Transgender Cohort Study of Gender Affirmation and HIV-related Health

An observational study of HIV/AIDS and STI, run by Fenway Community Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This observational research study will evaluate medical gender affirmation delivered in primary care as an intervention to reduce disparities in HIV-related outcomes (e.g., low rates of PrEP uptake for HIV-uninfected patients, high rates of viral suppression for HIV-infected patients) for transgender patients in two… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV/AIDS, STI, Gender Dysphoria
What is being tested?: Medical gender affirmation
How many people: 4,500 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2019to Dec 2021
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: A total of 4,500 participants (46% people of color; 45% transgender women, 33% transgender men; 22% nonbinary individuals) will be enrolled across both study sites.

Who may be able to join

Age 18 years or older;
Have a gender identity differing from their assigned sex at birth (verified at screening via two-step method cross-categorizing natal sex and gender identity);
Current or new primary care patient at Fenway Health or Callen-Lorde Community Health Center (primary care patients are defined as those who had at least one medical visit in a 12-month period);
Able to read, speak, and understand English and/or Spanish;
Willing and able to provide informed consent.

Who cannot join

Under 18 years of age;
Unable to read, speak, and understand English and/or Spanish;
Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fenway Community Health
Boston, Massachusetts, 02215

Other trials in United States

About this study

Read the detailed description

This observational, longitudinal prospective cohort study will evaluate whether medical gender affirmation delivered in primary care improves HIV-related outcomes for transgender patients. Medical gender affirmation therapies-hormones and surgical interventions-are medically necessary treatments shown to improve psychological functioning and quality of life for transgender patients. It is not yet known whether these treatments improve HIV-related outcomes over time because studies providing the best evidence of medical gender affirmation's clinical effectiveness do not examine HIV-related outcomes in transgender adult patients. To fill this gap, the proposed study will prospectively evaluate the effects of medical gender affirmation delivered in primary care on HIV-related outcomes in a multi-site clinic-based cohort of 4,500 diverse transgender patients from two urban U.S. health centers who are leaders in transgender healthcare. Transgender adult primary care patients at Fenway Health in Boston, MA and Callen-Lorde Community Health Center in New York City, NY will be enrolled over 12 months and followed prospectively for 12 months. Bio-behavioral data will be linked, including electronic patient-reported outcomes (baseline, 6-month, 12-month assessments), and electronic health record (EHR) data.

Conditions: HIV/AIDS, STI, Gender Dysphoria, Transsexualism, Gender Identity, Depression, Anxiety
Being tested: Medical gender affirmation
Keywords: Transgender, HIV/AIDS, Gender affirmation, PrEP
Medical subject headings: Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Gender Dysphoria, Transsexualism, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical gender affirmationOther
The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).

Study groups in NCT03595956
Study group	Role	What they receive
Medical Gender Affirmation (MGA) Cohort		Patients engaged in gender-affirming care. Receives: Other: Medical gender affirmation

What is being measured

The primary outcome is the main question the study is designed to answer.

Viral suppression in HIV-infected transgender patients
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV outcomes (i.e., viral suppression) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); viral suppression is defined as <200 copies/mL (Yes/No).
Measured: 12 months
Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV prevention (i.e., PrEP uptake) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); PrEP uptake is a dichotomous variable (Yes/No).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 2019Dec 2021

First posted23 Jul 2018
Study start11 Feb 2019
Primary completionDec 2020 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV/AIDSStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03595956
Sponsor's protocol ID: 1239849
Status last verified: Nov 2020
First submitted: 12 Jul 2018
Last updated: 18 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified IPD may be available to outside individuals by contacting the principal investigator (PI). The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators may welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the PI's web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transgender Cohort Study of Gender Affirmation and HIV-related Health
ClinicalTrials.gov ID: NCT03595956
Acronym / sponsor ID: 1239849
Conditions: HIV/AIDS, STI, Gender Dysphoria, Transsexualism, Gender Identity, Depression, Anxiety
Keywords: Transgender, HIV/AIDS, Gender affirmation, PrEP
Study type: Observational
Recruitment status: Unknown status
Enrolment: 4,500 participants (estimated)
Lead sponsor: Fenway Community HealthUniversity, hospital or other
Collaborators: Callen-Lorde Community Health Center, Patient-Centered Outcomes Research Institute
Study start: 11 Feb 2019 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 23 Jul 2018 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Medical Gender Affirmation (MGA) Cohort	–	Other: Medical gender affirmationPatients engaged in gender-affirming care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: A total of 4,500 participants (46% people of color; 45% transgender women, 33% transgender men; 22% nonbinary individuals) will be enrolled across both study sites.

Key inclusion criteria (5 listed)

Age 18 years or older;
Have a gender identity differing from their assigned sex at birth (verified at screening via two-step method cross-categorizing natal sex and gender identity);
Current or new primary care patient at Fenway Health or Callen-Lorde Community Health Center (primary care patients are defined as those who had at least one medical visit in a 12-month period);
Able to read, speak, and understand English and/or Spanish;
Willing and able to provide informed consent.

Key exclusion criteria (3 listed)

Under 18 years of age;
Unable to read, speak, and understand English and/or Spanish;
Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of consent.

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
Medical gender affirmationThe intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).	Other	Medical Gender Affirmation (MGA) Cohort

Primary outcome

Viral suppression in HIV-infected transgender patients
Time frame: 12 months
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV outcomes (i.e., viral suppression) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); viral suppression is defined as <200 copies/mL (Yes/No).
Uptake of pre-exposure prophylaxis (PrEP) in HIV-uninfected transgender patients
Time frame: 12 months
Longitudinally evaluate whether medical gender affirmation in primary care (i.e., hormones and/or surgical interventions) improve HIV prevention (i.e., PrEP uptake) in transgender adult patients over 12 months of follow-up. Medical gender affirmation is operationalized as a dichotomous variable (binary: hormones and/or surgery vs. none); PrEP uptake is a dichotomous variable (Yes/No).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Individual participant dataSharing planned: Yes. De-identified IPD may be available to outside individuals by contacting the principal investigator (PI). The first will be after all of the baseline data is collected. The investigators will institute a concept plan process where internal study staff first have the availability to write primary papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, the investigators may welcome this collaboration. A similar process will happen for outcome data; however this will not be possible until the publication and release of the outcome paper(s). Information regarding the availability of data for analysis will be listed on the PI's web page. Contact information for the PI will be listed in all manuscripts and publications as another means to access data.

Related trials for HIV/AIDS

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Not yet recruiting
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Recruiting
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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.

Sari Reisner, ScD principal investigator

Brigham and Women's Hospital & Harvard Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV/AIDS and STI, run by Fenway Community 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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?

Results are not available in the source record.

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?

Viral suppression in HIV-infected transgender patients (time frame: 12 months). The study lists 2 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 NCT03595956.

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 18 Nov 2020.