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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780260
• Other study ID #: 2R01DA013131-06A2
• Secondary ID: R01DA013131-06A2
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2008
• Last updated: December 10, 2013
• Start date: May 2007
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Current substance abuse

• Current high-risk sexual behavior

• African American racial identification

Exclusion Criteria:

• Non resident of Miami-Dade county

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• strengths-based case management
5 session individual strengths-based case management; peer-involvement v. no peer involvement

Locations

Country	Name	City	State
United States	Nova Southeastern University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance abuse treatment linkage at 3 months		3 months	No
Primary	Substance abuse treatment engagement at 6 months		6 months	No
Primary	HIV related care at 3 and 6 months		3 and 6 months	No
Primary	Other health service utilization at 3 and 6 months		3 and 6 months	No