Study protocol for a pilot randomized controlled trial to increase COVID-19 testing and vaccination among people who inject drugs in San Diego County

BACKGROUND: People who inject drugs (PWID) have low rates of COVID-19 testing and vaccination and are vulnerable to severe disease. We partnered with a local, community-based syringe service program (SSP) in San Diego County, CA, to develop the single-session theory- and evidence-informed “LinkUP” intervention to increase COVID-19 testing and vaccination. This paper details the protocol for a pilot randomized controlled trial (RCT) of the LinkUP intervention. METHODS: With significant community input into study design considerations, including through our Community and Scientific Advisory Board, the LinkUP pilot RCT leverages an ongoing cohort study with adult (≥ 18 years) PWID in San Diego County to recruit participants who have not recently undergone voluntary COVID-19 testing and are unvaccinated. Eligible participants are referred to SSP locations randomized to offer the active intervention (involving tailored education, motivational interviewing, and problem-solving strategies) or a didactic attention-control condition (information sharing only). Both conditions are delivered by trained peer counselors hired by the SSP and were designed to be delivered at mobile (outdoor) SSP sites in ~ 30 min. Intake data assesses COVID-19 testing and vaccination history, health status, and harm reduction needs (to facilitate SSP referrals). At the end of either intervention condition, peer counselors offer onsite rapid COVID-19 antigen testing and COVID-19 vaccination referrals. Out-take and follow-up data (via SSP and state health department record linkages) confirms whether participants received the intervention, COVID-19 testing (and results) onsite or within six months, and vaccination referrals (and uptake) within six months. Planned analyses, which are not powered to assess efficacy, will provide adequate precision for effect size estimates for primary (COVID-19 testing) and secondary (vaccination) intervention outcomes. Findings will be disseminated widely including to local health authorities, collaborating agencies, and community members. DISCUSSION: Lessons from this community-based pilot study include the importance of gathering community input into study design, cultivating research-community partnerships based on mutual respect and trust, and maintaining frequent communication regarding unexpected events (e.g., police sweeps, neighborhood opposition). Findings may support the adoption of COVID-19 testing and vaccination initiatives implemented through SSPs and other community-based organizations serving vulnerable populations of people impacted by substance use and addiction. Trial registration This trial was registered prospectively at ClinicalTrials.gov (identifier NCT05181657).