Effectiveness of Structured Ecosystems Therapy for Reducing HIV Risk Behaviors and Improving Treatment Adherence in HIV Infected Men Released From Prison

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00344591
First received: June 23, 2006
Last updated: July 22, 2015
Last verified: July 2015

June 23, 2006
July 22, 2015
January 2005
June 2009   (final data collection date for primary outcome measure)
  • HIV transmission risk behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HIV-related medical adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HIV transmission risk behaviors
  • HIV-related medical adherence (both measured at Months 4, 8, and 12)
Complete list of historical versions of study NCT00344591 on ClinicalTrials.gov Archive Site
  • Mediators of HIV transmission risk reduction and medical adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recidivism to prison [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mediators of HIV transmission risk reduction and medical adherence
  • Reduction in recidivism to prison (both measured at Months 4, 8, and 12)
Not Provided
Not Provided
 
Effectiveness of Structured Ecosystems Therapy for Reducing HIV Risk Behaviors and Improving Treatment Adherence in HIV Infected Men Released From Prison
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Behavioral: Structured Ecosystems Therapy (SET)
  • Behavioral: Individually tailored intervention
  • Experimental: Tailored SET program
    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
    Intervention: Behavioral: Structured Ecosystems Therapy (SET)
  • Active Comparator: Individually focused therapy
    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
    Intervention: Behavioral: Individually tailored intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
Not Provided
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00344591
R01 MH67495, R01MH067495, DAHBR 9A-ASI
Not Provided
University of California, San Francisco
University of California, San Francisco
National Institute of Mental Health (NIMH)
Principal Investigator: Olga Grinstead, PhD, MPH University of California, San Francisco
University of California, San Francisco
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP