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Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-Positive Crack Users
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), March 2007
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00447798
  Purpose

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, “Prevention Care Advocate” intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.


Condition Intervention
HIV Infections
Crack Cocaine Use
Risky Sexual Behavior
Behavioral: Prevention Care Advocate Interv (CBT & case mgmt)

MedlinePlus related topics: AIDS
Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title: Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-Positive Crack Users

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting.

Secondary Outcome Measures:
  • The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.

Estimated Enrollment: 520
Study Start Date: June 2005
Estimated Study Completion Date: March 2010
Detailed Description:

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, “Prevention Care Advocate” intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

This 8-session, multi-component, skills-building intervention adapted from strategies used in prior studies encourages participants to advocate prevention and receipt of primary care services for themselves and their peers. We will employ a randomized experimental design to compare the intervention’s efficacy with an attention-control group.

SPECIFIC AIMS Aim 1: To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting. The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.

Aim 2: To examine whether knowledge, motivation and perceived self-efficacy are impacted by the intervention, and if changes in these variables explain change in the behavioral outcomes of interest.

Aim 3: To determine the extent to which behavioral outcomes are maintained over time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV positive
  • Sexually active
  • Recruited from inpatient/hospital setting
  • Crack user

Exclusion Criteria:

  • HIV negative
  • Not sexually active
  • Not recruited from inpatient/hospital setting
  • Non crack user
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447798

Contacts
Contact: Lisa R Metsch, Ph.D. 305.243.3470 LMetsch@med.miami.edu
Contact: Lauren Gooden, M.P.H. 305.243.9844 LGooden@med.miami.edu

Locations
United States, Florida
University of Miami Hospital & Clinics/ Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Lauren Gooden, M.P.H.     305-243-9844     LGooden@med.miami.edu    
Principal Investigator: Lisa R Metsch, Ph.D.            
Sub-Investigator: Allan Rodriguez, M.D.            
Sub-Investigator: Shari Cayetano-Messinger, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa R Metsch, Ph.D. University of Miami
Principal Investigator: Carlos Del Rio, M.D. Emory University
  More Information

Sociomedical Sciences Research Group  This link exits the ClinicalTrials.gov site

Study ID Numbers: RO1DA017612
Study First Received: March 13, 2007
Last Updated: April 2, 2007
ClinicalTrials.gov Identifier: NCT00447798  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV positive
crack cocaine user
inpatient hospital setting
HIV knowledge
motivation
perceived self-efficacy
risky sexual behavior
HIV seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Cocaine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009