Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals

Open to people ages 18 years and up

• Transgender identity, defined as identifying differently from sex assigned at birth
• Age 18 years or older
• Risk of acquisition of HIV as evident by one or more of the following:

Has at least one HIV infected sexual partner for ≥4 weeks

OR,

Anticipated or concern of unprotected anal or vaginal sex with a partner in the next 3 months

OR,

Any partner in the past 12 months AND at least one of the following:

1. any condomless anal or vaginal sex in the past 12 months
2. any STI diagnosed or reported in the past 12 months
3. exchange of money, gifts, shelter, or drugs for sex

OR,

PEP-use in the past 12 months

• Negative for HIV infection by nucleic acid test (NAT) or other sensitive method such as 4th generation antigen/antibody test
• Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula (eCcr (male) in mL/min = [(140 - age in years) x (lean body weight in kg)] / (72 x serum creatinine in mg/dL) in the past 30 days

• Unable to give informed consent
• Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
• Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
• gastrointestinal condition that would impair absorption of study drugs
• known condition of reduce bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture
• neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP
• tubular or glomerular kidney disease that could be exacerbated by tenofovir
• other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP
• Suspected sensitivity or allergy to the study drug or any of its components
• Currently using an essential product or medication that interacts with the study drug such as the following:
• other antiretroviral agent (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents) - if currently on TDF/FTC for PEP or PrEP they can switch to study provided drug but can not continue any other antiretroviral agent
• agents with known nephrotoxic potential:
• aminoglycoside antibiotics (including gentamicin)
• IV amphotericin B
• cidofovir
• cisplatin
• foscarnet
• IV pentamidine
• IV vancomycin
• oral or IV gancyclovir
• other agents with significant nephrotoxic potential
• drugs that slow renal excretion
• probenecid
• immune system modulators
• systemic chemotherapeutic agents (i.e. cancer treatment medications)
• ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
• interleukin-2 (IL-2)
• interferon (alpha, beta, or gamma)
• other agent known to have a significant interaction with TDF or FTC
• Proteinuria 2+ or greater by urine dipstick
• Pregnancy (if individual has a uterus)
• Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives