An interventional study of Prevention Care Advocate in HIV Infections, Crack Cocaine Use and Risky Sexual Behavior, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-01.
Sponsored by Columbia University · Not applicable and Interventional
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 413 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion Criteria:
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
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).
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building \& strengths based case management
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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