Trial Outcomes & Findings for TAKE Steps: Motivational Interviewing to Prevent STIs (NCT NCT05215262)

Last Updated: 2025-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

94 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2025-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	54	40
Overall Study COMPLETED	42	40
Overall Study NOT COMPLETED	12	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Lost to Follow-up	12	0

Baseline Characteristics

Only 42 of the 54 allocated to the intervention had Baseline data used for analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=42 Participants 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.	Standard of Care n=40 Participants 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	Total n=82 Participants Total of all reporting groups
Age, Continuous	16.6 years STANDARD_DEVIATION 1 • n=93 Participants • Only 42 of the 54 allocated to the intervention had Baseline data used for analysis.	17.0 years STANDARD_DEVIATION 1 • n=4 Participants • Only 42 of the 54 allocated to the intervention had Baseline data used for analysis.	16.8 years STANDARD_DEVIATION 1 • n=27 Participants • Only 42 of the 54 allocated to the intervention had Baseline data used for analysis.
Sex: Female, Male Female	39 Participants n=93 Participants	35 Participants n=4 Participants	74 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=93 Participants	32 Participants n=4 Participants	69 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	38 Participants n=93 Participants	37 Participants n=4 Participants	75 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Change in prevention self-efficacy score from Baseline to Three Months.

Outcome measures

Outcome measures
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=42 Participants 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.	Standard of Care n=40 Participants 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
Change in Prevention Self-efficacy	1.87 score on a scale Interval 0.04 to 3.17	0.20 score on a scale Interval -1.59 to 1.99

SECONDARY outcome

Timeframe: Baseline

Population: Total number of patients recruited.

Feasibility of recruitment will be measured by calculating the proportion of patients enrolled / patients recruited.

Outcome measures

Outcome measures
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=639 Participants 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.	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
Recruitment Feasibility	94 Participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=26 Participants 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.	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
Intervention Acceptability	26 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=27 Participants 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.	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
Intervention Acceptability	27 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: Number of participants randomized to the intervention arm who completed at least 1 intervention session.

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..

Outcome measures

Outcome measures
Measure	T.A.K.E. Steps Motivational Interviewing Intervention n=42 Participants 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.	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
Retention Feasibility	28 Participants	—

Adverse Events

T.A.K.E. Steps Motivational Interviewing Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Wood, MD, MSHP

Mount Sinai Adolescent Health Center

Phone: (332) 227-4355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place