HIV/AIDSPhase 2/3BCAPNCT01607541
Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
A Phase 2/3 study testing BCAP peer-driven intervention (PDI) in people with HIV/AIDS, run by New York University at 1 site in United States.
Trial summary
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- BCAP peer-driven intervention (PDI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2016
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-60 years
- sexually active (vaginal, anal) with at least 1 opposite sex partner within the previous year
- reside in the central Brooklyn HRA defined in the Development Phase
- African-American or Latino/Hispanic race/ethnicity
- comprehend English or Spanish
- willing to provide locator information
Show all 10Show fewer
- willing to try to recruit peers
- not actively psychotic based on valid screening instrument
- not a participant in the two past NHBS studies with HHR (called HET1/HET2); not enrolled already in VBS or PDI/RDS in this study
- willing to be randomly assigned to intervention arm (initial seeds only, for PDI component)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University College of Nursing
New York, New York, 10003
About this study
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. The investigators research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR in central Brooklyn.
The primary goal of the proposed study is to evaluate the efficacy of a peer-driven intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a peer-based approach) versus venue-based sampling (a location-based approach).
Read more
The two main study hypotheses are:
(H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV compared to those recruited via venue-based sampling (VBS).
H2): Participants in the "Test and Treat: phase of the peer-driven intervention (all of whom will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time to starting HIV medication (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.
Read the detailed description
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. Our research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR. Reduced rates of HIV testing and treatment among HHR are due to structural (e.g., poor access), social (e.g., peer norms), and individual-level (e.g., low perceived risk) barriers. Thus active recruitment approaches modeled after NHBS are needed to overcome structural barriers, and peer-delivered interventions effectively reduce individual and social barriers to testing and treatment. The primary goal of the proposed study is to evaluate the efficacy of a multi-level enhanced peer-driven intervention (PDI) to seek, test, treat and retain HHR. The enhanced PDI is tailored specifically for HHR and includes computerized, navigation, and peer-delivered components to enhance future sustainability. The design of the intervention is guided by the Theories of Triadic Influence and Normative Regulation. Similar to NHBS, the enhanced PDI will use respondent-driven sampling (RDS). NHBS protocols use both venue-based sampling (VBS) and RDS for reaching populations at high risk. However, VBS and RDS have not yet been directly compared in terms of their yield of undiagnosed HIV infections. Thus the specific aims of this five-year proposed study are to: (1) compare the yield and efficiency of RDS and VBS to identify undiagnosed HIV infection among HHR; (2) measure the efficacy of an enhanced PDI compared to a control in terms of time to HIV care and HAART initiation, viral load suppression, and retention among those newly-diagnosed; (3) examine whether the effects of the PDI on HIV health/treatment outcomes are mediated by changes in individual (e.g., perceived risk), social (e.g., peer norms), and structural influences (e.g., enhanced access), and/or whether other factors (e.g., substance use) moderate its effects; and (4) to project the costs and cost-effectiveness of RDS vs. VBS and PDI.
The investigators will conduct the enhanced PDI (N=3000) in central Brooklyn, a location hyperendemic for HIV and where HHR experience poor access to testing and treatment. Simultaneously, VBS (N=400) will be undertaken in central Brooklyn. The proposed study complements local and national HIV prevention initiatives and is designed to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. The vast majority of HHR are African-American or Latino; therefore the proposed study may also impact racial/ethnic disparities in HIV/AIDS.
The study's main hypotheses are as follows:
(H1): Compared with venue-based sampling (VBS), and controlling for potential differences on key sociodemographic characteristics across the samples, participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV for the first time.
H2): Participants in the Test and Treat Phase of the BCAP PDI's intervention arm (all of whom will be HIV-infected) will evidence a shorter time to an HIV clinical appointment, a shorter time to initiating HAART (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.
- Conditions
- HIV/AIDS
- Being tested
- BCAP peer-driven intervention (PDI), Control intervention
- Keywords
- HIV/AIDS, vulnerable populations, heterosexuals at high risk, peer-driven intervention, tailored intervention, African-American, Latino/Hispanic, Seek, test, treat, and retain (STTR)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAP peer-driven intervention (PDI)Behavioural
Also called Brooklyn Community Action Project (BCAP) PDI
The Brooklyn Community Action Project (BCAP) PDI entails structured sessions including the computerized "CARE for Prevention" tool, 3 peer education experiences, and 6 months of navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and navigation).
