Clinical trial NCT01103856: Test of an Intervention to Improve HIV Care
Official title: Test of an Intervention to Improve HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV
adherence to care
retention in care
patient navigation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-04-15
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Engaged in outpatient HIV care
timeFrame: 6 Months
Secondary outcomes:
measure: 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.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Thomas P Giordano, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Sep 1;63(5):678-686. doi: 10.1093/cid/ciw322. Epub 2016 May 23.