• Screening visit
• Meditation or education sessions
• Study visits
• Other study steps
• How much time is involved
• Compensation
• What else you should know
• Interested in participating?

Screening visit

You’ll meet study staff and be asked to sign an informed consent form (more about this later). You’ll have blood drawn for CD4 T-cell and viral load testing and fill out some questionnaires. This will take about 1 hour. The visit will happen at the General Clinical Research Center (GCRC) at UCSF-Mt. Zion Hospital. This is at 1600 Divisadero Street (between Post and Sutter), 6th floor. The blood tests and questionnaires will be used to help make sure you are eligible for the study. Study staff will be able to give you results in about 1 – 2 weeks.

Meditation or education sessions

You will participate in either meditation-based stress management or education group sessions. There will be about 15-25 other people with HIV in each group.

You will attend group sessions (lasting 1.5-3 hours) every week for 8 weeks. These sessions will take place in the evening at the Osher Center for Integrative Medicine, located at 1701 Divisadero and Sutter Streets.

You will be randomly assigned to a group (either meditation or education). You will have a 50/50 chance (like flipping a coin) of being placed in one of the two groups. Neither study staff nor you will make the choice. You must be willing to participate in either group.

If you are assigned to the meditation group, you will:

• Have an individual 45 minute intake interview with the meditation teacher.
• Attend evening groups lasting 2.5 to 3 hours for 8 weeks.
• Attend an 8-hour silent retreat during the sixth week of the program.
• Do daily home assignments of 45 minutes per day of formal meditation practice.

If you are assigned to the education group, you will:

• Attend evening groups lasting 1.5 hours for 8 weeks.
• Participate in classes covering a variety of educational topics
  about managing HIV infection.
• Have the opportunity to participate for free in the meditation
  program at the end of the 1-year study period.

Study visits

In addition to the classes, you will have 5 study visits.

The first visit will be a screening visit to see if you are eligible for the study. You will have a blood draw for CD4 and viral load testing and will complete some questionnaires. This visit will last about 1 hour.

The other 4 visits will each last about 1.5-2 hours and will happen when you enter the study, and 3, 6, and 12 months later.

At these 4 visits you will:

• Complete questionnaires about your health, mood, stress, etc.
• Have blood drawn to measure CD4 count, viral load, stress hormones, etc.
• Have sensors placed on your skin for about 5 minutes to measure blood pressure and heart rate.

These visits will take place at the UCSF Mt Zion General Clinical Research Center, located at 1600 Divisadero and Post Streets.

Other study steps

Three times during the study, you will be given a kit to collect your saliva for four days at home. At these times, you will also answer questions about your mood and health behaviors. The saliva will be used to measure stress hormones.

Each month while you are in the study (12 times), you will complete a short questionnaire about whether you have had cold-type symptoms. This will be done by email or phone.

How much time is involved

This study requires a time commitment!

If you are in the meditation group, you will spend a total of about 80 hours over the one-year study period (about 30 hours in class and 42-48 hours on home assignments). If you are assigned to the education group, you will spend a total of approximately 20 hours over the course of the one-year study period (12 hours in class).

You will need to plan in advance to be available on the evening of the class for 8 weeks in a row. The study won’t work if you have to miss more than one class.

Because it takes hours to prepare blood that is drawn for all the tests, study visits at the GCRC must be scheduled weekday mornings (starting between 8:00 and 10:00a.m.). You will have some choice about the day of the week, but you will need to be able to come for these 1.5-2 hour appointments 4 times during the year-long study.

Compensation

At each of the 4 assessment visits, you will get $25 in cash plus either vouchers to cover parking or a $5 gift certificate to a local merchant.

You won’t be paid to attend the weekly classes or for the screening visit.

There is no cost to you for any of the tests or programs in the study. The meditation program usually costs $300.

What else you should know

If you come for a screening visit, you’ll need to sign a consent form. This will provide you with more details about the study. The aim of the consent form is to make sure you know what you’re getting into. It also shows that you agree to be part of the study and have been given information about the study. All medical research studies at UCSF are required to document consent of research participants in this way.

Being part of a study like this is voluntary. You should only be part of it if it really makes sense for you. There are no penalties for deciding not to be part of the study and it won’t affect medical care you might get at UCSF.

Interested in participating?

If you are interested in participating in the Staying Well study or would like more information, please contact us at 415.353.9744 or email us.