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



Status:Completed
Healthy:No
Age Range:16 - 24
Updated:3/1/2017
Start Date:June 2015
End Date:January 2016

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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.

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.

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.
We found this trial at
14
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Aurora, CO
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Boston, Massachusetts 02115
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Boston, MA
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Chicago, Illinois 60612
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Chicago, IL
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Detroit, MI
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Houston, TX
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New Orleans, Louisiana 70112
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New Orleans, LA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Washington, District of Columbia 20010
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Washington,
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