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

December 10, 2013 updated by: Nova Southeastern University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

562

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33137
        • Nova Southeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Current substance abuse
  • Current high-risk sexual behavior
  • African American racial identification

Exclusion Criteria:

  • Non resident of Miami-Dade county

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

October 24, 2008

First Posted (ESTIMATE)

October 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2R01DA013131-06A2 (NIH)
  • R01DA013131-06A2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on strengths-based case management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe