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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447798
• Other study ID #: AAAK3156
• Secondary ID: 1R01DA017612
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: March 31, 2015
• Start date: June 2005
• Est. completion date: May 2011

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Crack Cocaine Use
• HIV Infections
• HIV Seropositivity
• Risky Sexual Behavior

Intervention

Behavioral:
• Prevention Care Advocate
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management

Locations

Country	Name	City	State
United States	Grady Health System-Grady Memorial Hospital	Atlanta	Georgia
United States	University of Miami Hospital & Clinics/ Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	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.		1 year	No