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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	January 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	December 11, 2013
Last Verified:	December 2013

Keywords provided by Nova Southeastern University:

HIV/AIDS; African Americans; Women; Case Management