Trial Outcomes & Findings for Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening (NCT NCT06100250)

NCT ID: NCT06100250

Last Updated: 2025-07-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: Up to 8 weeks after participants complete the baseline survey
• Results posted on: 2025-07-01

Participant Flow

Participants were recruited between April 2024 and October 2024 via advertising on mobile dating apps and social networking sites.

Participant milestones

Measure	Telehealth Intervention Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Overall Study STARTED	75
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Telehealth Intervention Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Overall Study Lost to Follow-up	5

Baseline Characteristics

Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening

Baseline characteristics by cohort

Measure	Telehealth Intervention n=75 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Age, Continuous	44.91 years STANDARD_DEVIATION 11.46 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks after participants complete the baseline survey

Population: Analysis population includes all 75 participants who were invited to schedule a pre-test session after completing the baseline survey

Outcome measures

Measure	Telehealth Intervention n=75 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Schedule a Pre-test Session	74 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks after participants complete the baseline survey

Population: Analysis population only includes 74 participants who actually scheduled a pre-test session after being invited

Outcome measures

Measure	Telehealth Intervention n=74 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time	69 Participants

PRIMARY outcome

Timeframe: Up to 16 weeks after participants complete the baseline survey

Population: Analysis population only includes 69 participants who were shipped a specimen self-collection box after completing the pre-test session

Outcome measures

Measure	Telehealth Intervention n=69 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery Urine sample	57 Participants
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery Throat swab	57 Participants
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery Rectal swab	57 Participants
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery Blood sample	54 Participants

PRIMARY outcome

Timeframe: Up to 16 weeks after participants complete the baseline survey

Population: Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box

Outcome measures

Measure	Telehealth Intervention n=57 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing Urine sample	57 Participants
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing Throat swab	56 Participants
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing Rectal swab	55 Participants
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing Blood sample	47 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks after participants complete the baseline survey

Population: Analysis population only includes 57 participants who were invited to schedule a post-test session after returning at least one type of specimen

Outcome measures

Measure	Telehealth Intervention n=57 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Schedule a Post-test Session	57 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks after participants complete the baseline survey

Population: Analysis population only includes 57 participants who actually scheduled a post-test session after being invited

Outcome measures

Measure	Telehealth Intervention n=57 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time	55 Participants

PRIMARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 47 participants who answered the questions on satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session

Participants' satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater overall intervention satisfaction.

Outcome measures

Measure	Telehealth Intervention n=47 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Overall Intervention Satisfaction	28.09 score on a scale Standard Deviation 2.42

PRIMARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 51 participants who answered the questions on perceptions of the interventionist conducting the pre-test and the post-test sessions

Participants' perceptions of the interventionist conducting the pre-test and the post-test sessions will be assessed using two 12-item Counselor Rating Form Short scales included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 24-168, with higher scores indicating more positive interventionist perceptions.

Outcome measures

Measure	Telehealth Intervention n=51 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Interventionist Perceptions	163.92 score on a scale Standard Deviation 20.39

PRIMARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 52 participants who answered the questions on usability of the pre-test and the post-test sessions

Participants' usability of the pre-test and the post-test sessions will be assessed using two 4-item subscales from the Telehealth Usability Questionnaire on the quality of interactions with the interventionist during each session included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 8-56, with higher scores indicating greater usability of the pre-test and the post-test sessions.

Outcome measures

Measure	Telehealth Intervention n=52 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Usability of the Pre-test and the Post-test Sessions	53.56 score on a scale Standard Deviation 7.14

PRIMARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 48 participants who answered the questions on willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session

Participants' willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater willingness to repeat the intervention.

Outcome measures

Measure	Telehealth Intervention n=48 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Willingness to Repeat the Intervention	28.60 score on a scale Standard Deviation 2.32

PRIMARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 46 participants who answered the questions on likelihood of recommending the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session to friends or sex partners

Participants' likelihood of recommending the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session to friends or sex partners will be assessed using six 5-point Likert items included in the satisfaction survey. Response values will be summed to obtain a total score ranging from 6-30, with higher scores indicating greater likelihood of recommending the intervention to friends or sex partners.

Outcome measures

Measure	Telehealth Intervention n=46 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Likelihood of Recommending the Intervention to Friends or Sex Partners	28.33 score on a scale Standard Deviation 2.30

SECONDARY outcome

Timeframe: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)

Population: Analysis population only includes 67 participants who answered the questions assessing knowledge of gonorrhea, chlamydia, and syphilis in the baseline survey and the satisfaction survey

Potential changes in participants' knowledge of gonorrhea, chlamydia, and syphilis will be assessed by comparing responses to the same set of 22 items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 0-22, with higher scores indicating greater STI-related knowledge. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.

Outcome measures

Measure	Telehealth Intervention n=67 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Change in STI-related Knowledge Pre-intervention score (from the baseline survey)	16.34 score on a scale Standard Deviation 3.48
Change in STI-related Knowledge Post-intervention score (from the satisfaction survey)	17.16 score on a scale Standard Deviation 3.41
Change in STI-related Knowledge Difference	0.82 score on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: Up to 32 weeks after participants complete the baseline survey

Population: Analysis population only includes 70 participants who answered the question on likelihood of testing for bacterial STIs at least annually

Participants' likelihood of testing for bacterial STIs at least annually will be assessed using a single 5-point Likert item included in the satisfaction survey. Response values will range from 1-5, with higher values indicating greater likelihood of testing for bacterial STIs at least annually.

Outcome measures

Measure	Telehealth Intervention n=70 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Likelihood of Testing for Bacterial STIs at Least Annually	4.91 score on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)

Population: Analysis population only includes 48 participants who answered the questions assessing self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection in the baseline survey and the satisfaction survey

Potential changes in participants' self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection will be assessed by comparing responses to similar sets of four 5-point Likert items included in the baseline survey and the satisfaction survey. Response values will be summed to obtain separate total scores ranging from 4-20, with higher scores indicating greater self-efficacy for specimen self-collection. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.

Outcome measures

Measure	Telehealth Intervention n=48 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Change in Self-efficacy for Specimen Self-collection Pre-intervention score (from the baseline survey)	18.83 score on a scale Standard Deviation 1.64
Change in Self-efficacy for Specimen Self-collection Post-intervention score (from the satisfaction survey)	17.54 score on a scale Standard Deviation 2.69
Change in Self-efficacy for Specimen Self-collection Difference	-1.29 score on a scale Standard Deviation 2.17

SECONDARY outcome

Timeframe: Up to 16 weeks after participants complete the baseline survey

Population: Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box

Outcome measures

Measure	Telehealth Intervention n=57 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Gonorrhea PCR · Negative	43 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Gonorrhea PCR · Positive	11 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Gonorrhea PCR · Unable to Analyze Specimen	3 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Chlamydia PCR · Negative	50 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Chlamydia PCR · Positive	4 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Chlamydia PCR · Unable to Analyze Specimen	3 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Syphilis RPR · Negative	29 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Syphilis RPR · Positive	18 Participants
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis Syphilis RPR · Unable to Analyze Specimen	7 Participants

SECONDARY outcome

Timeframe: Up to 28 weeks after participants complete the baseline survey

Population: Analysis population only includes 24 participants who tested positive for gonorrhea, chlamydia, or syphilis

Outcome measures

Measure	Telehealth Intervention n=24 Participants Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were asked to attend a pre-test live AV conferencing session, collect and return a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing, and attend a post-test live AV conferencing session
Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result	5 Participants

Adverse Events

Telehealth Intervention

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

Dr. Akshay Sharma

University of Michigan

Phone: 734-647-0151

Email: akshaydr@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place