Hybrid Trial of Peer-Supported Affect Regulation and Contingency Management to Improve HIV Prevention Outcomes in the Southern United States

Wake Forest University Health Sciences, Winston-Salem NC

Investigators

Abstract

The rise in stimulant use is undermining HIV prevention efforts for women who inject drugs (WWID) in the southern U.S., where evidence-based interventions (EBIs) often fail to reach women. Contingency management (CM) is one of the most effective evidence-based interventions (EBI) for reducing stimulant use and preventing HIV among stimulant-using WWID. Incorporating positive affect (PA) strategies—such as activities that enhance feelings of joy, optimism, and gratitude—into CM may further strengthen its impact, making it more likely for WWID to achieve sustained stimulant use reduction and enhanced HIV prevention outcomes. To close the implementation gap for stimulant use EBI, implementation strategies must focus on the end-user, stimulant using WWID—amplifying their personal agency for HIV prevention and stimulant use. Our team of interdisciplinary experts, ideally positioned at the intersection of HIV prevention and stimulant use, implementation science, health outcomes research, and community-partnered research, will 1) use human- centered design to tailor a scalable CM+PA for HIV acquisition risk reduction among stimulant using WWID— SHE CARES; 2) conduct a pilot of SHE CARES and two-wave optimal validation study of objective measures of HIV acquisition risk reduction; and 3) compare the effectiveness and implementation of SHE CARES to an informational+CM-control for reducing HIV acquisition risk among stimulant using WWID. To develop SHE CARES, we will use the Discover/Design/Build/Test (DDBT) process to conduct in-depth interviews and focus group discussions with stimulant-using WWID and key informants to “discover” facilitators and barriers of a PA+CM for reducing HIV acquisition risk and hold stakeholder workshops to iteratively “design” and “build” SHE CARES. To “test” SHE CARES, understand user experiences, and determine revisions for SHE CARES we will conduct a brief, small-scale pilot among 30 WWID. We will also conduct a targeted validation of self- measured HIV acquisition risk among 60 WWID. To compare the effectiveness and implementation of SHE CARES to an informational+CM-control, we will deploy a type I effectiveness-implementation hybrid design, enrolling 350 stimulant-using WWID randomized 1:1 to SHE CARES or the informational+CM-control. Enrolled WWID will complete a 12-week CM program, with the SHE CARES arm also completing 5 PA sessions over the same period. CM and PA programs will be facilitated by trained peers. WWID will be followed for 9 months post-randomized and complete behavioral and biomedical assessments. Effectiveness will be measured as prevention-effective PrEP at 6 months. Guided by the RE-AIM framework, we will assess SHE CARES’ feasibility, cost, and economic value, ensuring it aligns with the needs of WWID while advancing HIV prevention. This project will prioritize the voices of WWID, providing a scalable model with potential for lasting public health impact in Ending the HIV Epidemic (EHE) regions.