Takemehome: innovative strategies to integrate prep and doxypep navigation into a nationwide home HIV/STI self-testing program in the united states

The National Institute of Mental Health awarded Public Health Foundation Enterprises, Inc. (doing business as Heluna Health) $610,601 on August 26, 2026, under the Mental Health Research Grants program (CFDA 93.242) to conduct a hybrid effectiveness-implementation study testing innovative strategies to increase pre-exposure prophylaxis (PrEP) and doxycycline post-exposure prophylaxis (DoxPEP) uptake and persistence among users of the TakemeHome.org home HIV/STI self-testing platform.

The recipient will evaluate two interventions across four high-prevalence jurisdictions: a direct-booking page enabling TakemeHome users to schedule virtual navigator visits facilitating linkage to PrEP and DoxPEP services, and integration with PrepMate, an interactive text-messaging program providing PrEP navigation and adherence support. The study includes interviews with 10–12 site staff annually to assess contextual, innovation, and implementation factors influencing successful linkage to PrEP and DoxPEP services.

Work is performed in City of Industry, California. The performance period runs from August 26, 2026, through June 30, 2031. The assistance type is a Project Grant.

Abstract

Pre-exposure prophylaxis (prep) use has the potential to substantially reduce new HIV infections throughout the US, but uptake and persistence remain low. Doxycycline post-exposure prophylaxis (doxypep) has been shown to decrease STI rates, particularly syphilis and chlamydia, but few are using IT nationwide. Takemehome.ORG is an online home HIV/STI testing program offered in nearly 30 jurisdictions across the US. Although a substantial proportion of people using takemehome fall into one or more of the high HIV seroincidence priority populations for prep use, prep uptake in this population is very low. We propose to leverage the takemehome.ORG platform and test two novel interventions to increase prep and doxypep uptake and persistence among takemehome testers. We developed a direct-booking page (DB) to allow individuals to schedule a virtual visit with a navigator to facilitate linkage to prep and doxypep services. In a pilot program, uptake of this service was high, with 90% completing a navigation visit. Additionally, we developed a program to link takemehome users to an interactive text-messaging program, prepmate, to facilitate ongoing prep navigation and provide adherence support for people starting prep. In a pilot study at 2 takemehome sites, prepmate had high feasibility and acceptability with nearly a third starting prep. We propose a hybrid type 3 effectiveness-implementation study of direct-booking with a navigator (DB) or DB + prepmate to increase prep and doxypep use across 4 jurisdictions with high HIV prevalence using takemehome. In aim 1, we propose to interview 10-12 site staff each year in these jurisdictions to assess inner and outer contextual, innovation, and bridging factors that influence successful linkage of takemehome testers to prep and doxypep services before and after implementation of DB and prepmate. We will also bring together navigators from collaborating clinics to learn from each other on how best to implement these interventions in a community of practice. In aim 2, we will enroll 300 takemehome users who express interest in prep into a 3-arm study and randomly assign them to 1) DB alone (n=100); 2) DB + prepmate (n=100); or standard of care (linkage to the website of a local prep clinic, n=100). Study participants will be followed for 9 months, and primary outcomes will include prep uptake and persistence assessed by electronic health record data (EHR) of participating clinics. Secondary outcomes will include objective measures of prep uptake and persistence (tenofovir diphosphate in dried blood spots, pictures of medication bottles) and EHR and self-reported doxypep uptake and persistence. Lastly, in aim 3, we will assess the cost and cost-effectiveness of both interventions. At the end of the study, we will have rigorously evaluated the implementation and effectiveness of two innovative strategies to facilitate prep and doxypep use among home HIV/STI testers in the US.