Case Management Alternatives for African American Women at High Risk for HIV - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00780260

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 III

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Case Management Alternatives for African American Women at High Risk for HIV

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	550
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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
University of Delaware Research Center
Miami, Florida, United States, 33134

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	James A Inciardi, Ph.D.	University of Delaware
Study Director:	Hilary L. Surratt, Ph.D.	University of Delaware

More Information

No publications provided

Responsible Party:	University of Delaware ( James A. Inciardi )
Study ID Numbers:	2 R01 DA013131-06A2
Study First Received:	October 24, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00780260 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

HIV/AIDS
African Americans
Women
Case Management

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on May 07, 2009