Sexually Transmitted InfectionsMIC-DROPNCT06183502
HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men
An observational study of Sexually Transmitted Infections and Gay, run by Emory University at 3 sites in United States.
Trial summary
The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, Gay, Pre Exposure Prophylaxis
- What is being tested?
- Quantitative survey, HIV and STI testing and Qualitative Assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 675 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary recruitment sources will be through online targeted advertisements to adult men in the three metropolitan areas (Atlanta, Detroit, and San Diego), including social media channels, such as Facebook, Instagram or Snapchat, Grindr, and other dating apps. Additionally, recruitment will be done through referrals from local clinics and community-based organizations. These organizations may provide palm cards or QR codes for interested participants to reach the eligibility screening survey.
Who may be able to join
- Male at birth
- Self-identify as Cis-gender Male
- Ages 18 or older
- ≥1 Male anal sex partner in the 6 months before the baseline screener
- Live in or near Atlanta, Chicago, or San Diego
- Owns cell phone with data service
Show all 11Show fewer
- Willing to download a health-related app to their cell phone as part of the research study
- Willing to participate in a 2-year cohort study with quarterly surveys and HIV and mailed STI self-testing
- Able to provide ≥ 2 means of contact
- Not currently enrolled in another HIV prevention clinical trial
- Not currently living with HIV
Who cannot join
- Female at birth
- Do not self-identify as Cis-gender Male
- Individuals < 18 years of age
- HIV positive status
- No male anal sex partner in the 6 months before the baseline interview
- Does not own a mobile phone with data service
Show all 9Show fewer
- Not willing to download a health-related app to their cell phone as part of the research study
- Live outside the metro Atlanta Metropolitan Statistical Area and/or planning to move from the Atlanta area in the next 2 years
- Currently enrolled in an HIV prevention or treatment clinical trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30307
University of Chicago
Chicago, Illinois, 60637
San Diego State University
San Diego, California, 92182
About this study
Official title: Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex With Men in a Transformational Era (MIC-DROP)
The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. The main objective is to study a prospective cohort of MSM in Atlanta, Chicago, and San Diego to understand men's strategies to prevent HIV/Sexually Transmissible Infections (STIs), including PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors
Participants will complete:
- Quantitative surveys quarterly
- HIV/ STI testing every 6 months
- Qualitative assessments: focus group discussions and in-depth interviews
Read the detailed description
The prevention of HIV in the United States is in a transformational era. In just a decade since the first finding of efficacy for daily oral PrEP, there has been a proliferation of new PrEP agents, including long-acting injectable PrEP, and regimens, including "event-driven" (also called "on demand" or 2-1-1 dosing) PrEP. There has also been new knowledge about the impact of antiretrovirals (ARVs) on the treatment of HIV, and an emergent understanding that people living with HIV who take ARVs and maintain a suppressed viral load are incapable of transmitting HIV to their sexual partners. In this context, the idea of "protected" sex - which historically meant sex protected by condoms - has become much more complex.6 Men who have sex with men (MSM) and others at risk for acquiring HIV are now making decisions about how to reduce their risks of HIV infection in a world where there are many more options to reduce risks of infection, and where those options also interact with the HIV status and viral suppression status of their sex partners. Understanding men's preferences for prevention products and strategies and what choices are being made by men with varying risk profiles is critical to public health responses and programs to reduce new HIV infections.
MSM are the most highly impacted groups by HIV in the US, with transmission largely driven by high per-act risk MSM. Among MSM, Black/African American (Black) and Hispanic/Latino (Hispanic) men experience nested health inequities: in 2020 Black men comprised 13% of US men and 38% of MSM diagnosed with HIV, and Hispanic men comprised 19% of US men and 33% of MSM diagnosed with HIV. Uptake of daily oral PrEP use by Black and Hispanic MSM has been slow and the extent of PrEP use among these men has not been equitable in light of their disproportionate impact in the HIV epidemic. Similarly, HIV incidence is concentrated in young MSM of all races. Thus, research to increase our understanding of men's awareness of, attitudes for and use of new prevention options must prioritize the equitable engagement of Black, Hispanic, and younger MSM.
