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

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV Test Offer
General Health Screen Offer
Sponsored by
North Bronx Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HIV Test Offer

General Health Screen Offer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acceptance of HIV Testing
Rate of participation in voluntary rapid oral HIV test in each group

Secondary Outcome Measures

Proportion of African immigrants that accept HIV testing
Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups
Proportion of IDU that accept HIV testing
Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups
Proportion of minority MSM that accept HIV testing
Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups
Linkage to Care
Proportion of positively-screened participants that attend follow-up specialized medical care

Full Information

First Posted
December 13, 2012
Last Updated
May 7, 2015
Sponsor
North Bronx Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT01751100
Brief Title
The Feasibility of Using a General Health Screen to Increase HIV Testing in Community Pharmacies
Official Title
Building Bridges: Addressing HIV Stigma in At-Risk Groups in Community Pharmacies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
We did not receive proper funding to complete this study.
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Bronx Healthcare Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV Test Offer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
General Health Screen Offer
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
HIV Test Offer
Intervention Description
HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test
Intervention Type
Behavioral
Intervention Name(s)
General Health Screen Offer
Intervention Description
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 Measure Information:
Title
Acceptance of HIV Testing
Description
Rate of participation in voluntary rapid oral HIV test in each group
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Proportion of African immigrants that accept HIV testing
Description
Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups
Time Frame
30 minutes
Title
Proportion of IDU that accept HIV testing
Description
Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups
Time Frame
30 minutes
Title
Proportion of minority MSM that accept HIV testing
Description
Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups
Time Frame
30 minutes
Title
Linkage to Care
Description
Proportion of positively-screened participants that attend follow-up specialized medical care
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette Calderon, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

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

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