Directly Administered HIV Therapy in Methadone Clinics

We propose to conduct a randomized, unblinded, clinical trial of a medication adherence
intervention in opioid-dependent, HIV-infected participants who are initiating new
antiretroviral therapy, and who receive opioid agonist maintenance therapy with methadone or
buprenorphine in opioid treatment programs (OTPs) in Baltimore, MD. Randomization will be
stratified by study site and prior antiretroviral exposure. Two hundred participants will
be randomly assigned 1:1 self-administered antiretroviral therapy (SAT) or directly
administered antiretroviral therapy (DAART). Subjects assigned to DAART will take morning
doses of antiretroviral therapy with a nurse or medical assistant in a private room at the
OTP. DAART subjects will be transferred to self-administered therapy after 12 months. This
is a 5 year study and participants will be enrolled between month 6 and month 42 of the
study. The maximum follow-up for individual participants will be 18 months. Based on our
pilot experience we anticipate 50% of subjects will be women, 80% African American, with a
median age of 44 years. The following outcomes will be compared in the two study arms:

- Suppression of the viral load (primary outcome)

- Changes in CD4+ cell counts

- The development of antiretroviral drug resistance

- Retention to opioid agonist maintenance therapy, urine toxicology screens for drugs of
abuse, and self-reported drug and alcohol use

- Self-reported adherence with therapy, retention to ART, and clinical and psychosocial
moderators of adherence

- Electronically monitored medication adherence, using MEMS caps, in the first 2 months
of the study

Outcomes data will be obtained at study assessment visits at baseline, 3 months, 6 months,
12 months, and 18 months. Participants will provide contact information, take an
interviewer-administered survey, and provide blood and urine samples at study assessment
visits. MEMS cap data will be captured at 1 month and 2 months. Subjects will be
compensated for successful completion of study assessment visits and MEMS interrogations.