Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT06100250
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R21AI168606-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |