sex, Unsafe, run by University of Washington.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient unprotected sexual occasions (time frame: 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03575585, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.

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