Trial record 13 of 36 for:    " May 18, 2013":" June 17, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Community-based Interventions to Increase HIV Testing and HIV Care Utilization

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Kaiser Permanente
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01867177
First received: May 29, 2013
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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. identification of HIV infection among recently infected adolescents and adults
  2. improved access to HIV care, particularly among newly diagnosed adolescents and adults

To achieve these objectives, the following outcomes are expected from grantee programs:

  1. increased HIV testing among populations at risk for HIV
  2. improved health care utilization among HIV infected adults and adolescents

This initiative has been undertaken by Kaiser to affect HIV at a population level via community approaches to prevention, intervention and care in minority communities most affected by HIV (e.g. gay, African American, and Latino communities). The University of California, San Diego has developed and will oversee a cross-site evaluation of Kaiser grantee programs funded under this initiative. Each site will have a treatment and comparison group, and will conduct follow up surveys with their participants three and six months after their interventions.


Condition Intervention
HIV
Other: HIV testing
Other: standard of HIV care
Behavioral: HIV care utilization

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Community-based Interventions to Increase HIV Testing and HIV Care Utilization

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Increased HIV care utilization [ Time Frame: 3 and 6 months following intervention ] [ Designated as safety issue: No ]
    Improved access to HIV care, particularly among newly diagnosed adults.


Secondary Outcome Measures:
  • Increased HIV testing among populations at risk for HIV [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Increased HIV testing among populations at risk for HIV and identification of HIV infection among recently infected adults.


Estimated Enrollment: 800
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HIV testing
Identification of HIV infection among recently infected adults
Other: HIV testing
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.
Experimental: HIV care utilization
Improved access to HIV care and HIV care utilization, particularly among newly diagnosed adults
Behavioral: HIV care utilization
Sites will use a peer-based, client navigation model of an Integrated HIV/AIDS Early Intervention Services (ARTAS) Community Health Worker (CHW) Program (1-5 sessions with newly dx/dx within 12mo; case management/support services (4 contacts/mo/client for 6mo) linking people to continuous, coordinated care after HIV dx. Another site will do 3, 2hr Motivational Enhancement Intervention (MEI) sessions in 3 wks for HIV+: quality of life workshops, support groups at Butterfly Nest (safe project office for transgender women); 1 booster session (2hrs) after 3-month follow-up; 6mo follow-up assessment. Health Educators recruit clients, make appointments, escort to test sites, intake, review. 4th site will hold monthly risk-reduction workshops, weekly HIV testing for formerly incarcerated.
Active Comparator: standard of care
Standard of HIV care; standard of linkage to HIV care
Other: standard of HIV care
Standard linkage and referral to HIV care includes HIV counseling, testing, and referrals. Both intervention and comparison groups will receive these.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  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: NCT01867177

Contacts
Contact: Alexandra Caraballo 510-267-2888 Alexandra.X.Caraballo@kp.org
Contact: Anita Raj, PhD anitaraj@ucsd.edu

Locations
United States, California
University of California, San Diego, School of Medicine, Division of Global Public Health Recruiting
La Jolla, California, United States, 92093
Contact: Jennifer Yore       jyore@ucsd.edu   
Contact: Anita Raj, PhD       anitaraj@ucsd.edu   
Principal Investigator: Anita Raj, PhD         
Sponsors and Collaborators
Kaiser Permanente
University of California, San Diego
Investigators
Principal Investigator: Anita Raj, PhD University of California, San Diego
  More Information

Publications:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01867177     History of Changes
Other Study ID Numbers: KP2012
Study First Received: May 29, 2013
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
HIV
health care utilization
HIV testing
access to care

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014