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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH119976-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T.A.K.E. Steps Motivational Interviewing Intervention | Experimental | Four MI intervention sessions, 1:1 with participant and health coach. |
|
| Standard of Care | Active Comparator | Standard of Care control visit with primary care physician (PCP) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treat Act Know Engage (T.A.K.E.) Steps | Behavioral | Intervention sessions will consist of psychoeducation, HIV/STI goal identification, referral to HIV testing and PrEP, and communication skill building. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility | Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah M Wood, MD, MSHP | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care, CHOP Clinic 3550 Market St | Philadelphia | Pennsylvania | 19104 | United States | ||
| CHOP Primary Care, Roxborough |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only 42 of the 54 allocated to the intervention had Baseline data used for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only 42 of the 54 allocated to the intervention had Baseline data used for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Change in prevention self-efficacy score from Baseline to Three Months. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Wood, MD, MSHP | Mount Sinai Adolescent Health Center | (332) 227-4355 | Sarah.Wood@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2024 | Dec 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2023 | Dec 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard or Care | Behavioral | 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 |
|
| 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. | 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.. | 3 months |
| Philadelphia |
| Pennsylvania |
| 19128 |
| United States |
| CHOP Karabots Pediatric Care Center, West Philadelphia | Philadelphia | Pennsylvania | 19139 | United States |
| CHOP Primary Care, Cobbs Creek | Philadelphia | Pennsylvania | 19139 | United States |
| CHOP Primary Care, South Philadelphia | Philadelphia | Pennsylvania | 19145 | United States |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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 |
|
|
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| Secondary | Recruitment Feasibility | Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited. | Total number of patients recruited. | Posted | Count of Participants | Participants | Baseline |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 1 week |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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.. | Number of participants randomized to the intervention arm who completed at least 1 intervention session. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
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