Clinical trial NCT01751100: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: North Bronx Healthcare Network
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Acceptance of HIV Testing
timeFrame: 30 minutes
Secondary outcomes:
measure: Proportion of African immigrants that accept HIV testing
timeFrame: 30 minutes
measure: Proportion of IDU that accept HIV testing
timeFrame: 30 minutes
measure: Proportion of minority MSM that accept HIV testing
timeFrame: 30 minutes
measure: Linkage to Care
timeFrame: up to one year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Yvette Calderon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: