Zenyth: Feasibility and Acceptability of an Motivational Interviewing (MI)-Based Telehealth Intervention for Bacterial Sexually Transmitted Infection (STI) Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Number of Participants That Schedule a Pre-test Session
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants That Schedule a Pre-test Session
时间窗: 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
时间窗: Up to 8 weeks after participants complete the baseline survey
Number of Participants That Schedule a Post-test Session
时间窗: 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
时间窗: Up to 24 weeks after participants complete the baseline survey
Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery
时间窗: Up to 16 weeks after participants complete the baseline survey
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing
时间窗: Up to 16 weeks after participants complete the baseline survey
Overall Intervention Satisfaction
时间窗: Up to 32 weeks after participants complete the baseline survey
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.
Usability of the Pre-test and the Post-test Sessions
时间窗: Up to 32 weeks after participants complete the baseline survey
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.
Interventionist Perceptions
时间窗: Up to 32 weeks after participants complete the baseline survey
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.
Willingness to Repeat the Intervention
时间窗: Up to 32 weeks after participants complete the baseline survey
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.
Likelihood of Recommending the Intervention to Friends or Sex Partners
时间窗: Up to 32 weeks after participants complete the baseline survey
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.
次要结局
- Change in STI-related Knowledge(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(Up to 32 weeks after participants complete the baseline survey)
- Change in Self-efficacy for Specimen Self-collection(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(Up to 16 weeks after participants complete the baseline survey)
- Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result(Up to 28 weeks after participants complete the baseline survey)
研究者
Akshay Sharma
Associate Professor, University of Michigan School of Nursing
University of Michigan