Sexual BehaviorNCT03895320
Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
A study testing Sexual Health Risk Assessment, Sexual Health Score and Sexual Health Messaging in people with Sexual Behavior and Unprotected Sex, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. Read more about this study
- Who is it for?
- Ages 14 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Unprotected Sex, Gonorrhea
- What is being tested?
- Sexual Health Risk Assessment, Sexual Health Score and Sexual Health Messaging
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14-26
- Native American ethnicity
- Membership in the participating Native American community. (Study participation is open to all Native American individuals who live on the participating Tribe's Reservation, on/near the border, and/or are employed on the participating Tribe's Reservation).
- Have had sex at least once in their lifetime (vaginal)
- Participant must have their own cell phone and agree to receiving generic text messages and phone calls from study staff
- All participants must sign informed consent
Who cannot join
- Unwilling to be randomized
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, 85941
About this study
Official title: Protecting Our Future: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.
Read the detailed description
The proposed study is a RCT to test the efficacy of a self-care intervention for sexual health promotion among youth and young adults in a participating Native American community. The goal of the intervention is to increase protective sexual health practices. The investigators will compare outcomes between two groups: the 1) experimental group and the 2) comparison group. Youth will be enrolled in the study and assessed at baseline, 3-months and 6-months post-intervention. Participants ages 14-26 will be enrolled through a non-probability sampling frame at: a) the local Indian Health Service (IHS) facility, including the Emergency Department waiting room; b) local schools; c) during health fairs and other community-based events; and d) other community gathering spots. Eligible individuals will be of Native American ethnicity, 14-26 years of age, and have primary residence and/or employment within the participating tribe's reservation. Research staff will screen potential participants for inclusion/exclusion criteria, explain study goals and procedures, and administer informed consent. After obtaining participant consent, participants will complete a baseline assessment and then be randomized to receive the self-care intervention or a control program. Follow-up assessments will be administered at 3-months and 6-months post-intervention for all study participants. Each assessment is expected to take 20-30 minutes to complete. The baseline assessment will take place at the location of recruitment and consent; follow-up assessments will take place at home or in a private location. All assessments will be self-administered on tablets using REDCap mobile technology.
- Conditions
- Sexual Behavior, Unprotected Sex, Gonorrhea, Chlamydia, Trichomonas, Sexually Transmitted Diseases
- Being tested
- Sexual Health Risk Assessment, Sexual Health Score, Sexual Health Messaging, Water SSB Quiz, Water SSB Score
- Keywords
- Native American, Youth, Young Adults, STI Screening, Self Administered Sample Collection
- Medical subject headings
- Sexual Behavior, Unsafe Sex, Gonorrhea, Chlamydia Infections, Trichomonas Infections, Sexually Transmitted Diseases, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Risk AssessmentBehavioural
The self-assessment ('Sexual Health Risk Assessment'), will pertain to sexual and reproductive health. The self-assessment, will include a valid clinical prediction tool, established to predict STI positivity.
Sexual Health ScoreBehavioural
The results of the 'Sexual Health Risk Assessment' will produce a score ('Sexual Health Score'). The 'Sexual Health Score' will be presented as a number (0/10) and will be organized by category: Low, Medium or High Risk.
Sexual Health MessagingBehavioural
After the score ('Sexual Health Score') the participant will receive personalized messaging ('Sexual Health Messaging') that relates to their score and risk level (i.e. Low, Medium or High). Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen that correspond to their 'Sexual Health Score.'
Water SSB QuizBehavioural
The self-assessment ('Water SSB Quiz') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment ('Water SSB Quiz).
Water SSB ScoreBehavioural
The results of the 'Water SSB Quiz' will produce a score ('Water SSB Score'). The 'Water SSB Score' will be presented as a number (0/10).
Water SSB MessagingBehavioural
After the score ('Water SSB Score') the participant will receive personalized messaging ('Water SSB Messaging') that relates to their score. Short messages that indicate key steps the person can take to meet the recommended daily intake for water and sugar sweetened beverages will be displayed on the screen that correspond to their 'Water SSB Score.'
STI ScreeningBehavioural
All participants regardless of group, will be offered a STI screening kit immediately after receipt of their respective program (intervention or control). Participants will have the option of completing the kit at the first study visit, taking it with them after the first study visit is over, or receiving it later from one of our staff either at our local project office or the kit can be dropped off at a location the participant chooses. Completed kits can be returned to our office or picked up by a study staff. (NOTE: while the STI screening kit will be available to all participants should they request it at subsequent study visits, e.g. the 3- and 6-month follow-ups, the STI screening kit will only be explicitly offered by the study team at the first study visit immediately after participants complete their respective quiz).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program | Experimental | The intervention and control programs will consist of similar, but not identical components. The intervention will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the intervention program, the self-assessment ('Sexual Health Quiz'), score ('Sexual Health Score') and messaging ('Sexual Health Messaging') will pertain to sexual and reproductive health. For the intervention program, the self-assessment, will include a valid clinical prediction tool, established to predict STI positivity. Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen after the risk score. The program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program. Receives: Behavioral: Sexual Health Risk Assessment; Behavioral: Sexual Health Score; Behavioral: Sexual Health Messaging; Behavioral: STI Screening |
| Control Program | Other | The intervention and control programs will consist of similar, but not identical components. The Control Program will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the Control Program, the self-assessment ('Water Sugar Sweetened Beverages (SSB) Quiz'), score ('Water SSB Score') and messaging ('Water SSB Messaging') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment. However, based on the answers given on the control quiz, steps the control participant can take to meet the recommended daily intake of water and sugar sweetened beverages will be displayed on the screen after they complete the quiz. The control program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program. Receives: Behavioral: Water SSB Quiz; Behavioral: Water SSB Score; Behavioral: Water SSB Messaging; Behavioral: STI Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported STI screening at 3-months and 6-months
Difference in completion of self-administered screening kit for gonorrhea, chlamydia, and trichomonas between intervention and control groups at 3-months and 6-months. Participants report if they completed a self-administered test at each time point.
Measured: 3-months and 6-months
Secondary outcomes (8)
Sex without condom
Change in sex without a condom, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Sex without birth control
Change in sex without birth control, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Multiple partners
Change in number of sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
New partners
Change in number of new sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Concurrent partners
Change in number of new sexual partners, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Current symptoms of STI
Change in current symptoms of STI, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Alcohol and drug use
Change in frequency of alcohol and drug use, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Alcohol and drug use before sex
Change in frequency of alcohol and drug use before sex, between intervention and control groups at 3-months and 6-months, as measured by a self-report questionnaire. A dichotomous scale will be used (0, No; 1, Yes). A higher value indicates a worse outcome.
Measured: 3-months and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Native American Research Center for Health
- Responsible party
- Sponsor
- Investigators
- Francene Larzelere, D BH, Study director, Johns Hopkins Bloomberg School of Public HealthRachel Chambers, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895320
- Sponsor's protocol ID
- 8964
- Other IDs
- IRB00008964
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lauren T, Catherine S, Rachel C, Hima P, Angelita L, Shauntel L, Laura M, Anna S, Anne R, Mariddie C, Charlotte G. Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults. BMC Public Health. 2019 Dec 2;19(1):1614. doi: 10.1186/s12889-019-7956-x.
PubMed 31791323
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Our Future: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention
- ClinicalTrials.gov ID
- NCT03895320
- Acronym / sponsor ID
- 8964
- Conditions
- Sexual Behavior, Unprotected Sex, Gonorrhea, Chlamydia, Trichomonas, Sexually Transmitted Diseases
- Keywords
- Native American, Youth, Young Adults, STI Screening, Self Administered Sample Collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Native American Research Center for Health
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 29 Mar 2019 (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 aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.
Detailed description
The proposed study is a RCT to test the efficacy of a self-care intervention for sexual health promotion among youth and young adults in a participating Native American community. The goal of the intervention is to increase protective sexual health practices. The investigators will compare outcomes between two groups: the 1) experimental group and the 2) comparison group. Youth will be enrolled in the study and assessed at baseline, 3-months and 6-months post-intervention. Participants ages 14-26 will be enrolled through a non-probability sampling frame at: a) the local Indian Health Service (IHS) facility, including the Emergency Department waiting room; b) local schools; c) during health fairs and other community-based events; and d) other community gathering spots. Eligible individuals will be of Native American ethnicity, 14-26 years of age, and have primary residence and/or employment within the participating tribe's reservation. Research staff will screen potential participants for inclusion/exclusion criteria, explain study goals and procedures, and administer informed consent. After obtaining participant consent, participants will complete a baseline assessment and then be randomized to receive the self-care intervention or a control program. Follow-up assessments will be administered at 3-months and 6-months post-intervention for all study participants. Each assessment is expected to take 20-30 minutes to complete. The baseline assessment will take place at the location of recruitment and consent; follow-up assessments will take place at home or in a private location. All assessments will be self-administered on tablets using REDCap mobile technology.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Sexual Health Risk Assessment, Behavioral: Sexual Health Score, Behavioral: Sexual Health Messaging, Behavioral: STI ScreeningThe intervention and control programs will consist of similar, but not identical components. The intervention will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the intervention program, the self-assessment ('Sexual Health Quiz'), score ('Sexual Health Score') and messaging ('Sexual Health Messaging') will pertain to sexual and reproductive health. For the intervention program, the self-assessment, will include a valid clinical prediction tool, established to predict STI positivity. Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen after the risk score. The program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program. |
| Control Program | Other | Behavioral: Water SSB Quiz, Behavioral: Water SSB Score, Behavioral: Water SSB Messaging, Behavioral: STI ScreeningThe intervention and control programs will consist of similar, but not identical components. The Control Program will include a) a brief self-assessment (also called 'quiz'), b) score, and c) personalized messaging. For the Control Program, the self-assessment ('Water Sugar Sweetened Beverages (SSB) Quiz'), score ('Water SSB Score') and messaging ('Water SSB Messaging') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment. However, based on the answers given on the control quiz, steps the control participant can take to meet the recommended daily intake of water and sugar sweetened beverages will be displayed on the screen after they complete the quiz. The control program will be delivered via tablet. All participants regardless of randomization group, will be offered a STI screening kit immediately after receipt of their respective program. |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 14-26
- Native American ethnicity
- Membership in the participating Native American community. (Study participation is open to all Native American individuals who live on the participating Tribe's Reservation, on/near the border, and/or are employed on the participating Tribe's Reservation).
