Clinical trial NCT00593983: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Beth Israel Medical Center
First posted: 2008-01-15
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Participation in screening for AIDS clinical trials to the point of determining eligibility, coded as yes/no.
timeFrame: within the participant's 52 week follow up period
Secondary outcomes:
measure: Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study
timeFrame: within the participant's 52 week follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: New York University
name: Marya Gwadz, PhD
role: PRINCIPAL_INVESTIGATOR
References: