Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials (the ACT2 Project)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Peer-driven intervention
Time-matched health education
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Control
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00593983
First Posted
January 2, 2008
Last Updated
October 31, 2022
Sponsor
New York University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00593983
Brief Title
Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials (the ACT2 Project)
Official Title
Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
According to a 2001 report by the U.S. Census Bureau, African Americans and Latinos make up 65% of all AIDS cases reported in the United States, yet they make up only 25% of the population in the United States. In addition, the number of women living with HIV/AIDS, many of whom are minorities, is rapidly increasing. ACTs are research studies designed to evaluate new therapies to fight HIV infection and prevent and treat opportunistic infections and cancers associated with AIDS. Preliminary research suggests that intensive intervention efforts are needed to improve rates of screening and to enroll more racial/ethnic minorities and women in ACTs. The purpose of this study is to identify effective intervention strategies to increase the low number of HIV infected racial/ethnic minorities and women who are screened for and enrolled into ACTs.
Each participant will be enrolled in the study for 12 months. Participants will be randomly assigned to either the intervention or control arm. Initial "seed" participants in the intervention arm will complete a peer-driven intervention consisting of four structured intervention sessions lasting 6 hours in total (occurring every week for 4 weeks), three peer education/recruitment experiences, and brief liaison contacts by an intervention facilitator during AIDS clinical trial screening. Participants in the control arm will complete a time-matched health education intervention lasting 6 hours. Participants in the control arm will also receive the community standard of care and be referred to their local ACT unit. Peer participants will be recruited by either a seed or through general recruitment; those recruited by an initial seed will participate in the same arm as the see d who recruited them. Study visits will occur throughout the study. Participants in the intervention arm will complete an interview at Week 30. At Weeks 8, 16 and 52, all participants will complete social impact assessments. At Weeks 16 and 52, all participants will complete follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Peer-driven intervention
Intervention Description
Consists of four structured intervention sessions lasting 6 hours in total, three peer education/recruitment experiences, and brief liaison contacts by an intervention facilitator during AIDS clinical trial screening
Intervention Type
Behavioral
Intervention Name(s)
Time-matched health education
Intervention Description
Health education and standard of care treatment
Primary Outcome Measure Information:
Title
Participation in screening for AIDS clinical trials to the point of determining eligibility, coded as yes/no.
Description
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).
Time Frame
within the participant's 52 week follow up period
Secondary Outcome Measure Information:
Title
Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study
Description
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).
Time Frame
within the participant's 52 week follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marya Gwadz, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials (the ACT2 Project)
We'll reach out to this number within 24 hrs