NIDA CTN Protocol 0049: Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users

Study ID
STU 012012-189

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Kathy Shores-Wilson
214-648-4615
kathy.shores-wilson@utsouthwestern.edu

Principal Investigator
Mamta Jain

Summary

This study is a three-group randomized, prospective trial for HiV-infected patients admitted for inpatient care who report having recently used opioids and/or stimulants and/or heavy alcohol in the past 12 months. Patients will be randomized to one of the following three groups: (1) Patient navigator intervention, (2) Patient navigator plus Contingency Management intervention, and (3)Treatment as usual.

The intervention content of these groups is briefly described below.
Patient navigator (Pn) Group: This intervention begins at bedside in the hospital and motivates individuals to engage in care and initiate or maintain antiretroviral therapy. The intervention also emphasizes the importance of drug treatment in assisting drug users to link to HiV primary care and views this as a critical and necessary part of the treatment plan.

Patient navigator plus Contingency Management (Pn+CM) Group: This intervention will combine the above-described Pn intervention with Contingency Management. Consistent with previous studies on contingency management, the interventionist (Patient navigator) will offer incentives on a progressive (escalating) scale of reinforcement. incentives will be provided for key behaviors including, but not limited to: attending HiV care and/or drug treatment appointments, and filling antiretroviral therapy medication prescriptions.

Treatment as usual (Tau) Group: This group will receive no protocol directed intervention. They will get standard of care referral/engagement services of the particular hospital site.

Participants assigned to the Pn and Pn+CM groups will meet (ideally at bedside if the participant is still hospitalized at the time of randomization) with the Patient navigator interventionist and will complete up to 11 intervention sessions over the 6-month-long intervention period. Participants assigned to the Tau group will receive care as it is typically offered in the inpatient setting. Follow-up visits will be conducted at 6 and 12 months post-randomization.

The primary outcome variable is binary: HiV viral suppression ([Less Than] 200copies/ml), as determined by blood draw at the 12 month follow-up versus presence of viral load [Greater Than] 200 or death (all-cause mortality). We are aware that, for patients on therapy, the goal of antiretroviral therapy is achieving a viral load [Quote]below the limit of detection of the assay[Quote] which currently is usually [Less Than] 40 copies/ml. However, we have chosen to define [Quote]suppression[Quote] as [Less Than] 200 copies/ml to be consistent with the January 2011 Guidelines for the use of antiretroviral agents in HiV-1-infected adults and adolescents. The date of randomization is the time point from which all outcomes will be measured.

an ancillary study was also added to collect a few additional variables via medical record extraction in order to develop a prediction model for readmission to a hospital.

Participant Eligibility

1. be admitted to a hospital and be HIV-infected at the time of recruitment
2. be at least18 years old
3. meet one of the following:
a. have an AIDS-defining illness during the current hospital admission OR
b. have the most recent CD4 count AND viral load performed within the past 6 months be <350 cells/uL AND >200 copies/mL OR
c. have the most recent CD4 count AND viral load performed with the past 12 months be <=500 cells/uL AND >200 copies/mL or unknown accompanied by the Site PI's discretion that the patient a) is likely to currently have a viral load >200 copies/mL, b) is not currently successfully/correctly taking ART, and c) needs to be on ART
4. report (OR have evidence in the medical record of) any opioid and/or stimulant and/or heavy alcohol use within the past 12 months. Medical record evidence may consist of a) positive toxicology screen(s) for stimulants or heavy alcohol or b) clinician notes indicating heavy use of alcohol, use of stimulants or non-prescribed opioids or abuse of prescribed opioids
5. have a Karnofsky performance scale index score of >= 60
6. provide informed consent
7. provide locator information
8. sign a HIPAA form / medical record release form to facilitate medical record abstraction
9. report living in the vicinity and being able to return for follow-up visits
10. complete the baseline assessment, including blood draw
11. be able to communicate in English