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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00447798 |
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: | Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-Positive Crack Users |
| Estimated Enrollment: | 520 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Active Comparator
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
|
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:
Exclusion Criteria:
Contacts and Locations| Contact: Lisa R Metsch, Ph.D. | 305.243.3470 | LMetsch@med.miami.edu |
| Contact: Tamy Kuper, BA | 305.243.6430 | Tkuper@med.miami.edu |
| United States, Florida | |
| University of Miami Hospital & Clinics/ Jackson Memorial Hospital | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Tamy Kuper, BA 305-243-6430 Tkuper@med.miami.edu | |
| Principal Investigator: Lisa R Metsch, Ph.D. | |
| Sub-Investigator: Allan Rodriguez, M.D. | |
| Sub-Investigator: Shari Cayetano-Messinger, Ph.D. | |
| Principal Investigator: | Lisa R Metsch, Ph.D. | University of Miami |
| Principal Investigator: | Carlos Del Rio, M.D. | Emory University |
More Information
| Responsible Party: | University of Miami, Miller School of Medicine ( Lisa R. Metsch, Ph.D./ PRINCIPAL INVESTIGATOR ) |
| Study ID Numbers: | RO1DA017612 |
| Study First Received: | March 13, 2007 |
| Last Updated: | February 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00447798 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV positive crack cocaine user inpatient hospital setting HIV knowledge |
motivation perceived self-efficacy risky sexual behavior HIV seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Cocaine Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases HIV Seropositivity HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