Control interventionBehavioural
The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Peer-driven intervention | Experimental | The PDI entails structured intervention sessions including a computerized "CARE for Prevention" tool and HIV pre-test and post-test counseling, the opportunity to educate three peers on core education messages, and navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and six months of navigation) Receives: Behavioral: BCAP peer-driven intervention (PDI) |
| Control | Active comparator | The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care. Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of newly diagnosed HIV infections
Measured: 2 months post-baseline
time to HIV clinical appointment
Measured: 12-months post intervention
time to initiation of HAART if medically indicated
Measured: 12-months post intervention
viral load suppression
Measured: 12-months post intervention
retention in care
Measured: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marya Gwadz, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607541
- Sponsor's protocol ID
- R11-01257
- Other IDs
- R01DA032083
- Acronym
- BCAP
- Status last verified
- Jun 2016
- First submitted
- 23 May 2012
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gwadz M, Cleland CM, Hagan H, Jenness S, Kutnick A, Leonard NR, Applegate E, Ritchie AS, Banfield A, Belkin M, Cross B, Del Olmo M, Ha K, Martinez BY, McCright-Gill T, Swain QL, Perlman DC, Kurth AE; BCAP Collaborative Research Team. Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a "seek, test, treat, and retain" study. BMC Public Health. 2015 May 10;15:481. doi: 10.1186/s12889-015-1816-0.
PubMed 25958200
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-driven Intervention to Seek, Test & Treat Heterosexuals at High Risk for HIV
- ClinicalTrials.gov ID
- NCT01607541
- Acronym / sponsor ID
- BCAP / R11-01257
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, vulnerable populations, heterosexuals at high risk, peer-driven intervention, tailored intervention, African-American, Latino/Hispanic, Seek, test, treat, and retain (STTR)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 May 2012 (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.
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. The investigators research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR in central Brooklyn.
The primary goal of the proposed study is to evaluate the efficacy of a peer-driven intervention (PDI) to seek, test, treat and retain HHR. The investigators will also compare the effectiveness of two sampling methods to reach HHR: Respondent-driven sampling (a peer-based approach) versus venue-based sampling (a location-based approach).
The two main study hypotheses are:
(H1): Participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV compared to those recruited via venue-based sampling (VBS).
H2): Participants in the "Test and Treat: phase of the peer-driven intervention (all of whom will be HIV-infected) will show a shorter time to an HIV clinical appointment, a shorter time to starting HIV medication (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.
Detailed description
Approximately 21% of HIV infections in the U.S. are undiagnosed, but only about 40% of all adults have been tested. Thus, late diagnosis of HIV is common, and, furthermore, treatment delays and disruptions are widespread. Heterosexuals at high risk (HHR) are significantly less likely to test for HIV, are more likely to be diagnosed with HIV late, and experience serious barriers to entering care compared to other groups. Our research team has studied HHR in New York City (NYC) as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. The investigators found an HIV prevalence rate of 7.4% among HHR in NYC, and only 6% of these infections had been previously diagnosed. Further, in central Brooklyn, 10% were newly diagnosed with HIV. The proposed study will use NHBS methodology to target HHR. Reduced rates of HIV testing and treatment among HHR are due to structural (e.g., poor access), social (e.g., peer norms), and individual-level (e.g., low perceived risk) barriers. Thus active recruitment approaches modeled after NHBS are needed to overcome structural barriers, and peer-delivered interventions effectively reduce individual and social barriers to testing and treatment. The primary goal of the proposed study is to evaluate the efficacy of a multi-level enhanced peer-driven intervention (PDI) to seek, test, treat and retain HHR. The enhanced PDI is tailored specifically for HHR and includes computerized, navigation, and peer-delivered components to enhance future sustainability. The design of the intervention is guided by the Theories of Triadic Influence and Normative Regulation. Similar to NHBS, the enhanced PDI will use respondent-driven sampling (RDS). NHBS protocols use both venue-based sampling (VBS) and RDS for reaching populations at high risk. However, VBS and RDS have not yet been directly compared in terms of their yield of undiagnosed HIV infections. Thus the specific aims of this five-year proposed study are to: (1) compare the yield and efficiency of RDS and VBS to identify undiagnosed HIV infection among HHR; (2) measure the efficacy of an enhanced PDI compared to a control in terms of time to HIV care and HAART initiation, viral load suppression, and retention among those newly-diagnosed; (3) examine whether the effects of the PDI on HIV health/treatment outcomes are mediated by changes in individual (e.g., perceived risk), social (e.g., peer norms), and structural influences (e.g., enhanced access), and/or whether other factors (e.g., substance use) moderate its effects; and (4) to project the costs and cost-effectiveness of RDS vs. VBS and PDI.