The next 5 years will be a period of rapid changes in the fallout of new PrEP options and will likely see the introduction of new PrEP modalities (e.g., long-acting injectable PrEP, lower frequency oral dosing). Understanding the choices and patterns of PrEP use and the reasons and motivations for those choices among geographically, racially, and ethnically diverse groups of MSM will be a critical part of monitoring the public health response and informing public health programs and messaging. Ideally, public health messaging will be driven by up-to-date information about the perceptions, preferences, and practices of those MSM at the highest risk of HIV acquisition. During this era of rapid change in the available PrEP options, it is critical to have a robust system of real-time monitoring for PrEP preferences, what prevention options men are choosing, and what messages might be most impactful to support the appropriate uptake of PrEP and persistence on PrEP. Because the investigators expect numerous changes in the availability of PrEP products and treatment guidelines, it is also critical to be able to process and interpret these data in a timely way, to best support nimble decisions in prevention messaging and programs in response to a changing landscape of prevention options
- Being tested
- Quantitative survey, HIV and STI testing, Qualitative Assessment
- Keywords
- MSM, Gay, Pre exposure Prophylaxis, STI
- Medical subject headings
- Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative surveyBehavioural
Quantitative surveys will be conducted through Alchemer, a HIPPA-compliant online survey system previously used by our group in collaborative research with CDC and supported by the Emory University Center for AIDS Research (CFAR). Surveys will be optimized for participants to take them through a personal computer, mobile phone, tablet, or the SMART study app. For participants who do not have any of these devices or prefer not to take the survey from their device, each city will have a research space where participants can schedule a convenient time to take the survey on a computer or tablet that the study will provide for that purpose.
HIV and STI testingProcedure or surgery
The research team has developed and validated procedures for self-collection of specimens for testing for STIs (syphilis, urethral, rectal, and pharyngeal gonorrhea/chlamydia) and HIV self-testing. All participants will be mailed self-collection kits to provide samples for STIs (urine, rectal swab, and pharyngeal swab for gonorrhea/chlamydia; dried blood spot (DBS) for syphilis testing) and HIV (HIV 4th generation testing on DBS specimens in a CLIA-certified laboratory). Participants will be asked to collect specimens for their STI and HIV testing (every 6 months) and return them to Molecular Testing Labs. For participants who prefer in-person procedures, they will meet study staff who will provide them with the STI and HIV self-collection kit and instructions and provide a room for participants to collect their specimens.
Qualitative AssessmentBehavioural
Focus group discussions (n=up to 48 men for 3 qualitative assessments; total n=up to 144 men) as a part of the study consisting of 9 to 12 focus group discussions (FGD) with an average of 8 (range 3-10) participants in each (3 per city). These focus groups will be conducted once during the first year of the study. FGD will be conducted by a trained moderator using a semi-structured interview guide developed in collaboration with CDC scientists. For the FGD, in each city, there will be one FGD with men who have never used PrEP, one with men who are using PrEP and report no adherence issues, and one with men who are currently using PrEP or used PrEP previously and report sub-optimal adherence. In-Depth Interviews (IDIs) A series of 90 in-depth interviews (same n=up to 45 men for each of 3 qualitative assessments) will be conducted over 18 months: up to 45 IDIs each 6 months apart, with up to 15 IDIs per city each wave.
| Study group | Role | What they receive |
|---|---|---|
| MSM using or not using Pre-exposure prophylaxis | 60% of MSM using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors.
40% of MSM not using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors. Receives: Behavioral: Quantitative survey; Procedure: HIV and STI testing; Behavioral: Qualitative Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring Measure: Survey reports
As a prospective observation cohort study, a primary purpose of this study is to monitor real-world, community- (non-clinic) -based HIV prevention behavior (PrEP use/adherence, condom use/adherence), including uptake and transitions among prevention modality (condom, daily oral, episodic oral, long-acting injectable) in an effort to identify patterns and gaps in HIV protection in order to develop more effective messaging to close those gaps. Rapid reports to Centers for Disease Control and Prevention (CDC) after each wave of data collection will summarize gaps in prevention and recommend the most advantageous messages to address gaps.
