This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Project Wellness: Increasing HIV Testing Among West African Immigrants

This study has been withdrawn prior to enrollment.
(We did not receive proper funding to complete this study)
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network Identifier:
First received: January 3, 2011
Last updated: May 7, 2015
Last verified: May 2015
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 Intervention
Diabetes Hypertension HIV Behavioral: HIV testing Behavioral: General Health Screen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Project Wellness: Increasing HIV Testing Among West African Immigrants

Resource links provided by NLM:

Further study details as provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:

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

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

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

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

Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: January 3, 2011
Last Updated: May 7, 2015

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:
HIV testing
black Africans
health screening processed this record on September 21, 2017