Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use

Abstract

Suboptimal adherence to oral PrEP medications, particularly among younger sexual minority men (SMM), continues to be a key barrier to achieving more substantial declines in new HIV infections. Although variety of interventions, including web and text-message-based applications, have successfully addressed PrEP adherence, very few have addressed the potential influence of alcohol. This pilot study explored whether the Game Plan for PrEP, a brief, web-based and text messaging intervention, helped promote PrEP persistence and adherence and reduced condomless sex and alcohol use. Seventy-three heavy-drinking SMM on PrEP were recruited online from states with Ending the HIV Epidemic jurisdictions and randomly assigned 1:1 to receive either the Game Plan for PrEP intervention or an attention-matched control. We collected online surveys assessing primary outcomes at one, three, and six months post-enrollment. As secondary outcomes, we also collected dried blood spot samples at baseline, three, and six months to analyze for biomarkers of PrEP and alcohol use. Our results showed that the odds of stopping PrEP or experiencing a clinically meaningful lapse in PrEP adherence (≥ 4 consecutive missed doses) were not different across the two conditions. We also did not find evidence of any differences in condomless sex or drinking outcomes across conditions, although participants in both conditions reported drinking less often over time. These findings were consistent across both self-reported outcomes and biomarkers. Overall, we did not find evidence that our brief, web and text messaging intervention encouraged more optimal PrEP coverage or moderate their alcohol use.

Keywords: Digital health; HIV prevention; Medication adherence; Pre-exposure prophylaxis; SMS; Text messaging; mHealth.