At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
In Brief
A clinical study evaluating Patient Navigation (PN) Group and Patient Navigator Plus Contingency Management (PN+CM) Group for HIV and 3 related conditions. Completed, enrolled 801 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
The patient navigator approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity.
Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM).