NCT01402466

Brief Summary

The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2 hiv

Timeline
Completed

Started Aug 2011

Typical duration for phase_2 hiv

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

June 28, 2011

Last Update Submit

March 25, 2016

Conditions

HIV

Keywords

Drug userscriminal justiceHIV careHAARTincarceration

Outcome Measures

Primary Outcomes (1)

  • Log10 viral load

    Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

    Every 3 months for 2 years

Secondary Outcomes (2)

  • Engagement in HIV Care

    Every 3 months for 2 years

  • Initiation of Highly Active Antiretroviral Therapy (HAART)

    Every 3 months for 2 years

Study Arms (2)

Standard Referral

ACTIVE COMPARATOR

Participants randomized to this arm will be referred to local HIV care resources

Behavioral: Standard Referral

Project Bridge

EXPERIMENTAL

Participants randomized to this arm will be given the Project Bridge intervention

Behavioral: Project Bridge

Interventions

Standard ReferralBEHAVIORAL

Participants randomized to this arm will be referred to local HIV care resources

Standard Referral
Project BridgeBEHAVIORAL

Arm 2

Project Bridge

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • HIV antibody positive
  • not currently receiving HIV care

You may not qualify if:

  • already in care
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RTI International Urban Health Program

San Francisco, California, 94104, United States

Location

MeSH Terms

Conditions

Drug Misuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alex H Kral, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 26, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

March 28, 2016

Record last verified: 2016-03

Locations

US(1)