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Antiretroviral
PrEP for HIV Prevention in Transgender Women
Phase 2 & 3
Waitlist Available
Research Sponsored by HIV Prevention Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of STI(s) in the past 6 months.
Any anal or vaginal sex with one or more serodiscordant or HIV-unknown serostatus sexual partners in the previous 3 months, regardless of condom use.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-36 months
Awards & highlights
Study Summary
This trial will test a new strategy to improve PrEP uptake and adherence among transgender people by integrating biomedical HIV prevention with gender-affirming transgender care and Peer Health Navigation using Strengths-Based Case Management.
Who is the study for?
This trial is for transgender women over 18 years old in the US and South America at risk of HIV, willing to take PrEP medication, and able to attend all study visits. They must have good general health with specific lab values met, no reactive HIV tests, and not be on conflicting medications or enrolled in interfering studies.Check my eligibility
What is being tested?
The trial is testing a strategy that combines PrEP drugs (Descovy in the US or Truvada in both regions) with gender-affirming care and peer support immediately or after a six-month delay. Participants are randomly assigned to either start right away or wait six months before receiving these interventions.See study design
What are the potential side effects?
Possible side effects from Descovy/Truvada include nausea, headache, stomach pain, weight loss, fatigue. Rarely kidney problems, bone thinning might occur. The extent of side effects can vary between individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a sexually transmitted infection in the last 6 months.
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I've had unprotected sex with a partner whose HIV status I don't know.
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I am 18 years old or older.
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My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/minute.
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I do not engage in receptive vaginal sex, as Descovy® is not suitable for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PrEP adherence and persistence
Uptake of hormonal therapy and PrEP
Secondary outcome measures
Changes in sexual risk taking behavior
HIV incidence
Measure of baseline lab data for suitability of this population for future PrEP research
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Immediate Intervention Arm Truvada in the USExperimental Treatment1 Intervention
PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in the US
Group II: Immediate Intervention Arm Truvada in BrazilExperimental Treatment1 Intervention
PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in Brazil
Group III: Immediate Intervention Arm Descovy in the USExperimental Treatment1 Intervention
PrEP provision, STI screening and treatment, gender affirming hormonal therapy, peer-health management using strengths-based management using Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) one tablet daily in the US
Group IV: Deferred Intervention Arm Truvada in the USExperimental Treatment1 Intervention
0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in the US
Group V: Deferred Intervention Arm Truvada in BrazilExperimental Treatment1 Intervention
0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) one tablet daily in Brazil
Group VI: Deferred Intervention Arm Descovy in the USExperimental Treatment1 Intervention
0-6 months PrEP provision, STI screening and treatment. From months 6-18 gender affirming hormonal therapy, peer-health management using strengths-based management using Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) one tablet daily in the US
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Who is running the clinical trial?
HIV Prevention Trials NetworkLead Sponsor
30 Previous Clinical Trials
568,397 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,534 Total Patients Enrolled
Tonia Poteat, PhD, MPHStudy ChairUNC Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk for HIV due to recent unprotected sex, sex work, or a recent STI.I have had a sexually transmitted infection in the last 6 months.My kidney function is good, my liver tests are normal, and I don't have hepatitis B or HIV.I've had unprotected sex with a partner whose HIV status I don't know.I have a history of blood clots or clotting disorders.I am 18 years old or older.My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/minute.I do not engage in receptive vaginal sex, as Descovy® is not suitable for me.I have a history of liver disease or known liver or bile duct problems, except for Gilbert's syndrome, asymptomatic gallstones, or if I've had my gallbladder removed.I am not taking any medications that badly interact with Truvada® or Descovy®.I am a transgender woman eligible for this study.I am at risk of getting HIV based on my activities.
Research Study Groups:
This trial has the following groups:- Group 1: Deferred Intervention Arm Truvada in Brazil
- Group 2: Immediate Intervention Arm Truvada in Brazil
- Group 3: Deferred Intervention Arm Truvada in the US
- Group 4: Immediate Intervention Arm Truvada in the US
- Group 5: Immediate Intervention Arm Descovy in the US
- Group 6: Deferred Intervention Arm Descovy in the US
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study limited to North America or are there other places where it is taking place as well?
"There are 4 locations where this clinical trial is taking place: New york, Philadelphia, San Francisco and other cities. If you enroll in the study, try to select a location that is close to reduce travel requirements."
Answered by AI
Has the study involving Truvada been conducted in other countries outside of the US?
"The Deferred Intervention Arm Truvada study was originally conducted in 2002 at University of Zurich. To date, there have been a total of 440 completed studies related to this topic. Additionally, as of right now, 125 clinical trials are actively recruiting patients; many New york-based medical centres are participating in these research efforts."
Answered by AI
What is the FDA-approved use for Deferred Intervention Arm Truvada in America?
"In the United States of America, treatment naive patients (both children and adults) that weigh more than 40 kilograms and have no resistance to darunavir can be treated using Deferred Intervention Arm Truvada."
Answered by AI
Are there any current vacancies for this research project?
"This specific trial is not enrolling patients at the moment, however there are 26 other clinical trials in America that are searching for individuals living with HIV. Additionally, if you're interested in prevention studies, there are 125 different deferred intervention arm Truvada studies seeking participants."
Answered by AI
How many test subjects are included in this experiment?
"This study is not enrolling new patients at the moment. The posting went up on March 26th, 2021 and was last updated on August 30th, 2022. However, there are presently 26 studies actively enrolling patients with hiv, prevention and 125 trials for Deferred Intervention Arm Truvada in the US recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Bridge HIV CRS
Houston AIDS Research Team CRS
What portion of applicants met pre-screening criteria?
Met criteria
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