Introduction
Advances in HIV treatment have proven to be effective in increasing
virological suppression, thereby decreasing morbidity, and increasing
survival. Medication adherence is an important factor in reducing viral
load among people living with HIV (PLWH) and in the elimination of
transmission of HIV to uninfected partners. Achieving optimal medication
adherence involves individuals taking their medications every day or as
prescribed by their provider. However, not all PLWH in the USA are
engaged in care, and only a minority have achieved suppressed viral load
(viral load that is lower than the detectable limit of the assay).
Sexual and gender minorities (SGM; those who do not identify as
heterosexual or those who do not identify as the sex they were assigned
at birth) represent a high-risk population for poor clinical outcomes
and increased risk of HIV transmission, as they face barriers that can
prevent optimal engagement in HIV care. Research in dyadic support,
specifically within primary romantic partnerships, offers a promising
avenue to improving engagement in care and treatment outcomes among SGM
couples. Dyadic interventions, especially focused on primary romantic
partnerships, have the potential to have a sustained impact after the
structured intervention ends.
Methods and analysis
This paper describes the protocol for a randomised control trial of
a theory-grounded, piloted intervention (DuoPACT) that cultivates and
leverages the inherent sources of support within primary romantic
relationships to improve engagement in HIV care and thus clinical
outcomes among persons who are living with HIV and who identify as SGM
(or their partners). Eligible participants must report being in a
primary romantic relationship for at least 3 months, speak English, at
least one partner must identify as a sexual or gender minority and at
least one partner must be HIV+ with suboptimal engagement in HIV care,
defined as less than excellent medication adherence, having not seen a
provider in at least the past 8 months, having a detectable or unknown
viral load or not currently on antiretroviral therapy. Eligible
consenting couples are allocated equally to the two study arms: a
structured six-session couples counselling intervention (DuoPACT) or a
three-session individually-delivered HIV adherence counselling
intervention (LifeSteps). The primary aim is to evaluate the efficacy of
DuoPACT on virological suppression among HIV+ members of SGM couples
with suboptimal engagement in care. The DuoPACT study began its target
enrolment of 150 couples (300 individuals) in August 2017, and will
continue to enrol until June 2021.
Ethics and dissemination
All procedures are approved by the Institutional Review Board at the
University of California, San Francisco. Written informed consent is
obtained from all participants at enrolment, and study progress is
reviewed twice yearly by an external Safety Monitoring Committee.
Dissemination activities will include formal publications and report
back sessions with the community.
Trial registration number
NCT02925949; Pre-results.
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