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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100250
• Other study ID #: HUM00240181
• Secondary ID: 1R21AI168606-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Akshay Sharma, PhD
• Phone: 734-647-0151
• Email: akshaydr[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• HIV
• Sexually Transmitted Diseases
• Syphilis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that schedule a pre-test session		Up to 8 weeks after participants complete the baseline survey
Primary	Number of participants that join the pre-test session within 30 minutes of the start time		Up to 30 minutes after the interventionist starts the pre-test session
Primary	Number of participants that return each type of specimen within 6 weeks of box delivery		Up to 6 weeks after participants receive the specimen self-collection box
Primary	Number of participants that provide specimens of adequate quality for lab testing		Up to 6 weeks after participants receive the specimen self-collection box
Primary	Number of participants that schedule a post-test session		Up to 8 weeks after the participants' lab test results are available
Primary	Number of participants that join the post-test session within 30 minutes of the start time		Up to 30 minutes after the interventionist starts the post-test session
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Improvement in STI-related knowledge	Potential increases 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.	Up to 32 weeks after participants complete the baseline survey
Secondary	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
Secondary	Improvement in self-efficacy for specimen self-collection	Potential increases 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.	Up to 32 weeks after participants complete the baseline survey
Secondary	Number of participants that test negative or positive for gonorrhea, chlamydia, and syphilis		Up to 6 weeks after participants receive the specimen self-collection box
Secondary	Number of participants that initiate treatment within 1 week of receiving a positive test result		Up to 1 week after receiving a positive test result