Sexually Transmitted DiseasesNCT06100250
Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
A study testing Motivational interviewing and specimen self-collection in people with Sexually Transmitted Diseases and Gonorrhea, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia
- What is being tested?
- Motivational interviewing and specimen self-collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
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.
Read the 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
- Being tested
- Motivational interviewing and specimen self-collection
- Keywords
- Specimen Collection, Audio/Video Conferencing, Motivational Interviewing, Sexual and Gender Minorities, Telemedicine
- Medical subject headings
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections, Syphilis, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing and specimen self-collectionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth intervention | Experimental | Participants will receive an MI-based telehealth intervention for bacterial STI screening. Receives: Behavioral: Motivational interviewing and specimen self-collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Schedule a Pre-test Session
Measured: Up to 8 weeks after participants complete the baseline survey
Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time
Measured: Up to 8 weeks after participants complete the baseline survey
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery
Measured: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing
Measured: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Schedule a Post-test Session
Measured: Up to 24 weeks after participants complete the baseline survey
Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time
Measured: Up to 24 weeks after participants complete the baseline survey
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.
Measured: Up to 32 weeks after participants complete the baseline survey
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.
Measured: Up to 32 weeks after participants complete the baseline survey
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.
Measured: Up to 32 weeks after participants complete the baseline survey
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.
Measured: Up to 32 weeks after participants complete the baseline survey
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.
Measured: Up to 32 weeks after participants complete the baseline survey
Secondary outcomes (5)
Change in STI-related Knowledge
Potential changes 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. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.
Measured: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)
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.
Measured: Up to 32 weeks after participants complete the baseline survey
Change in Self-efficacy for Specimen Self-collection
Potential changes 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. A positive value for the difference in scores (post-test minus pre-test) represents an increase, and a negative value for the difference in scores (post-test minus pre-test) represents a decrease.
Measured: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis
Measured: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result
Measured: Up to 28 weeks after participants complete the baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start19 Apr 2024
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Akshay Sharma, University of Michigan
- Investigators
- Akshay Sharma, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100250
- Sponsor's protocol ID
- HUM00240181
- Other IDs
- 1R21AI168606-01A1
- Status last verified
- Jun 2025
- First submitted
- 20 Oct 2023
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39208425
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
- ClinicalTrials.gov ID
- NCT06100250
- Acronym / sponsor ID
- HUM00240181
- Conditions
- Sexually Transmitted Diseases, Gonorrhea, Chlamydia, Syphilis, HIV
- Keywords
- Specimen Collection, Audio/Video Conferencing, Motivational Interviewing, Sexual and Gender Minorities, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth intervention | Experimental | Behavioral: Motivational interviewing and specimen self-collectionParticipants will receive an MI-based telehealth intervention for bacterial STI screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing and specimen self-collectionParticipants 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. | Behavioural | Telehealth intervention |
Primary outcome
Number of Participants That Schedule a Pre-test Session
Time frame: Up to 8 weeks after participants complete the baseline survey
Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time
Time frame: Up to 8 weeks after participants complete the baseline survey
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery
Time frame: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing
Time frame: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Schedule a Post-test Session
Time frame: Up to 24 weeks after participants complete the baseline survey
Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time
Time frame: Up to 24 weeks after participants complete the baseline survey
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.
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.
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.
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.
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.
5 secondary outcomes
Change in STI-related Knowledge
Time frame: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)
Likelihood of Testing for Bacterial STIs at Least Annually
Time frame: Up to 32 weeks after participants complete the baseline survey
Change in Self-efficacy for Specimen Self-collection
Time frame: Pre-intervention score (from the baseline survey); Post-intervention score (from the satisfaction survey completed up to 32 weeks after participants complete the baseline survey)
Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis
Time frame: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result
Time frame: Up to 28 weeks after participants complete the baseline survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39208425Sharma 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshay Sharma, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and specimen self-collection in people with Sexually Transmitted Diseases and Gonorrhea, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Schedule a Pre-test Session (time frame: Up to 8 weeks after participants complete the baseline survey). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.