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

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ClinicalTrials.gov Identifier: NCT00780260
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nova Southeastern University

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Behavioral: strengths-based case management Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Case Management Alternatives for African American Women at High Risk for HIV
Study Start Date : May 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Substance abuse treatment linkage at 3 months [ Time Frame: 3 months ]
  2. Substance abuse treatment engagement at 6 months [ Time Frame: 6 months ]
  3. HIV related care at 3 and 6 months [ Time Frame: 3 and 6 months ]
  4. Other health service utilization at 3 and 6 months [ Time Frame: 3 and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780260


Locations
United States, Florida
Nova Southeastern University
Miami, Florida, United States, 33137
Sponsors and Collaborators
Nova Southeastern University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Hilary L Surratt, Ph.D. Nova Southeastern University

Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00780260     History of Changes
Other Study ID Numbers: 2R01DA013131-06A2 ( U.S. NIH Grant/Contract )
R01DA013131-06A2 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

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