Sexually Transmitted Infection (STI) PreventionNCT01234103
Preventing Health Damaging Behaviors in Male and Female Army Recruits
A study testing Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits in people with Sexually Transmitted Infection (STI) Prevention and Unintended Pregnancy Prevention, run by United States Department of Defense at 1 site in United States.
Trial summary
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection (STI) Prevention, Unintended Pregnancy Prevention, Sexual Risk Reduction
- What is being tested?
- Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 933 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants will be 18 years of age or older, will be fluent in English, and able to provide written, informed consent.
Who cannot join
- AIT soldiers under the age of 18 will be excluded since it will be difficult to obtain parental consent. We anticipate that this exclusion will be rare.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Jackson Advance Individual Training Units
Columbia, South Carolina, 29044
About this study
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.
Read the detailed description
The primary hypotheses to be tested in this research are as follows. AIT soldiers participating in the experimental STI/UIP prevention intervention will: (a) have increased knowledge about the risk factors for and prevention of STIs, UIPs, alcohol and other substances, and intimate partner violence (IPV); (b) be more highly motivated to change risk behaviors associated with STIs and UIPs; (c) have higher levels of skills to prevent risk behaviors associated with STIs and UIPs and skills; (d) engage in more health promoting behaviors and fewer risk behaviors associated with STIs and UIPs, and (e) have fewer STIs and UIPs post-intervention compared with AIT solders who participate in a comparable control intervention focused on increasing healthy eating, maintaining physical fitness, and preventing fitness-related injuries.
The overall goal of this research is to evaluate the effectiveness a cognitive-behavioral skills-building intervention to prevent risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, IPV in AIT soldiers. Specifically, we will evaluate whether AIT soldiers who participate in the experimental intervention entitled, Staying Safe and in Control: Increasing Knowledge and Building Skills to Prevent Sexually Transmitted Infections and Unintended Pregnancies will reduce their risk for and acquisition of STIs, UIPs and their associated sexual and substance use behaviors compared with AIT soldiers who undergo the control intervention entitled, Fit You: Practical Tools for Healthy Eating, Physical Fitness, and Injury Prevention. This intervention will focus primarily on promoting healthy eating, maintaining physical fitness, and preventing work-related and exercise injury.
- Conditions
- Sexually Transmitted Infection (STI) Prevention, Unintended Pregnancy Prevention, Sexual Risk Reduction, Alcohol and Other Substance Use Prevention, Intimate Partner Violence Prevention
- Being tested
- Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
- Keywords
- sexually transmitted infection, sexual risk, HIV, young adults, cognitive-behavioral intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Helath Damaging Health Behaviors in Male and Female Army RecruitsBehavioural
Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Preventing sexual health risks | Experimental | The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse Receives: Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits |
| Improving nutrition, fitness and injury prevention | Other | The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress Receives: Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies
Measured: 6 to 9 months
Secondary outcomes (1)
Self-reported Behavioral Measures Related to STI/HIV Prevention
Measured: 6 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionJun 2013
Why it stopped: Due to lack of continue funding
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 (36)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Infection (STI) PreventionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 933 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Cherrie B. Boyer, PhD, University of California, San Francisco
- Investigators
- Cherrie B Boyer, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234103
- Sponsor's protocol ID
- W81XWH-04-1-0159
- Status last verified
- Aug 2017
- First submitted
- 3 Nov 2010
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gaydos CA, Howell MR, Pare B, Clark KL, Ellis DA, Hendrix RM, Gaydos JC, McKee KT Jr, Quinn TC. Chlamydia trachomatis infections in female military recruits. N Engl J Med. 1998 Sep 10;339(11):739-44. doi: 10.1056/NEJM199809103391105.
PubMed 9731090Boyer CB, Shafer MA, Moncada J, Schachter J, Shaffer RA, Brodine SK. Sociodemographic, behavioral, and clinical factors associated with STDs in a national sample of women entering the US military. ISSTDR: Sexually Transmitted Infections. 2001:241-246.
Shafer MA, Moncada J, Boyer CB, Betsinger K, Flinn SD, Schachter J. Comparing first-void urine specimens, self-collected vaginal swabs, and endocervical specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae by a nucleic acid amplification test. J Clin Microbiol. 2003 Sep;41(9):4395-9. doi: 10.1128/JCM.41.9.4395-4399.2003.
PubMed 12958275Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2000. Atlanta, GA: Division of Sexually Transmitted Diseases, National Center for HIV, STD and TB Prevention; 2001.
Cecil JA, Howell MR, Tawes JJ, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Features of Chlamydia trachomatis and Neisseria gonorrhoeae infection in male Army recruits. J Infect Dis. 2001 Nov 1;184(9):1216-9. doi: 10.1086/323662. Epub 2001 Sep 27.
