NCT01867177

Brief Summary

The purpose of this study is to conduct a cross-site evaluation of the Kaiser Permanente's Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program, designed to support community-based interventions to reduce the number of new HIV cases and to increase HIV care acquisition and maintenance in minority communities disproportionately affected by the HIV epidemic. This effort builds on the President's National Strategy for HIV Prevention and recent research documenting the importance and efficacy of "test and treat" and "treatment as prevention" approaches. Hence, goals of this important and novel work will focus on the following objectives:

  1. 1.identification of HIV infection among recently infected adolescents and adults
  2. 2.improved access to HIV care, particularly among newly diagnosed adolescents and adults
  3. 3.increased HIV testing among populations at risk for HIV
  4. 4.improved health care utilization among HIV infected adults and adolescents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
583

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable 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

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

3.5 years

First QC Date

May 29, 2013

Last Update Submit

July 27, 2018

Conditions

Keywords

HIVhealth care utilizationHIV testingaccess to care

Outcome Measures

Primary Outcomes (1)

  • Increased HIV care utilization

    Improved access to HIV care, particularly among newly diagnosed adults.

    3 and 6 months following intervention

Secondary Outcomes (1)

  • Increased HIV testing among populations at risk for HIV

    at baseline

Study Arms (3)

HIV testing

OTHER

Identification of HIV infection among recently infected adults

Other: HIV testing

HIV care utilization

EXPERIMENTAL

Improved access to HIV care and HIV care utilization, particularly among newly diagnosed adults

Behavioral: HIV care utilization

standard of care

ACTIVE COMPARATOR

Standard of HIV care; standard of linkage to HIV care

Other: standard of HIV care

Interventions

HIV testing. Enhanced testing protocol is used: RESPECT, an evidence-based HIV prevention counseling intervention helping people increase condom use, decrease risky behaviors (resulting in a decrease in STIs) compared to those who did not receive the intervention. RESPECT includes: one-on-one counseling using a structured protocol; "teachable moments" during counseling to motivate clients to change risk-taking behaviors; to explore the contexts in which risk behaviors occur to increase awareness of susceptibility; and negotiate achievable "next steps" with the client that support the larger risk reduction goal. Implemented using a structured protocol with monitoring to ensure the fidelity of the testing intervention.

HIV testing

Standard linkage and referral to HIV care includes HIV counseling, testing, and referrals. Both intervention and comparison groups will receive these.

standard of care

Sites will use a peer-based, client navigation model of an Integrated HIV/AIDS Early Intervention Services (ARTAS), Community Health Worker (CHW) Program, case management/support services linking people to continuous, coordinated care after HIV dx. Another site will do Motivational Enhancement Intervention (MEI) sessions with quality of ife workshops and support groups. Health Educators recruit clients, make appointments, escort to test sites, intake, review. Additional components can include food security support, social and group support, drop in centers, text messaging and social media, depending on sites. All sites focus on approaches to reach community members and facilitate their supportive linkage to care with behavioral and structural supports.

HIV care utilization

Eligibility Criteria

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

You may qualify if:

  • Individuals will be adults,
  • aged 18 and over,
  • with the capacity to give informed consent.

You may not qualify if:

  • Those who do not have the capacity to give informed consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego, School of Medicine, Division of Global Public Health

La Jolla, California, 92093, United States

Location

Related Publications (4)

  • CDC, HIV/AIDS Surveillance Report. 2007; 19:7. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2007report/pdf/2007SurveillanceRpoert.pdf

    BACKGROUND
  • Losina E, Schackman BR, Sadownik SN, Gebo KA, Walensky RP, Chiosi JJ, Weinstein MC, Hicks PL, Aaronson WH, Moore RD, Paltiel AD, Freedberg KA. Racial and sex disparities in life expectancy losses among HIV-infected persons in the united states: impact of risk behavior, late initiation, and early discontinuation of antiretroviral therapy. Clin Infect Dis. 2009 Nov 15;49(10):1570-8. doi: 10.1086/644772.

    PMID: 19845472BACKGROUND
  • Ojikutu B, Johns Hopkins Advanced Studies in Medicine, Overcoming Challenges To Accessing and Adhering to Care in Minority Patients Living with HIV, 2010;2:37-41

    BACKGROUND
  • HIV Prevention Trials Network. Available at http://www.hptn.org/web%20documents/PressReleases/HPTN052PressReleaseFINAL5_12_118am.pdf.

    BACKGROUND

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Microbiological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Anita Raj, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations