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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

December 13, 2012
December 14, 2012
July 2013
May 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01751100 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Feasibility of Using a General Health Screen to Increase HIV Testing in Community Pharmacies
Building Bridges: Addressing HIV Stigma in At-Risk Groups in Community Pharmacies

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
  • HIV Counseling and Testing
  • HIV Infections
  • Behavioral: HIV Test Offer
    HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral 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.
  • 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.
    Intervention: Behavioral: HIV Test Offer
  • 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.
    Intervention: Behavioral: General Health Screen Offer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1200
July 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact: John Y. Rhee, BS 646-241-6792 john.rhee@nbhn.net
Contact: Mark Iscoe, BA 718-918-5476 mark.iscoe@nbhn.net
United States
 
NCT01751100
RFA-MH-13-092-001
No
Yvette Calderon,MD, MS, North Bronx Healthcare Network
North Bronx Healthcare Network
Not Provided
Principal Investigator: Yvette Calderon, MD, MS Albert Einstein College of Medicine of Yeshiva University
North Bronx Healthcare Network
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP