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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
94
Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.
S.O.C. arm will receive treatment as usual. After the baseline interview, participants will be referred to their PCP for management of any clinical issues that arise. Their clinic visit schedule will follow their clinical needs and recommendations of their clinic provider
Primary Care, CHOP Clinic 3550 Market St
Philadelphia, Pennsylvania, United States
CHOP Primary Care, Roxborough
Philadelphia, Pennsylvania, United States
CHOP Karabots Pediatric Care Center, West Philadelphia
Philadelphia, Pennsylvania, United States
CHOP Primary Care, Cobbs Creek
Philadelphia, Pennsylvania, United States
Change in Prevention Self-efficacy
Differences in the change in prevention self-efficacy scores from baseline to three months between the control arm compared to the intervention arm will be assessed using a modified version of the Generalized Self Efficacy (GSE) measure. The GSE measure is a 10-item measure assessing participants' confidence in carrying out their self-identified prevention goals. The total score of the GSE measure is calculated by finding the sum of all 10 items - the sum ranging between 10 and 40 with a higher score indicating more self-efficacy. This outcome is measuring the differences in mean total scores over time.
Time frame: Baseline and 3 months
Recruitment Feasibility
Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited.
Time frame: Baseline
Intervention Acceptability
Intervention acceptability will be measured at 1-week and 3-months by a 7-item satisfaction survey. This outcome measures the percentage participants who agreed or strongly agreed with statements on a 7-item acceptability survey completed at their 1-week intervention coaching session.
Time frame: 1 week
Intervention Acceptability
Intervention acceptability will be measured at 1-week and 3-months by a 7-item satisfaction survey. This outcome measures the percentage participants who agreed or strongly agreed with statements on a 7-item acceptability survey completed at their 3-month intervention coaching session.
Time frame: 3 months
Retention Feasibility
Retention feasibility will be measured by calculating the proportion of participants who completed the three month (final) intervention visit out of participants randomized to the intervention arm who completed at least one intervention session..
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CHOP Primary Care, South Philadelphia
Philadelphia, Pennsylvania, United States
Time frame: 3 months