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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Sexually Transmitted Diseases
Syphilis
Gonorrhea
Chlamydia
HIV

Treatments

Behavioral: Motivational interviewing and specimen self-collection

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06100250
HUM00240181
1R21AI168606-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

Telehealth intervention
Experimental group
Description:
Participants will receive an MI-based telehealth intervention for bacterial STI screening.
Treatment:
Behavioral: Motivational interviewing and specimen self-collection

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Akshay Sharma, PhD

Data sourced from clinicaltrials.gov

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