The Fenway Institute participated in several HIV Vaccine Studies over the course of 2019. During the fiscal year, we enrolled 30 participants in our HIV Vaccine Studies. We recently began enrollment for a Phase III HIV vaccine efficacy study which will enroll 40 participants at Fenway.

During fiscal year 2019, The Fenway Institute began enrolling for the PrEP @ Home Study, a trial of a home-based system of PrEP care that involves mail-in STI and HIV testing, as well as video conferences with a study provider. Since participants must be new to PrEP in order to be eligible, our research recruitment team has worked hard to develop new, creative outreach strategies to reach people not already engaged in PrEP care. We are also excited to be introducing same-day PrEP prescriptions, a practice shared by our partner sites, for the first time at Fenway Health.

RCT2, or the Rectal Chlamydia study, is part of a DMID sponsored STI clinical trial group (CTG) that Fenway was selected as a site for, comparing the efficacy of azithromycin vs doxycycline in the treatment of rectal chlamydia in adults 18 years and older who were assigned male sex at birth.  Enrollment began in summer of 2018 and was stopped in early 2020 due to an efficacy endpoint being reached. Fenway staff eagerly await study results which will likely be shared at an academic conference in the fall of 2020.

Another DMID STI CTG protocol, the Syphilis Study is assessing the effectiveness of a single 2.4 million unit dose of benzathine penicillin G (commonly referred to by the brand name Bicillin) vs. three doses given once weekly for three successive weeks in participants with primary, secondary or early latent syphilis. Eligible participants are adults 18 years and older of any gender. We began enrolling in November of 2018 and accrual is ongoing.

ExGen, or internally referred to as The Swab Study, compared the diagnostic abilities of four chlamydia and gonorrhea assays for rectal and oropharyngeal samples in adults 18 and over of any gender. We began enrolling in September 2018 and successfully enrolled 170 subjects before the study closed in June 2019.

A phase IV open-label evaluation of safety, tolerability, and acceptability of a fixed-dose formulation of bictegravir, emtricitabine/tenofovir alafenamide (B/F/TAF) for non-occupational prophylaxis following potential exposure to HIV-1”  This study was authored solely by Fenway Community Health. The primary objective of the study is to describe the safety and tolerability of a regimen containing BIC/F/TAF, once daily, when given for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. Every person enrolled will be screened and if eligible will receive a 28-day course of Biktarvy. Follow-up will include a total of 4 study visits over a 3-month period. We have enrolled 54 people so far.

MyChoices is an intervention development and feasibility and acceptability study of MyChoices, a theory-driven mobile app to increase HIV testing and PrEP uptake by young men who have sex with men (YMSM), ages 15-24. MyChoices app will be refined in theater testing and an open technical pilot, and will then the acceptability and feasibility of this integrated app will be evaluated in a pilot randomized controlled trial (RCT) among YMSM at risk for HIV acquisition in the US. Phase III (RCT) opened to accrual in October 2018 and participant follow-up will be complete in November 2019 . The cohort was fully enrolled with 60 participants on April 2019.

The ATN’s LSPY protocol will entail a two-phase study that includes individual, qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement; and a pilot randomized controlled trial (RCT) of up to 30 YMSM to assess feasibility, acceptability and preliminary efficacy of the LSPY compared to standard of PrEP care only to improve PrEP adherence. Our long-term goal is to develop scalable protocols to optimize at risk YMSM’s PrEP uptake and adherence in order to decrease HIV incidence. The adaptation for LifeSteps for PrEP for YMSM will be informed, developed, and refined through formative research that involves YMSM at all levels. Phase 1 has been completed, and enrollment of the pilot RCT began in September 2019 in Boston, Atlanta and Chicago.

P3 is a three arm, randomized-controlled trial (RCT) that will test the efficacy of the P3, a novel, theory-based mobile app that utilizes game mechanics and social networking features to improve PrEP adherence, retention in PrEP clinical care and PrEP persistence among young men who have sex with men (YMSM) and trans women who have sex with men (YTW), ages 16-24. We will test the efficacy of P3 and P3+, which adds Next Step Counseling delivered by an adherence counselor through the app, against PrEP standard of care. Participants will be randomized to P3, P3+, or standard of care. A cost comparison between P3 and P3+ will be conducted. Enrollment for P3 began in May 2019. To date, there have been 30 out of 34 participants enrolled in this study putting Fenway a year ahead of enrollment schedule.

