HIV InfectionsPhase 2NCT00593983
Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials (the ACT2 Project)
A Phase 2 study testing Peer-driven intervention and Time-matched health education in people with HIV Infections, run by New York University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Peer-driven intervention and Time-matched health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- HIV infected
- Willing to recruit HIV infected peers
- Able to conduct research activities (e.g., speaking and writing when necessary) in English
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Peer-driven intervention, Time-matched health education
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-driven interventionBehavioural
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
Time-matched health educationBehavioural
Health education and standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Peer-driven intervention |
| 2 | Placebo comparator | Control Receives: Behavioral: Time-matched health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within the participant's 52 week follow up period
Secondary outcomes (1)
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).
Measured: within the participant's 52 week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Medical Center
- Responsible party
- Sponsor
- Investigators
- Marya Gwadz, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593983
- Sponsor's protocol ID
- ACT2
- Other IDs
- R01AI070005
- Status last verified
- May 2012
- First submitted
- 2 Jan 2008
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials
- ClinicalTrials.gov ID
- NCT00593983
- Acronym / sponsor ID
- ACT2
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Medical Center
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Peer-driven intervention |
| 2 | Placebo comparator | Behavioral: Time-matched health educationControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-driven interventionConsists 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 | Behavioural | 1 |
| Time-matched health educationHealth education and standard of care treatment | Behavioural | 2 |
Primary outcome
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).
1 secondary outcome
Enrollment into an AIDS clinical trial or HIV/AIDS biomedical research study
Time frame: within the participant's 52 week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marya Gwadz, PhD principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peer-driven intervention and Time-matched health education in people with HIV Infections, run by New York University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.