Trial record 14 of 34 for:    " May 23, 2012":" June 22, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Minority AIDS Initiative Retention and Re-Engagement Project

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Care Resource
Program for AIDS Treatment & Health at The Brooklyn Hospital Center
Puerto Rico Community Network for Clinical Research on AIDS
Justice Resource Institute
Kansas City Free Health Clinic
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01616940
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:

  • Introduction and Assessment
  • HIV Transmission & Viral Life Cycle
  • Effective Communication and Self-Advocacy
  • Understanding Lab Values
  • HIV Medications
  • Drug Resistance & Adherence, and Understanding & Managing Side Effects
  • Disclosure and Stigma
  • Harm & Risk Reduction

Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks:

  • Are any services needed?
  • Have referrals or appointments been made?
  • Does patient need accompaniment to a visit?
  • Connect patient with services as needed.
  • Appointment reminders.
  • Overall well-being?
  • Schedule next peer contact.
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616940

Locations
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
Sponsors and Collaborators
Boston University
Care Resource
Program for AIDS Treatment & Health at The Brooklyn Hospital Center
Puerto Rico Community Network for Clinical Research on AIDS
Justice Resource Institute
Kansas City Free Health Clinic
Investigators
Principal Investigator: Carol Tobias, MHHS Health and Disability Working Group, Boston University School of Public Health
  More Information

No publications provided

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014