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The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic. The two approaches are:
Full description
We, the investigators at Johns Hopkins University, propose to enroll and randomize 120 opioid-dependent, HIV-infected participants, who receive care in the Johns Hopkins HIV Clinic to either:
The study interventions and follow-up will last 12 months. Participants will be enrolled over a 3-year period. Participants who are assigned to the clinic-based BPN/NX arm will receive BPN/NX (Suboxone®), individual counseling from a nurse interventionist, and group therapy sessions. Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic (Project LINK). LINK provides intensive case management, education, and support by a team that includes a social worker, a nurse, a pharmacist educator, and peer advocates. In addition to providing counseling and linkage to needed services, LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence. The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months. The case-management and referral arm represents standard-of-care in our clinic, which has been enhanced and codified for this trial. Study outcome visits will be performed at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months.
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120 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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