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

NCT06100250 | Completed Results

• 2 other identifiers: HUM002401811R21AI168606-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia; Syphilis; HIV

Keywords

Specimen Collection; Audio/Video Conferencing; Motivational Interviewing; Sexual and Gender Minorities; Telemedicine

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (5)

• Change in STI-related Knowledge

  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

  Up to 32 weeks after participants complete the baseline survey

• Change in Self-efficacy for Specimen Self-collection

  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

Study Arms (1)

Telehealth intervention

EXPERIMENTAL

Participants will receive an MI-based telehealth intervention for bacterial STI screening.

Behavioral: Motivational interviewing and specimen self-collection

Interventions

Motivational interviewing and specimen self-collection BEHAVIORAL

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.

Telehealth intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individual self-reports identifying as a man (regardless of sex assigned at birth)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Sharma A, Boyd S, Bonar EE. Feasibility and Acceptability of a Motivational Interviewing-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening: Protocol for a Sequential Explanatory Mixed Methods Study. JMIR Res Protoc. 2024 Aug 29;13:e64433. doi: 10.2196/64433.

  PMID: 39208425 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia Infections; Syphilis; Coitus

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Chlamydiaceae Infections; Treponemal Infections; Spirochaetales Infections; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Akshay Sharma
• Organization: University of Michigan

akshaydr@umich.edu

734-647-0151

Study Officials

• Akshay Sharma, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Michigan School of Nursing

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: April 19, 2024
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• Access Criteria: Creating an account on the ICPSR website.

Locations

US (1)