Test of an Intervention to Improve HIV Care
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|ClinicalTrials.gov Identifier: NCT01103856|
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : June 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Behavioral: Patient Mentor Intervention Behavioral: HIV transmission risk reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Test of an Intervention to Improve HIV Care|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||May 2016|
Experimental: Patient Mentor Intervention
The patient mentor intervention from TSHC has been adapted to the inpatient setting. Participants randomized to that arm will receive 2 sessions with a patient mentor during their hospitalization, as well as 5 phone call sessions over the 10 weeks after discharge and a brief meeting between the subject and the mentor when the subject attends their first outpatient visit at TSHC after discharge.
Behavioral: Patient Mentor Intervention
The first session includes an exploration of needs, barriers, and facilitators to HIV care. HIV educational materials are introduced to identify areas of need. Mentors will address concerns and possible barriers to care using their own experiences. Mentors will encourage participants to set goals related to acquisition of care following discharge and how to address possible barriers to that goal. The second session will reinforce the first session. Mentors will call the patient 5 times over the 10 weeks after discharge. These phone calls will be brief and goal centered, to either reinforce positive behavior if the patient is in care, or continue to help the patient re-engage in outpatient HIV care.
Placebo Comparator: HIV transmission risk reduction
Participants randomized to the control arm will receive an attention control intervention delivered by a patient educator who is not an HIV patient mentor. We will use a modified version of the RESPECT intervention for our attention control group. Similar to the active intervention, these patients will receive 2 sessions in the hospital and 5 phone calls over 10 weeks after discharge.
Behavioral: HIV transmission risk reduction
The control intervention is a modification of the project RESPECT intervention. We will use material from sessions 1, 2, and 3 of the RESPECT enhanced counseling intervention. These interactions will include a personalized assessment of risk behaviors and changing condom use self-efficacy. The second interaction will build on material covered during the first interaction, with additional focus on condom use attitudes. The counselors will call the patient 5 times in the 10 weeks after discharge. These phone-based sessions will be brief and goal centered, to reinforce safe HIV transmission behaviors.
Other Name: RESPECT
- Engaged in outpatient HIV care [ Time Frame: 6 Months ]A composite of attending at least one HIV primary care visit within 30 days of discharge AND at least one between 31 and 180 days AND, for patient with an indication for ART, achieving a one log10 decrease in HIV VL or maintaining a VL <400 c/mL at 180 days after discharge.
- Completion of at least one HIV primary care visit at TSHC within 30 days of discharge, health services use, changes in CD4 cell count and HIV VL, and quality of life. [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103856
|United States, Texas|
|Ben Taub General Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas P Giordano, MD, MPH||Baylor College of Medicine|