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

Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening

In the United States (US), gay and bisexual men living with human immunodeficiency virus (HIV) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis. It is important to diagnose and treat STIs in a timely manner to prevent health complications and reduce transmissions. The purpose of this study is to understand whether gay and bisexual men living with HIV are willing to collect and return specimens for bacterial STI testing when combined with live audio/video (AV) conferencing support.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV; Chlamydia; Gonorrhea; Syphilis
• Intervention / Treatment: Behavioral: Motivational interviewing and specimen self-collection

Detailed Description

Participants will be recruited from across the US via social media advertising and peer referral. Seventy-five participants that complete an online survey (called the baseline survey) will be 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, attend a post-test live AV conferencing session, and complete another online survey (called the satisfaction survey). Some participants (20 of 75) will also be invited to attend an online interview to share study-related experiences.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individual self-reports identifying as a man (regardless of sex assigned at birth) in the eligibility screener
• Individual self-reports residing in a US state or territory in the eligibility screener
• Individual self-reports being physically located in a US state or territory when completing study activities in the eligibility screener
• Individual self-reports being greater than or equal to (≥)18 years of age in the eligibility screener
• Individual self-reports being of legal age to provide consent for research participation in the US state or territory of residence in the eligibility screener
• Individual self-reports having been diagnosed with HIV in the eligibility screener
• Individual self-reports having any kind of condomless sex (e.g., oral, anal) with ≥2 men in the past year in the eligibility screener
• Individual self-reports being willing to provide contact information (full name, email address, mobile phone number, and mailing address) in the eligibility screener
• Individual self-reports being able to participate in live AV conferencing sessions using an internet-connected device (e.g., computer, tablet, smartphone) in the eligibility screener
• Individual self-reports being willing to receive a box that contains kits to self-collect a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing in the eligibility screener
• Individual provides valid contact information (full name, email address, mobile phone number, and mailing address) in the contact information form
• Individual completes the baseline survey in order to receive the intervention

Exclusion Criteria:

• Individual self-reports not identifying as a man (regardless of sex assigned at birth) in the eligibility screener
• Individual self-reports not residing in a US state or territory in the eligibility screener
• Individual self-reports not being physically located in a US state or territory when completing study activities in the eligibility screener
• Individual self-reports not being ≥18 years of age in the eligibility screener
• Individual self-reports not being of legal age to provide consent for research participation in the US state or territory of residence in the eligibility screener
• Individual self-reports not having been diagnosed with HIV in the eligibility screener
• Individual self-reports not having any kind of condomless sex (e.g., oral, anal) with ≥2 men in the past year in the eligibility screener
• Individual self-reports not being willing to provide contact information (full name, email address, mobile phone number, and mailing address) in the eligibility screener
• Individual self-reports not being able to participate in live AV conferencing sessions using an internet-connected device (e.g., computer, tablet, smartphone) in the eligibility screener
• Individual self-reports not being willing to receive a box that contains kits to self-collect a urine sample, a throat swab, a rectal swab, and a blood sample for bacterial STI testing in the eligibility screener
• Individual does not provide valid contact information (full name, email address, mobile phone number, and mailing address) in the contact information form
• Individual does not complete the baseline survey in order to receive the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth intervention; Participants will receive an MI-based telehealth intervention for bacterial STI screening.	Behavioral: Motivational interviewing and specimen self-collection; Participants will be 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Schedule a Pre-test Session		Up to 8 weeks after participants complete the baseline survey
Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time		Up to 8 weeks after participants complete the baseline survey
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery		Up to 16 weeks after participants complete the baseline survey
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing		Up to 16 weeks after participants complete the baseline survey
Number of Participants That Schedule a Post-test Session		Up to 24 weeks after participants complete the baseline survey
Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time		Up to 24 weeks after participants complete the baseline survey
Overall Intervention Satisfaction	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.	Up to 32 weeks after participants complete the baseline survey
Interventionist Perceptions	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.	Up to 32 weeks after participants complete the baseline survey
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.	Up to 32 weeks after participants complete the baseline survey
Willingness to Repeat the Intervention	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.	Up to 32 weeks after participants complete the baseline survey
Likelihood of Recommending the Intervention 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.	Up to 32 weeks after participants complete the baseline survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in STI-related Knowledge	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.	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)
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.	Up to 32 weeks after participants complete the baseline survey
Change in Self-efficacy for Specimen Self-collection	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.	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)
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis		Up to 16 weeks after participants complete the baseline survey
Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result		Up to 28 weeks after participants complete the baseline survey

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Akshay Sharma, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): March 7, 2025
• Study Completion (Actual): March 7, 2025

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Motivational Interviewing; Sexual and Gender Minorities; Specimen Collection; Audio/Video Conferencing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Treponemal Infections; Sexually Transmitted Diseases; Gonorrhea; Syphilis
• Other Study ID Numbers: HUM00240181; 1R21AI168606-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results will be publicly reported through presentations at domestic and international conferences, and publications in peer-reviewed journals. Once analyses relating to the major aims of the proposed study have been completed and reported, the data will be deposited with the Inter-university Consortium for Political and Social Research (ICPSR) located at the University of Michigan. All confidentiality requirements will be followed as outlined on the website. ICPSR will make the data available to over 750 universities, government agencies, and other institutions, permitting other researchers to conduct secondary analyses. Data availability will be announced on the ICPSR website.
• IPD Sharing Time Frame: Data will be made available within 6 months after analyses relating to the major aims of the proposed study have been completed and reported, and will remain available for at least 5 years.
• IPD Sharing Access Criteria: Creating an account on the ICPSR website.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No