Clinical trial NCT01616940: Minority AIDS Initiative Retention and Re-Engagement Project
Official title: Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Peer support
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Care Resource
name: The Brooklyn Hospital Center
name: Puerto Rico Community Network for Clinical Research on AIDS
name: Justice Resource Institute
name: Kansas City Free Health Clinic
First posted: 2012-06-12
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with HIV/AIDS into care.

Detailed description: This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.

Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.

Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.

Eligibility criteria: Inclusion Criteria:

* HIV-positive; AND
* Age 18 years or older; AND
* Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
* New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
* The individual has been out of medical care at your clinic for 4 months or more.

Primary outcomes:
measure: Number of participants retained continuously in quality HIV care
timeFrame: 1 year
measure: Number of participants who are virally suppressed
timeFrame: 1 year
Secondary outcomes:
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 1 year
measure: Change from Baseline in Self-Efficacy
timeFrame: 1 year
measure: Change from Baseline in HIV knowledge
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Care Resource
state: Florida
city: Boston
country: United States
facility: Center for Advancing Health Policy and Practice
state: Massachusetts
city: Brooklyn
country: United States
facility: PATH Center, The Brooklyn Hospital
state: New York
city: San Juan
country: Puerto Rico
facility: Puerto Rico Community Network for Clinical Research on AIDS
Study officials:
affiliation: Center for Advancing Health Policy and Practice, Boston University School of Public Health
name: Jane Fox, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Advancing Health Policy and Practice, Boston University School of Public Health
name: Serena Rajabiun, MA, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biostatistics, Boston University School of Public Health
name: Howard Cabral, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States. AIDS Behav. 2018 Aug;22(8):2627-2639. doi: 10.1007/s10461-017-1999-8.