Clinical trial NCT05215262: TAKE Steps: Motivational Interviewing to Prevent STIs
Official title: TAKE Steps: Motivational Interviewing to Improve Comprehensive HIV and Sexually Transmitted Infection Prevention in Adolescent Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Efficacy
HIV Prevention
STI Prevention
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-31
Enrollment: 94
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (STIs). The sessions will provide HIV/STI prevention education, use motivational interviewing (MI) to enhance goal setting, and providing skill building and referral to evidence based STI and HIV prevention strategies Pre-Exposure Prophylaxis (PrEP), condom use, and partner notification.

Detailed description: Pilot phase: Pilot testing will occur over a 3-month period to prime intervention for implementation, with the aim of recruiting n=10 pilot participants. Pilot phase participants will follow the same study procedure timeline as participants randomized to the MI intervention arm of the randomized control trial (RCT), excluding the 6-month follow-up visit. Pilot participants will not be followed in the RCT or contribute outcome data. At the end of every intervention visit in the pilot phase (the baseline, 1-week, 1-month and 3-month visits), participants will complete a brief feedback interview to ensure face validity and identify areas needing refinement. Feedback will be incorporated into the study design, with amendments submitted to the Institutional Review Board (IRB) as needed. Data from pilot participants will not be included in analysis of the RCT.

Intervention phase:The RCT will randomize youth with recent STI 2:1 to the TAKE Steps intervention vs a standard of care (SOC) control. Both arms (intervention and SOC) will have data collection visits at the baseline, the 3-month, and the 6-month-follow-up time points. In addition, the intervention group will have intervention sessions at baseline, 1 week, 1 month and 3 months.

The study treatment phase for the RCT will consist of data collection and motivational interviewing sessions over a 6-month period. Intervention sessions will consist of HIV and STI prevention education, motivational interviewing, skill building, and referral to therapy.

All visits can occur in-person or remotely.

Eligibility criteria: Inclusion Criteria:

* Males or females aged 13 to 19 years.
* History of ≥1 STI in the 30 days prior to recruitment
* Confirmed treatment for a laboratory confirmed diagnosis of Trichomonas vaginalis (via microscopy or nucleic acid amplification test \[NAAT\]), Neisseria gonorrhea (NAAT), Chlamydia trachomatis (NAAT), Treponema pallidum \[via new positive rapid plasmin reagin (RPR) assay\] within the prior 30 days
* Self-reported HIV negative status.
* Able to speak and understand written English

Exclusion Criteria:

* Unable to provide informed consent due to intoxication or severe psychological distress.

Primary outcomes:
measure: Change in Prevention Self-efficacy
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Recruitment Feasibility
timeFrame: Baseline
measure: Intervention Acceptability
timeFrame: 1 week
measure: Intervention Acceptability
timeFrame: 3 months
measure: Retention Feasibility
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Primary Care, CHOP Clinic 3550 Market St
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care, Roxborough
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Karabots Pediatric Care Center, West Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care, Cobbs Creek
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care, South Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sarah M Wood, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: