Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
Recruitment status was Active, not recruiting
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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 Behavioral: Attention Control |
| 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 |
- 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 ]
- 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: | August 2012 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management
|
Behavioral: Prevention Care Advocate
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management
|
|
Active Comparator: 2
Attention Control: HIV education plus 8 discussion-facilitated videos on health promotion, employment, & lifestyle
|
Behavioral: Attention Control
Attention Control: HIV education plus 8 discussion-facilitated videos on health promotion, employment, & lifestyle
|
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 |
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| United States, Florida | |
| University of Miami Hospital & Clinics/ Jackson Memorial Hospital | |
| Miami, Florida, United States, 33136 | |
| 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 R Metsch, Principal Investigator, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00447798 History of Changes |
| Other Study ID Numbers: | RO1DA017612, 1R01DA017612 |
| Study First Received: | March 13, 2007 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Miami:
|
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 May 22, 2013