CVCTPlus: A Couples-Based Approach to Linkage to Care and ARV Adherence

Since the earliest reports of AIDS in the United States, men who have sex with men (MSM) have
been, and continue to be, the most heavily impacted risk group in the US HIV epidemic. In
2009, MSM accounted for 61% of new HIV diagnoses, an increase from 53% of HIV incidence in
2006. The "test and treat" strategy for HIV infection entails universal testing with
immediate treatment for those who test seropositive, with the aim of achieving viral
suppression among positives. The efficacy of treatment as prevention demonstrated in HPTN 052
has reinvigorated the discussion over using a "test and treat" strategy to reduce the
incidence of HIV infection in the US. However, engagement-in-care research raises a note of
caution regarding potential pitfalls in the effectiveness of this strategy. The recently
published MMWR "Vital Signs" Report, showed only 28% of all HIV-infected persons in the US
has a suppressed viral load. The estimates published by Gardner show that of the estimated
1.1 million persons infected with HIV in the United States, 21% of HIV-infected persons are
currently undiagnosed. Of those who are diagnosed, losses occur at initial linkage to care
and later in care such that only 50% remain in care, such that only 19% of HIV-infected
persons in the US currently having viral load below the limits of assay detection. There is
now substantial evidence of the role of couples - or main partnerships - in fueling the HIV
epidemic among MSM in the US. A recent CDC analysis found that 68% of new infections among
MSM in the US were ascribed to main sex partners, and the proportion of new infections from
main sex partners was even higher among younger MSM. Led by Sullivan and Stephenson, recent
work has illustrated the feasibility of enrolling couples into HIV prevention efforts and
demand for couples-focused services among MSM. A response to the growing demand for
couples-focused services has been the adaptation of Couples Voluntary Counseling and Testing
(CVCT) for MSM in the US. A recent NIMH-funded RCT of CVCT versus traditional VCT among MSM
(Sullivan PI) showed 22% of MSM couples to be sero-discordant. This collective evidence
provides the foundation for the proposed activities. We know that a significant proportion of
new HIV infections occur within couples, and we know that current levels of linkage to care,
retention in care and adherence to ARVs are below par among US MSM. In April 2012, WHO
released new guidelines for Couples HIV testing and counseling, including ARV for treatment
and prevention among sero-discordant couples [7]. The guidelines report a significant gap in
evidence around the uptake and adherence to ARV among couples, and the role of CVCT in
shaping uptake and adherence to ARVs: the proposed research has the potential to add
significantly to our understanding of these issues. The proposed activities investigate the
utility of CVCT combined with dyadic adherence counseling for improving linkage to care,
retention in care and adherence to ARVs. Through the screening of 350 MSM couples and the
enrollment of couples in a RCT, the study aims to examine the impact of CVCTPlus (CVCT plus
dyadic adherence counseling) versus the current standard of care (individual testing only) on
linkage to HIV care, retention in HIV care, adherence to ARV and achievement of viral
suppression among sero-discordant MSM couples. The specific aims are:

Primary Aims:

1. i. Aim 1: Examine if testing together for HIV and receiving dyadic adherence counseling
(Partner-STEPS) increases linkage to care as defined as: within three months after HIV
diagnosis, having (1) at least one clinical care appointment, (2) at least one CD4 count test
performed, and (3) at least one viral load test performed

ii. Aim 2: Examine if testing together for HIV and receiving dyadic adherence counseling
(Partner-STEPS) increases retention in care, as defined as: within the past 12 months, having
(1) at least two routine HIV care visits at least three months apart, (2) two or more CD4
tests, and (3) two or more viral load tests

iii. Aim 3: Examine if testing together for HIV and receiving dyadic adherence counseling
(Partner-STEPS) increases adherence to anti-retroviral therapy and reductions in viral loads
/ achievement of viral suppression

iv. Aim 4: Examine if testing together for HIV decreases sexual risk-taking both within dyads
and with outside sexual partners

v. Aim 5: Examine if testing together increases couples' coping and communication abilities

Hypothesis: Couples who receive a package of CVCT and a dyadic-focused adherence intervention
will achieve greater linkage to care, retention in care, adherence to ARVs and viral
suppression than couples who receive the standard of care (individualized VCT and adherence
counseling).

With increasing evidence of the role of ARVs in reducing HIV transmission, MSM couples
represent a significant target group for new interventions. The proposed activities will
provide new information demonstrating the efficacy of using a couples-based approach for
increasing ARV adherence and care seeking among couples.

b. Inclusion Criteria i. Male sex at birth ii. Male gender iii. 18 or older iv. Living in
Atlanta, Chicago, or Boston for at least three months v. Has a main Male Sexual Partner of
relationship duration one month or longer vi. In a known or assumed serodiscordant
relationship, that is, where one member of the couple is HIV-positive and one is either
known to be or believed to be HIV-negative or of unknown HIV status vii. If HIV-positive,
reporting of one or more of the following forms of suboptimal HIV medication adherence:

1. Never having seen a prescribing provider for HIV care

2. Not having a viral load test performed in the past six months, or not knowing if a
viral load test has been performed in the past six months

3. Never having been prescribed anti-HIV medications

4. Never having begun taking anti-HIV medications

5. Adherence to 90% or less of anti-HIV medications in the past week viii. No recent
(one-year) severe intimate partner violence reported within the couple (note: mutually
agreed-upon BDSM practices are excluded and not analogous with experiences of IPV)

(1) In the past six months, has he: i. Punched, hit or slapped you? ii. Kicked you? iii.
Pushed or shoved you? iv. Used force or threats of force to make you do something sexual
that you didn't want to do? v. Raped you? ix. No coercion to test for HIV reported within
the couple x. Willingness to be tested for HIV with one's male sexual partner xi.
Willingness to be randomized to either study arm xii. Participant reports feeling safe in
his relationship

c. Exclusion Criteria i. Sex at birth other than male ii. Gender other than male iii.
Either partner aged 17 or younger iv. Either partner living outside the Atlanta, Chicago,
or Boston areas, or having moved to these areas within the past three months v. Does not
have a main male sex partner or has a main male sex partner of relationship duration less
than one month vi. Both partners have known or assumed negative HIV status vii. Both
partners have known or assumed positive HIV status viii. Either partner reports
experiencing or perpetrating severe physical or sexual intimate partner violence within the
couple within the past year (see above, note that consensual BDSM practices are not
classified as IPV) ix. Either partner reports feeling unsafe in his relationship x. Either
partner reports feeling coerced or pressured into testing for HIV xi. Either partner
reports feeling coerced or pressured into joining the research study xii. Unwillingness to
test for HIV together with one's sexual partner xiii. Unwillingness to be randomized