Measured: 3 months, 6 months, 9 months,12 months,15 months,18 months
Change in condom and PrEP use and adherence based on messages for current PrEP users
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
Measured: 3 months, 6 months, 9 months,12 months,15 months,18 months
Change in condom and PrEP use and adherence based on messages for current non adherent PrEP users
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
Measured: 3 months, 6 months, 9 months,12 months,15 months,18 months
Change in condom and PrEP use and adherence based on messages for people who never used PrEP
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
Measured: 3 months, 6 months, 9 months,12 months,15 months,18 months
Secondary outcomes (2)
Change in number of HIV diagnoses
All participants will have a known HIV-negative status at enrollment and will be provided with HIV and STI tests at baseline and every 6 months thereafter. Men who have a new HIV diagnosis or during the study will be helped with accessing HIV care and treatment services and will not proceed in the study
Measured: Baseline, 6 months, 12 months, 18 months
Change in number of STI diagnoses
All participants will be provided with HIV and STI tests at baseline and every 6 months thereafter. Men who have a new STI diagnosis during the study will be helped with accessing STI care and treatment services
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start29 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, University of Chicago, CDC Foundation
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick Sullivan, DVM, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183502
- Sponsor's protocol ID
- STUDY00005355
- Other IDs
- U01PS005244
- Acronym
- MIC-DROP
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share individual de-identified participant data (including data dictionaries). Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex With Men in a Transformational Era (MIC-DROP)
- ClinicalTrials.gov ID
- NCT06183502
- Acronym / sponsor ID
- MIC-DROP / STUDY00005355
- Keywords
- MSM, Gay, Pre exposure Prophylaxis, STI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- San Diego State University, University of Chicago, CDC Foundation
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. The main objective is to study a prospective cohort of MSM in Atlanta, Chicago, and San Diego to understand men's strategies to prevent HIV/Sexually Transmissible Infections (STIs), including PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors
Participants will complete:
- Quantitative surveys quarterly
- HIV/ STI testing every 6 months
- Qualitative assessments: focus group discussions and in-depth interviews
Detailed description
The prevention of HIV in the United States is in a transformational era. In just a decade since the first finding of efficacy for daily oral PrEP, there has been a proliferation of new PrEP agents, including long-acting injectable PrEP, and regimens, including "event-driven" (also called "on demand" or 2-1-1 dosing) PrEP. There has also been new knowledge about the impact of antiretrovirals (ARVs) on the treatment of HIV, and an emergent understanding that people living with HIV who take ARVs and maintain a suppressed viral load are incapable of transmitting HIV to their sexual partners. In this context, the idea of "protected" sex - which historically meant sex protected by condoms - has become much more complex.6 Men who have sex with men (MSM) and others at risk for acquiring HIV are now making decisions about how to reduce their risks of HIV infection in a world where there are many more options to reduce risks of infection, and where those options also interact with the HIV status and viral suppression status of their sex partners. Understanding men's preferences for prevention products and strategies and what choices are being made by men with varying risk profiles is critical to public health responses and programs to reduce new HIV infections.
MSM are the most highly impacted groups by HIV in the US, with transmission largely driven by high per-act risk MSM. Among MSM, Black/African American (Black) and Hispanic/Latino (Hispanic) men experience nested health inequities: in 2020 Black men comprised 13% of US men and 38% of MSM diagnosed with HIV, and Hispanic men comprised 19% of US men and 33% of MSM diagnosed with HIV. Uptake of daily oral PrEP use by Black and Hispanic MSM has been slow and the extent of PrEP use among these men has not been equitable in light of their disproportionate impact in the HIV epidemic. Similarly, HIV incidence is concentrated in young MSM of all races. Thus, research to increase our understanding of men's awareness of, attitudes for and use of new prevention options must prioritize the equitable engagement of Black, Hispanic, and younger MSM.
The next 5 years will be a period of rapid changes in the fallout of new PrEP options and will likely see the introduction of new PrEP modalities (e.g., long-acting injectable PrEP, lower frequency oral dosing). Understanding the choices and patterns of PrEP use and the reasons and motivations for those choices among geographically, racially, and ethnically diverse groups of MSM will be a critical part of monitoring the public health response and informing public health programs and messaging. Ideally, public health messaging will be driven by up-to-date information about the perceptions, preferences, and practices of those MSM at the highest risk of HIV acquisition. During this era of rapid change in the available PrEP options, it is critical to have a robust system of real-time monitoring for PrEP preferences, what prevention options men are choosing, and what messages might be most impactful to support the appropriate uptake of PrEP and persistence on PrEP. Because the investigators expect numerous changes in the availability of PrEP products and treatment guidelines, it is also critical to be able to process and interpret these data in a timely way, to best support nimble decisions in prevention messaging and programs in response to a changing landscape of prevention options
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSM using or not using Pre-exposure prophylaxis | – | Behavioral: Quantitative survey, Procedure: HIV and STI testing, Behavioral: Qualitative Assessment60% of MSM using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors. 40% of MSM not using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary recruitment sources will be through online targeted advertisements to adult men in the three metropolitan areas (Atlanta, Detroit, and San Diego), including social media channels, such as Facebook, Instagram or Snapchat, Grindr, and other dating apps. Additionally, recruitment will be done through referrals from local clinics and community-based organizations. These organizations may provide palm cards or QR codes for interested participants to reach the eligibility screening survey.
