Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
Public ClinicalTrials.gov record NCT01612169. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01612169
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 801 participants
Conditions and interventions
Conditions
Interventions
- Patient Navigation (PN) Group Behavioral
- Patient Navigator Plus Contingency Management (PN+CM) Group Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2012 (Type not available)
- Primary completion
- Jun 2015 (Actual)
- Completion
- Jun 2015 (Actual)
- Last update posted
- Mar 14, 2016
2012 – 2015
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital At University of Alabama, Birmingham (Uab) | Birmingham | Alabama | 35294 | — |
| Los Angeles County Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30322 | — |
| Stroger Cook County Hospital/Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Saint Luke's Roosevelt Hospital Center | New York | New York | 10019 | — |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | — |
| University of Pittsburgh Medical Center (Upmc) | Pittsburgh | Pennsylvania | 15213 | — |
| Parkland Health and Human Services | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01612169, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 14, 2016 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01612169 live on ClinicalTrials.gov.