The investigators will conduct the enhanced PDI (N=3000) in central Brooklyn, a location hyperendemic for HIV and where HHR experience poor access to testing and treatment. Simultaneously, VBS (N=400) will be undertaken in central Brooklyn. The proposed study complements local and national HIV prevention initiatives and is designed to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. The vast majority of HHR are African-American or Latino; therefore the proposed study may also impact racial/ethnic disparities in HIV/AIDS.
The study's main hypotheses are as follows:
(H1): Compared with venue-based sampling (VBS), and controlling for potential differences on key sociodemographic characteristics across the samples, participants recruited by respondent-driven sampling (RDS) will be more likely to test positive for HIV for the first time.
H2): Participants in the Test and Treat Phase of the BCAP PDI's intervention arm (all of whom will be HIV-infected) will evidence a shorter time to an HIV clinical appointment, a shorter time to initiating HAART (when medically indicated), higher rates of viral load suppression, and higher rates of retention in care compared to those in the control arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-driven intervention | Experimental | Behavioral: BCAP peer-driven intervention (PDI)The PDI entails structured intervention sessions including a computerized "CARE for Prevention" tool and HIV pre-test and post-test counseling, the opportunity to educate three peers on core education messages, and navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and six months of navigation) |
| Control | Active comparator | Behavioral: Control interventionThe control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- aged 18-60 years
- sexually active (vaginal, anal) with at least 1 opposite sex partner within the previous year
- reside in the central Brooklyn HRA defined in the Development Phase
- African-American or Latino/Hispanic race/ethnicity
- comprehend English or Spanish
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BCAP peer-driven intervention (PDI)Also: Brooklyn Community Action Project (BCAP) PDIThe Brooklyn Community Action Project (BCAP) PDI entails structured sessions including the computerized "CARE for Prevention" tool, 3 peer education experiences, and 6 months of navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and navigation). | Behavioural | Peer-driven intervention |
| Control interventionThe control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care. | Behavioural | Control |
Primary outcome
proportion of newly diagnosed HIV infections
Time frame: 2 months post-baseline
time to HIV clinical appointment
Time frame: 12-months post intervention
time to initiation of HAART if medically indicated
Time frame: 12-months post intervention
viral load suppression
Time frame: 12-months post intervention
retention in care
Time frame: 12 months post-intervention
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 3 Nov 2022.
- Derived from this study: PubMed 25958200Gwadz M, Cleland CM, Hagan H, Jenness S, Kutnick A, Leonard NR, Applegate E, Ritchie AS, Banfield A, Belkin M, Cross B, Del Olmo M, Ha K, Martinez BY, McCright-Gill T, Swain QL, Perlman DC, Kurth AE; BCAP Collaborative Research Team. Strategies to uncover undiagnosed HIV infection among heterosexuals at high risk and link them to HIV care with high retention: a "seek, test, treat, and retain" study. BMC Public Health. 2015 May 10;15:481. doi: 10.1186/s12889-015-1816-0.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BCAP peer-driven intervention (PDI) in people with HIV/AIDS, run by New York University at 1 site in United States.
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 10 inclusion and 0 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
proportion of newly diagnosed HIV infections (time frame: 2 months post-baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607541, which also lists 1 linked publication.
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 3 Nov 2022.