Key inclusion criteria (11 listed)
- Male at birth
- Self-identify as Cis-gender Male
- Ages 18 or older
- ≥1 Male anal sex partner in the 6 months before the baseline screener
- Live in or near Atlanta, Chicago, or San Diego
Key exclusion criteria (9 listed)
- Female at birth
- Do not self-identify as Cis-gender Male
- Individuals < 18 years of age
- HIV positive status
- No male anal sex partner in the 6 months before the baseline interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative surveyQuantitative surveys will be conducted through Alchemer, a HIPPA-compliant online survey system previously used by our group in collaborative research with CDC and supported by the Emory University Center for AIDS Research (CFAR). Surveys will be optimized for participants to take them through a personal computer, mobile phone, tablet, or the SMART study app. For participants who do not have any of these devices or prefer not to take the survey from their device, each city will have a research space where participants can schedule a convenient time to take the survey on a computer or tablet that the study will provide for that purpose. | Behavioural | MSM using or not using Pre-exposure prophylaxis |
| HIV and STI testingThe research team has developed and validated procedures for self-collection of specimens for testing for STIs (syphilis, urethral, rectal, and pharyngeal gonorrhea/chlamydia) and HIV self-testing. All participants will be mailed self-collection kits to provide samples for STIs (urine, rectal swab, and pharyngeal swab for gonorrhea/chlamydia; dried blood spot (DBS) for syphilis testing) and HIV (HIV 4th generation testing on DBS specimens in a CLIA-certified laboratory). Participants will be asked to collect specimens for their STI and HIV testing (every 6 months) and return them to Molecular Testing Labs. For participants who prefer in-person procedures, they will meet study staff who will provide them with the STI and HIV self-collection kit and instructions and provide a room for participants to collect their specimens. | Procedure or surgery | MSM using or not using Pre-exposure prophylaxis |
| Qualitative AssessmentFocus group discussions (n=up to 48 men for 3 qualitative assessments; total n=up to 144 men) as a part of the study consisting of 9 to 12 focus group discussions (FGD) with an average of 8 (range 3-10) participants in each (3 per city). These focus groups will be conducted once during the first year of the study. FGD will be conducted by a trained moderator using a semi-structured interview guide developed in collaboration with CDC scientists. For the FGD, in each city, there will be one FGD with men who have never used PrEP, one with men who are using PrEP and report no adherence issues, and one with men who are currently using PrEP or used PrEP previously and report sub-optimal adherence. In-Depth Interviews (IDIs) A series of 90 in-depth interviews (same n=up to 45 men for each of 3 qualitative assessments) will be conducted over 18 months: up to 45 IDIs each 6 months apart, with up to 15 IDIs per city each wave. | Behavioural | MSM using or not using Pre-exposure prophylaxis |
Primary outcome
Monitoring Measure: Survey reports
Time frame: 3 months, 6 months, 9 months,12 months,15 months,18 months
As a prospective observation cohort study, a primary purpose of this study is to monitor real-world, community- (non-clinic) -based HIV prevention behavior (PrEP use/adherence, condom use/adherence), including uptake and transitions among prevention modality (condom, daily oral, episodic oral, long-acting injectable) in an effort to identify patterns and gaps in HIV protection in order to develop more effective messaging to close those gaps. Rapid reports to Centers for Disease Control and Prevention (CDC) after each wave of data collection will summarize gaps in prevention and recommend the most advantageous messages to address gaps.
Change in condom and PrEP use and adherence based on messages for current PrEP users
Time frame: 3 months, 6 months, 9 months,12 months,15 months,18 months
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
Change in condom and PrEP use and adherence based on messages for current non adherent PrEP users
Time frame: 3 months, 6 months, 9 months,12 months,15 months,18 months
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
Change in condom and PrEP use and adherence based on messages for people who never used PrEP
Time frame: 3 months, 6 months, 9 months,12 months,15 months,18 months
The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages
2 secondary outcomes
Change in number of HIV diagnoses
Time frame: Baseline, 6 months, 12 months, 18 months
Change in number of STI diagnoses
Time frame: Baseline, 6 months, 12 months, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. The investigators plan to share individual de-identified participant data (including data dictionaries). Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures, and appendices) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Sullivan, DVM principal investigator
Rollins School of Public Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infections and Gay, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring Measure: Survey reports (time frame: 3 months, 6 months, 9 months,12 months,15 months,18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.