HIV InfectionsPhase 2NCT00344591
Effectiveness of Structured Ecosystems Therapy for Reducing HIV Risk Behaviors and Improving Treatment Adherence in HIV Infected Men Released From Prison
A Phase 2 study testing Structured Ecosystems Therapy (SET) and Individually tailored intervention in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and improving treatment adherence in HIV infected men newly released from prison. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- Structured Ecosystems Therapy (SET) and Individually tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2009
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Scheduled to be released from the California Medical Facility Prison in Vacaville, California or from San Quentin State Prison in Marin County, California between 21 to 90 days following study entry
- Speaks English or Spanish
- Able to provide contact information for at least one adult who will be living in the area and is able to participate in the study
Who cannot join
- Participation in the pilot study or previous enrollment in the study
- Release into another correctional facility or other restricted environment (after the initial release from prison) that would prevent participation in the study for more than 2 weeks (e.g., drug treatment program that does not allow visitors)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94105
About this study
Official title: Ecosystems Therapy for Men Reintegrating Into Their Family
This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and improving treatment adherence in HIV infected men newly released from prison.
Read the detailed description
Individuals in prison are four times more likely to have HIV or AIDS as compared to non-incarcerated people. Once HIV infected individuals are released from prison, they have a high risk of transmitting HIV to their sexual or needle-sharing partners. Therefore, it is important to encourage HIV risk reduction behavior among such inmates who are nearing release from prison. SET is a therapy program that mobilizes family and caregivers as a way to support and encourage behavior change within an individual. This study will use a tailored SET program to meet the specific needs of prisoners who are infected with HIV. The purpose of the study is to compare the effectiveness of the tailored SET program versus an individually focused therapy program at reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison.
This 12-month study will enroll HIV infected men who are being released from the California Medical Facility Prison in Vacaville, California or the San Quentin State Prison in Marin County, California. Participants will meet with study recruiters while in prison and complete questionnaires to assess sexual and drug-related HIV transmission risk behaviors and treatment adherence; they will also participate in a health education session. Participants will then be randomly assigned to either a 4-month tailored SET program or a 4-month individually focused therapy program. All participants will meet with study counselors twice while still in prison, and then weekly during the first 4 months following release from prison. Participants in the SET program will work with study counselors to tailor the program to meet their individual needs. Therapy sessions will be designed to restructure interactions and communication patterns between the participant and his support network; main goals will include reducing sexual and drug-related risk behaviors and improving HIV treatment adherence. Participants in the individually focused therapy program will focus on harm reduction, goal setting, and motivational enhancement. HIV transmission risk behaviors and treatment adherence will be assessed with surveys administered at Months 4, 8, and 12 for all participants.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- Structured Ecosystems Therapy (SET), Individually tailored intervention
- Keywords
- HIV, AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Ecosystems Therapy (SET)Behavioural
Individually tailored interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tailored SET program | Experimental | tailored SET program for reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison Receives: Behavioral: Structured Ecosystems Therapy (SET) |
| Individually focused therapy | Active comparator | Individually focused therapy program for reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison Receives: Behavioral: Individually tailored intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV transmission risk behaviors
Measured: 12 months
HIV-related medical adherence
Measured: 12 months
Secondary outcomes (2)
Mediators of HIV transmission risk reduction and medical adherence
Measured: 12 months
Recidivism to prison
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2009
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 University of California, San FranciscoThe 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Olga Grinstead, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344591
- Sponsor's protocol ID
- R01MH067495
- Other IDs
- R01MH067495, DAHBR 9A-ASI
- Status last verified
- Jul 2015
- First submitted
- 23 Jun 2006
- Last updated
- 24 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecosystems Therapy for Men Reintegrating Into Their Family
- ClinicalTrials.gov ID
- NCT00344591
- Acronym / sponsor ID
- R01MH067495
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- HIV, AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2005
- Primary completion
- Jun 2009 (actual)
- First posted
- 27 Jun 2006 (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.
This study will evaluate the effectiveness of Structured Ecosystems Therapy (SET), a form of therapy that includes family and caregivers, at reducing HIV transmission risk behaviors and improving treatment adherence in HIV infected men newly released from prison.
Detailed description
Individuals in prison are four times more likely to have HIV or AIDS as compared to non-incarcerated people. Once HIV infected individuals are released from prison, they have a high risk of transmitting HIV to their sexual or needle-sharing partners. Therefore, it is important to encourage HIV risk reduction behavior among such inmates who are nearing release from prison. SET is a therapy program that mobilizes family and caregivers as a way to support and encourage behavior change within an individual. This study will use a tailored SET program to meet the specific needs of prisoners who are infected with HIV. The purpose of the study is to compare the effectiveness of the tailored SET program versus an individually focused therapy program at reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison.
This 12-month study will enroll HIV infected men who are being released from the California Medical Facility Prison in Vacaville, California or the San Quentin State Prison in Marin County, California. Participants will meet with study recruiters while in prison and complete questionnaires to assess sexual and drug-related HIV transmission risk behaviors and treatment adherence; they will also participate in a health education session. Participants will then be randomly assigned to either a 4-month tailored SET program or a 4-month individually focused therapy program. All participants will meet with study counselors twice while still in prison, and then weekly during the first 4 months following release from prison. Participants in the SET program will work with study counselors to tailor the program to meet their individual needs. Therapy sessions will be designed to restructure interactions and communication patterns between the participant and his support network; main goals will include reducing sexual and drug-related risk behaviors and improving HIV treatment adherence. Participants in the individually focused therapy program will focus on harm reduction, goal setting, and motivational enhancement. HIV transmission risk behaviors and treatment adherence will be assessed with surveys administered at Months 4, 8, and 12 for all participants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored SET program | Experimental | Behavioral: Structured Ecosystems Therapy (SET)tailored SET program for reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison |
| Individually focused therapy | Active comparator | Behavioral: Individually tailored interventionIndividually focused therapy program for reducing sexual and drug-related HIV transmission risk factors and increasing HIV treatment adherence in HIV infected men who have recently been released from prison |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- Scheduled to be released from the California Medical Facility Prison in Vacaville, California or from San Quentin State Prison in Marin County, California between 21 to 90 days following study entry
- Speaks English or Spanish
- Able to provide contact information for at least one adult who will be living in the area and is able to participate in the study
Key exclusion criteria (2 listed)
- Participation in the pilot study or previous enrollment in the study
- Release into another correctional facility or other restricted environment (after the initial release from prison) that would prevent participation in the study for more than 2 weeks (e.g., drug treatment program that does not allow visitors)
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 |
|---|---|---|
| Structured Ecosystems Therapy (SET) | Behavioural | Tailored SET program |
| Individually tailored intervention | Behavioural | Individually focused therapy |
Primary outcome
HIV transmission risk behaviors
Time frame: 12 months
HIV-related medical adherence
Time frame: 12 months
2 secondary outcomes
Mediators of HIV transmission risk reduction and medical adherence
Time frame: 12 months
Recidivism to prison
Time frame: 12 months
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 24 Jul 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.
Olga Grinstead, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Structured Ecosystems Therapy (SET) and Individually tailored intervention in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 1 site 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 2 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HIV transmission risk behaviors (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Jul 2015.