- Have had sex at least once in their lifetime (vaginal)
- Participant must have their own cell phone and agree to receiving generic text messages and phone calls from study staff
Key exclusion criteria (2 listed)
- Unwilling to be randomized
- Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
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 |
|---|---|---|
| Sexual Health Risk AssessmentThe self-assessment ('Sexual Health Risk Assessment'), will pertain to sexual and reproductive health. The self-assessment, will include a valid clinical prediction tool, established to predict STI positivity. | Behavioural | Intervention Program |
| Sexual Health ScoreThe results of the 'Sexual Health Risk Assessment' will produce a score ('Sexual Health Score'). The 'Sexual Health Score' will be presented as a number (0/10) and will be organized by category: Low, Medium or High Risk. | Behavioural | Intervention Program |
| Sexual Health MessagingAfter the score ('Sexual Health Score') the participant will receive personalized messaging ('Sexual Health Messaging') that relates to their score and risk level (i.e. Low, Medium or High). Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen that correspond to their 'Sexual Health Score.' | Behavioural | Intervention Program |
| Water SSB QuizThe self-assessment ('Water SSB Quiz') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment ('Water SSB Quiz). | Behavioural | Control Program |
| Water SSB ScoreThe results of the 'Water SSB Quiz' will produce a score ('Water SSB Score'). The 'Water SSB Score' will be presented as a number (0/10). | Behavioural | Control Program |
| Water SSB MessagingAfter the score ('Water SSB Score') the participant will receive personalized messaging ('Water SSB Messaging') that relates to their score. Short messages that indicate key steps the person can take to meet the recommended daily intake for water and sugar sweetened beverages will be displayed on the screen that correspond to their 'Water SSB Score.' | Behavioural | Control Program |
| STI ScreeningAll participants regardless of group, will be offered a STI screening kit immediately after receipt of their respective program (intervention or control). Participants will have the option of completing the kit at the first study visit, taking it with them after the first study visit is over, or receiving it later from one of our staff either at our local project office or the kit can be dropped off at a location the participant chooses. Completed kits can be returned to our office or picked up by a study staff. (NOTE: while the STI screening kit will be available to all participants should they request it at subsequent study visits, e.g. the 3- and 6-month follow-ups, the STI screening kit will only be explicitly offered by the study team at the first study visit immediately after participants complete their respective quiz). | Behavioural | Control Program, Intervention Program |
Primary outcome
Change in self-reported STI screening at 3-months and 6-months
Time frame: 3-months and 6-months
Difference in completion of self-administered screening kit for gonorrhea, chlamydia, and trichomonas between intervention and control groups at 3-months and 6-months. Participants report if they completed a self-administered test at each time point.
8 secondary outcomes
Sex without condom
Time frame: 3-months and 6-months
Sex without birth control
Time frame: 3-months and 6-months
Multiple partners
Time frame: 3-months and 6-months
New partners
Time frame: 3-months and 6-months
Concurrent partners
Time frame: 3-months and 6-months
Current symptoms of STI
Time frame: 3-months and 6-months
Alcohol and drug use
Time frame: 3-months and 6-months
Alcohol and drug use before sex
Time frame: 3-months and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 31791323Lauren T, Catherine S, Rachel C, Hima P, Angelita L, Shauntel L, Laura M, Anna S, Anne R, Mariddie C, Charlotte G. Protecting our future generation: study protocol for a randomized controlled trial evaluating a sexual health self-care intervention with Native American youth and young adults. BMC Public Health. 2019 Dec 2;19(1):1614. doi: 10.1186/s12889-019-7956-x.
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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.
Francene Larzelere, D BH study director
Johns Hopkins Bloomberg School of Public Health
Rachel Chambers, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Risk Assessment, Sexual Health Score and Sexual Health Messaging in people with Sexual Behavior and Unprotected Sex, run by Johns Hopkins Bloomberg School of Public Health 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 6 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 23 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 self-reported STI screening at 3-months and 6-months (time frame: 3-months and 6-months). 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 NCT03895320, 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 23 Feb 2024.