FREQUENTLY ASKED QUESTIONS

Currently, several studies are testing whether a drug called tenofovir could prevent HIV infection in people who are HIV-negative. This study will examine whether different doses of tenofovir can be measured using hair samples. This study will be helpful in developing hair as a tool for measuring how well people are taking tenofovir and how well it is metabolized by the body.

This study is being conducted by the San Francisco Department of Public Health (SFDPH) in partnership with the University of California, San Francisco and is sponsored by the National Institutes of Mental Health (NIMH).

You are eligible if you meet all of the following:

• You are 18 years old or older
• You are HIV negative
• You are not currently pregnant or plan to become pregnant within the next year (for women)

This study may provide valuable information to help fight HIV/AIDS globally and increase our understanding of using hair to measure how well people take their medications.

Tenofovir is a medication that has been shown to be generally safe, effective and well tolerated in the treatment of HIV. It is used in combination with other medications in the treatment of HIV worldwide, and is currently being tested for HIV prevention.

You are eligible if you meet all of the following:

• You will be asked to take a pill on 3 different dosing schedules (2, 4, and 7 doses per week).
• Each dosing schedule will be 6 weeks long, with a break of at least 3 weeks in between. For students, there will be 1 dosing schedule per academic quarter.
• You will come in for brief dosing visits during the week to take the study medication.
• Longer study visits will also be scheduled every 3 weeks when you are taking the tenofovir.
• Participation in this study is completely voluntary and you may quit at any time.

You are eligible if you meet all of the following:

• During the weeks you are taking the tenofovir, you will have short dosing visits (approximately 5 minutes) so that you can be given a dose (pill) and be observed taking it.
• Longer visits, scheduled every 3 weeks when you are taking the tenofovir, will include some or all of the following:
  • Rapid HIV test and same-day results
  • Giving your medical history and having a physical exam
  • Blood, hair and urine samples collected at some visits
  • 0ne 24-hour overnight stay at UCSF Clinical Research Center.

Because there will be breaks of at least 3 weeks between the 3 periods of time you will take the study drug, the total time from start to finish will be at least 5 months.

You will receive up to $1300 for your participation, including $30 for each study visit, $10 for taking each scheduled dose, and $150 for the overnight stay. You will also receive $50 at the end of the study if you complete all your clinical visits.