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

NCT00593983 | Completed Phase 2

• 2 other identifiers: ACT2R01AI070005
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study

  within the participant's 52 week follow-up period

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Peer-driven intervention

2

PLACEBO COMPARATOR

Control

Behavioral: Time-matched health education

Interventions

Peer-driven intervention BEHAVIORAL

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

1

Time-matched health education BEHAVIORAL

Health education and standard of care treatment

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Beth Israel Medical Center: collaborator

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marya Gwadz, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Study Start: May 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 2, 2022

Record last verified: 2012-05