A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.
From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.
This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.
This RCT was registered on www.clinicaltrials.gov (
Increasing demand for haematological specialist care makes the optimisation of referrals and outpatient workflow a priority. Automated placing of standardised test orders prior to the first appointment may provide haematologists with necessary information to reach diagnoses and initiate treatment at the first patient encounter, reducing low-value follow-up appointments. We aimed to evaluate rates of patient participation in an initiative using artificial intelligence to place standardised test orders as well as reasons for non-participation, differences in the number of participants and non-participants discharged back to primary care with a diagnosis or appropriate treatment plan, and potentially avoidable referrals.
A retrospective, multicentric cohort study.
Four academic hospitals in Madrid, Spain.
18 190 patients referred for a first haematologist appointment for 11 included presenting complaints.
Referral notes from primary care were classified using natural language processing and automated placement of standardised test order sets was carried out prior to first appointment for participating patients.
We compared demographic differences between participants and non-participants, the main motives for not participating, and the number of patients discharged back to primary care at first appointment with a diagnosis and treatment plan. Most frequent International Classification of Diseases, tenth revision codes for each of the included presenting complaints were described.
During the study period, 18 190 (41%) patients were referred for a first haematologist appointment for presenting complaints included in the intervention (‘eligible patients’), of which 612 (3.3%) patients agreed to participate in the intervention. Participants were significantly younger than non-participants. Most common motives for not participating were administrative reasons (6268, 76.9%). Only 122 (1.5%) patients expressed explicit unwillingness to participate. A significant increase in the number of patients discharged upon first appointment was observed for participants (146 (23.9%) vs 3375 (19.36%); p=0.041), signifying a 22% relative reduction in avoidable follow-up. The diagnosis ‘haematological disorders ruled out’ was constantly observed as one of the ten most common diagnoses made by the haematology specialist for all but one of the included presenting complaints.
Natural language processing of referrals from primary to specialist haematology care with automated placing of standardised test orders can decrease low-value follow-up appointments. Explicit refusal to participate was low. Participants tended to be younger than non-participants, underlining the importance of designing strategies to target the older population in order to improve participation.
Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool.
This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomised clinical trial.
The protocol was approved by the participant ethics committees. Results will be disseminated in scientific conferences and peer-reviewed journals.