Human Papillomavirust2pNCT02994108
txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
A study testing txt2protect in people with Human Papillomavirus, run by Northwestern University at 1 site in United States.
Trial summary
Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- txt2protect
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must:
- Be male (sex at birth and gender identity)
- Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically attracted to men
- Be English speaking
- Live in the Chicago metro area
- Be the exclusive owner of a cell phone
Show all 9Show fewer
- Have used text messaging for at least 6 months
- Plan to have the same cell phone number for the next 9 months
- Be enrolled in an unlimited text messaging plan
Who cannot join
- Participants must not have been previously vaccinated for HPV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are disproportionately affected by HPV-related cancers. A safe and effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the U.S. have been low, particularly among males. To remedy this gap, the goal of this study is to develop and pilot test a text messaging intervention to increase HPV vaccination in young MSM.
The study has two specific aims:
Read more
- Develop, iteratively refine, and pre-test messages using a formative research procedure for designing targeted health interventions. The procedure consists of the following steps: 1) conduct online focus groups, an online survey, and in-depth interviews to inform message content, 2) draft initial messages based on focus group findings and pilot data, 3) refine message content and assess acceptability using content advisory teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test the protocol.
- Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial (RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. The treatment condition will receive a culturally appropriate text messaging-based HPV vaccination intervention based on the Information, Motivation, and Behavioral Skills model, whereas the control condition will receive a text messaging-based sexual health intervention that includes basic facts about HPV vaccination readily accessible online.
Primary outcome measures include intervention feasibility (e.g., retention in the trial), acceptability (satisfaction with the intervention), and preliminary efficacy as determined by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month trial.
The study team hypothesizes that participants in the t2p condition (vs. control) will report greater acceptability of the intervention and will be significantly more likely to initiate and complete the 3-dose HPV vaccine series by the end of the trial.
- Conditions
- Human Papillomavirus
- Being tested
- txt2protect, Sexual Health Control
- Keywords
- Human Papillomavirus, Men Who Have Sex with Men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
txt2protectBehavioural
Also called t2p
Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
Sexual Health ControlBehavioural
Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
| Study group | Role | What they receive |
|---|---|---|
| txt2protect | Experimental | Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program.
txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination. Receives: Behavioral: txt2protect |
| Sexual Health Control | Active comparator | Content was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program.
Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. Receives: Behavioral: Sexual Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.
Measured: 9 Month
Intervention Acceptability for Phase 1
Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 12 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
Measured: 3 Weeks
Intervention Acceptability for Full Intervention
Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 11 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
Measured: 9 Month
Number of Participants Who Initiated the HPV Vaccine Series
A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.
Measured: 9 Month
Number of Participants Who Completed the HPV Vaccine Series
A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.
Measured: 9 Month
Secondary outcomes (9)
Information: HPV-related Knowledge
Assessed with two questions (e.g., "HPV can cause anal cancer.") interspersed among other true/false questions assessing HIV/STI knowledge. Participants received one point for each correct response and zero points for incorrect and "don't know" responses. Points were summed to create a composite score that ranged from 0 to 2.
Measured: 3 Weeks
Motivation: Attitudes
Assessed with one item: "My attitude toward getting vaccinated for HPV in the next 9 months is..." 1 = very negative to 5 = very positive.
Measured: 3 Weeks
Motivation: Subjective Norms
Assessed with one item: "People who are important to me would want me to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.
Measured: 3 Weeks
Motivation: Perceived Susceptibility
Assessed with four items (e.g., "If you don't get the HPV vaccine, what do you think are the chances that you will get HPV?" 1 = very unlikely to 5 = very likely).
Measured: 3 Weeks
Motivation: Perceived Severity
Assessed with four items (e.g., "How serious would each of the following be for you: If you developed warts on your penis or scrotum?" 1 = not at all serious to 5 = very serious).
Measured: 3 Weeks
Motivation: Anticipated Regret
Assessed with two items (e.g., "How much regret would you feel if you decided not to get the HPV vaccine and later developed genital or anal warts?" 1 = none to 5 = quite a lot).
Measured: 3 Weeks
Behavioral Skills: Perceived Behavioral Control
Assessed with one item: "To what extent is whether or not you get vaccinated for HPV in the next 9 months under your control?" 1 = not at all to 5 = completely.
Measured: 3 Weeks
Behavioral Skills: Self-efficacy
Assessed with one item: "Assuming you wanted to, how hard or easy would it be for you to get vaccinated for HPV in the next 9 months?" 1 = very hard to 5 = very easy.
Measured: 3 Weeks
Behavioral Intentions
Assessed with one item: "I intend to get vaccinated for HPV in the next 9 months." 1 = strongly disagree to 5 = strongly agree.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start3 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary Gerend, Florida State University
- Investigators
- Mary Gerend, PhD, Principal investigator, Florida State UniversityBrian Mustanski, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994108
- Sponsor's protocol ID
- 1R21CA208329-01
- Other IDs
- 1R21CA208329-01
- Acronym
- t2p
- Status last verified
- Jul 2020
- First submitted
- 9 Dec 2016
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.
Publications
Gerend MA, Madkins K, Crosby S, Korpak AK, Phillips GL, Bass M, Houlberg M, Mustanski B. Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial. Ann Behav Med. 2021 Apr 7;55(4):321-332. doi: 10.1093/abm/kaaa056.
PubMed 32914838
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
- ClinicalTrials.gov ID
- NCT02994108
- Acronym / sponsor ID
- t2p / 1R21CA208329-01
- Conditions
- Human Papillomavirus
- Keywords
- Human Papillomavirus, Men Who Have Sex with Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are disproportionately affected by HPV-related cancers. A safe and effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the U.S. have been low, particularly among males. To remedy this gap, the goal of this study is to develop and pilot test a text messaging intervention to increase HPV vaccination in young MSM.
