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Project Wellness: Increasing HIV Testing Among West African Immigrants

This study is not yet open for participant recruitment.
Verified August 2011 by North Bronx Healthcare Network
Sponsor:
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network
ClinicalTrials.gov Identifier:
NCT01270061
First received: January 3, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Project Wellness: Increasing HIV Testing Among West African Immigrants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:
  • HIV testing rate [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    rate of participation in voluntary rapid oral HIV test in each group


Secondary Outcome Measures:
  • Health Knowledge [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    Change in knowledge of diabetes, hypertension, and HIV.

  • Risk perception [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    Change in participants' score on a validated health risk perception measure

  • Linkage to care [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    Proportion of positively-screened participants that attend follow-up specialized medical care.


Estimated Enrollment: 120
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270061

Contacts
Contact: Christopher M Brusalis, BA 718-918-5476 christopher.brusalis@nbhn.net

Sponsors and Collaborators
North Bronx Healthcare Network
Investigators
Principal Investigator: Yvette Calderon, MD, MS North Bronx Healthcare Network
  More Information

No publications provided

Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT01270061     History of Changes
Other Study ID Numbers: 2010-587
Study First Received: January 3, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:
HIV testing
black Africans
immigrants
health screening

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
HIV Antibodies
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 03, 2013