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

University of Michigan75 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Sexually Transmitted Diseases Gonorrhea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 32 weeks after participants complete the baseline survey

Secondary Outcomes

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.

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

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.

Time frame: 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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes