LGBTQNCT04718194
Developing Online Interventions to Reduce Stigma-Related Stress, Sexual Health, and HIV Risk Among Young Chinese MSM
A study testing ESTEEM iCBT in people with LGBTQ and Sexual Behavior, run by Yale University at 1 site in China.
Trial summary
This study is a 2-arm RCT that will assess the efficacy of a culturally adapted, 10-session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among young men who have sex with men (YMSM) in Hunan province China. Read more about this study
- Who is it for?
- Ages 16 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- LGBTQ, Sexual Behavior, HIV Risk
- What is being tested?
- ESTEEM iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2021to 30 Nov 2022
- 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 16 to 30 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-30 years old
- Live in Hunan province China
- Current gender identity as male
- Report past 12-month sex with men
- Be confirmed HIV-negative upon at-home testing
- Report past 3-month condomless/PrEP-less anal sex
Show all 11Show fewer
- Past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff of 2.5 on either the depression subscale, anxiety subscale, or both
- No past 3-month mental health services of more than 2 visits per month
- Weekly access to internet on a laptop, desktop, or tablet device
- Ability to read, write, and speak in Mandarin
- Provision of informed consent
Who cannot join
- Current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive ideation)
- Evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM
This study is a 2-arm RCT that will assess the efficacy of a culturally adapted, 10-session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among young men who have sex with men (YMSM) in Hunan province China. The affirmative treatment called ESTEEM is based on a minority stress-focused, CBT framework. In collaboration with colleagues at Central South University (CSU), the investigators will assess whether a culturally adapted version of iCBT ESTEEM demonstrates significant reductions in HIV risk behavior and mental health symptoms (e.g., depression, anxiety) compared to self-monitoring of stress and mood.
Read the detailed description
The primary objective is to evaluate the preliminary efficacy of a Chinese-adapted version of iCBT ESTEEM on YMSM's sexual health and HIV risk behavior. The secondary objectives of this study are to determine whether iCBT ESTEEM impacts HIV/sexually transmitted infections (STI) results and symptoms of depression and anxiety, as well as whether baseline minority stress exposure moderates treatment efficacy, such that participants with the most minority stress exposure benefit more from iCBT ESTEEM than those in the self-monitoring of stress and mood condition.
The proposed prospective study will follow a 2-arm RCT design where 120 Chinese YMSM participants will be randomly assigned to one of two conditions:
- ESTEEM iCBT: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Modules contain weekly psychoeducational text and vignettes about minority stress and mental health; brief videos illustrating the CBT skills; and homework exercises that therapists review and provide feedback on. Homework exercises include weekly tracking of stress and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), and exercises related to considering the origins of stress and negative emotions that participants may be experiencing. Therapists provide feedback after each homework assignment, including reviewing each participant's treatment goals as part of the first session's homework. Therapists who support this condition will be instructed to incorporate SGM-specific content and feedback into homework reviews. In the US, modules were adapted directly from the in-person materials (e.g., therapist manual, participant handouts) used in our previously successful trials of this treatment. The treatment has also been recently culturally adapted for in-person treatment among Chinese YMSM and found to be acceptable and feasible.
- Self-monitoring control: In this control condition, participants will be asked to indicate their past 7-day mood, stress experiences, and mental and behavioral health on an online survey. This type of self-monitoring has been shown to yield improvement in behavioral health outcomes. Self-reporting SGM stress experiences has also been shown to produce reductions in depression symptoms over time. Participants will record these experiences once per week for 10 weeks.
Before the full trial is launched, the investigators will ensure comprehension of the ESTEEM iCBT online module material with 10 separate YMSM, as well as gather their feedback on the usability of the iCBT online platform.
- Conditions
- LGBTQ, Sexual Behavior, HIV Risk
- Being tested
- ESTEEM iCBT, Self-monitoring control
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTEEM iCBTBehavioural
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Self-monitoring controlBehavioural
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| ESTEEM iCBT | Experimental | The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Receives: Behavioral: ESTEEM iCBT |
| Self-monitoring | Placebo comparator | Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks Receives: Behavioral: Self-monitoring control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Past 90-Day Condomless Anal Sex Acts
The Timeline Follow-Back (TLFB) assesses retrospective estimates of HIV-related sexual behavior in the past 30 days. The TLFB was originally developed in interview format, but has been adapted as online self-report questionnaire. Participants report on daily partner type (e.g. main, casual), type of sexual behavior (e.g. insertive anal sex, receptive anal sex, oral sex), and condom use. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for HIV-related sexual behavior. Administration time ranges from 10-30 minutes.
For this primary outcome measure, condomless anal sex (CAS) with main or casual partners will be determined. The primary comparison will be change in the number of CAS acts from baseline to 8 months post-baseline.
Measured: Baseline, 4 months, 8 months
Secondary outcomes (17)
Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners
The Timeline Follow-Back (TLFB) assesses retrospective estimates of HIV-related sexual behavior in the past 30 days. The TLFB was originally developed in interview format, but has been adapted as online self-report questionnaire. Participants report on daily partner type (e.g. main, casual), type of sexual behavior (e.g. insertive anal sex, receptive anal sex, oral sex), and condom use. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for HIV-related sexual behavior. Administration time ranges from 10-30 minutes.
For this secondary outcome measure, condomless anal sex (CAS) with casual partners only will be determined.
Measured: Baseline, 4 months, 8 months
Change in Depression
Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A sum score of 9 items indicates depression severity, with higher scores indicating higher severity and a scores ranging from 0-27. A 10th item indicates functional impairment. A cutoff score of 7 or more indicates high likelihood of a depressive episode.
Measured: Baseline, 4 months, 8 months
Change in Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder-7 scale (GAD-7). A sum score of 7 items indicates anxiety severity, with higher scores indicating higher severity and scores ranging from 0 to 21. An 8th item indicates functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively.
Measured: Baseline, 4 months, 8 months
Change in Disordered Alcohol Use
Disordered alcohol use will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Items 1 to 9 are scored 0, 1, 2, 3, or 4, and item 10 is scored 0, 2, or 4. Higher scores indicate greater alcohol use, with scores ranging from 0 to 40. Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.
Measured: Baseline, 4 months, 8 months
Change in Disordered Drug Use
Disordered drug use other than alcohol will be assessed using the Drug Use Disorders Identification (DUDIT) instrument. The DUDIT consists of 11 items. Items 1 to 9 are scored 0, 1, 2, 3, or 4, and items 10 and 11 are scored 0, 2, or 4. Higher scores indicate greater drug use, with scores ranging from 0 to 44. A score of 25 points or more is recommended as an indicator of drug dependence.
Measured: Baseline, 4 months, 8 months
Change in Suicidal Ideation
Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS). Total SIDAS scores are calculated as the sum of the five items, with controllability (item 2) reverse scored (10=0, 9=1, …, 0=10). Higher scores indicate greater suicidality, with total scores ranging from 0 to 50.
Measured: Baseline, 4 months, 8 months
Change in Concealment Motivation
Motivation to conceal sexual minority identity will be assessed using the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total score, ranging from 1 to 6. Higher scores indicate higher concealment motivation.
Measured: Baseline, 4 months, 8 months
Change in Acceptance Concerns
Acceptance concerns of sexual minority identity will be assessed using the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total scores ranging from 1 to 6. Higher scores indicate higher acceptance concerns.
Measured: Baseline, 4 months, 8 months
Change in Internalized Homonegativity
Internalized homonegativity will be assessed using the Internalized Homophobia subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total scores, ranging from 1 to 6. Higher scores indicate higher internalized homonegativity.
Measured: Baseline, 4 months, 8 months
Change in Emotion Dysregulation
Emotion dysregulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). Items are rated on a 5-point scale from 1-5; items 1, 4, and 6 are reverse coded. Items are summed for a total score, ranging from 18 to 90, where higher scores indicate higher emotion dysregulation.
Measured: Baseline, 4 months, 8 months
Change in Perceived Social Support
Perceived social support will be measured using the 12-item Multidimensional Scale of Perceived Social Support (MPSS). Items are rated on a 7-point scale from 1-7 and averaged for a total score, ranging from 1 to 7, with higher scores indicating higher perceived social support.
