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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00344591
First received: June 23, 2006
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Acquired Immunodeficiency Syndrome
Behavioral: Structured Ecosystems Therapy (SET)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Ecosystems Therapy for Men Reintegrating Into Their Family

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • HIV transmission risk behaviors
  • HIV-related medical adherence (both measured at Months 4, 8, and 12)

Secondary Outcome Measures:
  • Mediators of HIV transmission risk reduction and medical adherence
  • Reduction in recidivism to prison (both measured at Months 4, 8, and 12)

Estimated Enrollment: 200
Study Start Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344591

Contacts
Contact: Olga Grinstead, PhD, MPH 415-597-9168 ogrinstead@psg.ucsf.edu
Contact: Kathleen McCartney 415-597-9279 kmccartney@psg.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94105
Contact: Kathleen McCartney    415-597-9279    kmccartney@psg.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Olga Grinstead, PhD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00344591     History of Changes
Other Study ID Numbers: R01 MH67495, R01MH067495, DAHBR 9A-ASI
Study First Received: June 23, 2006
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
HIV
AIDS

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014