- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00593983
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
|
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 komparator: 2
Control
|
Health education and standard of care treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Participation in screening for AIDS clinical trials to the point of determining eligibility, coded as yes/no.
Tidsramme: 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).
|
within the participant's 52 week follow up period
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study
Tidsramme: 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).
|
within the participant's 52 week follow-up period
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marya Gwadz, PhD, New York University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACT2
- R01AI070005 (U.S. NIH-bevilling/kontrakt)
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