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Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials (the ACT2 Project)

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ClinicalTrials.gov Identifier: NCT00593983
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : May 9, 2012
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Medical Center
Information provided by (Responsible Party):
Marya Gwadz, New York University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Peer-driven intervention Behavioral: Time-matched health education Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials
Study Start Date : May 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1 Behavioral: Peer-driven intervention
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
Placebo Comparator: 2
Control
 Behavioral: Time-matched health education
Health education and standard of care treatment


Outcome Measures
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Primary Outcome Measures :
  1. Participation in screening for AIDS clinical trials to the point of determining eligibility, coded as yes/no. [ Time Frame: within the participant's 52 week follow up period ]
    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 :
  1. Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study [ Time Frame: within the participant's 52 week follow-up period ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593983


Sponsors and Collaborators
New York University
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Medical Center
Investigators
Principal Investigator: Marya Gwadz, PhD New York University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Marya Gwadz, Senior Research Scientist, New York University
ClinicalTrials.gov Identifier: NCT00593983     History of Changes
Other Study ID Numbers: ACT2
R01AI070005 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases