NCT00344591

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

4.4 years

First QC Date

June 23, 2006

Last Update Submit

July 22, 2015

Conditions

Keywords

HIVAIDS

Outcome Measures

Primary Outcomes (2)

  • HIV transmission risk behaviors

    12 months

  • HIV-related medical adherence

    12 months

Secondary Outcomes (2)

  • Mediators of HIV transmission risk reduction and medical adherence

    12 months

  • Recidivism to prison

    12 months

Study Arms (2)

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

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

Behavioral: Individually tailored intervention

Interventions

Tailored SET program
Individually focused therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Olga Grinstead, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

January 1, 2005

Primary Completion

June 1, 2009

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations