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Completed

NCT Number: NCT00447798

Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Hospital & Clinics/ Jackson Memorial Hospital, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention Care Advocate

Behavioral

Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building & strengths based case management

Primary outcomes

  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.

    Time frame: 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2007
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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