Minority AIDS Initiative Retention and Re-Engagement Project
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Purpose
| Condition | Intervention |
|---|---|
|
HIV/AIDS |
Behavioral: Enhanced Peer Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project |
- Number of participants retained continuously in quality HIV care [ Time Frame: 1 year ] [ Designated as safety issue: No ]"In HIV care" is defined as having a medical visit with a provider with prescribing privileges in an HIV care setting two or more times at least 3 months apart during the measurement year (HAB Performance Measure and National AIDS Strategy).
- Number of participants who are virally suppressed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Change from Baseline in Health-related Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.
- Change from Baseline in Self-Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
This will be measured using a scale that was developed and tested for the Chronic Disease Self-Management study*.
* Lorig, K., Stewart, A., Ritter, P., Gonzalez, V., Laurent, D. & Lynch, J. (1996). Outcome Measures for Health Education and other Health Care Interventions. Thousand Oaks CA: Sage Publications, 24-25, 41-45.
- Change from Baseline in HIV knowledge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HIV Knowledge will be measured using The HIV Treatment Knowledge Scale*.
*Balfour, L., MacPherson, P., Garber, G., Beique, L. & Cameron, D. (2007). Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care, 19, 1141-1148.
| Estimated Enrollment: | 375 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard-of-care
Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services.
|
|
|
Experimental: Enhanced Peer Intervention
Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.
|
Behavioral: Enhanced Peer Intervention
Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention:
Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks:
Other Name: Peer Re-Engagement Project (PREP)
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01616940
| United States, Florida | |
| Care Resource | |
| Miami, Florida, United States, 33137 | |
| United States, New York | |
| PATH Center, The Brooklyn Hospital | |
| Brooklyn, New York, United States, 11226 | |
| Puerto Rico | |
| Puerto Rico Community Network for Clinical Research on AIDS | |
| San Juan, Puerto Rico, 00928-0850 | |
| Principal Investigator: | Carol Tobias, MHHS | Health and Disability Working Group, Boston University School of Public Health |
More Information
| Responsible Party: | Boston University |
| ClinicalTrials.gov Identifier: | NCT01616940 History of Changes |
| Other Study ID Numbers: | U69HA23262 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United States: U.S. Department of Health and Human Services, Health Resources and Services Administration |
ClinicalTrials.gov processed this record on September 30, 2016