DiabetesNCT01270061
Project Wellness: Increasing HIV Testing Among West African Immigrants
A study testing HIV testing and General Health Screen in people with Diabetes and Hypertension, run by North Bronx Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, HIV
- What is being tested?
- HIV testing and General Health Screen
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or older
- African-born
Who cannot join
- unable to understand the consent process
- known HIV status
- tested within the past 3 months
- language other than English or French
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Black African immigrants living in the United States have exceptionally high rates of HIV and AIDS. Sub-Saharan Africa remains the epicenter of the global HIV epidemic, accounting for 22.5 of the 33.3 million people living with HIV worldwide. Political, economic, and social instability in many African countries has resulted in an escalating number of Africans migrating to the United States. The number of black African immigrants in the U.S. is growing, having increased 166% between 1990 and 2000. The 1.4 million documented African-born immigrants in the U.S. in 2007 does not account for the many undocumented Africans living in the U.S. Immigrant-related stressors, particularly for undocumented migrants, present challenges to both black Africans and healthcare providers seeking to engage this community in HIV testing and treatment. Characteristically long delays in accessing health services and accepting HIV testing have resulted in a greater proportion of black Africans presenting with an AIDS diagnosis (45%), compared to both U.S.-born non-blacks (25%) and U.S.-born blacks (35%). As the U.S. community of black Africans continues to grow, efforts are needed to reduce the impact of HIV within such marginalized communities.
The lack of culturally sensitive voluntary HIV testing programs has discouraged early diagnoses and treatment for African-born immigrants in the United States. The investigators are developing a new theory-driven HIV testing program that builds on the successful history of developing HIV testing models in the emergency department (ED), but relies on partners from the black African immigrant community to address specific cultural, social, and practical barriers to HIV testing faced by their communities. Traditional methods of HIV testing have not been successful in testing high percentages of black Africans in the U.S. for several reasons including (1) their reluctance to access health care for prevention; (2) their unwillingness to disclose information to their social networks, thus rendering ineffective the CDC-recommended social networking strategies for reaching disaffected populations; (3) the stigma of HIV; and (4) cultural and migrant-specific factors that pose barriers to accessing health care. The investigators propose to partner with black African immigrant community members to identify the cultural and migrant-specific factors that interfere with HIV testing, identify those that characterize the African migrant experience regardless of country of origin, and develop videos that can be used to increase willingness to be tested at community testing sites. The investigators plan to develop and pilot Project Consensus, which will use a trusted community setting - the pharmacy - to establish a permanent site for HIV testing that will engage large numbers of black Africans; increase HIV awareness and eliminate the need to rely on social networks; and reduce stigma by placing HIV testing in the context of a general health screening.
This proposal is based on eight years of research and experience developing and testing BRIEF, a Bronx-based rapid HIV testing program in the ED that utilizes theory-based risk reduction videos and a user-friendly interactive touch screen computer program. The investigators have tested over 53,000 Bronx residents, with high acceptance rates (95%) for adult HIV testing and a high rate (85%) of linking HIV+ patients into specialized medical care. Project Consensus was developed out of recognition that BRIEF does not eliminate important barriers to HIV testing for black African immigrants, a community that suffers disproportionately from the health and social consequences of HIV. Given an increasing emphasis within the U.S. on efficient preventive care, this intervention has the potential to provide an exemplary method for engaging members of immigrant communities in earlier stages of disease.
The study has three phases: Phase 1 consists of interviews and focus groups to obtain community input on social and cultural barriers to testing. This input will frame the content of a health education video, as well as the creation of an effective HIV testing program. Phase 2 will develop the HIV testing intervention. Phase 3 is a feasibility trial to prepare for a future randomized controlled trial. An advisory board composed of a diverse group of African community leaders will inform and guide all three phases. There are three specific aims:
- Use individual interviews and focus groups to identify specific barriers to HIV testing and assess appropriate methods to increase participation in voluntary HIV testing among black African immigrants;
- Develop a theory-based HIV video to educate and encourage black African immigrants to get tested;
- Establish the feasibility of the intervention in a community pharmacy that places HIV testing in a general health context, as determined by: standard deviation for the primary outcome of HIV testing rates, use of a computer-based model; recruitment of black Africans in the pharmacies.
- Determine the percentage of individuals diagnosed with one of three chronic illnesses linked to care and determine predictors of those that refuse testing.
- Conditions
- Diabetes, Hypertension, HIV
- Being tested
- HIV testing, General Health Screen
- Keywords
- HIV testing, black Africans, immigrants, health screening
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV testingBehavioural
HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test.
General Health ScreenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General Health Screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing rate
rate of participation in voluntary rapid oral HIV test in each group
Measured: up to 1 hour
Secondary outcomes (3)
Health Knowledge
Change in knowledge of diabetes, hypertension, and HIV.
