Case Management Alternatives for African American Women at High Risk for HIV

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00780260
First received: October 24, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to test two innovative case management approaches designed to increase linkages and engagement with drug abuse treatment, HIV-related care, and other health services among an underserved population of African American women at risk for HIV.


Condition Intervention Phase
HIV
Behavioral: strengths-based case management
Phase 3

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: Case Management Alternatives for African American Women at High Risk for HIV

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Substance abuse treatment linkage at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Substance abuse treatment engagement at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HIV related care at 3 and 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Other health service utilization at 3 and 6 months [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 562
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5 session strengths-based case management intervention delivered by a professional case manager and a peer support specialist team
Behavioral: strengths-based case management
5 session individual strengths-based case management; peer-involvement v. no peer involvement
Active Comparator: 2
5 session strengths-based case management intervention delivered by a professional case manager.
Behavioral: strengths-based case management
5 session individual strengths-based case management; peer-involvement v. no peer involvement

Detailed Description:

The study is fundamentally concerned with the implementation and evaluation of theoretically-based, culturally appropriate case management interventions targeting individual, social and environmental factors among highly vulnerable African American women. The research is designed to test innovative, comprehensive approaches to HIV prevention/intervention through case management driven service linkage and engagement. Testing new approaches to intervention with African-American women at high risk for HIV addresses a particularly urgent public health need in Miami, as well as other large metropolitan areas, where officials continue to document epidemic rates of HIV/AIDS clustered in urban, impoverished African-American communities.

Comparison: Participants will be randomly assigned to: a Strengths-Based / Professional Only Condition in which clients participate in a "strengths-based" case management approach; or, a Strengths-Based / Professional/Peer Condition in which a team composed of: a) a credentialed, professional case manager and b) a recovering addict peer - both trained in "strengths-based" case management techniques - develop and facilitate the implementation of a service plan.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current substance abuse
  • Current high-risk sexual behavior
  • African American racial identification

Exclusion Criteria:

  • Non resident of Miami-Dade county
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780260

Locations
United States, Florida
Nova Southeastern University
Miami, Florida, United States, 33137
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Hilary L Surratt, Ph.D. Nova Southeastern University
  More Information

No publications provided

Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00780260     History of Changes
Other Study ID Numbers: 2 R01 DA013131-06A2, R01DA013131-06A2
Study First Received: October 24, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Nova Southeastern University:
HIV/AIDS
African Americans
Women
Case Management

ClinicalTrials.gov processed this record on April 14, 2014