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.

Background

Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the Financial Incentives, Randomization, with Stepped Treatment (FIRST) Trial, a multi-site randomized controlled efficacy trial.

Methods

PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1: Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2: Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described.

Conclusions

The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH.

Clinicaltrials

gov identifier: NCT03089320.