NCT01751100

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

December 13, 2012

Last Update Submit

May 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptance of HIV Testing

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

    30 minutes

Secondary Outcomes (4)

  • Proportion of African immigrants that accept HIV testing

    30 minutes

  • Proportion of IDU that accept HIV testing

    30 minutes

  • Proportion of minority MSM that accept HIV testing

    30 minutes

  • Linkage to Care

    up to one year

Study Arms (2)

HIV Test Offer

ACTIVE COMPARATOR

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

General Health Screen Offer

EXPERIMENTAL

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

Interventions

HIV Test OfferBEHAVIORAL

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

HIV Test 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.

General Health Screen Offer

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 64 at time of recruitment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Yvette Calderon, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations