Clinical trial NCT03575585: BEing Safe in Treatment
Official title: Maximizing the Patient-counselor Relationship to Reduce Sexual Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Risk Behavior
Sex, Unsafe
Substance Use
Risk Reduction
Keywords: HIV
Counselor Skills Training
Behavioral Intervention
Personalized Feedback Report
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-07-02
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Patient unprotected sexual occasions
timeFrame: 3-month follow-up
measure: Patient unprotected sexual occasions
timeFrame: 6-month follow-up
measure: Discussions of sex during counseling session
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Patient sexual partners
timeFrame: 3- and 6-month follow-up
measure: Patient unprotected sexual occasions with a casual partner
timeFrame: 3- and 6-month follow-up
measure: Combining sex and drugs
timeFrame: 3- and 6-month follow-up
measure: Patient attitudes toward condoms
timeFrame: 3- and 6-month follow-up
measure: Patient HIV transmission knowledge
timeFrame: 3- and 6-month follow-up
measure: Patient risk reduction activities
timeFrame: 3- and 6-month follow-up
measure: Counselor sexual attitudes
timeFrame: Baseline to 1-week post-training and 3-months
measure: Counselor self-efficacy for discussing sex
timeFrame: Baseline to 1-week post-training and 3-month follow-up
measure: Counselor skill for discussing sexual issues in counseling sessions
timeFrame: 1-week post-training and 3-month follow-up
measure: Counselor HIV transmission knowledge
timeFrame: Baseline to 1-week post-training and 3-month follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.