The study has two specific aims:
- Develop, iteratively refine, and pre-test messages using a formative research procedure for designing targeted health interventions. The procedure consists of the following steps: 1) conduct online focus groups, an online survey, and in-depth interviews to inform message content, 2) draft initial messages based on focus group findings and pilot data, 3) refine message content and assess acceptability using content advisory teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test the protocol.
- Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial (RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. The treatment condition will receive a culturally appropriate text messaging-based HPV vaccination intervention based on the Information, Motivation, and Behavioral Skills model, whereas the control condition will receive a text messaging-based sexual health intervention that includes basic facts about HPV vaccination readily accessible online.
Primary outcome measures include intervention feasibility (e.g., retention in the trial), acceptability (satisfaction with the intervention), and preliminary efficacy as determined by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month trial.
The study team hypothesizes that participants in the t2p condition (vs. control) will report greater acceptability of the intervention and will be significantly more likely to initiate and complete the 3-dose HPV vaccine series by the end of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| txt2protect | Experimental | Behavioral: txt2protectContent was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules. Module 1 addressed information about HPV infection and HPV vaccination. Module 2 addressed motivation to receive HPV vaccine. Module 3 addressed behavioral skills and self-efficacy for initiating and completing the 3-dose series (e.g., talking with their doctor about the vaccine). Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program. txt2protect: Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination. |
| Sexual Health Control | Active comparator | Behavioral: Sexual Health ControlContent was delivered in 2 phases over 36 weeks. During Phase 1 (weeks 1-3), participants received 10-12 messages daily. During Phase 2 (weeks 4-36), message frequency decreased to monthly messages. Phase 1 content was presented in 3 modules; however, unlike the treatment group, content was topic-based rather than theory-based and focused on general sexual health. Module 1 addressed basic facts about HIV and sexually transmitted infections (STI), including HPV. Module 2 addressed HIV/STI prevention (e.g., condom use, PrEP) and will included basic facts about HPV vaccination currently available online. Module 3 addressed tips for healthy relationships. Phase 2 "booster" messages largely reinforced Phase 1 content to foster continued engagement with the program. Sexual Health Control: Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be male (sex at birth and gender identity)
- Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically attracted to men
- Be English speaking
- Live in the Chicago metro area
- Be the exclusive owner of a cell phone
Key exclusion criteria (1 listed)
- Participants must not have been previously vaccinated for HPV.
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 |
|---|---|---|
| txt2protectAlso: t2pText messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination. | Behavioural | txt2protect |
| Sexual Health ControlText messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination. | Behavioural | Sexual Health Control |
Primary outcome
Retention
Time frame: 9 Month
Intervention feasibility will be evaluated by retention in the RCT. The retention rate will be computed at the end of the 9-month trial by dividing the total number of participants who completed the trial (i.e., completed the 9-month assessment) by the total number of participants who were randomized to the treatment or control condition at the beginning of the trial. An 80% 9-month retention rate will be used to indicate a feasible intervention.
Intervention Acceptability for Phase 1
Time frame: 3 Weeks
Intervention acceptability for the first 3 weeks of the intervention (Phase 1) will be assessed at the 3-week assessment. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 12 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items were combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
Intervention Acceptability for Full Intervention
Time frame: 9 Month
Intervention acceptability for the full intervention will be assessed at the end the 9-month trial. The scale includes both open-ended ("What did you like about the program? What could be improved?") and 11 closed-ended questions (e.g., "I would recommend a program like this to my friends" 1=strongly disagree to 5=strongly agree). Closed-ended items will be combined to compute an average score (minimum value = 1; maximum value = 5). Higher scores indicate greater satisfaction with the program. An average score ≥4 will be used to indicate an acceptable intervention.
Number of Participants Who Initiated the HPV Vaccine Series
Time frame: 9 Month
A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses and received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine initiation was defined as receipt of one or more doses of HPV vaccine by the end of the 9-month trial.
Number of Participants Who Completed the HPV Vaccine Series
Time frame: 9 Month
A final confirmatory assessment of HPV vaccination status will be conducted at the 9-month follow-up. Participants will be asked whether they received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of doses received. Vaccination status will be confirmed by consulting the Illinois Comprehensive Automated Immunization Registry (I-CARE). HPV vaccine completion was defined as receipt of three doses of HPV vaccine by the end of the 9-month trial.
9 secondary outcomes
Information: HPV-related Knowledge
Time frame: 3 Weeks
Motivation: Attitudes
Time frame: 3 Weeks
Motivation: Subjective Norms
Time frame: 3 Weeks
Motivation: Perceived Susceptibility
Time frame: 3 Weeks
Motivation: Perceived Severity
Time frame: 3 Weeks
Motivation: Anticipated Regret
Time frame: 3 Weeks
Behavioral Skills: Perceived Behavioral Control
Time frame: 3 Weeks
Behavioral Skills: Self-efficacy
Time frame: 3 Weeks
Behavioral Intentions
Time frame: 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32914838Gerend MA, Madkins K, Crosby S, Korpak AK, Phillips GL, Bass M, Houlberg M, Mustanski B. Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial. Ann Behav Med. 2021 Apr 7;55(4):321-332. doi: 10.1093/abm/kaaa056.
- Individual participant dataSharing planned: Yes. The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.
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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.
Mary Gerend, PhD principal investigator
Florida State University
Brian Mustanski, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing txt2protect in people with Human Papillomavirus, run by Northwestern University at 1 site 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 9 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention (time frame: 9 Month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994108, which also lists 1 linked publication.
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 20 Jul 2020.