An interventional study of Motivational interviewing and specimen self-collection in Sexually Transmitted Diseases, Gonorrhea and Chlamydia, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's enrollment of 75 is below the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an MI-based telehealth intervention for bacterial STI screening.
Behavioral: Motivational 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.
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
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
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
Participants were recruited between April 2024 and October 2024 via advertising on mobile dating apps and social networking sites.
| Milestone | Telehealth Intervention |
|---|---|
| Started | 75 |
| Completed | 70 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 5 |
| Participants | Telehealth Intervention |
|---|---|
| Number of Participants That Schedule a Pre-test Session | 74 |
| Participants | Telehealth Intervention |
|---|---|
| Number of Participants That Join the Pre-test Session Within 30 Minutes of the Start Time | 69 |
| Participants | Telehealth Intervention |
|---|---|
| Urine sample | 57 |
| Throat swab | 57 |
| Rectal swab | 57 |
| Blood sample | 54 |
| Participants | Telehealth Intervention |
|---|---|
| Urine sample | 57 |
| Throat swab | 56 |
| Rectal swab | 55 |
| Blood sample | 47 |
| Participants | Telehealth Intervention |
|---|---|
| Number of Participants That Schedule a Post-test Session | 57 |
| Participants | Telehealth Intervention |
|---|---|
| Number of Participants That Join the Post-test Session Within 30 Minutes of the Start Time | 55 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Overall Intervention Satisfaction | 28.09 ± 2.42 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Interventionist Perceptions | 163.92 ± 20.39 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Usability of the Pre-test and the Post-test Sessions | 53.56 ± 7.14 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Willingness to Repeat the Intervention | 28.60 ± 2.32 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Likelihood of Recommending the Intervention to Friends or Sex Partners | 28.33 ± 2.30 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Pre-intervention score (from the baseline survey) | 16.34 ± 3.48 |
| Post-intervention score (from the satisfaction survey) | 17.16 ± 3.41 |
| Difference | 0.82 ± 2.66 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Likelihood of Testing for Bacterial STIs at Least Annually | 4.91 ± 0.37 |
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.
| score on a scale | Telehealth Intervention |
|---|---|
| Pre-intervention score (from the baseline survey) | 18.83 ± 1.64 |
| Post-intervention score (from the satisfaction survey) | 17.54 ± 2.69 |
| Difference | -1.29 ± 2.17 |
| Participants | Telehealth Intervention |
|---|---|
| Gonorrhea PCR — Negative | 43 |
| Gonorrhea PCR — Positive | 11 |
| Gonorrhea PCR — Unable to Analyze Specimen | 3 |
| Chlamydia PCR — Negative | 50 |
| Chlamydia PCR — Positive | 4 |
| Chlamydia PCR — Unable to Analyze Specimen | 3 |
| Syphilis RPR — Negative | 29 |
| Syphilis RPR — Positive | 18 |
| Syphilis RPR — Unable to Analyze Specimen | 7 |
| Participants | Telehealth Intervention |
|---|---|
| Number of Participants That Initiate Treatment Within 1 Week of Receiving a Positive Test Result | 5 |
Collected over Up to 32 weeks after participants complete the baseline survey. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telehealth Intervention | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| Age, Continuous(years) | Telehealth Intervention |
|---|---|
| Mean | 44.91 ± 11.46 |
| Sex: Female, Male(Participants) | Telehealth Intervention |
|---|---|
| Female | 0 |
| Male | 75 |
| Ethnicity (NIH/OMB)(Participants) | Telehealth Intervention |
|---|---|
| Hispanic or Latino | 23 |
| Not Hispanic or Latino | 52 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Telehealth Intervention |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 43 |
| More than one race | 5 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | Telehealth Intervention |
|---|---|
| United States | 75 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study results will be publicly reported through presentations at domestic and international conferences, and publications in peer-reviewed journals. Once analyses relating to the major aims of the proposed study have been completed and reported, the data will be deposited with the Inter-university Consortium for Political and Social Research (ICPSR) located at the University of Michigan. All confidentiality requirements will be followed as outlined on the website. ICPSR will make the data available to over 750 universities, government agencies, and other institutions, permitting other researchers to conduct secondary analyses. Data availability will be announced on the ICPSR website.
Supporting information: Study protocol, Informed consent form
Time frame: Data will be made available within 6 months after analyses relating to the major aims of the proposed study have been completed and reported, and will remain available for at least 5 years.
Access criteria: Creating an account on the ICPSR website.
Data sharing details ↗ · www.icpsr.umich.edu
Ran from Apr 2024 to primary completion in Mar 2025, 10 months.
Results were first posted in Jul 2025, 3 months after primary completion.
Of 172 non-industry interventional studies with no phase under Sexually Transmitted Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 10 months is below that.
Counting every sponsor, half of 182 studies reached it within 31 months; a quarter within 16 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases →