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

This study is a 3-arm randomized, prospective trial in which HIV-infected inpatients who report substance use at screening will be randomized in 1:1:1 ratio to Patient Navigator (PN) vs. Patient Navigator + Contingency Management (PN+CM) vs. Treatment as Usual (TAU). Randomization will occur after screening, informed consent, baseline assessment and collection of biological (blood) specimens. 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 approximately 6 and 12 months post-randomization.

To minimize patient and staff burden, sites may implement a pre-screening procedure with permission from their respective IRBs to determine which inpatients would meet the study's AIDS-defining illness/CD4 count/viral load inclusion criteria. Pre-screening, screening, enrollment, assessment, randomization and the initial intervention visit will (ideally) occur during the participant's stay at an inpatient facility. Recognizing that participants may be recruited at various stages of illness during their inpatient visit, however, this may not be possible. To allow maximum flexibility, all activities that occur after the screening informed consent may be completed after the patient has been discharged from the hospital. The intervention duration will be 6 months with sessions ideally occurring weekly during the first month, bi-weekly during months 2 and 3 and monthly during months 4- 6. Follow-up visits will occur at approximately 6 and 12 months post-randomization. Therefore, the total duration of individual participation in the study is approximately 12 months.

Prior to approaching patients to recruit them into the study, members of the medical teams within each hospital (i.e., attending physicians, fellows, residents and nurse practitioners) who are involved in patient care and who know the patients' HIV-infected status will assess the medical stability of the patients. If a patient has expressed interest in potentially participating in research and is deemed medically stable, then a study staff member will meet with the patient at bedside to discuss the study. Strict ethical guidelines regarding professional conduct and confidentiality will be enforced for all study staff.

Prior to screening individuals to determine their eligibility to participate, the research staff will briefly explain the study purpose, procedures, potential risks and benefits and voluntary nature of participation. Individuals willing to be screened to determine eligibility will provide written informed consent, including providing HIPAA authorization for medical record abstraction. After signing the consent and HIPAA forms, participants will be offered copies of the forms to keep for their records.

After the enrollment process (providing written informed consent and completing a locator form) is complete and a brief rapport-building discussion between the interviewer and participant has taken place, the research interviewer will administer the baseline assessment through a handheld Computer Assisted Personal Interview (CAPI) device. The CAPI system displays each assessment question on a computer monitor, allowing the interviewer to read the questions and then enter the participants' responses directly into the computer. The baseline assessment will include, but not be limited to questions on participant demographics, HIV care, medication adherence, substance use and co morbid conditions such as hepatitis, depression, etc.