Clinical trial NCT06100250: Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
Official title: Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Gonorrhea
Chlamydia
Syphilis
HIV
Keywords: Specimen Collection
Audio/Video Conferencing
Motivational Interviewing
Sexual and Gender Minorities
Telemedicine
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-10-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of participants that schedule a pre-test session
timeFrame: Up to 8 weeks after participants complete the baseline survey
measure: Number of participants that join the pre-test session within 30 minutes of the start time
timeFrame: Up to 30 minutes after the interventionist starts the pre-test session
measure: Number of participants that return each type of specimen within 6 weeks of box delivery
timeFrame: Up to 6 weeks after participants receive the specimen self-collection box
measure: Number of participants that provide specimens of adequate quality for lab testing
timeFrame: Up to 6 weeks after participants receive the specimen self-collection box
measure: Number of participants that schedule a post-test session
timeFrame: Up to 8 weeks after the participants' lab test results are available
measure: Number of participants that join the post-test session within 30 minutes of the start time
timeFrame: Up to 30 minutes after the interventionist starts the post-test session
measure: Overall intervention satisfaction
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Interventionist perceptions
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Usability of the pre-test and the post-test sessions
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Willingness to repeat the intervention
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Likelihood of recommending the intervention to friends or sex partners
timeFrame: Up to 32 weeks after participants complete the baseline survey
Secondary outcomes:
measure: Improvement in STI-related knowledge
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Likelihood of testing for bacterial STIs at least annually
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Improvement in self-efficacy for specimen self-collection
timeFrame: Up to 32 weeks after participants complete the baseline survey
measure: Number of participants that test negative or positive for gonorrhea, chlamydia, and syphilis
timeFrame: Up to 6 weeks after participants receive the specimen self-collection box
measure: Number of participants that initiate treatment within 1 week of receiving a positive test result
timeFrame: Up to 1 week after receiving a positive test result
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Akshay Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References: