Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
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|ClinicalTrials.gov Identifier: NCT00447798|
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Crack Cocaine Use Risky Sexual Behavior||Behavioral: Prevention Care Advocate||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||May 2011|
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).
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447798
|United States, Florida|
|University of Miami Hospital & Clinics/ Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Grady Health System-Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Lisa R Metsch, Ph.D.||University of Miami|
|Principal Investigator:||Carlos del Rio, M.D.||Emory University|