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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00780260
First received: October 24, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Case Management Alternatives for African American Women at High Risk for HIV

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

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 ]

Enrollment: 562
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780260

Locations
United States, Florida
Nova Southeastern University
Miami, Florida, United States, 33137
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Hilary L Surratt, Ph.D. Nova Southeastern University
  More Information

No publications provided

Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00780260     History of Changes
Other Study ID Numbers: 2 R01 DA013131-06A2, R01DA013131-06A2
Study First Received: October 24, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014