AzTrials
AzTrials

HIV/AIDSBCUNCT02421159

Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage

A study testing Seek and Test Phase and Treat and Retain Phase in people with HIV/AIDS, run by New York University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Seek and Test Phase and Treat and Retain Phase
How many people
500 participants
Where
1 siteUnited States
Study dates
Feb 2015to Dec 2016
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • sexually active (vaginal, anal) with at least one partner of the opposite sex within the previous year;
  • reside in the 7 zip code central Brooklyn HRA (initial seeds only; peers may reside in the larger 19 zip code HRA);
  • comprehend English or Spanish;
  • HIV negative or unknown HIV status (initial seeds only; peers may be 'known positives');
  • willing to try to recruit peers;

Who cannot join

  • actively psychotic based on valid screening instrument;
  • participant in the past NHBS studies with HHR (called HET1, 2, 3);
  • enrolled already in the supplement study (RDS-ASTN), VBS or RDS-CTTN in the main study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York University College of Nursing

    New York, New York, 10003

Other trials in United States

About this study

The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).

HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample.

Read more

The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn.

The supplement study hypotheses are:

(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.

(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.

(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.

(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.

Read the detailed description

The Brooklyn Community United (BCU) study is a supplement to the main research study to seek, test, treat and retain heterosexuals at high risk for HIV. The main research study is entitled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project or BCAP (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling and Confidential Two-Session Testing with Navigation).

We have studied HHR in New York City as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. Building on the NHBS work, we are currently in our third year of the main study (R01DA032083, R#: 11-01257), the primary aim of which is to compare the efficacy of a peer-driven intervention that uses a respondent-driven sampling strategy ("RDS-CTTN") and venue-based sampling (VBS) with respect to identifying previously undiagnosed HIV infection. The main study is located in central Brooklyn, a high-risk area (HRA) with elevated rates of poverty, high heterosexual HIV prevalence, and where a generalized HIV epidemic may be said to exist.

To date, RDS-CTTN and VBS have enrolled approximately 45% of their samples (RDS-CTTN 1338/3000; VBS 174/400). Participants in both samples evidence high rates of risk factors (substance use, incarceration, homelessness, unemployment). As hypothesized, PDI/RDS is reaching a population with higher rates of risk factors, and lower rates of HIV testing compared to VBS. Almost all in RDS-CTTN and VBS had been tested at least once previously (> 86%), but fewer than half have been tested in the past year. Among those with lifetime testing, data suggest testing is infrequent with a median of 2.5 tests per ten years of adulthood. Interestingly, almost all of those who enroll in RDS-CTTN and VBS elected to test for HIV (> 90%), with no difference in HIV testing acceptance rates between those who tested previously and first-time testers. This suggests that those who enroll in the study, although they have known barriers to HIV testing and a range of risk factors for adverse outcomes, are open to confidential HIV testing. These findings support the promise of the RDS-CTTN approach, but preliminary studies also signal the need to reach those with the greatest fears of and barriers to HIV testing who will not engage in confidential testing.

With approximately 45% of the sample enrolled, HIV prevalence in the RDS-CTTN sample is 3.45% (37/1071); 35.14% of these are newly diagnosed (13/37). Rates of newly diagnosed HIV infection may continue to increase as recruitment chains reach deeper into hidden and more vulnerable components of networks. In VBS, 1.89% is newly diagnosed with HIV (3/159). Yet these HIV prevalence rates are lower than those found in two previous heterosexual cycles of NHBS in the local area: 7% in HET1 and 12.3% in HET2 spurring our interest in additional innovative strategies to seek out those with undiagnosed HIV.

Despite its high acceptability among enrolled participants and preliminary evidence of efficacy, the two-session RDS-CTTN approach may be less successful in enrolling those in the HRA who would decline confidential HIV testing in a formal setting or have poor access to such testing. The RDS-CTTN intervention may not be optimal for reaching those with the greatest psychosocial barriers to regular HIV testing, who may for a number of reasons have high rates of undiagnosed HIV, or individuals, particularly women, with multiple job and family responsibilities who may not have time for a two-session intervention. (Indeed women are under-represented in both RDS-CTTN [~ 40%] and VBS [~30%].) It is possible to test participants for HIV in a first encounter, aswe do in VBS and as other studies have done. In the supplement study, we build on lessons learned from themain study in progress and the literature to address this concern.

Anonymous testing is available in state and local health departments, in cases of occupational exposure, through home test/self-test technologies, and research studies including our local NHBS studies with HHR. There is some evidence to suggest individuals who test anonymously do so earlier in the course of their HIV disease than those who engage in confidential testing. Additionally, anonymous testing may be useful for and/or preferred by individuals from marginalized populations. As Kegeles and colleagues have found, many who seek anonymous HIV-antibody testing would avoid it under other circumstances, and anonymous testing may be preferred among those who suspect they are infected, and by bisexual individuals, and those who fear stigma and discrimination. Thus, a brief, anonymous HIV testing effort may appeal to and engage HHR who face barriers to confidential HIV testing.

While anonymous testing may be an effective and/or efficient strategy in the 'seek' phase of STTR, in the majority of studies and testing programs it does not address the vital step of linkage to care. Although anonymous testing tends to yield individuals earlier in their HIV disease, those who test anonymously are more likely to experience delays entering care, because anonymous testing sites and programs do not typically have the resources to engage individuals into linkage programs and are not co-located with medical care. For example, in a study of characteristics of the HIV testing encounter and linkage to care, Reed (2009) found that 36% of those testing anonymously did not enter care within three months of diagnosis, compared with 26% of those testing confidentially.

The supplement study hypotheses are:

(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.

(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.

(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.

(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.

Conditions
HIV/AIDS
Being tested
Seek and Test Phase, Treat and Retain Phase
Keywords
HIV/AIDS, vulnerable populations, heterosexuals at high risk, peer-driven intervention, tailored intervention, African-American, Latino/Hispanic, Seek, test, treat, and retain (STTR), Brooklyn
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.

  • Seek and Test PhaseBehavioural

    The primary endpoint for this phase is the proportion of newly identified HIV infections of the RDS-ASTN intervention. Components for eligible and willing participants are a computerized baseline interview, counseling session, blood draw for HIV testing, HIV pre-test counseling, use of blood samples for clinical lab tests if found to be HIV infected, semi-structured interviews (if selected), the opportunity to recruit peers for the study, and the post-test counseling session.

  • Treat and Retain PhaseBehavioural

    The primary endpoints for this phase are: proportion linked to care within three months and time to the HIV care appointment. Participants with HIV infection who are interested in participating will be enrolled in this phase and navigated to HIV primary care over three months. Components are the locator form, patient navigation and support contacts, medical report form, follow-up contacts to update locator information, semi-structured interviews, follow-up interview, and blood draw for clinical lab testing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of newly diagnosed HIV infections

    Measured: 1 week post-baseline

Secondary outcomes (2)
  1. proportion linked to care

    Measured: 3 months post-baseline

  2. time to the HIV care appointment

    Measured: 3 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJan 2016
  4. Study completionDec 2016

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02421159
Sponsor's protocol ID
14-00963
Acronym
BCU
Status last verified
Mar 2017
First submitted
15 Apr 2015
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Gwadz M, Cleland CM, Leonard NR, Kutnick A, Ritchie AS, Banfield A, Hagan H, Perlman DC, McCright-Gill T, Sherpa D, Martinez BY; BCAP Collaborative Research Team. Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling. BMC Public Health. 2015 Nov 16;15:1133. doi: 10.1186/s12889-015-2451-5.

    PubMed 26572865

Questions about this trial

What is this clinical trial studying?

A study testing Seek and Test Phase and Treat and Retain Phase 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 5 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 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.

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: 1 week post-baseline). 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 NCT02421159, 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; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in