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

Not Applicable

Completed

• Conditions: Crack Cocaine Use; Risky Sexual Behavior; HIV Infections

• Registration Number: NCT00447798
• Lead Sponsor: Columbia University

Brief 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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of Miami Hospital & Clinics/ Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Grady Health System-Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States