Objectives Doxycycline as bacterial sexually transmitted infection (STI) postexposure prophylaxis (DoxyPEP) has shown high efficacy in clinical trials. We evaluated the impact of DoxyPEP on chlamydia (CT), gonorrhoea (GC) and syphilis incidence among pre-exposure prophylaxis (PrEP) users in a sexual health clinic in San Francisco, California, USA. Methods DoxyPEP was offered to all PrEP clients at routine clinical visits starting on 30 November 2022. We included PrEP clients who received DoxyPEP (DoxyPEP users) or never initiated DoxyPEP (non-DoxyPEP users). Among DoxyPEP users, the 'pre-DoxyPEP' period was from 1 June 2022 until DoxyPEP initiation, and the 'post-DoxyPEP' period started after DoxyPEP initiation through 7 September 2023. STI testing included three sites-GC, CT and early syphilis testing. STI incidence rate ratios (IRRs) per quarter were evaluated using a pre-analysis, post-analysis and a controlled interrupted time series (CITS) analysis, with mixed-effects Poisson regression used to evaluate intervention effects. Results Among 3081 PrEP clients, 1209 (39%) initiated DoxyPEP. During the pre-DoxyPEP period, any STI, CT, GC and syphilis mean quarterly positivity was 18.1%, 9.2%, 8.1% and 2.2% among DoxyPEP users and 7%, 3.2%, 3% and 0.7% among non-DoxyPEP users, respectively. In pre-implementation and post-implementation analysis of DoxyPEP users, DoxyPEP was associated with lower STI incidence for any STI (IRR 0.42, 95% CI 0.24 to 0.74, p=0.003), CT (IRR 0.33, 95% CI 0.23 to 0.46, p<0.001) and syphilis (IRR 0.22, 95% CI 0.07 to 0.54, p=0.001), but not GC (IRR 0.89, 95% CI 0.69 to 1.15, p=0.383). In a CITS analysis, DoxyPEP was associated with a significant decline in any STI incidence (0.67, 95% CI 0.46 to 0.96, p<0.030). Conclusions Observed DoxyPEP uptake reflected strong demand among PrEP users when offered in a clinical setting. Overall, STI incidence declined rapidly after implementation, demonstrating the high impact of this intervention in a real-world setting. Continued evaluation of uptake, adherence and impact on bacterial STIs will be essential as DoxyPEP implementation expands.
Description: REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) showed benefits of pitavastatin as preventive therapy for atherosclerotic cardiovascular disease (ASCVD) in people with HIV (PWH). In February 2024, the U.S. Department of Health and Human Services Panel for the Use of Antiretroviral Agents in Adults and Adolescents with HIV (ARV Guidelines Panel) developed statin therapy recommendations for PWH. These recommendations were issued in collaboration with representatives from the American College of Cardiology (ACC), the American Heart Association (AHA), and the HIV Medicine Association (HIVMA). This synopsis summarizes the development process, the recommendations, and how they supplement the AHA/ACC/multisociety cholesterol guidelines and outlines gaps in primary prevention of ASCVD for PWH. Methods: The ARV Guidelines Panel convened a writing group of 10 members (6 members of the Panel with expertise in HIV-related comorbid conditions, biostatistics, and pharmacology and 4 consultants representing ACC, AHA, and HIVMA with cardiometabolic and HIV management expertise). The writing group reviewed REPRIEVE trial data, other studies evaluating the use of statins in PWH, and the AHA/ACC/multisociety cholesterol guidelines to devise recommendations. Recommendations were based on scientific evidence with a rating scheme developed since the 1998 inception of the ARV guidelines. Proposed recommendations were presented to the full ARV Guidelines Panel, rated via vote, and approved by the Panel's voting members. These recommendations were then endorsed by ACC, AHA, and HIVMA. Recommendations: The ARV Guidelines Panel issued a strong recommendation for initiating statin therapy among PWH with a 10-year ASCVD risk score of 5% or higher, whose absolute benefit from statins in REPRIEVE was greatest. For patients with a 10-year ASCVD risk score below 5%, the Panel favored statins but recommended patient-clinician risk discussions considering additional HIV-related factors that can increase ASCVD risk.
