Project Wellness: Increasing HIV Testing Among West African Immigrants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01270061
Recruitment Status : Withdrawn (We did not receive proper funding to complete this study)
First Posted : January 5, 2011
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network

Brief Summary:
Project Wellness is a new intervention that combines the use of culturally-sensitive, video-based education, a general health screening approach, and a community pharmacy setting into one program to improve black African immigrant participation in voluntary HIV testing. The study is divided into three phases: qualitative research; video production; and a feasibility trial. In Phase 1, the investigators will conduct in-depth interviews and focus group discussions with black African participants to obtain insights on overlapping and resonating themes that will help increase participation in HIV testing among black Africans in the Bronx. In Phase 2, data obtained through qualitative work will guide the development of four health education videos. A culturally-tailored educational video on diabetes, hypertension, and HIV will be developed and produced for each gender and in both English and French. In phase 3, the investigators will test the feasibility of a pharmacy-based, culturally-tailored, general health screen that includes rapid HIV testing. The trial will help determine the feasibility of using a computer-based model; recruitment of black Africans in the pharmacies; acceptance of testing; and linking individuals diagnosed with health problems into medical care. A secondary analysis will also determine predictors of refusing to be tested.

Condition or disease Intervention/treatment
Diabetes Hypertension HIV Behavioral: HIV testing Behavioral: General Health Screen

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Project Wellness: Increasing HIV Testing Among West African Immigrants
Study Start Date : April 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: HIV testing
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 testing
HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test.
Experimental: General Health Screening
In Group 2 (Intervention), a theory-based video is used to obtain informed consent for a free general health screening that includes a blood pressure check, blood glucose measurement, and an HIV test.
Behavioral: General Health Screen
A video will provide health education on diabetes, hypertension, and HIV. The video will then offer free blood pressure check, blood glucose measuring, and a free, rapid oral HIV test.

Primary Outcome Measures :
  1. HIV testing rate [ Time Frame: up to 1 hour ]
    rate of participation in voluntary rapid oral HIV test in each group

Secondary Outcome Measures :
  1. Health Knowledge [ Time Frame: up to 1 hour ]
    Change in knowledge of diabetes, hypertension, and HIV.

  2. Risk perception [ Time Frame: up to 1 hour ]
    Change in participants' score on a validated health risk perception measure

  3. Linkage to care [ Time Frame: up to one year ]
    Proportion of positively-screened participants that attend follow-up specialized medical care.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • aged 18 years or older
  • African-born

Exclusion Criteria:

  • unable to understand the consent process
  • known HIV status
  • tested within the past 3 months
  • language other than English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270061

United States, New York
Community Bronx
Bronx, New York, United States, 10467
Sponsors and Collaborators
North Bronx Healthcare Network
Principal Investigator: Yvette Calderon, MD, MS North Bronx Healthcare Network

Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network Identifier: NCT01270061     History of Changes
Other Study ID Numbers: 2010-587
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:
HIV testing
black Africans
health screening