Study Profile:
Directly Observed HAART for Active Substance Abusers (The DOT Study)

December 5, 2006

Brown University School of Medicine

Directly Observed HAART for Active Substance Abusers (The DOT Study)

Closed to enrollment

Timothy P. Flanigan, MD

2000-2005

1. To determine whether directly observed once-a-day HAART over a twelve-month period is more effective than self-administered once-a-day HAART in the suppression of plasma HIV RNA among current drug users
2. To evaluate and compare patterns of adherence in the DOT (intervention) arm and the standard of care (control) arm during all phases of the study utilizing a variety of measures including audio computer-assisted self interview (ACASI) reports
3. To compare the development of antiretroviral resistance between the DOT and standard of care arm
4. To determine the effect of an intensive phase (12 months) followed by a tapering phase (6 months) of DOT on subsequent plasma HIV RNA and patterns of adherence
5. To identify factors that influence the sustainability of adherence after DOT

The Miriam Hospital

120

90

1. Age greater than or equal to thirteen years of age
2. Eligible for initiation or change of HAART based on guidelines
3. Subject understands the study, agrees to procedures and follow-up visits, and signs the consent form
4. Self-reported substance use

1. Less than 13 years of age
2. Unable to give informed consent
3. Reported pregnancy and/or positive pregnancy test at time of recruitment
4. Percent PVL less than 1,000
5. Genotype that demonstrates resistance to once-a-day regimens
6. Informed consent not granted

A drug user in this study is defined as anyone who:

1. Reports having used heroin or cocaine ever in the past six months, or
2. Using marijuana, sedative or pain medications, or street drugs at least 4 out of the past 7 days, or
3. Answers yes to one of four CAGE questions AND reports at least 14 drinks per week or greater than 4 drinks at one time (males) or reports at least seven drinks per week or greater than 3 drinks at one time (females)

Approximately 25%

100%

100%

Collected at baseline, 1 month, 3 months, and every three months until 24 months

Questionnaire:

• Socio-demographic information
• Medical history, medications, HIV medication side effects
• General health (self-report), use of alternative health practices
• Quality of life, depression
• HIV attitudes, social support, disclosure
• Drug use and sexual risk behaviors
• Adherence to HAART
• Questionnaires DOT

Laboratory Tests:

• Viral load
• CBC, differential, platelets
• T-cell subsets Genotype (Only at screening/baseline and at the time of a confirmed treatment failure)
• Pregnancy test (at screening/baseline only)

See box above