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

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.

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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