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HIV InfectionsNCT01751100

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

A study testing HIV Test Offer and General Health Screen Offer in people with HIV Infections, run by North Bronx Healthcare Network at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
HIV Test Offer and General Health Screen Offer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 64 at time of recruitment

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
HIV Test Offer, General Health Screen Offer
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV Test OfferBehavioural

    HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test

  • General Health Screen OfferBehavioural

    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.

Study groups in NCT01751100
Study groupRoleWhat they receive
HIV Test OfferActive comparatorGroup 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.
Receives: Behavioral: HIV Test Offer
General Health Screen OfferExperimentalIn 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.
Receives: Behavioral: General Health Screen Offer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance of HIV Testing

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

    Measured: 30 minutes

Secondary outcomes (4)
  1. Proportion of African immigrants that accept HIV testing

    Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups

    Measured: 30 minutes

  2. Proportion of IDU that accept HIV testing

    Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups

    Measured: 30 minutes

  3. Proportion of minority MSM that accept HIV testing

    Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups

    Measured: 30 minutes

  4. Linkage to Care

    Proportion of positively-screened participants that attend follow-up specialized medical care

    Measured: up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2012 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Why it stopped: We did not receive proper funding to complete this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01751100
Sponsor's protocol ID
RFA-MH-13-092-001
Status last verified
May 2015
First submitted
13 Dec 2012
Last updated
8 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing HIV Test Offer and General Health Screen Offer in people with HIV Infections, run by North Bronx Healthcare Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance of HIV Testing (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.

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