The Feasibility of Using a General Health Screen to Increase HIV Testing in Community Pharmacies

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by North Bronx Healthcare Network
Sponsor:
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network
ClinicalTrials.gov Identifier:
NCT01751100
First received: December 13, 2012
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to see if offering a general health screening tailored towards high-risk groups (African immigrants, injection drug users (IDUs), and minority men who have sex with men (MSM)) will increase human immunodeficiency virus (HIV) testing, counseling, and linkage acceptance rates in community pharmacies.


Condition Intervention
HIV Counseling and Testing
HIV Infections
Behavioral: HIV Test Offer
Behavioral: General Health Screen Offer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Building Bridges: Addressing HIV Stigma in At-Risk Groups in Community Pharmacies

Resource links provided by NLM:


Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:
  • Acceptance of HIV Testing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Rate of participation in voluntary rapid oral HIV test in each group


Secondary Outcome Measures:
  • Proportion of African immigrants that accept HIV testing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups

  • Proportion of IDU that accept HIV testing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups

  • Proportion of minority MSM that accept HIV testing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups

  • Linkage to Care [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    Proportion of positively-screened participants that attend follow-up specialized medical care


Estimated Enrollment: 1200
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HIV Test Offer
Group 1 (Control) is the current standard of care in HIV testing. A trained counselor provides required information to obtain informed consent for HIV testing and provides rapid HIV testing on site.
Behavioral: HIV Test Offer
HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test
Experimental: General Health Screen Offer
In Group 2 (Intervention), a free general health screening is offered that may include a blood pressure check, blood glucose measurement, a Hepatitis C (HCV) test, and an HIV test.
Behavioral: General Health Screen Offer
A Research Assistant (RA) will provide health education on diabetes, hypertension, and HIV. The RA will then offer free blood pressure check, blood glucose measuring, rapid Hepatitis C (HCV) test, and a free, rapid oral HIV test.

Detailed Description:

About one-fifth of HIV-positive people in the United States remain unaware of their HIV status, and these individuals account for the majority of new transmissions. The preponderance of barriers to HIV has delayed diagnoses and treatment for HIV-infected individuals in the US, and such late diagnoses result in poorer outcomes for HIV-infected individuals and increased cost of medical care. The National HIV/AIDS Strategy for the United States has called for expanded HIV testing, but if the investigators simply replicate existing models, the investigators will continue to fail to reach and engage strategic at-risk populations. Project Building Bridges will use a community setting - the pharmacy - to establish an alternative site for HIV testing to engage large numbers of at risk populations, specifically men who have sex with men (MSM) of color, injection drug users (IDU), and African immigrants; increase HIV awareness, and reduce stigma by placing HIV testing in the context of a general health screening. There are two specific aims: 1) Build partnerships with community stakeholders to understand current barriers to HIV testing, and 2) Determine the effectiveness of a health screening approach by measuring acceptance of HIV testing. In the qualitative research phase, we will conduct focus group discussions of MSM of color, IDUs, and African immigrants, led by the Latino Commission on AIDS, a community-based organization with extensive experience in cultural competency training and utilizations of community social networks, especially with higher risk minority populations, to obtain insights that will help increase participation in HIV testing. Data obtained through qualitative work will guide the development of the "health screening" model, which would include other screening tests (like sugar, blood pressure, hepatitis C, etc) with an HIV test, depending on what the high risk groups preferred in the wellness bundle. The hypothesis is that, by tailoring the health screens, this bundling model will circumvent the stigma associated with HIV testing in these high-risk populations and increase HIV testing acceptance rates. The investigators will conduct a two-group randomized control trial comparing the "health screening" model (intervention) to an HIV test offer (control) in community pharmacies in the Bronx. The trial will help determine the preliminary impact on the acceptance of HIV testing when coupled with an overall health wellness screen. The investigators will also conduct a secondary analysis on HIV testing acceptance rates based on each high-risk groups.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 to 64 at time of recruitment

Exclusion Criteria:

  • Known to be HIV positive
  • Unable to understand the consent process for the study; or otherwise unable to consent to HIV testing
  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: NCT01751100

Contacts
Contact: John Y. Rhee, BS 646-241-6792 john.rhee@nbhn.net
Contact: Mark Iscoe, BA 718-918-5476 mark.iscoe@nbhn.net

Locations
United States, New York
Albert Einstein College of Medicine Not yet recruiting
Bronx, New York, United States, 10461
Contact: Yvette Calderon, MD, MS    718-918-5845    yvette.calderon@nbhn.net   
Sub-Investigator: Rosy Chhabra, PsyD         
Sub-Investigator: Ethan Cowan, MD, MS         
Sub-Investigator: Jason M Leider, MD, PhD         
Sub-Investigator: Laurie Bauman, PhD         
Sponsors and Collaborators
North Bronx Healthcare Network
Investigators
Principal Investigator: Yvette Calderon, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT01751100     History of Changes
Other Study ID Numbers: RFA-MH-13-092-001
Study First Received: December 13, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Antibodies
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014