What are the recommended testing and Pre-Exposure Prophylaxis (PrEP) guidelines for a bisexual transgender male with inconsistent condom use and a recently negative Human Immunodeficiency Virus (HIV) test result?

PrEP Recommendation and Testing for a Bisexual Transgender Male with Inconsistent Condom Use

This 34-year-old bisexual transgender male with inconsistent condom use should be started on daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP immediately after confirming HIV-negative status, with quarterly HIV testing and STI screening thereafter. 1

Immediate PrEP Initiation

• PrEP should be initiated as soon as feasible for individuals choosing to use it, without delay 1
• Since the patient had a negative HIV test a few months ago, same-day PrEP initiation is appropriate if a combined HIV antibody and antigen test (4th generation) performed within 7 days is negative and there are no symptoms of acute HIV infection 1, 2
• If the test result is not immediately available, perform a rapid point-of-care test at the visit and start PrEP if negative, while also sending a laboratory-based HIV antibody and antigen test 1, 2
• Do not delay PrEP initiation while waiting for other baseline test results (creatinine, hepatitis B, STI screening) 2

Baseline Testing Requirements

Before or at PrEP initiation, obtain the following tests (but do not delay PrEP for results except HIV testing): 1, 2

• Combined HIV antibody and antigen test (4th generation) - this is the only test that should delay PrEP if results are pending 1, 2
• HIV RNA testing only if clinical suspicion of acute HIV infection exists (fever, rash, lymphadenopathy, flu-like symptoms) - withhold PrEP until results available 1, 2
• Serum creatinine with calculated creatinine clearance 1, 2
• Hepatitis B surface antigen 1, 2
• Hepatitis C antibody 1, 2
• Genital and non-genital gonorrhea and chlamydia testing by nucleic acid amplification test (NAAT) 1
• Syphilis testing 1
• Pregnancy testing if applicable 1, 2

Recommended PrEP Regimen

Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is the recommended first-line PrEP regimen 1

• Prescribe no more than a 30-day supply initially, then 90-day supplies thereafter 1
• For this patient (transgender male), tenofovir alafenamide/emtricitabine (TAF/FTC) is an alternative option if there are pre-existing kidney dysfunction, osteopenia, or osteoporosis concerns 1, 3
• The 2-1-1 (on-demand) dosing method is only recommended for cisgender men who have sex with men, not for transgender individuals or those with vaginal/receptive intercourse 1

Follow-Up Testing Schedule

At 1 Month After Initiation: 1

• Combined HIV antibody and antigen test 1
• Assess adherence and side effects 1

Quarterly (Every 3 Months): 1

• Combined HIV antibody and antigen test 1
• Genital and non-genital gonorrhea and chlamydia testing by NAAT 1
• Syphilis testing 1
• Pregnancy testing if applicable 1
• Estimated creatinine clearance at first quarterly visit, then annually thereafter 1

Annually: 1

• Hepatitis C antibody testing 1
• Creatinine clearance 1

Critical Caveats

If the patient reports a high-risk exposure within the past 72 hours, initiate a 3-drug post-exposure prophylaxis (PEP) regimen for 28 days first, then transition seamlessly to 2-drug PrEP without a gap 1, 2

For patients at increased risk for kidney injury (age >50, baseline creatinine clearance <90 mL/min, diabetes, hypertension), monitor creatinine clearance every 3-6 months instead of annually 1

Condom use should be strongly encouraged despite PrEP, as PrEP does not prevent other sexually transmitted infections 1

PrEP is not fail-safe - seroconversion can occur with high viral inoculum or viral resistance, though this is rare with good adherence 1, 4

Alternative PrEP Options

Long-acting injectable cabotegravir every 8 weeks is an FDA-approved alternative for cisgender men and transgender women who have sex with men, though daily oral TDF/FTC remains the standard first-line option 1