Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users

Study Summary

Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU). Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of \<= 200 copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will differ from each other at the 12 month follow-up. Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of \<= 200 copies/mL) in the PN+CM group will be greater than that in the TAU group. Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than that in the PN group. Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that in the TAU group. Secondary Objectives: 1. To evaluate the effect of the experimental interventions on: HIV virological suppression and CD4 T-cell count changes at 6 months post-randomization; engagement in HIV primary care and visit attendance; and rate of hospitalizations. 2. To evaluate the effect of the experimental interventions on: drug use frequency and severity; and drug use treatment engagement and session attendance. 3. To assess selected mechanisms of action of the intervention (.i.e. mediators of intervention effect). 4. To assess potential characteristics associated with differential treatment effectiveness (i.e. moderators of intervention effect). 5. To evaluate the incremental cost and cost-effectiveness of the interventions.

Primary Outcome

The primary outcome variable is binary: HIV viral suppression (\<= 200 copies/ml), as determined by blood draw at/near the 12 month follow-up versus presence of viral load \> 200 or death (all-cause mortality). We are aware that, for patients on therapy, the goal of antiretroviral therapy is achieving a viral load "below the limit of detection of the assay" which currently is usually \< 40 copies/ml. However, we have chosen to define "suppression" as \<= 200 copies/ml to be consistent with the J

Interventions

• BEHAVIORAL Patient Navigation (PN) Group
• BEHAVIORAL Patient Navigator Plus Contingency Management (PN+CM) Group