HIV Prevention, Self Efficacy, STI Prevention
Conditions
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.
Interventions
BEHAVIORALTreat Act Know Engage (T.A.K.E.) Steps
Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building.
BEHAVIORALStandard or Care
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
Sponsors
National Institute of Mental Health (NIMH)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Prevention Self-efficacy | Baseline and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | Baseline | Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited. |
| Intervention Acceptability | 1 week | 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. |
| Retention Feasibility | 3 months | 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.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention Four MI intervention sessions, 1:1 with participant and health coach.
Treat Act Know Engage (T.A.K.E.) Steps: Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building. | 42 |
| Standard of Care Standard of Care control visit with primary care physician (PCP)
Standard or Care: 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 | 40 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Total | T.A.K.E. Steps Motivational Interviewing Intervention |
|---|---|---|---|
| Age, Continuous | 17.0 years STANDARD_DEVIATION 1 | 16.8 years STANDARD_DEVIATION 1 | 16.6 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 69 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 75 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 35 Participants | 74 Participants | 39 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 0 / 42 | 0 / 40 |
| serious Total, serious adverse events | 0 / 42 | 0 / 40 |
Outcome results
Primary
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
Population: Change in prevention self-efficacy score from Baseline to Three Months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Change in Prevention Self-efficacy | 1.87 score on a scale |
| Standard of Care | Change in Prevention Self-efficacy | 0.20 score on a scale |
p-value: 0.0495% CI: [0.04, 3.17]Mixed Models Analysis
p-value: 0.8295% CI: [-1.59, 1.99]Mixed Models Analysis
Comparison: Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.p-value: 0.295% CI: [-0.89, 4.23]Mixed Models Analysis
Secondary
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
Population: This analysis is based on a sample size of n=26 intervention participants who completed acceptability surveys at their 1-week intervention coaching sessions. Surveys asked participants for their agreement level of satisfaction on 7 statements about the intervention sessions. All 26 participants showed agreement or strong agreement with the 7 statements.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Intervention Acceptability | 26 Participants |
Secondary
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
Population: This analysis is based on a sample size of n=27 intervention participants who completed acceptability surveys at their 3-month intervention coaching sessions. Surveys asked participants for their agreement level of satisfaction on 7 statements about the intervention sessions. All 27 participants showed agreement or strong agreement with the 7 statements.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Intervention Acceptability | 27 Participants |
Secondary
Recruitment Feasibility
Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited.
Time frame: Baseline
Population: Total number of patients recruited.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Recruitment Feasibility | 94 Participants |
Secondary
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..
Time frame: 3 months
Population: Number of participants randomized to the intervention arm who completed at least 1 intervention session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Retention Feasibility | 28 Participants |