Trial record 4 of 21 for:    " March 07, 2007":" April 06, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT00447798
First received: March 13, 2007
Last updated: July 29, 2013
Last verified: February 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

Resource links provided by NLM:


Further study details as provided by Columbia University:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 520
Study Start Date: June 2005
Estimated Study Completion Date: October 2013
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevention Care Advocate
Prevention Care Advocate (PCA) intervention contains elements based on cognitive-behavioral theories and strengths-based case management. Intervention arm participants will undergo an 8 session intervention comprised of three components: 1) An individual strengths-based case management approach aimed at motivating participants to seek or maintain their engagement with HIV primary care and drug treatment; 2) A cognitive-behavioral, skills-building approach to increase participants' risk reduction knowledge, skills, and perceived self-efficacy as well as intention to change high risk transmission behaviors; and 3) A community placement in which study participants will have the opportunity to practice their advocacy skills in prevention and care setting.
Behavioral: Prevention Care Advocate
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management
No Intervention: Standard of Care
Standard of Care (SOC) condition involves standard practice, consisting of usual inpatient/hospital services provided within normal clinical practice, plus a brief educational session consisting of the review of the topics in the "Living with HIV" brochure published by the Centers for Disease Control and Prevention (CDC).

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
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: NCT00447798

Locations
United States, Florida
University of Miami Hospital & Clinics/ Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Lisa R Metsch, Ph.D. University of Miami
Principal Investigator: Carlos Del Rio, M.D. Emory University
  More Information

Additional Information:
No publications provided

Responsible Party: Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT00447798     History of Changes
Other Study ID Numbers: AAAK3156, 1R01DA017612
Study First Received: March 13, 2007
Last Updated: July 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
HIV positive
crack cocaine user
inpatient hospital setting
HIV knowledge
motivation
perceived self-efficacy
risky sexual behavior
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 14, 2014