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Transgender PersonsPhase 4NCT03120936

The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community

A Phase 4 study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support in people with Transgender Persons and Pre-Exposure Prophylaxis, run by Public Health Foundation Enterprises, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Transgender Persons, Pre-Exposure Prophylaxis
What is being tested?
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
5 sitesUnited States
Study dates
8 Aug 2017to 1 Dec 2020
Phase
Phase 4
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

Who may be able to join

  • Self-identify as a transgender woman, transgender man, or gender non-conforming
  • Willing and able to provide written informed consent;
  • Age ≥ 18 years;
  • HIV-1-uninfected defined per site HIV testing algorithm performed within 7 (and up to 14) days of enrollment if PrEP naïve or within 90 days if currently on PrEP (see SSP manual)
  • Expressed desired to use or continue PrEP, anticipated risk, or evidence of risk for acquiring HIV-1 infection including having any cisgender male or transgender female partners in the past 12 months and not in a mutually monogamous partnership with a recently tested, HIV-negative partner AND at least one of the following;
  • any anal or vaginal sex in the past 12 months; or
Show all 10Show fewer
  • any STI diagnosed or reported in the past 12 months; or
  • an ongoing sexual relationship with an HIV-positive partner; or
  • exchange of money, gifts, shelter, or drugs for sex
  • Fluent in English or Spanish

Who cannot join

  • Individuals with any of the following will be excluded:
  • confirmed HIV infection by laboratory testing
  • clinical symptoms consistent with possible acute HIV infection [fatigue, fever, rash, night sweats, and adenopathy];
  • underlying bone disease (osteopenia or osteoporosis)
  • Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid)
  • No prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity.
  • Unwilling to attend quarterly follow-up visits, which will include risk reduction/adherence counseling and repeat laboratory testing
  • Has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Tri-City Health Center

    Fremont, California, 94538

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California, 94102

  • Tom Waddell Urban Health Clinic

    San Francisco, California, 94102

  • San Francisco Community Health Clinic

    San Francisco, California, 94109

  • Castro-Mission Health Center

    San Francisco, California, 94114

Other trials in United States

About this study

The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community. Approximately 188 HIV-uninfected participants will be enrolled at 4 sites in San Francisco and Fremont and will be provided Truvada to take orally once daily as PrEP.

Read the detailed description

PrEP stands for Pre-Exposure Prophylaxis, an HIV prevention method that involves HIV negative people taking antiviral drugs daily to try to help prevent HIV infection. Studies with men who have sex with men (MSM) and transgender women showed that people who took PrEP were less likely to become infected with HIV than those who did not take it.

The main purpose of this PrEP Demonstration Project is to make PrEP accessible to people in the transgender community. As part of this project, we will study whether transgender women and men are interested in taking PrEP, and, if so, for how long and how frequently they take the medication and how these relate to demographics (such as race, age, and education). We will also assess reasons for stopping PrEP and measure sexual behaviors of participants in the demonstration project.

Being tested
Emtricitabine / Tenofovir Disoproxil Oral Tablet, PrEP support
Keywords
Adherence, Transgender, PrEP, HIV Prevention, Truvada, HIV Risk Reduction

What participants receive

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

  • Emtricitabine / Tenofovir Disoproxil Oral TabletDrug

    Also called Truvada, PrEP

    Open-label emtricitabine 200mg/tenofovir 300mg

  • PrEP supportBehavioural

    HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.

Study groups in NCT03120936
Study groupRoleWhat they receive
MainOtherEmtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Behavioral: PrEP support

What is being measured

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

  1. PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices

    Combined analysis of PrEP acceptance and refusal rates and sociodemographic correlates of PrEP acceptance and refusal.

    Measured: Baseline

  2. Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study.

    Combined analysis of PrEP adherence rates as measured by: Tenofovir-diphosphate (TFV-DP) levels in dried blood spots (DBS); medication possession ratio; self-reported adherence. Patterns and correlates of adherence

    Measured: 12 months

Secondary outcomes (15)

  1. Reasons transgender people choose to initiate PrEP

    Reasons for initiating PrEP

    Measured: Baseline

  2. Reasons transgender people choose to decline PrEP

    Reasons for declining PrEP

    Measured: Baseline

  3. Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP

    Computer-Assisted Self-interview (CASI) data: Numbers of sexual partners, by serostatus and condom use, and anal/vaginal sex episodes, by partner serostatus, role of respondent, and condom use; sexually transmitted infection (STI) testing

    Measured: 12 months

  4. Measure of changes in STI among Stay Study participants taking PrEP

    STI testing

    Measured: 12 months

  5. Side effects and toxicities of PrEP among study participants

    Combined analysis of side effects and toxicities, including creatinine elevations

    Measured: 12 months

  6. PrEP discontinuations and reasons for discontinuation

    PrEP discontinuations, reasons for discontinuation

    Measured: 12 months

  7. Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices

    Combined analysis of CASI and interview data.

    Measured: 15 months

  8. The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project

    HIV drug resistance patterns among persons who become infected

    Measured: 12 months

  9. Effects of PrEP on hormone levels

    Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma

    Measured: 12 months

  10. The effect of hormone use on tenofovir-diphosphate concentrations among study participants

    Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma

    Measured: 12 months

  11. Social harms experienced by study participants

    Social Impact questionnaire

    Measured: 12 months

  12. Social benefits experienced by study participants

    Social impact questionnaire

    Measured: 12 months

  13. Referrals to other HIV prevention services within the Stay Study

    Combined analysis of CASI and interview data

    Measured: 15 months

  14. Access to and uptake of PrEP after project completion

    Combined analysis of the proportion of participants interested in continuing PrEP and successfully able to access PrEP

    Measured: 3 months

  15. Acceptability and uptake of Stay Study PrEP support components

    Combined analysis of CASI and interview responses.

    Measured: 12 months

Timeline

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

  1. First posted19 Apr 2017
  2. Study start8 Aug 2017
  3. Primary completion27 Aug 2020
  4. Study completion1 Dec 2020

Resources

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120936
Sponsor's protocol ID
16-20339
Other IDs
PR15-SFDPH-026
Status last verified
Apr 2021
First submitted
11 Apr 2017
Last updated
21 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support in people with Transgender Persons and Pre-Exposure Prophylaxis, run by Public Health Foundation Enterprises, Inc. at 5 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 10 inclusion and 8 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices (time frame: Baseline). 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 NCT03120936.

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 21 Apr 2021.

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