In years 1-3 of the iTech, we will have optimized and pilot-tested using a similar study design and identical study outcomes two distinct mobile apps, LYNX and MyChoices, designed to increase HIV testing and PrEP uptake among YMSM. The apps were developed based on different theories of behavior change, and therefore contain different components, differing messaging strategies and different approaches for engaging youth. The individual apps will be tested in this follow-on research study to evaluate for efficacy. Comparing the apps will allow us to identify any efficacy differences in increasing HIV testing or increasing PrEP uptake between the two apps. If justified, we will combine the components of each app that have the greatest impact on behaviors into a final, composite app for dissemination. Enrollment for COMPARE began in September 2019.

TechStep is a two-condition, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative trans feminine, trans masculine, and gender non-conforming (here after: trans*) youth for reducing sexual risk behaviors (e.g., condomless anal intercourse, engagement in sex work, sex while feeling the effects of alcohol or drugs) and increasing PrEP uptake. Enrollment for TechStep began in September 2019 and to date, Fenway has enrolled 10 participants.

• Project Matter, is a refined text-enhanced psycho-behavioral randomized control trial to reduce under-addressed and modifiable barriers to engagement in HIV care, including internalized stigma and related emotions, among HIV-positive men who have sex with men who use substances and are sub-optimally engaged in HIV care. The project is funded by NIDA and aims to elucidate behavioral and social mechanisms associated with substance use, and optimize treatment success among this population.

• THRIVE+ is a behavioral intervention to treat trauma symptoms among HIV-positive MSM who have a history of trauma and are poorly engaged in HIV care.

• The MUSIC Study is an app-based music intervention to treat pain among people living with HIV who experience chronic pain and use opioids to manage their pain.
• Project Matter, is a refined text-enhanced psycho-behavioral randomized control trial to reduce under-addressed and modifiable barriers to engagement in HIV care, including internalized stigma and related emotions, among HIV-positive men who have sex with men who use substances and are sub-optimally engaged in HIV care. The project is funded by NIDA and aims to elucidate behavioral and social mechanisms associated with substance use, and optimize treatment success among this population.
• THRIVE+ is a behavioral intervention to treat trauma symptoms among HIV-positive MSM who have a history of trauma and are poorly engaged in HIV care.
• The MUSIC Study is an app-based music intervention to treat pain among people living with HIV who experience chronic pain and use opioids to manage their pain.
• The Algorithm Study provides smoking cessation pharmacotherapy recommendations integrated into HIV primary care for people living with HIV who smoke cigarettes. Enrollment begins December 2019.
• Project QUIT is a behavioral intervention to treat anxiety and depression and to increase rates of smoking cessation among people living with HIV who smoke cigarettes. Enrollment begins December 2019.

In December 2017, we conducted a national online survey of trans masculine people who have sex with cisgender men (TMSM) to better understand the unique HIV risk behaviors of this understudied population, and to assess PrEP use/awareness in the sample. In total, 857 people completed the survey; the main findings manuscript was published in the Journal of the International AIDS Society in September 2019.

The LITE Study, the largest longitudinal cohort of transgender women to date, began enrollment in March 2018. To date, 173 transgender women have participated at Fenway, with 147 eligible and enrolled in the longitudinal cohort; 687 have enrolled in the cohort across all 6 cities (Boston, New York, Baltimore, Washington D.C., Atlanta, Miami).

The Fenway Institute supports clinical, research and public health services through state of the art health informatics and data systems. Fenway’s Informatics and Data Center continues to be a leader among Community Health Centers in developing data capacity and Health Information Technology (HIT) initiatives. We continue to refine our integration with Electronic Patient Reported Outcomes (ePRO) enabling us to develop algorithms to better meet the clinical needs of patients and performance measures. They provide consultation and technical assistance on federal initiatives and to federal agencies and CHC’s on HIT, data management activities that streamline and improve data capture and reporting processes. Our Data Center collaborates with other departments to provide clinical, financial and productivity data.

The Center worked closely with AthenaHealth, our Electronic Health Records (EHR) vendor, to develop a product called ‘Centricity Now’ that will enable hospitalists and on-call providers to access to patient records wherever they are. It also works with other HIT vendors in using latest technologies to improve patient communication and health outcomes. For example, Fenway has collaborated with FHIR to conduct webinars and in-person trainings around the US on SOGI implementation and analyzing outcomes. The Data team has produced over 75 data analysis sets from our EHR focusing on the LGBTQ patients, and continues to advise other EHR vendors on refining their products to meet the needs of the LGBTQIA+ patients. It also collaborates with national and federal partners to develop tools to monitor health outcomes; for example, Fenway worked with NACHC and CDC to evaluate a Hepatitis C Care Cascade. The Center participates in four national data registry projects whose funders include NIH and PCORI. These projects combine de-identified patient data into a shared clinical database to evaluate patient outcomes in real world settings.