Measured: Baseline, 4 months, 8 months
Change in Rumination
Rumination will be measured using the 5-item Brooding Subscale of the Ruminative Responses Scale (RRS). Items are rated on a 4-point scale from 1-4 and summed for a total scores, ranging from 5 to 20, with higher scores indicating higher rumination.
Measured: Baseline, 4 months, 8 months
Change in HIV/STI Testing
The Past 4-month HIV/STI Testing Questionnaire consists of 7 multiple choice questions previously developed by the study PI for another study asking participants about their HIV/STI testing history. The questionnaire consists of questions, such as, "Have you provided a urine sample as part of any STI test in the last 4 months" with response options of "yes," "no," or "I don't remember." Scores were coded with "yes" being 1 and "no" being 0, and and a total score was assessed as the average of all scores. Thus, total scores ranged from 0 to 1, with higher scores indicating greater HIV/STI testing in the past 4 months.
Measured: Baseline, 4 months, 8 months
Change in Condom Use
The Decisional Balance for Condom Use Scale is an 18-item psychometrically validated scale measuring one's motivation to increase condom use (e.g., "I would feel bad if my friends found out I had sex without a condom"), with response options ranging between 1 = not at all to 5 = extremely. Scores are summed for a total scores, ranging from 18 to 90, with lower scores are indicative of greater likelihood to use a condom.
Measured: Baseline, 4 months, 8 months
Change in Safer Sex
The Safer Sex Questionnaire is a psychometrically validated measure and consists of 13-items based on a 5-point Likert scale assessing one's confidence in avoiding having anal sex without a condom in various contexts. Scores are summed for a total score, ranging from 13 to 65, with higher scores are indicative of greater safer sex self-efficacy.
Measured: Baseline, 4 months, 8 months
Change in HIV Test Results
Participants will be provided with self-administered rapid HIV testing kits at baseline and 8-months post-baseline to assess for incidence of HIV.
Measured: Baseline, 4 months, 8 months
Change in Syphilis Test Results
Participants will be provided with self-administered rapid syphilis testing kits at baseline and 8-months post-baseline to assess for incidence of syphilis.
Measured: Baseline, 4 months, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start19 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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.
- Other trials for LGBTQStudies of the same condition, open and under way.
- More trials run by Yale 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Central South University, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- John Pachankis, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718194
- Sponsor's protocol ID
- 2000029433
- Other IDs
- 1R21TW011762-01, 5R21TW011762-02
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2021
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM
- ClinicalTrials.gov ID
- NCT04718194
- Acronym / sponsor ID
- 2000029433
- Conditions
- LGBTQ, Sexual Behavior, HIV Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Central South University, Fogarty International Center of the National Institute of Health
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 2-arm RCT that will assess the efficacy of a culturally adapted, 10-session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among young men who have sex with men (YMSM) in Hunan province China. The affirmative treatment called ESTEEM is based on a minority stress-focused, CBT framework. In collaboration with colleagues at Central South University (CSU), the investigators will assess whether a culturally adapted version of iCBT ESTEEM demonstrates significant reductions in HIV risk behavior and mental health symptoms (e.g., depression, anxiety) compared to self-monitoring of stress and mood.
Detailed description
The primary objective is to evaluate the preliminary efficacy of a Chinese-adapted version of iCBT ESTEEM on YMSM's sexual health and HIV risk behavior. The secondary objectives of this study are to determine whether iCBT ESTEEM impacts HIV/sexually transmitted infections (STI) results and symptoms of depression and anxiety, as well as whether baseline minority stress exposure moderates treatment efficacy, such that participants with the most minority stress exposure benefit more from iCBT ESTEEM than those in the self-monitoring of stress and mood condition.
The proposed prospective study will follow a 2-arm RCT design where 120 Chinese YMSM participants will be randomly assigned to one of two conditions:
- ESTEEM iCBT: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Modules contain weekly psychoeducational text and vignettes about minority stress and mental health; brief videos illustrating the CBT skills; and homework exercises that therapists review and provide feedback on. Homework exercises include weekly tracking of stress and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), and exercises related to considering the origins of stress and negative emotions that participants may be experiencing. Therapists provide feedback after each homework assignment, including reviewing each participant's treatment goals as part of the first session's homework. Therapists who support this condition will be instructed to incorporate SGM-specific content and feedback into homework reviews. In the US, modules were adapted directly from the in-person materials (e.g., therapist manual, participant handouts) used in our previously successful trials of this treatment. The treatment has also been recently culturally adapted for in-person treatment among Chinese YMSM and found to be acceptable and feasible.
