Chlamydia, Gonorrhea, HIV, Sexually Transmitted Diseases, Syphilis
Conditions
Keywords
Specimen Collection, Audio/Video Conferencing, Motivational Interviewing, Sexual and Gender Minorities, Telemedicine
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.
Interventions
BEHAVIORALMotivational interviewing and specimen self-collection
Participants 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, and attend a post-test live AV conferencing session.
Sponsors
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of Recommending the Intervention to Friends or Sex Partners | 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. |
| Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time | Up to 24 weeks after participants complete the baseline survey | — |
| Overall Intervention Satisfaction | 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. |
| Interventionist Perceptions | 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. |
| Usability of the Pre-test and the Post-test Sessions | 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. |
| Willingness to Repeat the Intervention | 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. |
| Number of Participants That Schedule a Pre-test Session | 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 | 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 | Up to 16 weeks after participants complete the baseline survey | — |
| Number of Participants That Provide Specimens of Adequate Quality for Lab Testing | Up to 16 weeks after participants complete the baseline survey | — |
| Number of Participants That Schedule a Post-test Session | Up to 24 weeks after participants complete the baseline survey | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likelihood of Testing for Bacterial STIs at Least Annually | Up to 32 weeks after participants complete the baseline survey | 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. |
| 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) | 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. |
| 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 | — |
| 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between April 2024 and October 2024 via advertising on mobile dating apps and social networking sites.
Participants by arm
| Arm | Count |
|---|---|
| Telehealth Intervention Participants received an MI-based telehealth intervention for bacterial STI screening. Participants were 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, and attend a post-test live AV conferencing session | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Telehealth Intervention |
|---|---|
| Age, Continuous | 44.91 years STANDARD_DEVIATION 11.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
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
Population: Analysis population only includes 51 participants who answered the questions on perceptions of the interventionist conducting the pre-test and the post-test sessions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Interventionist Perceptions | 163.92 score on a scale | Standard Deviation 20.39 |
Primary
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
Population: Analysis population only includes 46 participants who answered the questions on 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Likelihood of Recommending the Intervention to Friends or Sex Partners | 28.33 score on a scale | Standard Deviation 2.3 |
Primary
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
Population: Analysis population only includes 57 participants who actually scheduled a post-test session after being invited
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time | 55 Participants |
Primary
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
Population: Analysis population only includes 74 participants who actually scheduled a pre-test session after being invited
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time | 69 Participants |
Primary
Number of Participants That Provide Specimens of Adequate Quality for Lab Testing
Time frame: Up to 16 weeks after participants complete the baseline survey
Population: Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telehealth Intervention | Number of Participants That Provide Specimens of Adequate Quality for Lab Testing | Urine sample | 57 Participants |
| Telehealth Intervention | Number of Participants That Provide Specimens of Adequate Quality for Lab Testing | Throat swab | 56 Participants |
| Telehealth Intervention | Number of Participants That Provide Specimens of Adequate Quality for Lab Testing | Rectal swab | 55 Participants |
| Telehealth Intervention | Number of Participants That Provide Specimens of Adequate Quality for Lab Testing | Blood sample | 47 Participants |
Primary
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
Population: Analysis population only includes 69 participants who were shipped a specimen self-collection box after completing the pre-test session
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telehealth Intervention | Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery | Blood sample | 54 Participants |
| Telehealth Intervention | Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery | Urine sample | 57 Participants |
| Telehealth Intervention | Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery | Throat swab | 57 Participants |
| Telehealth Intervention | Number of Participants That Return Each Type of Specimen Within 6 Weeks of Box Delivery | Rectal swab | 57 Participants |
Primary
Number of Participants That Schedule a Post-test Session
Time frame: Up to 24 weeks after participants complete the baseline survey
Population: Analysis population only includes 57 participants who were invited to schedule a post-test session after returning at least one type of specimen
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants That Schedule a Post-test Session | 57 Participants |
Primary
Number of Participants That Schedule a Pre-test Session
Time frame: Up to 8 weeks after participants complete the baseline survey
Population: Analysis population includes all 75 participants who were invited to schedule a pre-test session after completing the baseline survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants That Schedule a Pre-test Session | 74 Participants |
Primary
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
Population: Analysis population only includes 47 participants who answered the questions on satisfaction with the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Overall Intervention Satisfaction | 28.09 score on a scale | Standard Deviation 2.42 |
Primary
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
Population: Analysis population only includes 52 participants who answered the questions on usability of the pre-test and the post-test sessions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Usability of the Pre-test and the Post-test Sessions | 53.56 score on a scale | Standard Deviation 7.14 |
Primary
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
Population: Analysis population only includes 48 participants who answered the questions on willingness to repeat the pre-test session, urine sample collection, throat swab collection, rectal swab collection, blood sample collection, and the post-test session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Willingness to Repeat the Intervention | 28.60 score on a scale | Standard Deviation 2.32 |
Secondary
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)
Population: Analysis population only includes 48 participants who answered the questions assessing self-efficacy for urine sample collection, throat swab collection, rectal swab collection, and blood sample collection in the baseline survey and the satisfaction survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth Intervention | Change in Self-efficacy for Specimen Self-collection | Pre-intervention score (from the baseline survey) | 18.83 score on a scale | Standard Deviation 1.64 |
| Telehealth Intervention | Change in Self-efficacy for Specimen Self-collection | Post-intervention score (from the satisfaction survey) | 17.54 score on a scale | Standard Deviation 2.69 |
| Telehealth Intervention | Change in Self-efficacy for Specimen Self-collection | Difference | -1.29 score on a scale | Standard Deviation 2.17 |
Comparison: Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0p-value: <0.01Paired sample t-test, 2 sided
Secondary
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)
Population: Analysis population only includes 67 participants who answered the questions assessing knowledge of gonorrhea, chlamydia, and syphilis in the baseline survey and the satisfaction survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telehealth Intervention | Change in STI-related Knowledge | Pre-intervention score (from the baseline survey) | 16.34 score on a scale | Standard Deviation 3.48 |
| Telehealth Intervention | Change in STI-related Knowledge | Post-intervention score (from the satisfaction survey) | 17.16 score on a scale | Standard Deviation 3.41 |
| Telehealth Intervention | Change in STI-related Knowledge | Difference | 0.82 score on a scale | Standard Deviation 2.66 |
Comparison: Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0p-value: 0.01Paired sample t-test, 2 sided
Secondary
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
Population: Analysis population only includes 70 participants who answered the question on likelihood of testing for bacterial STIs at least annually
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telehealth Intervention | Likelihood of Testing for Bacterial STIs at Least Annually | 4.91 score on a scale | Standard Deviation 0.37 |
Secondary
Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result
Time frame: Up to 28 weeks after participants complete the baseline survey
Population: Analysis population only includes 24 participants who tested positive for gonorrhea, chlamydia, or syphilis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth Intervention | Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result | 5 Participants |
Secondary
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
Population: Analysis population only includes 57 participants who returned at least one type of specimen after receiving the specimen self-collection box
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Chlamydia PCR | Positive | 4 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Chlamydia PCR | Unable to Analyze Specimen | 3 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Gonorrhea PCR | Negative | 43 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Gonorrhea PCR | Positive | 11 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Gonorrhea PCR | Unable to Analyze Specimen | 3 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Chlamydia PCR | Negative | 50 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Syphilis RPR | Negative | 29 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Syphilis RPR | Positive | 18 Participants |
| Telehealth Intervention | Number of Participants That Test Negative or Positive for Gonorrhea, Chlamydia, and Syphilis | Syphilis RPR | Unable to Analyze Specimen | 7 Participants |