PubMed 11598849Brodine SK, Shafer MA, Shaffer RA, Boyer CB, Putnam SD, Wignall FS, Thomas RJ, Bales B, Schachter J. Asymptomatic sexually transmitted disease prevalence in four military populations: application of DNA amplification assays for Chlamydia and gonorrhea screening. J Infect Dis. 1998 Oct;178(4):1202-4. doi: 10.1086/515685.
PubMed 9806061Shafer MA, Boyer CB, Shaffer RA, Schachter J, Ito SI, Brodine SK. Correlates of sexually transmitted diseases in a young male deployed military population. Mil Med. 2002 Jun;167(6):496-500.
PubMed 12099086Yen S, Shafer MA, Moncada J, Campbell CJ, Flinn SD, Boyer CB. Bacterial vaginosis in sexually experienced and non-sexually experienced young women entering the military. Obstet Gynecol. 2003 Nov;102(5 Pt 1):927-33. doi: 10.1016/s0029-7844(03)00858-5.
PubMed 14672465Howell MR, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Control of Chlamydia trachomatis infections in female army recruits: cost-effective screening and treatment in training cohorts to prevent pelvic inflammatory disease. Sex Transm Dis. 1999 Oct;26(9):519-26. doi: 10.1097/00007435-199910000-00007.
PubMed 10534206Shafer MA, Pantell RH, Schachter J. Is the routine pelvic examination needed with the advent of urine-based screening for sexually transmitted diseases? Arch Pediatr Adolesc Med. 1999 Feb;153(2):119-25. doi: 10.1001/archpedi.153.2.119.
PubMed 9988241Magann EF, Nolan TE. Pregnancy outcome in an active-duty population. Obstet Gynecol. 1991 Sep;78(3 Pt 1):391-3.
PubMed 1876371McNeary AM, Lomenick TS. Military duty: risk factor for preterm labor? A review. Mil Med. 2000 Aug;165(8):612-5.
PubMed 10957855Clark JB, Holt VL, Miser F. Unintended pregnancy among female soldiers presenting for prenatal care at Madigan Army Medical Center. Mil Med. 1998 Jul;163(7):444-8.
PubMed 9695607United States Department of Health and Human Services. Alcohol research & health: highlights from the tenth special report to Congress, Health risks and benefits of alcohol consumption. Vol 24. Washington, DC: U.S. Government Printing Office; 2000.
Bray RM, Fairbank JA, Marsden ME. Stress and substance use among military women and men. Am J Drug Alcohol Abuse. 1999 May;25(2):239-56. doi: 10.1081/ada-100101858.
PubMed 10395158
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Health Damaging Behaviors in Male and Female Army Recruits
- ClinicalTrials.gov ID
- NCT01234103
- Acronym / sponsor ID
- W81XWH-04-1-0159
- Conditions
- Sexually Transmitted Infection (STI) Prevention, Unintended Pregnancy Prevention, Sexual Risk Reduction, Alcohol and Other Substance Use Prevention, Intimate Partner Violence Prevention
- Keywords
- sexually transmitted infection, sexual risk, HIV, young adults, cognitive-behavioral intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of continue funding
- Enrolment
- 933 participants (actual)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 25 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.
Detailed description
The primary hypotheses to be tested in this research are as follows. AIT soldiers participating in the experimental STI/UIP prevention intervention will: (a) have increased knowledge about the risk factors for and prevention of STIs, UIPs, alcohol and other substances, and intimate partner violence (IPV); (b) be more highly motivated to change risk behaviors associated with STIs and UIPs; (c) have higher levels of skills to prevent risk behaviors associated with STIs and UIPs and skills; (d) engage in more health promoting behaviors and fewer risk behaviors associated with STIs and UIPs, and (e) have fewer STIs and UIPs post-intervention compared with AIT solders who participate in a comparable control intervention focused on increasing healthy eating, maintaining physical fitness, and preventing fitness-related injuries.
The overall goal of this research is to evaluate the effectiveness a cognitive-behavioral skills-building intervention to prevent risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, IPV in AIT soldiers. Specifically, we will evaluate whether AIT soldiers who participate in the experimental intervention entitled, Staying Safe and in Control: Increasing Knowledge and Building Skills to Prevent Sexually Transmitted Infections and Unintended Pregnancies will reduce their risk for and acquisition of STIs, UIPs and their associated sexual and substance use behaviors compared with AIT soldiers who undergo the control intervention entitled, Fit You: Practical Tools for Healthy Eating, Physical Fitness, and Injury Prevention. This intervention will focus primarily on promoting healthy eating, maintaining physical fitness, and preventing work-related and exercise injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventing sexual health risks | Experimental | Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army RecruitsThe over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse |
| Improving nutrition, fitness and injury prevention | Other | Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army RecruitsThe goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will be 18 years of age or older, will be fluent in English, and able to provide written, informed consent.
