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

NCT ID: NCT06100250

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2025-03-07

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.

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.

Conditions

Sexually Transmitted Diseases; Gonorrhea; Chlamydia; Syphilis; HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telehealth intervention

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

Group Type: EXPERIMENTAL

Motivational interviewing and specimen self-collection

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Akshay Sharma

Associate Professor, University of Michigan School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akshay Sharma, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39208425 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21AI168606-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00240181

Identifier Type: -

Identifier Source: org_study_id