Project Wellness: Increasing HIV Testing Among West African Immigrants

NCT01270061 | Withdrawn

• 1 other identifier: 2010-587
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension; HIV

Keywords

HIV testing; black Africans; immigrants; health screening

Outcome Measures

Primary Outcomes (1)

• HIV testing rate

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

  up to 1 hour

Secondary Outcomes (3)

• Health Knowledge

  up to 1 hour

• Risk perception

  up to 1 hour

• Linkage to care

  up to one year

Study Arms (2)

HIV testing

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 testing

General Health Screening

EXPERIMENTAL

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

Interventions

HIV testing BEHAVIORAL

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

HIV testing

General Health Screen BEHAVIORAL

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.

General Health Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• African-born

You may not qualify if:

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

Sponsors & Collaborators

• North Bronx Healthcare Network: lead

Study Sites (1)

Community Bronx

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yvette Calderon, MD, MS

  North Bronx Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)