Key exclusion criteria (1 listed)
- AIT soldiers under the age of 18 will be excluded since it will be difficult to obtain parental consent. We anticipate that this exclusion will be rare.
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 |
|---|---|---|
| Preventing Helath Damaging Health Behaviors in Male and Female Army RecruitsGroups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors. | Behavioural | Improving nutrition, fitness and injury prevention, Preventing sexual health risks |
Primary outcome
Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies
Time frame: 6 to 9 months
1 secondary outcome
Self-reported Behavioral Measures Related to STI/HIV Prevention
Time frame: 6 to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9731090Gaydos CA, Howell MR, Pare B, Clark KL, Ellis DA, Hendrix RM, Gaydos JC, McKee KT Jr, Quinn TC. Chlamydia trachomatis infections in female military recruits. N Engl J Med. 1998 Sep 10;339(11):739-44. doi: 10.1056/NEJM199809103391105.
- BackgroundBoyer CB, Shafer MA, Moncada J, Schachter J, Shaffer RA, Brodine SK. Sociodemographic, behavioral, and clinical factors associated with STDs in a national sample of women entering the US military. ISSTDR: Sexually Transmitted Infections. 2001:241-246.
- Background: PubMed 12958275Shafer MA, Moncada J, Boyer CB, Betsinger K, Flinn SD, Schachter J. Comparing first-void urine specimens, self-collected vaginal swabs, and endocervical specimens to detect Chlamydia trachomatis and Neisseria gonorrhoeae by a nucleic acid amplification test. J Clin Microbiol. 2003 Sep;41(9):4395-9. doi: 10.1128/JCM.41.9.4395-4399.2003.
- BackgroundCenters for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2000. Atlanta, GA: Division of Sexually Transmitted Diseases, National Center for HIV, STD and TB Prevention; 2001.
- Background: PubMed 11598849Cecil JA, Howell MR, Tawes JJ, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Features of Chlamydia trachomatis and Neisseria gonorrhoeae infection in male Army recruits. J Infect Dis. 2001 Nov 1;184(9):1216-9. doi: 10.1086/323662. Epub 2001 Sep 27.
- Background: PubMed 9806061Brodine SK, Shafer MA, Shaffer RA, Boyer CB, Putnam SD, Wignall FS, Thomas RJ, Bales B, Schachter J. Asymptomatic sexually transmitted disease prevalence in four military populations: application of DNA amplification assays for Chlamydia and gonorrhea screening. J Infect Dis. 1998 Oct;178(4):1202-4. doi: 10.1086/515685.
- Background: PubMed 12099086Shafer MA, Boyer CB, Shaffer RA, Schachter J, Ito SI, Brodine SK. Correlates of sexually transmitted diseases in a young male deployed military population. Mil Med. 2002 Jun;167(6):496-500.
- Background: PubMed 14672465Yen S, Shafer MA, Moncada J, Campbell CJ, Flinn SD, Boyer CB. Bacterial vaginosis in sexually experienced and non-sexually experienced young women entering the military. Obstet Gynecol. 2003 Nov;102(5 Pt 1):927-33. doi: 10.1016/s0029-7844(03)00858-5.
- Background: PubMed 10534206Howell MR, Gaydos JC, McKee KT Jr, Quinn TC, Gaydos CA. Control of Chlamydia trachomatis infections in female army recruits: cost-effective screening and treatment in training cohorts to prevent pelvic inflammatory disease. Sex Transm Dis. 1999 Oct;26(9):519-26. doi: 10.1097/00007435-199910000-00007.
- Background: PubMed 9988241Shafer MA, Pantell RH, Schachter J. Is the routine pelvic examination needed with the advent of urine-based screening for sexually transmitted diseases? Arch Pediatr Adolesc Med. 1999 Feb;153(2):119-25. doi: 10.1001/archpedi.153.2.119.
- Background: PubMed 1876371Magann EF, Nolan TE. Pregnancy outcome in an active-duty population. Obstet Gynecol. 1991 Sep;78(3 Pt 1):391-3.
- Background: PubMed 10957855McNeary AM, Lomenick TS. Military duty: risk factor for preterm labor? A review. Mil Med. 2000 Aug;165(8):612-5.
- Individual participant dataSharing planned: No
Related trials for Sexually Transmitted Infection (STI) Prevention
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
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.
Cherrie B Boyer, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits in people with Sexually Transmitted Infection (STI) Prevention and Unintended Pregnancy Prevention, run by United States Department of Defense 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 1 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: stopped early, as of the sponsor's last update on 25 Aug 2017. 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 25 Aug 2017). 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?
Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies (time frame: 6 to 9 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 NCT01234103, which also lists 36 linked publications.
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 25 Aug 2017.