N/A
N=75
Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
Sexually Transmitted Diseases · Gonorrhea · Chlamydia · Syphilis · HIV
Bottom Line
View on ClinicalTrials.gov: NCT06100250 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Participants That Schedule a Pre-test Session — 74 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational interviewing and specimen self-collection (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Schedule a Pre-test Session |
74 | — |
| PRIMARY Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time |
69 | — |
| PRIMARY Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery |
57; 57; 57; 54 | — |
| PRIMARY Number of Participants That Provide Specimens of Adequate Quality for Lab Testing |
57; 56; 55; 47 | — |
| PRIMARY Number of Participants That Schedule a Post-test Session |
57 | — |
| PRIMARY Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time |
55 | — |
| PRIMARY Overall Intervention Satisfaction |
28.09 | — |
| PRIMARY Interventionist Perceptions |
163.92 | — |
| PRIMARY Usability of the Pre-test and the Post-test Sessions |
53.56 | — |
| PRIMARY Willingness to Repeat the Intervention |
28.60 | — |
| PRIMARY Likelihood of Recommending the Intervention to Friends or Sex Partners |
28.33 | — |
| SECONDARY Change in STI-related Knowledge |
16.34; 17.16; 0.82 | 0.01 sig |
| SECONDARY Likelihood of Testing for Bacterial STIs at Least Annually |
4.91 | — |
| SECONDARY Change in Self-efficacy for Specimen Self-collection |
18.83; 17.54; -1.29 | <0.01 sig |
| SECONDARY Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis |
43; 11; 3; 50; 4; 3 | — |
| SECONDARY Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result |
5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06100250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.