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

Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Peer-driven intervention; Behavioral: Time-matched health education

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 Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Beth Israel Medical Center
• Investigators: Principal Investigator: Marya Gwadz, PhD, New York University

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ACT2; R01AI070005 (U.S. NIH Grant/Contract)