Telehealth effectiveness for pre-exposure prophylaxis delivery in Brazilian public services: the Combine! Study.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) delivery based on user needs can enhance PrEP access and impact. We examined whether telehealth for daily oral PrEP delivery could change the indicators of care related to prophylactic use in five Brazilian public HIV clinics (testing centres, outpatient clinics and infectious disease hospitals). METHODS: Between July 2019 and December 2020, clients on PrEP for at least 6 months could transition to telehealth or stay with in-person follow-up. Clients were clinically monitored until June 2021. A desktop or mobile application was developed, comprising three asynchronous consultations and one annual in-person consultation visit. Predictors influencing telehealth preference and care outcomes were examined. The analysis encompassed intent-to-treat (first choice) and adjustments for sexual practices, schooling, age, duration of PrEP use and PrEP status during the choice period. RESULTS: Of 470 users, 52% chose telehealth, with the adjusted odds ratio (aOR) increasing over time for PrEP use (aOR for 25-months of use: 4.90; 95% CI: 1.32-18.25), having discontinued PrEP at the time of the choice (aOR: 2.91; 95% CI: 1.40-6.06) and having health insurance (aOR: 1.91; 95% CI: 1.24-2.94) and decreasing for those who reported higher-risk behaviour (aOR for unprotected anal sex: 0.51; 95% CI: 0.29-0.88). After an average follow-up period of 1.6 years (95% CI: 1.5-1.7), the risk of discontinuing PrEP (not having the medication for more than 90 days) was 34% lower with telehealth (adjusted hazard ratio: 0.66; 95% CI: 0.45-0.97). When adjusted by mixed linear regression, no differences in adherence (measured by mean medication possession rate) were found between in-person and telehealth (p = 0.486) or at pre- and post-telehealth follow-ups (p = 0.245). Sexually transmitted infections increased between the pre-follow-up and post-follow-up choices and were not associated with in-person or telehealth (p = 0.528). No HIV infections were observed. CONCLUSIONS: Our findings indicate that telehealth for PrEP delivery can enhance service rationalization and reinforce the prevention cascade. This approach reduces prophylaxis interruptions and is mainly preferred by individuals with lower demands for healthcare services.

Inflammatory cytologic alterations in the oral epithelium associated with HIV pre-exposure prophylaxis: a preliminary study.

OBJECTIVE: The objective of this study was to assess inflammatory cytologic alterations in the oral epithelium of patients on human immunodeficiency virus pre-exposure prophylaxis (PrEP). MATERIAL AND METHODS: Epithelial cells from the buccal mucosa of 30 patients were collected by exfoliative cytology and were evaluated according to inflammatory cellular alterations: karyomegaly, bi- or multinucleation, karyopyknosis, karyorrhexis, perinuclear halo formation, metachromasia, cytoplasmic vacuolization, indistinct cytoplasmic border, keratinization, and atrophy. Epithelial cells were collected initially before PrEP onset (T1) and then after 30 days of PrEP use (T2). Two experienced cytopathologists independently analyzed the slides. RESULTS: The nonparametric Wilcoxon test showed that there was a statistically significant increase in the number of cells with karyomegaly at T2 compared to T1 (P = .033). The other cellular alterations did not present with statistically significant differences between the 2 moments of evaluation (P > .05). CONCLUSION: The increased number of oral epithelial cells with karyomegaly after 30 days of using PrEP suggests the presence of inflammatory alterations at this site.

Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

INTRODUCTION: Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. METHODS AND ANALYSIS: A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals and meetings.