Transgender, HIV Continuum of CareNCT02449629
Assessing the Engagement of Transgender and Other Gender Minority Youth Across the HIV Continuum of Care
An observational study of Transgender, HIV Continuum of Care, run by University of North Carolina, Chapel Hill at 14 sites in United States.
Trial summary
This study uses a transformative multiphasic mixed-methods research design that incorporates elements of the following designs: Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086, and ATN 106, to influence the development of the qualitative interview and quantitative survey… Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender, HIV Continuum of Care
- How many people
- 187 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2015to Jan 2016
- Phase
- Observational
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The three population groups are: 1. TGMY (16-24 years of age) currently in HIV care at an Adolescent Medicine Trials Unit (AMTU) site or elsewhere. 2. TGMY (16-24 years of age) not currently in care who are living with HIV, not living with HIV, or those who are unaware of their HIV status. 3. Health care and social service providers who work with TGMY at AMTU sites or elsewhere that serve TGMY within the AMTU cities.
Who may be able to join
- To be considered eligible for enrollment, an individual must meet the criteria listed below.
- Received at least one HIV related service (e.g., medical care, social services, case management, etc.) at an AMTU or elsewhere in the six months prior to consent;
- Does not identify solely with sex assigned at birth (may identify as trans, transgender, trans woman, trans man, man, woman, gender nonconforming, genderqueer, or any other gender, so long as their current gender identity and/or expression do not match their sex assigned at birth);
- Self reports to be HIV-infected;
- Self reports to be between the ages of 16-24 years inclusive at time of consent;
- Ability to understand both written and spoken English;
Show all 36Show fewer
- Willingness to participate in an in-depth face-to-face qualitative interview about gender minority identity and personal experiences seeking services across the HIV Continuum of Care;
- Willingness to participate in a web-based quantitative survey about gender minority identity and personal experiences seeking services across the HIV Continuum of Care; and
- Able to understand and willing to provide signed informed consent as applicable for study participation.
- Exclusion Criteria: Youth Currently in HIV Care To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Active psychiatric condition that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Visibly distraught or visibly emotionally unstable (e.g., active hallucinations, exhibiting suicidal, homicidal, or violent behavior) condition that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Acute illness that, in the opinion of the site personnel, would interfere with the subject's ability to adhere to the protocol requirements and/or interfere with the protocol objectives; and
- Site IRB requires parental permission and subject is <18 years of age.
- Inclusion Criteria: Youth Not Currently in Care To be considered eligible for enrollment, an individual must meet the criteria listed below.
- Did not receive HIV related services (e.g., medical care, social services, case management, etc.) at an AMTU or elsewhere in the six months prior to the time of consent;
- Does not identify solely with sex assigned at birth (may identify as trans, transgender, trans woman, trans man, woman, man, gender nonconforming, genderqueer, or any other gender, so long their current gender identity and/or expression do not match their sex assigned at birth);
- Self reports to be between the ages of 16-24 years inclusive at time of consent;
- Ability to understand both written and spoken English;
- Willingness to participate in an in-depth face-to-face qualitative interview about gender minority identity and personal experiences seeking services across the HIV Continuum of Care;
- Willingness to participate in a web-based quantitative survey about transgender and other gender minority identity and personal experiences seeking services across the HIV Continuum of Care; and
- Willingness to provide signed informed consent for study participation.
- Exclusion Criteria: Youth Not Currently in HIV Care To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Active psychiatric condition that in the opinion of the site personnel would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Visibly distraught or visibly emotionally unstable (e.g., active hallucinations, exhibiting suicidal, homicidal, or violent behavior) condition that, in the opinion of the site personnel interferes with the ability to give true informed consent and to adhere to the study requirements;
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with the ability to give true informed consent and to adhere to the study requirements;
- Acute illness that, in the opinion of the site personnel, would interfere with the subject's ability to adhere to the protocol requirements and/or interfere with the protocol objectives; and
- Site IRB requires parental permission and subject is <18 years of age.
