HIV Engage—a Randomized Controlled Efficacy Trial of an Acceptance-Based Behavioral Therapy Intervention to Improve Retention in Care for HIV Treatment Naïve Patients: Study Protocol

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Second Department


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Contemporary Clinical Trials


Introduction: People with HIV (PWH) who are not consistently retained in medical care, particularly when they are first diagnosed, are at risk for: delayed antiretroviral therapy (ART) initiation, suboptimal ART adherence, unsuppressed viremia, and mortality. Suboptimal retention means effective ART cannot be leveraged to prevent onward HIV transmission. To address this, we developed and previously pilot tested the HIV Engage intervention—a novel behavioral approach to enhance retention in HIV care using acceptance-based behavioral therapy (ABBT)—and established feasibility and acceptability of this approach. In the current study, we investigate the efficacy of ABBT compared to an attention-matched control condition in a full-scale randomized controlled efficacy trial. Methods: Two hundred seventy HIV care naïve patients from geographically diverse clinics will be recruited and equally randomized to receive (a) the HIV Engage intervention, consisting of two 20–30 min ABBT sessions delivered in-person or remotely, or (b) an attention-matched HIV education control condition. Primary outcomes are number of HIV care appointments kept and HIV viral load suppression. Secondary outcomes are higher self-reported ART adherence, HIV status disclosure, increased social support, and reductions in perceived HIV stigma. Hypothesized mediators include acceptance of one's HIV diagnosis and willingness to disclose serostatus. We will also assess for epidemiologically-linked moderators of the treatment effect. Conclusions: ABBT represents a novel, potentially promising approach to enhance retention in ongoing HIV care among treatment naïve PWH. This study will contribute significant actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT.

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