Measured: up to 1 hour
Risk perception
Change in participants' score on a validated health risk perception measure
Measured: up to 1 hour
Linkage to care
Proportion of positively-screened participants that attend follow-up specialized medical care.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startApr 2012
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: We did not receive proper funding to complete this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bronx Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvette Calderon,MD, MS, North Bronx Healthcare Network
- Investigators
- Yvette Calderon, MD, MS, Principal investigator, North Bronx Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270061
- Sponsor's protocol ID
- 2010-587
- Status last verified
- May 2015
- First submitted
- 3 Jan 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Wellness: Increasing HIV Testing Among West African Immigrants
- ClinicalTrials.gov ID
- NCT01270061
- Acronym / sponsor ID
- 2010-587
- Conditions
- Diabetes, Hypertension, HIV
- Keywords
- HIV testing, black Africans, immigrants, health screening
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We did not receive proper funding to complete this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- North Bronx Healthcare NetworkUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Black African immigrants living in the United States have exceptionally high rates of HIV and AIDS. Sub-Saharan Africa remains the epicenter of the global HIV epidemic, accounting for 22.5 of the 33.3 million people living with HIV worldwide. Political, economic, and social instability in many African countries has resulted in an escalating number of Africans migrating to the United States. The number of black African immigrants in the U.S. is growing, having increased 166% between 1990 and 2000. The 1.4 million documented African-born immigrants in the U.S. in 2007 does not account for the many undocumented Africans living in the U.S. Immigrant-related stressors, particularly for undocumented migrants, present challenges to both black Africans and healthcare providers seeking to engage this community in HIV testing and treatment. Characteristically long delays in accessing health services and accepting HIV testing have resulted in a greater proportion of black Africans presenting with an AIDS diagnosis (45%), compared to both U.S.-born non-blacks (25%) and U.S.-born blacks (35%). As the U.S. community of black Africans continues to grow, efforts are needed to reduce the impact of HIV within such marginalized communities.
The lack of culturally sensitive voluntary HIV testing programs has discouraged early diagnoses and treatment for African-born immigrants in the United States. The investigators are developing a new theory-driven HIV testing program that builds on the successful history of developing HIV testing models in the emergency department (ED), but relies on partners from the black African immigrant community to address specific cultural, social, and practical barriers to HIV testing faced by their communities. Traditional methods of HIV testing have not been successful in testing high percentages of black Africans in the U.S. for several reasons including (1) their reluctance to access health care for prevention; (2) their unwillingness to disclose information to their social networks, thus rendering ineffective the CDC-recommended social networking strategies for reaching disaffected populations; (3) the stigma of HIV; and (4) cultural and migrant-specific factors that pose barriers to accessing health care. The investigators propose to partner with black African immigrant community members to identify the cultural and migrant-specific factors that interfere with HIV testing, identify those that characterize the African migrant experience regardless of country of origin, and develop videos that can be used to increase willingness to be tested at community testing sites. The investigators plan to develop and pilot Project Consensus, which will use a trusted community setting - the pharmacy - to establish a permanent site for HIV testing that will engage large numbers of black Africans; increase HIV awareness and eliminate the need to rely on social networks; and reduce stigma by placing HIV testing in the context of a general health screening.
This proposal is based on eight years of research and experience developing and testing BRIEF, a Bronx-based rapid HIV testing program in the ED that utilizes theory-based risk reduction videos and a user-friendly interactive touch screen computer program. The investigators have tested over 53,000 Bronx residents, with high acceptance rates (95%) for adult HIV testing and a high rate (85%) of linking HIV+ patients into specialized medical care. Project Consensus was developed out of recognition that BRIEF does not eliminate important barriers to HIV testing for black African immigrants, a community that suffers disproportionately from the health and social consequences of HIV. Given an increasing emphasis within the U.S. on efficient preventive care, this intervention has the potential to provide an exemplary method for engaging members of immigrant communities in earlier stages of disease.
The study has three phases: Phase 1 consists of interviews and focus groups to obtain community input on social and cultural barriers to testing. This input will frame the content of a health education video, as well as the creation of an effective HIV testing program. Phase 2 will develop the HIV testing intervention. Phase 3 is a feasibility trial to prepare for a future randomized controlled trial. An advisory board composed of a diverse group of African community leaders will inform and guide all three phases. There are three specific aims:
- Use individual interviews and focus groups to identify specific barriers to HIV testing and assess appropriate methods to increase participation in voluntary HIV testing among black African immigrants;
- Develop a theory-based HIV video to educate and encourage black African immigrants to get tested;
- Establish the feasibility of the intervention in a community pharmacy that places HIV testing in a general health context, as determined by: standard deviation for the primary outcome of HIV testing rates, use of a computer-based model; recruitment of black Africans in the pharmacies.
- Determine the percentage of individuals diagnosed with one of three chronic illnesses linked to care and determine predictors of those that refuse testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV testing | Active comparator | Behavioral: HIV testingGroup 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. |
| General Health Screening | Experimental | Behavioral: General Health ScreenIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 years or older
- African-born
Key exclusion criteria (4 listed)
- unable to understand the consent process
- known HIV status
- tested within the past 3 months
- language other than English or French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV testingHIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test. | Behavioural | HIV testing |
| General Health ScreenA 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. | Behavioural | General Health Screening |
Primary outcome
HIV testing rate
Time frame: up to 1 hour
rate of participation in voluntary rapid oral HIV test in each group
3 secondary outcomes
Health Knowledge
Time frame: up to 1 hour
Risk perception
Time frame: up to 1 hour
Linkage to care
Time frame: up to one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvette Calderon, MD, MS principal investigator
North Bronx Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV testing and General Health Screen in people with Diabetes and Hypertension, run by North Bronx Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing rate (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.