Missed opportunities for guidance on sexually transmitted infection services: a global review of national HIV PrEP guidance.

OBJECTIVES: People who use or would benefit from pre-exposure prophylaxis (PrEP) for HIV infection are disproportionately affected by sexually transmitted infections (STIs). Integrating STI services when offering PrEP fosters synergies and efficiencies in response to HIV/STI and promotes people-centred care. Including guidance on STI interventions for people on PrEP may facilitate implementation and uptake. We conducted a global review of national PrEP guidance documents and analysed the inclusion of recommendations for the provision of STI services by country level of income. METHODS: We searched national PrEP guidance documents published by WHO Member States through the WHO, the Joint United Nations Programme on HIV/AIDS (UNAIDS) databases, the PrEPWatch repository and Google. Information on a range of STI-related interventions was extracted from documents available by October 2023. RESULTS: Of the 113 national PrEP guidance documents retrieved, STIs were mentioned in 77% (90/117). Viral hepatitis B testing and vaccination were recommended by most high-income countries (HICs) and low-income and middle-income countries (LMICs). Recommendation for syphilis testing was prominent in HICs (91%) and moderately noted in LMICs (68%). Gonorrhoea and chlamydia testing was recommended frequently in HICs (88%) and 42% in LMICs. However, the review noted that, to a much lesser extent, specific type of testing for these pathogens was mentioned. Recommendation for quarterly STI testing for syphilis, gonorrhoea and chlamydia was ubiquitous, while the need to offer STI partner services was rarely mentioned. CONCLUSIONS: PrEP services offer an opportunity for improved and expanded STI services, increasing person-centred care and addressing STI epidemics alongside HIV. Our review highlights the strengths and gaps in incorporating critical STI interventions into national PrEP normative guidance. Addressing these gaps through a stepwise approach and increasing targeted testing and partner services can help improve quality of care and support an effective response to HIV and other STIs.

Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service.

OBJECTIVES: In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. METHODS: We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen's kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). RESULTS: 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen's kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. CONCLUSIONS: POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.

A Comparison of Tenofovir Predose Concentrations in Generic Pre-exposure Prophylaxis Formulations: A Short Communication.

BACKGROUND: There is extensive evidence to show that pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate (TDF)-based formulations dramatically reduces the risk of HIV acquisition among individuals without HIV infection. Here, the authors aim to compare tenofovir plasma predose concentrations in subjects taking PrEP daily versus on demand and using different TDF-based generic formulations. METHODS: Subjects providing informed signed consent for the measurement of tenofovir plasma levels were included in the study. Predose drug concentrations were stratified according to PrEP administration and the type of TDF-based formulation. The control group consisted of patients with HIV infection who were matched for renal function and were administered branded TDF that was not combined with boosted-antiretroviral drugs. RESULTS: The study consisted of 100 subjects (mean age, 39 ± 10 years; body weight, 77 ± 11 kg). A wide distribution in tenofovir predose concentrations was observed, with values ranging from 17 to 297 ng/mL (coefficient of variation 77%). No significant differences were noted in tenofovir predose concentrations between subjects who were administered PrEP daily (n = 75) or on demand (n = 25) [94 (35-255) versus 104 (37-287) ng/mL; P = 0.476]. Comparable tenofovir predose concentrations were found between patients with HIV infection (n = 220) who were administered branded TDF and those without HIV infection who were treated with 5 different generic TDF-based formulations with generics-to-branded ratios. These were always within the range of 80%-125% and were used to define bioequivalence. CONCLUSIONS: The marketed generic formulations of TDF delivered tenofovir plasma predose concentrations comparable with those delivered by branded formulations.

Temporary adaptations to sexual behaviour during the mpox outbreak in 23 countries in Europe and the Americas: findings from a retrospective cross-sectional online survey.

BACKGROUND: After rapid epidemic growth between May and August, 2022, new mpox diagnoses declined in Europe and the Americas, with low-level transmission continuing thereafter. Characterising the extent of behavioural adaptation, mpox vaccination, and mpox prevalence across these regions could improve our understanding of the transmission dynamics of the virus. We aimed to characterise the presence and duration of adaptations to sexual behaviour related to the emergence of mpox during the first year of the outbreak among affected communities in Europe and the Americas. METHODS: This retrospective, cross-sectional online survey was conducted in 23 countries in Europe and the Americas between May 19 and May 31, 2023. The survey was advertised via four geospatial dating apps used by affected communities. Eligible participants were aged 18 years or older and identified as a gay man, a bisexual man, a man who has sex with men, as transgender, or as non-binary. We described and regionally compared the mpox prevalence, mpox vaccination rates (one dose or two doses of modified vaccinia virus Bavarian Nordic), and the extent and duration of behavioural adaptation during the outbreak. For these behavioural outcomes, we used regression analyses to estimate crude prevalence ratios (PRs) and adjusted prevalence ratios (aPRs) with 95% CIs. FINDINGS: Of 17 428 individuals who completed the survey, 16 875 (96·8%) met the eligibility criteria and were included in the study. 1086 (6·4%) participants reported having mpox during the outbreak. Vaccination with at least one dose was reported by 4987 (29·6%) participants; 3502 (20·8%) reported two doses. Vaccination rates in Latin America and eastern Europe and the western Balkans were significantly lower than in western Europe and northern America (p<0·0001). Adaptations to sexual behaviour were reported by 8583 (50·9%) of 16 875 participants and across all regions; 3045 (35·5%) of these 8583 participants said they continued adapting their sexual behaviour until May, 2023. Participants who reported concerns about mpox (9884 [58·6%] of 16 875) were more likely to adapt their behaviour than those who did not report concerns (PR 2·43 [95% CI 2·34-2·53]). In adjusted regression models, participants who reported vaccination (aPR 0·25 [95% CI 0·21-0·28] for two doses and 0·43 [0·37-0·51] for one dose) or having had mpox (0·37 [0·30-0·44]) were less likely to continue adaptations than those who did not. Participants in Latin America or northern America were significantly more likely to adapt their sexual behaviour and to continue with adaptations than those in western Europe. INTERPRETATION: Adaptations to sexual behaviour due to mpox were widespread, dynamic, and responded to evolving individual risk perceptions. We propose that the decline in mpox transmission seen at the end of 2022 resulted primarily from a combination of behavioural adaptation and naturally acquired immunity. As mpox vaccination is an important preventive measure, stark vaccine inequity highlights the need to increase access to mpox vaccines. FUNDING: WHO Contingency Fund for Emergencies.