BEing Safe in Treatment
BEST
Maximizing the Patient-counselor Relationship to Reduce Sexual Risk
2 other identifiers
interventional
537
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedJuly 2, 2018
June 1, 2018
2.5 years
April 11, 2018
June 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (10)
Patient sexual partners
3- and 6-month follow-up
Patient unprotected sexual occasions with a casual partner
3- and 6-month follow-up
Combining sex and drugs
3- and 6-month follow-up
Patient attitudes toward condoms
3- and 6-month follow-up
Patient HIV transmission knowledge
3- and 6-month follow-up
- +5 more secondary outcomes
Study Arms (4)
Comparator: No Feedback, Standard Counselor
EXPERIMENTALPatient assigned to a Standard Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
Active1: Feedback, Standard Counselor
EXPERIMENTALPatient assigned to a Standard Training counselor, completed the BEST assessment, and received a personalized feedback report.
Active2: No feedback, Enhanced Counselor
EXPERIMENTALPatient assigned to a Enhanced Training counselor, completed the BEST assessment, but did NOT receive a feedback report.
Active3: Feedback, Enhanced Counselor
EXPERIMENTALPatient assigned to a Enhanced Training counselor, completed the BEST assessment, and received a personalized feedback report.
Interventions
Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels.
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.
2 hours of training on how to use the BEST patient feedback report
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35751944DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 11, 2018
First Posted
July 2, 2018
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 2, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available at the end of the project after our primary outcome paper is published.
- Access Criteria
- Requests can be made to the Principal Investigators.
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.