Trial record 2 of 99 for:    CONTINUUM

Assessing the Engagement of Transgender and Other Gender Minority Youth Across the HIV Continuum of Care

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2015 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT02449629
First received: May 18, 2015
Last updated: NA
Last verified: May 2015
History: No changes posted
  Purpose

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.

Condition Intervention
Transgender, HIV Continuum of Care
Other: Semi-Structured Qualitative Interview for Transgender and Other Minority Youth
Other: Semi-Structured Qualitative Interview Guide for Providers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing the Engagement of Transgender and Other Gender Minority Youth Across the HIV Continuum of Care

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Facilitators and barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care - TGMY with HIV in HIV Care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Explore, from the perspective of TGMY living with HIV who are in HIV care, what socio-ecological facilitators and 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.

  • Facilitators and barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care - TGMY not in HIV Care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 and 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.

  • Facilitators and barriers that influence the full participation of TGMY in the various stages of the HIV Continuum of Care - Health Care and Social Service Providers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Explore, from the perspective of health care and social service providers who provide care and supportive services to TGMY, what socio-ecological facilitators and 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.

  • Create theoretical and empirical models that will guide the development of future interventions for TGMY [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Create theoretical and empirical models that will guide the development of future interventions within the ATN and elsewhere aimed at facilitating 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.

  • Create recommendations and multi-media resources for health care and social service providers that detail concrete steps to include TGMY in HIV Continuum of Care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Create recommendations and multi-media resources for health care and social service providers that detail concrete steps at each socio-ecological level (intrapersonal, interpersonal, institutional/community, and sociocultural/policy) that can be taken to promote the full inclusion 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.


Estimated Enrollment: 392
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TGMY in Care
TGMY (16-24 years of age) currently in HIV care at an Adolescent Medicine Trials Unit (AMTU) site or elsewhere.
Other: Semi-Structured Qualitative Interview for Transgender and Other Minority Youth
The semi-structured qualitative interview guide for youth is grounded in phenomenological and constructivist frameworks, which provide a general structure for discussion but require subjects to provide their own definitions based on their life experiences and perceptions. There are two youth versions of the interview guide: one for youth who are living with HIV, and one for youth who are either not living with HIV or who are unaware of their HIV status.
TGMY Not in 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.
Other: Semi-Structured Qualitative Interview for Transgender and Other Minority Youth
The semi-structured qualitative interview guide for youth is grounded in phenomenological and constructivist frameworks, which provide a general structure for discussion but require subjects to provide their own definitions based on their life experiences and perceptions. There are two youth versions of the interview guide: one for youth who are living with HIV, and one for youth who are either not living with HIV or 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.
Other: Semi-Structured Qualitative Interview Guide for Providers
The semi-structured qualitative interview guide for providers is also grounded in phenomenological and constructivist frameworks. This interview will begin by eliciting information regarding subjects' experiences working with TGMY. For each stage of the HIV Continuum of Care (i.e., prevention, HIV testing, diagnosis, linkage to care, engagement in care, retention in care, initiation of ART, adherence to ART, and viral suppression) they will then be asked about their perception of the experiences TGMY have accessing or trying to access services in that stage of the continuum.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria: Youth Currently in HIV Care

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;
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02449629

Contacts
Contact: Georgine Price, MPH 301-610-4990 georgineprice@westat.com

Locations
United States, Colorado
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's Hosp National Med Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fenway Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Pennsylvania
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Gary Harper, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02449629     History of Changes
Other Study ID Numbers: ATN 130
Study First Received: May 18, 2015
Last Updated: May 18, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
Transgender
HIV Continuum of Care

ClinicalTrials.gov processed this record on May 26, 2015