- Inclusion Criteria: Health Care and Social Service Providers
- To be considered eligible for enrollment, an individual must meet the criteria listed below.
- Fits into one of the following categories: (1) medical provider (physician, nurse, nurse practitioner, physician's assistant); (2) mental health professional (psychologist, psychiatrist, clinical social worker, counselor); (3) case manager/care coordinator; (4) HIV test counselor; (5) or health educator/outreach worker;
- Provides services at one of the 14 AMTU or elsewhere within the AMTU cities; and
- Currently works directly with or has formerly worked directly with TGMY.
- Exclusion Criteria: Health Care and Social Service Providers
- There are no exclusion criteria.
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, 48201
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's Hosp National Med Center
Washington D.C., District of Columbia, 20010
About this study
This study uses a transformative multiphasic mixed-methods research design that incorporates elements of the following designs:
- Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086, and ATN 106, to influence the development of the qualitative interview and quantitative survey instruments for primary data collection.
- Convergent parallel: concurrent collection and analysis of both qualitative and quantitative primary data that will be combined to address the study objectives.
Read the detailed description
The ultimate goal of this study is to assess engagement of TGMY across the HIV Continuum of Care. This will be accomplished through a transformative multiphasic mixed-methods research study that will engage all sites in the ATN network and collect data from both internal and external sources regarding the facilitators and barriers affecting TGMY's engagement across the HIV Continuum of Care. Empirical and theoretical models will be produced that will guide the future development of HIV-related interventions for TGMY (to be published by the study team in peer-reviewed literature). In addition, findings will be translated into more immediate provider-focused recommendations and multi-media resources that provide concrete guidance and tools that can be applied across socio-ecological levels to promote the full inclusion of TGMY in the various stages of the HIV Continuum of Care. The production of multidisciplinary provider-focused materials that will support the delivery of gender affirming and appropriate HIV care to TGMY is in alignment with many contemporary views of translational research and will have an immediate impact on the ability of providers at AMTU sites and elsewhere to provide HIV-related care to TGMY across the full HIV Continuum of Care.
The research design incorporates elements of both a sequential design (secondary data analysis from ATN 039 and ATN 086/106 influenced the development of measures for primary data collection) and a convergent parallel design (concurrent collection and analysis of both qualitative and quantitative primary data that will be combined to address the specific aims. This design is considered a transformative mixed-methods design due to the study's theoretical and conceptual grounding in Bioecological Systems Theory (BST), Gender Affirmation, and Gender Minority Stress, and the focus on advancing the needs of underrepresented and marginalized populations. Mixed methods studies typically involve collecting and analyzing data derived from both quantitative and qualitative data sources in order to gain greater insight into a research problem than would be gained by using only one of the two methods in isolation. By combining methods, the limitations and biases inherent in one single methodology can be lessened by using multiple forms of data collection. The qualitative phase of the study will use a phenomenological investigative approach, which will help to understand the sociocultural behaviors, language, roles, and interactions within a culture-sharing group (i.e., TGMY) and triangulation of the qualitative data with the quantitative data strengthens the validity of the information received by using a combination of data sources.
- Conditions
- Transgender, HIV Continuum of Care
- Keywords
- HIV, Transgender, HIV Continuum of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TGMY in HIV Care | TGMY (16-24 years of age) currently in HIV care at an Adolescent Medicine Trials Unit (AMTU) site or elsewhere. | |
| TGMY Not in HIV Care | TGMY (16-24 years of age) not currently in care who are living with HIV, not living with HIV, or those who are unaware of their HIV status. | |
| Health Care and Social Service Providers | Health care and social service providers who work with TGMY at AMTU sites or elsewhere that serve TGMY within the AMTU cities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY with HIV in HIV Care
Explore, from the perspective of TGMY living with HIV who are in HIV care, what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Measured: Entry Visit
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY with HIV in HIV Care
Explore, from the perspective of TGMY living with HIV who are in HIV care, what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Measured: Entry Visit
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY not in HIV Care
Explore, from the perspective of TGMY who are not in HIV care (including those who are living with HIV, not living with HIV, and those who are unaware of their HIV status), what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Measured: Entry Visit
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY not in HIV Care
Explore, from the perspective of TGMY who are not in HIV care (including those who are living with HIV, not living with HIV, and those who are unaware of their HIV status), what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Measured: Entry Visit
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of health care and social service providers
Explore, from the perspective of health care and social service providers who provide care and supportive services to TGMY, what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART and viral suppression.
Measured: Entry Visit
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of health care and social service providers
Explore, from the perspective of health care and social service providers who provide care and supportive services to TGMY, what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART and viral suppression.
Measured: Entry Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Transgender, HIV Continuum of CareStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gary Harper, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449629
- Sponsor's protocol ID
- ATN 130
- Status last verified
- Mar 2016
- First submitted
- 18 May 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jadwin-Cakmak L, Reisner SL, Hughto JMW, Salomon L, Martinez M, Popoff E, Rivera BA, Harper GW. HIV prevention and HIV care among transgender and gender diverse youth: design and implementation of a multisite mixed-methods study protocol in the U.S. BMC Public Health. 2019 Nov 15;19(1):1531. doi: 10.1186/s12889-019-7605-4.
PubMed 31730450
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Engagement of Transgender and Other Gender Minority Youth Across the HIV Continuum of Care
- ClinicalTrials.gov ID
- NCT02449629
- Acronym / sponsor ID
- ATN 130
- Conditions
- Transgender, HIV Continuum of Care
- Keywords
- HIV, Transgender, HIV Continuum of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 May 2015 (estimated)
- 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.
This study uses a transformative multiphasic mixed-methods research design that incorporates elements of the following designs:
- Sequential: a secondary data analysis was conducted, using data from ATN 039, ATN 086, and ATN 106, to influence the development of the qualitative interview and quantitative survey instruments for primary data collection.
- Convergent parallel: concurrent collection and analysis of both qualitative and quantitative primary data that will be combined to address the study objectives.
Detailed description
The ultimate goal of this study is to assess engagement of TGMY across the HIV Continuum of Care. This will be accomplished through a transformative multiphasic mixed-methods research study that will engage all sites in the ATN network and collect data from both internal and external sources regarding the facilitators and barriers affecting TGMY's engagement across the HIV Continuum of Care. Empirical and theoretical models will be produced that will guide the future development of HIV-related interventions for TGMY (to be published by the study team in peer-reviewed literature). In addition, findings will be translated into more immediate provider-focused recommendations and multi-media resources that provide concrete guidance and tools that can be applied across socio-ecological levels to promote the full inclusion of TGMY in the various stages of the HIV Continuum of Care. The production of multidisciplinary provider-focused materials that will support the delivery of gender affirming and appropriate HIV care to TGMY is in alignment with many contemporary views of translational research and will have an immediate impact on the ability of providers at AMTU sites and elsewhere to provide HIV-related care to TGMY across the full HIV Continuum of Care.