- Self-monitoring control: In this control condition, participants will be asked to indicate their past 7-day mood, stress experiences, and mental and behavioral health on an online survey. This type of self-monitoring has been shown to yield improvement in behavioral health outcomes. Self-reporting SGM stress experiences has also been shown to produce reductions in depression symptoms over time. Participants will record these experiences once per week for 10 weeks.
Before the full trial is launched, the investigators will ensure comprehension of the ESTEEM iCBT online module material with 10 separate YMSM, as well as gather their feedback on the usability of the iCBT online platform.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTEEM iCBT | Experimental | Behavioral: ESTEEM iCBTThe online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
| Self-monitoring | Placebo comparator | Behavioral: Self-monitoring controlParticipants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 16-30 years old
- Live in Hunan province China
- Current gender identity as male
- Report past 12-month sex with men
- Be confirmed HIV-negative upon at-home testing
Key exclusion criteria (2 listed)
- Current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive ideation)
- Evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research
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 |
|---|---|---|
| ESTEEM iCBTThe online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. | Behavioural | ESTEEM iCBT |
| Self-monitoring controlParticipants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks | Behavioural | Self-monitoring |
Primary outcome
Change in Number of Past 90-Day Condomless Anal Sex Acts
Time frame: Baseline, 4 months, 8 months
The Timeline Follow-Back (TLFB) assesses retrospective estimates of HIV-related sexual behavior in the past 30 days. The TLFB was originally developed in interview format, but has been adapted as online self-report questionnaire. Participants report on daily partner type (e.g. main, casual), type of sexual behavior (e.g. insertive anal sex, receptive anal sex, oral sex), and condom use. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for HIV-related sexual behavior. Administration time ranges from 10-30 minutes. For this primary outcome measure, condomless anal sex (CAS) with main or casual partners will be determined. The primary comparison will be change in the number of CAS acts from baseline to 8 months post-baseline.
17 secondary outcomes
Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners
Time frame: Baseline, 4 months, 8 months
Change in Depression
Time frame: Baseline, 4 months, 8 months
Change in Anxiety
Time frame: Baseline, 4 months, 8 months
Change in Disordered Alcohol Use
Time frame: Baseline, 4 months, 8 months
Change in Disordered Drug Use
Time frame: Baseline, 4 months, 8 months
Change in Suicidal Ideation
Time frame: Baseline, 4 months, 8 months
Change in Concealment Motivation
Time frame: Baseline, 4 months, 8 months
Change in Acceptance Concerns
Time frame: Baseline, 4 months, 8 months
Change in Internalized Homonegativity
Time frame: Baseline, 4 months, 8 months
Change in Emotion Dysregulation
Time frame: Baseline, 4 months, 8 months
Change in Perceived Social Support
Time frame: Baseline, 4 months, 8 months
Change in Rumination
Time frame: Baseline, 4 months, 8 months
Change in HIV/STI Testing
Time frame: Baseline, 4 months, 8 months
Change in Condom Use
Time frame: Baseline, 4 months, 8 months
Change in Safer Sex
Time frame: Baseline, 4 months, 8 months
Change in HIV Test Results
Time frame: Baseline, 4 months, 8 months
Change in Syphilis Test Results
Time frame: Baseline, 4 months, 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
John Pachankis, Ph.D. principal investigator
Yale 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 ESTEEM iCBT in people with LGBTQ and Sexual Behavior, run by Yale University at 1 site in China.
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 2 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 16 Feb 2024. 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 China. 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. Some participants in this study may receive a placebo. 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 17 Jan 2024). 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?
Change in Number of Past 90-Day Condomless Anal Sex Acts (time frame: Baseline, 4 months, 8 months). 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 16 Feb 2024.