NCT00780260

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
562

participants targeted

Target at P50-P75 for phase_3 hiv

Timeline
Completed

Started May 2007

Typical duration for phase_3 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.7 years

First QC Date

October 24, 2008

Last Update Submit

December 10, 2013

Conditions

HIV

Keywords

HIV/AIDSAfrican AmericansWomenCase Management

Outcome Measures

Primary Outcomes (4)

  • Substance abuse treatment linkage at 3 months

    3 months

  • Substance abuse treatment engagement at 6 months

    6 months

  • HIV related care at 3 and 6 months

    3 and 6 months

  • Other health service utilization at 3 and 6 months

    3 and 6 months

Study Arms (2)

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

2

ACTIVE COMPARATOR

5 session strengths-based case management intervention delivered by a professional case manager.

Behavioral: strengths-based case management

Interventions

strengths-based case managementBEHAVIORAL

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

12

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Non resident of Miami-Dade county

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Miami, Florida, 33137, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Hilary L Surratt, Ph.D.

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

US(1)