The EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) Study: Protocol for the Design, Implementation, and Evaluation of a Community-Based Combination HIV Prevention Intervention for Female Sex Workers in Baltimore, Maryland
Authors: Silberzahn Bradley E , Tomko Catherine A , Clouse Emily , Haney Katherine , Allen Sean T , Galai Noya , Footer Katherine H A , Sherman Susan G 
Published: February 2021

Background
Cisgender female sex workers (FSWs) experience high rates of HIV and sexually transmitted infections (STIs), including chlamydia and gonorrhea. Community empowerment–based responses to the risk environment of FSWs have been associated with significant reductions in HIV and STI risk and associated risk behaviors; however, evaluations of US-based interventions targeting FSWs are limited.

Objective
The objective of this study is to describe the design, implementation, and planned evaluation strategy of an ongoing comprehensive community-level intervention in Baltimore City, Maryland, which aims to improve HIV and STI risk and cumulative incidence among FSWs. The two intervention components are the SPARC (Sex Workers Promoting Action, Risk Reduction, and Community Mobilization) drop-in center and the accompanying comprehensive mobile outreach program. The mission of SPARC is to provide low-barrier harm reduction services to FSWs, with a special focus on women who sell sex and use drugs. Services are provided through a harm reduction framework and include reproductive health and sexual health care; medication-assisted treatment; legal aid; counseling; showers, lockers, and laundry; and the distribution of harm reduction tools, including naloxone and sterile drug use supplies (eg, cookers, cotton, syringes, and pipes).

Methods
The SPARC intervention is being evaluated through the EMERALD (Enabling Mobilization, Empowerment, Risk Reduction, and Lasting Dignity) study, which consists of a prospective 2-group comparative nonrandomized trial (n=385), a cross-sectional survey (n=100), and in-depth interviews assessing SPARC implementation (n=45). Participants enrolled in the nonrandomized trial completed a survey and HIV and STI testing at 4 intervals (baseline and 6, 12, and 18 months). Participants recruited from predefined areas closest to SPARC comprised the intervention group, and participants from all other areas of Baltimore were included in the control group.

Results
We hypothesize that addressing structural drivers and more immediate medical needs, in combination with peer outreach, will improve the HIV and STI risk environment, leading to community empowerment, and reduce the HIV and STI cumulative incidence and behavioral risks of FSWs. Data collection is ongoing. A baseline description of the cohort is presented.

Conclusions
In the United States, structural interventions aimed at reducing HIV and STIs among FSWs are scarce; to our knowledge, this is the first intervention of its kind in the United States. The results of the EMERALD study can be used to inform the development of future interventions targeting FSWs and other at-risk populations.

Trial Registration
ClinicalTrials.gov NCT04413591; https://clinicaltrials.gov/ct2/show/NCT04413591.

International Registered Report Identifier (IRRID)
DERR1-10.2196/23412