Expired Study
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Miami, Florida 33137


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Current substance abuse - Current high-risk sexual behavior - African American racial identification Exclusion Criteria: - Non resident of Miami-Dade county


Study is Available At:


Original ID:

2 R01 DA013131-06A2


NCT ID:

NCT00780260


Secondary ID:

R01DA013131-06A2


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nova Southeastern University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

562


Enrollment Type:

Actual


Overall Contact Information

Official Name:Hilary L Surratt, Ph.D.
Principal Investigator
Nova Southeastern University

Study Dates

Start Date:May 2007
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:January 2011
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 10, 2013
First Received Date:October 24, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Other health service utilization at 3 and 6 months
Time Frame:3 and 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:HIV related care at 3 and 6 months
Time Frame:3 and 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Substance abuse treatment engagement at 6 months
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Substance abuse treatment linkage at 3 months
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:strengths-based case management
Description:5 session individual strengths-based case management; peer-involvement v. no peer involvement
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:5 session strengths-based case management intervention delivered by a professional case manager.
Study Arm Type:Experimental
Arm Name:1
Description:5 session strengths-based case management intervention delivered by a professional case manager and a peer support specialist team

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Nova Southeastern University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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