HIV Infections Clinical Trial
Official title:
Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials
Verified date | May 2012 |
Source | New York University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
African Americans and Latinos are increasingly affected by HIV/AIDS in the United States. Despite the increase in the number of infections in minority populations, these individuals are not adequately represented in AIDS clinical trials (ACTs). The purpose of this study is to identify effective intervention strategies to increase the number of HIV infected racial/ethnic minorities and women who are screened for and enrolled into ACTs.
Status | Completed |
Enrollment | 540 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for Initial Seeds: - HIV infected - Seen at the Betances Health Center or AIDS Service Center at least once in the last 6 months prior to study entry - Of African-American or Latino descent - Willing to recruit HIV infected peers - Able to conduct research activities (e.g., speaking and writing when necessary) in English Inclusion Criteria for Peers: - Documented recruitment for study participation - HIV infected - Willing to recruit HIV infected peers - Able to conduct research activities (e.g., speaking and writing when necessary) in English Exclusion Criteria: - Currently enrolled in an HIV/AIDS clinical trial - Currently psychotic based on standard assessment (e.g., MINI, Lecrubier et al., 1997) - Any condition that, in the opinion of the investigator, would interfere with participation in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
New York University | Beth Israel Medical Center, National Institute of Allergy and Infectious Diseases (NIAID) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participation in screening for AIDS clinical trials to the point of determining eligibility, coded as yes/no. | During interventions, participants in both arms receive contact information for local AIDS clinical trials units. Two sources of data are used to determine whether screening occurred. First, for participants screened at Beth Israel Medical Center, the study's main collaborating site, the screener notes the screening event in a participant status file. Second, during follow-up interviews at 16 and 52 weeks post-baseline, participants' screening experiences at other units are assessed. This self-reported screening is confirmed with the clinical trials units (all screening reports are verified). | within the participant's 52 week follow up period | |
Secondary | Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study | Two sources of data are used to determine whether enrollment occurred. First, for participants screened at Beth Israel Medical Center, the study's main collaborating site, study staff confirms participation in the trial with participants and trials units and log this in a participant status file. Second, during follow-up interviews at 16 and 52 weeks post-baseline, enrollment in studies and trials is assessed. This self-reported enrollment is confirmed with the clinical trials units (all enrollment reports are verified). | within the participant's 52 week follow-up period |
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