Clinical trial NCT00447798: Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
Official title: Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Crack Cocaine Use
Risky Sexual Behavior
Keywords: HIV positive
crack cocaine user
inpatient hospital setting
HIV knowledge
motivation
perceived self-efficacy
risky sexual behavior
HIV seronegativity
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-03-15
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital & Clinics/ Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Health System-Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: University of Miami
name: Lisa R Metsch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carlos del Rio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: