Decentralizing PrEP delivery: Implementation and dissemination strategies to increase PrEP uptake among MSM in Toronto, Canada.

Pre-exposure prophylaxis (PrEP) is traditionally prescribed by HIV specialist physicians. Given finite specialist resources, there is a need to scale up PrEP delivery by decentralizing services via other healthcare professionals. We aimed to assess the feasibility of delivering PrEP to men who have sex with men (MSM) through primary care physicians and sexual health clinic nurses. We piloted a multi-component, implementation and dissemination research program to increase provision of PrEP through primary care physicians and sexual health clinic nurses in Toronto, Canada. Community-based organizations (CBOs) provided prospective participants with information cards that contained links to an online module on engaging providers in a conversation about PrEP. In our patient-initiated continuing medical education (PICME) strategy, participants saw their family doctors and gave them the card, which also contained a link to a Continuing Medical Education module. In the nurse-led strategy, participants visited one of two participating clinics to obtain PrEP. We administered an optional online questionnaire to patients and providers at baseline and six months. CBOs distributed 3043 cards. At least 339 men accessed the online module and 196 completed baseline questionnaires. Most (55%) intended to visit nurses while 21% intended to consult their physicians. Among 45 men completing follow-up questionnaires at 6 months, 31% reported bringing cards to their physicians and obtaining PrEP through them; sexual health clinics delivered PrEP to 244 patients. Participants who went through the PICME approach reported no changes in relationships with their providers. Nurses showed fidelity to PrEP prescribing guidelines. Nurse-led PrEP and patient-initiated continuing medical education (PICME) for primary care physicians are feasible strategies to increase PrEP uptake. Nurse-led PrEP delivery was preferred by most patients.

Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study.

BACKGROUND: Preexposure prophylaxis is efficacious at preventing HIV infection, but concerns persist about adherence and sexually transmitted infections (STIs). We assessed preexposure prophylaxis acceptability, adherence and clinical outcomes in a pilot demonstration project. METHODS: HIV-uninfected adult gay and bisexual men who scored 10 or higher on a validated HIV risk score (HIV Incidence Risk Index for MSM) and reported condomless receptive anal sex were sequentially enrolled into a 1-year open-label single-arm pilot study of daily oral therapy with tenofovir disoproxil fumarate/emtricitabine in Toronto. The primary outcome was acceptability of preexposure prophylaxis. Secondary outcomes were preexposure prophylaxis adherence (4-d recall, pill count and dried blood spot analysis), HIV seroconversion, STIs and adverse events. RESULTS: Of the 86 men screened, 52 were enrolled. Participants were mostly young (median age 33 yr [interquartile range (IQR) 28-37 yr) white (38 [73%]) gay (49 [94%]) men. Preexposure prophylaxis acceptability was high: all participants reported their experience as "good" or "very good." The median adherence rate was high, at 100% (IQR 95%-100%) by self-report and 96.9% (IQR 93.4%-98.4%) by pill count. Dried blood spot analysis suggested that doses were taken 4-7 days/week at 88.7% (173/195) of month 3-12 visits. No cases of HIV seroconversion occurred, but 25 participants (48%) experienced at least 1 bacterial STI, with incidence rates per 100 person-years of 32.8, 32.8, 8.2 and 8.2 for chlamydia, gonorrhea, syphilis and lymphogranuloma venereum, respectively. No adverse events led to discontinuation of prophylaxis, but the estimated glomerular filtration rate declined by 0.22 mL/min per month. INTERPRETATION: Preexposure prophylaxis was associated with high adherence and acceptability and no HIV infections in this study. Frequent STIs and clinically unapparent toxic renal effects reinforce the need for ongoing vigilance. TRIAL REGISTRATION: ClinicalTrials. gov, no. NCT02149888.

High HIV risk and syndemic burden regardless of referral source among MSM screening for a PrEP demonstration project in Toronto, Canada.

BACKGROUND: To maximize public health impact and cost-effectiveness, HIV pre-exposure prophylaxis (PrEP) must reach individuals at high HIV risk. Referrals for PrEP can be self- or provider-initiated, but there are several challenges to both. We assessed whether HIV risk differed by referral source among gay, bisexual and other men who have sex (gbMSM) screening for an HIV PrEP demonstration project. METHODS: PREPARATORY-5 was an open-label PrEP demonstration project enrolling gbMSM at high risk of HIV acquisition in Toronto, Canada. Study eligibility criteria related to high risk was defined as scoring ≥10 on the HIV Incidence Risk Index for MSM (HIRI-MSM) and engaging in at least 1 act of condomless receptive anal sex within the past 6 months. Recruitment was promoted through self-referrals (ads in a sexual networking app and gay newspaper/website) and provider-referrals (10 community-based organizations, CBOs). HIV risk score (HIRI-MSM) and syndemic health burden were measured among gbMSM screened for study participation and compared according to referral source. RESULTS: Between October 16 and December 30, 2014, online ads generated 1518 click-throughs and CBOs referred 115 individuals. Overall, 165 men inquired about the trial, of which 86 underwent screening. The majority of screened men were self-referrals (60.5%), scored ≥10 on HIRI-MSM (96.5%), and reported condomless receptive anal sex in the past 6 months (74.2%). Self- and provider-referrals had similarly high HIV risk profiles, with a median (IQR) HIRI-MSM score of 26.0 (19.0-32.5) and 28.5 (20.0-34.0) (p = 0.3), and 75.0% and 73.5% reporting condomless receptive anal sex (p = 0.9), respectively. The overall burden of syndemic health problems was also high, with approximately one-third overall identified as having depressive symptoms (39.5%), alcohol-related problems (39.5%), multiple drug use (31.4%), or sexual compulsivity (31.4%). There were no significant differences in syndemic health problems by referral source. CONCLUSIONS: HIV risk and syndemic burden were high among gbMSM presenting for this PrEP demonstration project regardless of referral source. Self-referral may be a useful and efficient strategy for identifying individuals suitable for PrEP use. Online strategies and CBOs working in gay men's health may play important roles in connecting individuals at high HIV risk to PrEP services. TRIAL REGISTRATION: ClinicalTrials.gov NCT02149888 . Registered May 12th 2014.