Motivational Interviewing for STI Screening

Overseen By Akshay Sharma, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not male, Not US resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if gay and bisexual men living with HIV will collect and return samples for STI (sexually transmitted infection) testing when supported through live video calls. It employs a motivational interviewing approach, a counseling method, to encourage participants to test for infections like gonorrhea, chlamydia, and syphilis. The trial may suit men who have had condomless sex with at least two other men in the past year and are comfortable using video conferencing. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance STI testing methods for the community.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this motivational interviewing-based telehealth intervention is safe?

Research has shown that using motivational interviewing in telehealth is generally safe. Studies have found this method to be effective and acceptable to participants, allowing them to use it without major issues.

Motivational interviewing resembles a conversation with a supportive coach. It helps individuals discuss changes they wish to make, set goals, and determine how to achieve them.

In previous studies, participants did not report any serious side effects from this approach. As a non-invasive method, it involves no medication or physical procedures. While these studies did not identify significant negative effects, asking questions if concerns arise remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods of STI screening that often require in-person visits and can involve face-to-face interviews, the motivational interviewing-based telehealth intervention offers a virtual approach. This telehealth method enables participants to engage in STI screening from the comfort and privacy of their own homes, potentially increasing accessibility and convenience. Researchers are excited about this approach because it may reduce barriers to screening, such as transportation issues or stigma associated with visiting a clinic, thus encouraging more individuals to get tested and treated for bacterial STIs.

What evidence suggests that this motivational interviewing-based telehealth intervention is effective for STI screening?

Research has shown that motivational interviewing (MI) effectively changes health-related behaviors. Studies have found that short MI sessions help reduce risky sexual behaviors, decrease substance use, and support consistent HIV medication adherence. This method has also successfully prevented the spread of HIV and other sexually transmitted infections (STIs). In this trial, participants will receive a telehealth intervention based on MI to increase STI screening. MI helps people discuss their motivations and goals to make healthier choices. It is practical and well-received by participants, making it a promising approach to increase STI screening among gay and bisexual men living with HIV. ^{1 2 4 6 7}

Who Is on the Research Team?

Akshay Sharma, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

The Zenyth trial is for gay and bisexual men over 18 years old living with HIV in the US, who've had condomless sex with at least two men in the past year. Participants must be willing to self-collect samples for STI testing and engage in motivational interviewing via live audio/video conferencing.

Inclusion Criteria

I have been diagnosed with HIV.

You must be located in a US state or territory while completing the eligibility screener.

I am willing to self-collect samples for STI testing.

Exclusion Criteria

Individual self-reports not being willing to provide contact information (full name, email address, mobile phone number, and mailing address) in the eligibility screener

I am under 18 years old.

Individual self-reports not residing in a US state or territory in the eligibility screener

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test Session

Participants attend a live AV conferencing session and collect samples for STI testing

1 week

1 visit (virtual)

Post-test Session

Participants attend a post-test live AV conferencing session and complete a satisfaction survey

1 week

1 visit (virtual)

Follow-up

Participants are monitored for satisfaction and knowledge improvement up to 32 weeks after the baseline survey

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing-based Telehealth Intervention

Trial Overview This study tests if motivational interviewing through telehealth can encourage these individuals to self-collect specimens for bacterial STI screening, aiming to improve timely diagnosis and treatment of infections like syphilis, chlamydia, and gonorrhea.

How Is the Trial Designed?

Group I: Telehealth intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393502/

Feasibility and Acceptability of a Motivational Interviewing– ... Brief (eg, 30-45 minutes) in-person MI sessions have proven effective in reducing sexual risk behaviors, substance use, and ART nonadherence in people living ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06100250

NCT06100250 | Zenyth: Motivational Interviewing-based ... Participants will receive an MI-based telehealth intervention for bacterial STI screening. Intervention/Treatment, Behavioral : Motivational interviewing and ...

3. researchprotocols.org researchprotocols.org/2025/1/e69540

Evaluating the Effectiveness of a Mobile HIV Prevention ... Brief behavioral motivational interviewing–based interventions are effective in preventing HIV and STI transmission [33], and motivational ...

4. researchgate.net researchgate.net/publication/383551403_Feasibility_and_Acceptability_of_a_Motivational_Interviewing-Based_Telehealth_Intervention_for_Bacterial_Sexually_Transmitted_Infection_Screening_Protocol_for_a_Sequential_Explanatory_Mixed_Methods_St

Protocol for a Sequential Explanatory Mixed Methods Study Feasibility and Acceptability of a Motivational Interviewing–Based Telehealth Intervention for Bacterial Sexually Transmitted Infection ...

5. researchprotocols.org researchprotocols.org/2025/1/e69540/PDF

Evaluating the Effectiveness of a Mobile HIV Prevention ... Brief behavioral motivational interviewing–based interventions are effective in preventing HIV and STI transmission [33], and motivational ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/50/NCT06100250/ICF_002.pdf

Zenyth: Motivational Interviewing-based Telehealth Intervention ... The purpose of this study is to understand whether gay and bisexual men living with HIV are willing to collect and return their specimens for bacterial ...

7. researchprotocols.org researchprotocols.org/2020/3/e15569/

Brief Intervention to Prevent Sexually Transmitted ... This feasibility study will determine whether the implementation of brief intervention programs aimed at improving sexual health outcomes is possible.