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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01751100
Recruitment Status : Withdrawn (We did not receive proper funding to complete this study.)
First Posted : December 17, 2012
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Behavioral: HIV Test Offer Behavioral: General Health Screen Offer Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Building Bridges: Addressing HIV Stigma in At-Risk Groups in Community Pharmacies
Study Start Date : July 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Acceptance of HIV Testing [ Time Frame: 30 minutes ]
    Rate of participation in voluntary rapid oral HIV test in each group

Secondary Outcome Measures :
  1. Proportion of African immigrants that accept HIV testing [ Time Frame: 30 minutes ]
    Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups

  2. Proportion of IDU that accept HIV testing [ Time Frame: 30 minutes ]
    Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups

  3. Proportion of minority MSM that accept HIV testing [ Time Frame: 30 minutes ]
    Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups

  4. Linkage to Care [ Time Frame: up to one year ]
    Proportion of positively-screened participants that attend follow-up specialized medical care

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01751100

United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
North Bronx Healthcare Network
Principal Investigator: Yvette Calderon, MD, MS Albert Einstein College of Medicine, Inc.

Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network Identifier: NCT01751100     History of Changes
Other Study ID Numbers: RFA-MH-13-092-001
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases