Table 1

NZPrEP: A demonstration study of HIV pre-exposure prophylaxis in Aotearoa New New Zealand study procedures

ProceduresVisit 0Visit 1
Week 1
Visit 2
Week 4
Visit 3
Week 12
Visit 4
Week 24
Visit 5
Week 36
Visits 6–10 until study completion
Week 96
Exit
Consent formX*X†
Assessment of eligibility criteriaXX
Review of medical history‡XX
Sexual history§XXXXXXXX
Review of concomitant medicationsXXXXXXXX
Review of adherenceXXXXXX
Behavioural surveyXXXXXX
Truvada prescriptionX**X††X††X††X††
Physical examinationXX
Symptom-directedXXXXXX
Observations (BP, BMI)X
Assessment of adverse eventsXXXXXX
Clinical laboratoryHIV testX‡‡X§§X§§X§§X§§X§§X§§
Creatinine, eGFRXXXXXX
Liver FunctionTestsXXXXXX
Urine P/Cr ratioXXX
Urinalysis¶¶XXXXXXX
Concomitant STIsSyphilis serologyXXXXXXX
Multisite g***XXXXXXX
Hepatitis screeningHAV and HBV serologies†††X
Hepatitis C Virus AntibodyXXX
  • Criteria for premature discontinuation: (1) positive HIV test result (see below), (2) renal toxicity, (3) non-adherence to medication or appointments, (4) using the medication for other purposes than intended (eg, giving it to others, using it on demand and so on), (5) reduction of risk behaviours to such extent that PrEP is no longer indicated, and (6) patient’s request.

  • *Give and discuss consent form and other patient information material.

  • †Discuss and sign consent form.

  • ‡Take full family and personal medical history and vaccinations (HAV, HBV, HPV).

  • §Partners (number, gender, casual/regular, HIV status), practices (oral/anal intercourse, sex toys, ‘chem sex’ and so on), condom use and history of STIs (what, when, treatments and so on).

  • ¶Prescribe 30 tablets.

  • **Prescribe 60 tablets.

  • ††Prescribe 90 tablets.

  • ‡‡HIV enzyme immunoassay (EIA) fourth-generation (Antigen/Antibody combination) must be negative at baseline visit (day 0), and the prescriber must document that history and clinical examination do not raise the suspicion of recently acquired HIV infection still in the window period. DO NOT PRESCRIBE Truvada if criteria are not met; patients will be eligible for PrEP if a repeat HIV test 4 weeks later (with no additional risk in the mean time) is still negative. 

  • §§A positive HIV test at any visit after baseline (day 0) is a criteria for premature discontinuation. If signs/symptoms of acute retroviral infection at any visit after baseline, send for HIV RNA together with HIV EIA combo Ag/Ab. Terminate the study, obtain confirmatory test (western blot, HIV RNA including genotype for drug resistance) and discuss options with the patient regarding ongoing care.

  • ¶¶For proteinuria.

  • ***Urinary, pharyngeal and rectal chlamydia and gonorrhoea testing by strand displacement amplification (BD ViperTM).

  • †††Hepatitis A virus and hepatitis B virus; Vaccinate if not immune as per standard protocol. 

  • BMI, body mass index; BP, blood pressure; eGFR, estimated glomerular filtration rate; PrEP, pre-exposure prophylaxis; STI, sexually transmissible infection.

  • References

  • (1) Guidance for the Use of Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Infection, New York State Department of Health AIDS Institute (NYSDOH AI), www.hivguidelines.org (accessed 21/08/2015).

  • (2) Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Practice Guideline, CDC/DHHS/US Public Health Service, www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf (accessed 21/08/2015).

  • (3) Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2014 Clinical Providers’ Supplement, CDC/DHHS/US Public Health Service.