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

Primary Purpose

Sexually Transmitted Diseases, Gonorrhea, Chlamydia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing and specimen self-collection
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sexually Transmitted Diseases focused on measuring Specimen Collection, Audio/Video Conferencing, Motivational Interviewing, Sexual and Gender Minorities, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telehealth intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants that schedule a pre-test session
Number of participants that join the pre-test session within 30 minutes of the start time
Number of participants that return each type of specimen within 6 weeks of box delivery
Number of participants that provide specimens of adequate quality for lab testing
Number of participants that schedule a post-test session
Number of participants that join the post-test session within 30 minutes of the start time
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Number of participants that test negative or positive for gonorrhea, chlamydia, and syphilis
Number of participants that initiate treatment within 1 week of receiving a positive test result

Full Information

First Posted
October 20, 2023
Last Updated
October 20, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT06100250
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Gonorrhea, Chlamydia, Syphilis, HIV
Keywords
Specimen Collection, Audio/Video Conferencing, Motivational Interviewing, Sexual and Gender Minorities, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth intervention
Arm Type
Experimental
Arm Description
Participants will receive an MI-based telehealth intervention for bacterial STI screening.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing and specimen self-collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that schedule a pre-test session
Time Frame
Up to 8 weeks after participants complete the baseline survey
Title
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
Title
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
Title
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
Title
Number of participants that schedule a post-test session
Time Frame
Up to 8 weeks after the participants' lab test results are available
Title
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
Title
Overall intervention satisfaction
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Interventionist perceptions
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Usability of the pre-test and the post-test sessions
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Willingness to repeat the intervention
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Likelihood of recommending the intervention to friends or sex partners
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Secondary Outcome Measure Information:
Title
Improvement in STI-related knowledge
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Likelihood of testing for bacterial STIs at least annually
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
Improvement in self-efficacy for specimen self-collection
Description
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.
Time Frame
Up to 32 weeks after participants complete the baseline survey
Title
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
Title
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Individual self-reports identifying as a man (regardless of sex assigned at birth)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akshay Sharma, PhD
Phone
734-647-0151
Email
akshaydr@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akshay Sharma, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akshay Sharma, PhD
Phone
734-647-0151
Email
akshaydr@umich.edu
First Name & Middle Initial & Last Name & Degree
Akshay Sharma, PhD
First Name & Middle Initial & Last Name & Degree
Erin Bonar, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Creating an account on the ICPSR website.
IPD Sharing URL
https://www.icpsr.umich.edu/web/pages/

Learn more about this trial

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

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