Test of an Intervention to Improve HIV Care

HIV Infection Clinical Trial

Official title:

Test of an Intervention to Improve HIV Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103856
• Other study ID #: 1R01MH085527-01A1
• Secondary ID: 1R01MH085527-01A
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: June 20, 2016
• Start date: May 2010
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

At Thomas Street Health Center (TSHC), one of the largest outpatient HIV clinics in the country, we developed a structured, theory-based, Patient Mentor Program to improve retention in HIV primary care. Many patients with HIV infection hospitalized at Ben Taub General Hospital (BTGH) do not successfully return to TSHC after discharge from the hospital. The purpose of this study is to test the efficacy of a patient mentor intervention in a 5-year randomized, controlled trial in more than 430 socio-economically and racially diverse HIV-infected patients hospitalized at BTGH. We hypothesize that the intervention will meaningfully increase retention in HIV primary care after discharge compared to an attention control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1) Hospitalized at BTGH; 2) expected to be in the hospital for at least one more night at the time of enrollment; 3) at least 18 years of age at enrollment; 4) able to speak English or Spanish; 5) HIV infected, whether previously diagnosed or diagnosed this hospital stay; 6) cognitively aware enough to provide informed consent and participate in the study. Patients who are temporarily cognitively incapacitated (e.g., from an acute process) will be followed and approached for enrollment if and when they are cognitively and physically capable of participating in the study.

Exclusion Criteria:

1) Intending to use a source of HIV primary care other than TSHC after discharge from the hospital, because TSHC-specific mentoring is not relevant to them and the data on their appointments after discharge cannot be tracked; 2) in the opinion of the primary medical team, likely to be discharged to an institutional setting; 3) in the opinion of the primary medical team caring for the patient, likely to die in the hospital or be discharged to hospice; 4) cognitive impairment that in the opinion of the primary medical team caring for the patient is not expected to improve by discharge; 5) prisoner at admission and expected to be discharged back to prison or jail; 6) having had an HIV primary care visit in at least 3 of the 4 previous quarter-years AND having had at least 3 consecutive HIV VL<400 c/mL over at least 6 months, the most recent of which is within 3 months of enrollment; 7) enrolled in any other research project with prospective follow-up; 8) already enrolled in this study at any time.

For the purposes of this study, "prisoner" will be defined in accordance with Federal regulations, as "any individual involuntarily confined or detained in a penal institution...[including] individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing…Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners." Parolees meeting the definition of prisoner will be ineligible for the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Giordano TP, Cully J, Amico KR, Davila JA, Kallen MA, Hartman C, Wear J, Buscher A, Stanley M. A Randomized Trial to Test a Peer Mentor Intervention to Improve Outcomes in Persons Hospitalized With HIV Infection. Clin Infect Dis. 2016 May 23. pii: ciw322. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engaged in outpatient HIV care	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.	6 Months	No
Secondary	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.		6 Months	No