HIV InfectionsNCT00447798
Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
A study testing Prevention Care Advocate in people with HIV Infections and Crack Cocaine Use, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Crack Cocaine Use, Risky Sexual Behavior
- What is being tested?
- Prevention Care Advocate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV positive
- Sexually active
- Recruited from inpatient/hospital setting
- Crack user
Who cannot join
- HIV negative
- Not sexually active
- Not recruited from inpatient/hospital setting
- Non crack user
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System-Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Miami Hospital & Clinics/ Jackson Memorial Hospital
Miami, Florida, 33136
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.
Read the 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.
- Conditions
- HIV Infections, Crack Cocaine Use, Risky Sexual Behavior
- Being tested
- Prevention Care Advocate
- Keywords
- HIV positive, crack cocaine user, inpatient hospital setting, HIV knowledge, motivation, perceived self-efficacy, risky sexual behavior, HIV seronegativity
- Medical subject headings
- HIV Infections, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Care AdvocateBehavioural
Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building \& strengths based case management
| Study group | Role | What they receive |
|---|---|---|
| Prevention Care Advocate | Experimental | 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. Receives: Behavioral: Prevention Care Advocate |
| Standard of Care | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startJun 2005
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa R Metsch, Ph.D., Principal investigator, University of MiamiCarlos del Rio, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447798
- Sponsor's protocol ID
- AAAK3156
- Other IDs
- 1R01DA017612
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2007
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users
- ClinicalTrials.gov ID
- NCT00447798
- Acronym / sponsor ID
- AAAK3156
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Care Advocate | Experimental | Behavioral: Prevention Care AdvocatePrevention 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. |
| Standard of Care | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive
- Sexually active
- Recruited from inpatient/hospital setting
- Crack user
Key exclusion criteria (4 listed)
- HIV negative
- Not sexually active
- Not recruited from inpatient/hospital setting
- Non crack user
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention Care AdvocatePrevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building \& strengths based case management | Behavioural | Prevention Care Advocate |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R Metsch, Ph.D. principal investigator
University of Miami
Carlos del Rio, M.D. principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Care Advocate in people with HIV Infections and Crack Cocaine Use, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.