BACKGROUND:Increasingly, persons with HIV in Liberia are receiving antiretroviral therapy containing the integrase strand-transfer inhibitor (InSTI) dolutegravir (DTG), but the prevalence of and factors associated with virologic failure and HIV drug resistance (HIVDR) remain unknown. METHODS:Cross-sectional analysis of 2019-2022 enrolment data from 1276 persons with HIV in the HONOR cohort included sociodemographic information, plasma viral loads (pVL), CD4 counts, and HIVDR testing by next generation sequencing in participants with virologic failure (pVL≥1000 copies/mL). RESULTS:Of the 1201 participants with pVL results, 72% are female and median age is 42 (interquartile range [IQR] 35-50) years. All are on ART (median 6.1 [2.1-11] years): 74% on DTG-based and 23% on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens. Ninety (7.5%) had virologic failure; 970 (81%) are suppressed (<40 copies/mL). Virologic failure is less prevalent with DTG- versus NNRTI-based regimens (5.3% vs. 14%, adjusted prevalence ratio [aPR]=0.3, 95% confidence interval [CI] 0.2-0.5) and is associated with age <50 years, CD4 count <200 cells/µL, and hemoglobin <11 g/dL. In 70 participants with virologic failure and successful sequencing, HIVDR prevalence is 81% for any ARV, 5.7% for InSTIs, 79% for NNRTIs, and 61% for nucleos(t)ide reverse transcriptase inhibitors (NRTIs). Intermediate-to-high resistance to ≥1 NRTI in current ART is less prevalent with DTG+2NRTIs than NNRTI+2NRTIs regimens (aPR = 0.5, 95%CI 0.3-0.8). CONCLUSIONS:Most participants in the cohort are virologically-suppressed. Among those with virologic failure, HIVDR prevalence is high to NRTIs and NNRTIs, but low to InSTIs. Ongoing evaluation is necessary to determine the durability of DTG-based ART.
BACKGROUND Interventions to improve performance of global programs in the HIV cascade of care are widespread and increasing the focus of implementation science. At present, however, there is no clear consensus on how to conceptualize their improvement at the program level. The commonly used measures of association, based on ratios of probabilities (or odds), have well-known defects in public health applications. They yield large effect sizes even when the absolute effects, and therefore the public health impact, are small. On the other hand, risk differences create problems because settings with higher baseline values are penalized. We aim to examine ways of quantifying improvement in each health center of a cluster-randomized trial in Uganda to accelerate antiretroviral therapy initiation among HIV-infected adults. METHODS We formalize the concept of the ‘improvement index,’ defined as the fraction of gaps closed as a metric of improvement, and suggest that it has unique features and strengths when compared to risk ratios and risk differences. RESULTS Overall agreement between the different indices was not high, especially among health centers that were among the top 5 or 10. However, all ranking showed broad similarities at the far ends of the spectrum. On scatter plots, there was a positive linear relationship between the metrics, and the Bland Altman (B-A) plots were in agreement. CONCLUSION The improvement index can be used as an alternative measure of association in implementation science interventions. It can be useful for public health purposes as it demonstrates how much can be covered from the baseline.
Background: HIV testing for marginalized populations is critical to controlling the HIV epidemic. However, the HIV testing rate among men who have sex with men (MSM) in China remains low. Crowdsourcing, the process of shifting individual tasks to a group, has been increasingly adopted in public health programs and may be a useful tool for spurring innovation in HIV testing campaigns. We designed a multi-site study to develop a crowdsourced HIV test promotion campaign and evaluate its effectiveness against conventional campaigns among MSM in China.Methods: This study will use an adaptation of the stepped wedge, randomized controlled trial design. A total of eight major metropolitan cities in China will be randomized to sequentially initiate interventions at 3-month intervals. The intervention uses crowdsourcing at multiple steps to sustain crowd contribution. Approximately 1280 MSM, who are 16 years of age or over, live in the intervention city, have not been tested for HIV in the past 3 months, and are not living with HIV, will be recruited. Recruitment will take place through banner advertisements on a large gay dating app along with other social media platforms. Participants will complete one follow-up survey every 3 months for 12 months to evaluate their HIV testing uptake in the past 3 months and secondary outcomes including syphilis testing, sex without condoms, community engagement, testing stigma, and other related outcomes.Discussion: MSM HIV testing rates remain poor in China. Innovative methods to promote HIV testing are urgently needed. With a large-scale, stepped wedge, randomized controlled trial our study can improve understanding of crowdsourcing's long-term effectiveness in public health campaigns, expand HIV testing coverage among a key population, and inform intervention design in related public health fields.