The research design incorporates elements of both a sequential design (secondary data analysis from ATN 039 and ATN 086/106 influenced the development of measures for primary data collection) and a convergent parallel design (concurrent collection and analysis of both qualitative and quantitative primary data that will be combined to address the specific aims. This design is considered a transformative mixed-methods design due to the study's theoretical and conceptual grounding in Bioecological Systems Theory (BST), Gender Affirmation, and Gender Minority Stress, and the focus on advancing the needs of underrepresented and marginalized populations. Mixed methods studies typically involve collecting and analyzing data derived from both quantitative and qualitative data sources in order to gain greater insight into a research problem than would be gained by using only one of the two methods in isolation. By combining methods, the limitations and biases inherent in one single methodology can be lessened by using multiple forms of data collection. The qualitative phase of the study will use a phenomenological investigative approach, which will help to understand the sociocultural behaviors, language, roles, and interactions within a culture-sharing group (i.e., TGMY) and triangulation of the qualitative data with the quantitative data strengthens the validity of the information received by using a combination of data sources.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TGMY in HIV Care | – | –TGMY (16-24 years of age) currently in HIV care at an Adolescent Medicine Trials Unit (AMTU) site or elsewhere. |
| TGMY Not in HIV Care | – | –TGMY (16-24 years of age) not currently in care who are living with HIV, not living with HIV, or those who are unaware of their HIV status. |
| Health Care and Social Service Providers | – | –Health care and social service providers who work with TGMY at AMTU sites or elsewhere that serve TGMY within the AMTU cities. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The three population groups are: 1. TGMY (16-24 years of age) currently in HIV care at an Adolescent Medicine Trials Unit (AMTU) site or elsewhere. 2. TGMY (16-24 years of age) not currently in care who are living with HIV, not living with HIV, or those who are unaware of their HIV status. 3. Health care and social service providers who work with TGMY at AMTU sites or elsewhere that serve TGMY within the AMTU cities.
Key inclusion criteria (36 listed)
- To be considered eligible for enrollment, an individual must meet the criteria listed below.
- Received at least one HIV related service (e.g., medical care, social services, case management, etc.) at an AMTU or elsewhere in the six months prior to consent;
- Does not identify solely with sex assigned at birth (may identify as trans, transgender, trans woman, trans man, man, woman, gender nonconforming, genderqueer, or any other gender, so long as their current gender identity and/or expression do not match their sex assigned at birth);
- Self reports to be HIV-infected;
- Self reports to be between the ages of 16-24 years inclusive at time of consent;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY with HIV in HIV Care
Time frame: Entry Visit
Explore, from the perspective of TGMY living with HIV who are in HIV care, what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY with HIV in HIV Care
Time frame: Entry Visit
Explore, from the perspective of TGMY living with HIV who are in HIV care, what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY not in HIV Care
Time frame: Entry Visit
Explore, from the perspective of TGMY who are not in HIV care (including those who are living with HIV, not living with HIV, and those who are unaware of their HIV status), what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY not in HIV Care
Time frame: Entry Visit
Explore, from the perspective of TGMY who are not in HIV care (including those who are living with HIV, not living with HIV, and those who are unaware of their HIV status), what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression.
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of health care and social service providers
Time frame: Entry Visit
Explore, from the perspective of health care and social service providers who provide care and supportive services to TGMY, what socio-ecological facilitators exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART and viral suppression.
Types of barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of health care and social service providers
Time frame: Entry Visit
Explore, from the perspective of health care and social service providers who provide care and supportive services to TGMY, what socio-ecological barriers exist that influence the full participation of TGMY in the various stages of the HIV Continuum of Care: prevention and testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART and viral suppression.
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 28 Feb 2017.
- Derived from this study: PubMed 31730450Jadwin-Cakmak L, Reisner SL, Hughto JMW, Salomon L, Martinez M, Popoff E, Rivera BA, Harper GW. HIV prevention and HIV care among transgender and gender diverse youth: design and implementation of a multisite mixed-methods study protocol in the U.S. BMC Public Health. 2019 Nov 15;19(1):1531. doi: 10.1186/s12889-019-7605-4.
- ATN websiteLink provided by the sponsor.
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.
Gary Harper, PhD principal investigator
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender, HIV Continuum of Care, run by University of North Carolina, Chapel Hill at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 0 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Types of facilitators that influence the full participation of TGMY in the various stages of the HIV Continuum of Care from the perspective of TGMY with HIV in HIV Care (time frame: Entry Visit). The study lists 6 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 NCT02449629, 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 28 Feb 2017.