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

• ClinicalTrials.gov Identifier: NCT06100250
• Recruitment Status: Recruiting
• First Posted: October 25, 2023
• Last Update Posted: April 23, 2024
• Sponsor: University of Michigan
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Akshay Sharma, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sexually Transmitted Diseases; Gonorrhea; Chlamydia; Syphilis; HIV	Behavioral: Motivational interviewing and specimen self-collection	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
• Actual Study Start Date: April 19, 2024
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: January 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of participants that schedule a pre-test session [ Time Frame: Up to 8 weeks after participants complete the baseline survey ]
2. Number of participants that join the pre-test session within 30 minutes of the start time [ Time Frame: Up to 30 minutes after the interventionist starts the pre-test session ]
3. Number of participants that return each type of specimen within 6 weeks of box delivery [ Time Frame: Up to 6 weeks after participants receive the specimen self-collection box ]
4. Number of participants that provide specimens of adequate quality for lab testing [ Time Frame: Up to 6 weeks after participants receive the specimen self-collection box ]
5. Number of participants that schedule a post-test session [ Time Frame: Up to 8 weeks after the participants' lab test results are available ]
6. Number of participants that join the post-test session within 30 minutes of the start time [ Time Frame: Up to 30 minutes after the interventionist starts the post-test session ]
7. Overall intervention satisfaction [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
8. Interventionist perceptions [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
9. Usability of the pre-test and the post-test sessions [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
10. Willingness to repeat the intervention [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
    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.
11. Likelihood of recommending the intervention to friends or sex partners [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
    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.

Secondary Outcome Measures :

1. Improvement in STI-related knowledge [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
2. Likelihood of testing for bacterial STIs at least annually [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
3. Improvement in self-efficacy for specimen self-collection [ Time Frame: Up to 32 weeks after participants complete the baseline survey ]
   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.
4. Number of participants that test negative or positive for gonorrhea, chlamydia, and syphilis [ Time Frame: Up to 6 weeks after participants receive the specimen self-collection box ]
5. Number of participants that initiate treatment within 1 week of receiving a positive test result [ Time Frame: Up to 1 week after receiving a positive test result ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Individual self-reports identifying as a man (regardless of sex assigned at birth)
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Akshay Sharma, PhD; 734-647-0151; akshaydr@umich.edu

Locations

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Akshay Sharma, PhD 734-647-0151 akshaydr@umich.edu

Principal Investigator: Akshay Sharma, PhD

Sub-Investigator: Erin Bonar, PhD

Sponsors and Collaborators

University of Michigan

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Akshay Sharma, PhD; University of Michigan

More Information

• Responsible Party: Akshay Sharma, Assistant Professor, University of Michigan School of Nursing, University of Michigan
• ClinicalTrials.gov Identifier: NCT06100250
• Other Study ID Numbers: HUM00240181; 1R21AI168606-01A1 ( U.S. NIH Grant/Contract )
• First Posted: October 25, 2023
• Last Update Posted: April 23, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Informed Consent Form (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.
• URL: https://www.icpsr.umich.edu/web/pages/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Akshay Sharma, University of Michigan:

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

Additional relevant MeSH terms:

Sexually Transmitted Diseases; Gonorrhea; Syphilis; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Neisseriaceae Infections; Treponemal Infections; Spirochaetales Infections