Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants.

Doxycycline postexposure prophylaxis (doxy-PEP) reduces sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW). In a clinical trial of doxy-PEP, we sought to assess acceptability, impact, and meaning of doxy-PEP use among MSM/TGW. We conducted semistructured, in-depth 1:1 interviews with MSM and TGW enrolled in the intervention arm of the Doxy-PEP study. We queried motivations for and meaning of use, attitudes, beliefs, adherence, effect on sexual behaviors, and partner, community, and structural factors related to use. We coded interview transcripts into content areas, followed by thematic analysis. We interviewed 44 participants (median age 38), 2% were TGW, 17% Black, 61% White, 30% Hispanic, and 45% persons with HIV. We identified three overarching themes. First, participants found doxy-PEP acceptable, and believed it was effective based on their history of STIs, easy to adhere to, and acceptable to sex partners. Second, doxy-PEP benefited their quality of life and mental health, offering "peace of mind" by reducing their anxiety about acquisition or unwitting transmission of STIs. Participants reported feeling more "in control" of preventing STIs, and positive about supporting their personal, partner, and community health. Third, impact on sexual behavior was variable, with most reporting no change or a brief initial change. Participants in a multi-site clinical trial of doxycycline for STI prevention perceived it to be efficacious, and that it provided quality-of-life benefits, including reduced anxiety and sense of control over sexual health. Doxy-PEP had limited impact on sexual behavior. Clinicaltrials.gov: NCT03980223.

Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections.

BACKGROUND: Interventions to reduce sexually transmitted infections (STIs) among men who have sex with men (MSM) are needed. METHODS: We conducted an open-label, randomized study involving MSM and transgender women who were taking preexposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection (PrEP cohort) or living with HIV infection (persons living with HIV infection [PLWH] cohort) and who had had Neisseria gonorrhoeae (gonorrhea), Chlamydia trachomatis (chlamydia), or syphilis in the past year. Participants were randomly assigned in a 2:1 ratio to take 200 mg of doxycycline within 72 hours after condomless sex (doxycycline postexposure prophylaxis) or receive standard care without doxycycline. STI testing was performed quarterly. The primary end point was the incidence of at least one STI per follow-up quarter. RESULTS: Of 501 participants (327 in the PrEP cohort and 174 in the PLWH cohort), 67% were White, 7% Black, 11% Asian or Pacific Islander, and 30% Hispanic or Latino. In the PrEP cohort, an STI was diagnosed in 61 of 570 quarterly visits (10.7%) in the doxycycline group and 82 of 257 quarterly visits (31.9%) in the standard-care group, for an absolute difference of -21.2 percentage points and a relative risk of 0.34 (95% confidence interval [CI], 0.24 to 0.46; P<0.001). In the PLWH cohort, an STI was diagnosed in 36 of 305 quarterly visits (11.8%) in the doxycycline group and 39 of 128 quarterly visits (30.5%) in the standard-care group, for an absolute difference of -18.7 percentage points and a relative risk of 0.38 (95% CI, 0.24 to 0.60; P<0.001). The incidences of the three evaluated STIs were lower with doxycycline than with standard care; in the PrEP cohort, the relative risks were 0.45 (95% CI, 0.32 to 0.65) for gonorrhea, 0.12 (95% CI, 0.05 to 0.25) for chlamydia, and 0.13 (95% CI, 0.03 to 0.59) for syphilis, and in the PLWH cohort, the relative risks were 0.43 (95% CI, 0.26 to 0.71), 0.26 (95% CI, 0.12 to 0.57), and 0.23 (95% CI, 0.04 to 1.29), respectively. Five grade 3 adverse events and no serious adverse events were attributed to doxycycline. Of the participants with gonorrhea culture available, tetracycline-resistant gonorrhea occurred in 5 of 13 in the doxycycline groups and 2 of 16 in the standard-care groups. CONCLUSIONS: The combined incidence of gonorrhea, chlamydia, and syphilis was lower by two thirds with doxycycline postexposure prophylaxis than with standard care, a finding that supports its use among MSM with recent bacterial STIs. (Funded by the National Institutes of Health; DoxyPEP ClinicalTrials.gov number, NCT03980223.).

Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.

OBJECTIVE: Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. STUDY DESIGN: A single-arm, open-label investigational-device clinical trial. SETTING: Two private-practice and one hospital-based ENT clinics. PATIENTS: Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. INTERVENTION: Bilateral amplification delivered via a light-driven contact hearing aid comprising a Tympanic Lens (Lens) with a customized platform to directly drive the umbo and a behind-the-ear sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens. MAIN OUTCOME MEASURES: The primary safety endpoint was a determination of "no change" (PTA4 < 10 dB) in residual unaided hearing at the 120-day measurement interval. The primary efficacy endpoint was improvement in word recognition using NU-6 at the 30-day measurement interval over the baseline unaided case. Secondary efficacy endpoints included functional gain from 2 to 10 kHz and speech-in-noise improvement over the baseline unaided case using both omnidirectional and directional microphones. RESULTS: The results for the 86 ears in the study determined a mean change of -0.40 dB in PTA4, indicating no change in residual hearing (p < 0.0001). There were no serious device- or procedure-related adverse events, or unanticipated adverse events. Word recognition aided with the Earlens improved significantly (p < 0.0001) over the unaided performance, by 35% rationalized arcsine units on average. Mean functional gain was 31 dB across 2 to 10 kHz. The average speech-recognition threshold improvement over the unaided case for the Hearing in Noise Test was 0.75 dB (p = 0.028) and 3.14 dB (p < 0.0001) for the omnidirectional and directional microphone modes, respectively. CONCLUSION: The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.

Temporal-Bone Measurements of the Maximum Equivalent Pressure Output and Maximum Stable Gain of a Light-Driven Hearing System That Mechanically Stimulates the Umbo.

HYPOTHESIS: That maximum equivalent pressure output (MEPO) and maximum stable gain (MSG) measurements demonstrate high output and high gain margins in a light-driven hearing system (Earlens). BACKGROUND: The nonsurgical Earlens consists of a light-activated balanced-armature transducer placed on the tympanic membrane (Lens) to drive the middle ear through direct umbo contact. The Lens is driven and powered by encoded pulses of light. In comparison to conventional hearing aids, the Earlens is designed to provide higher levels of output over a broader frequency range, with a significantly higher MSG. MEPO provides an important fitting guideline. METHODS: Four fresh human cadaveric temporal bones were used to measure MEPO directly. To calculate MEPO and MSG, we measured the pressure close to the eardrum and the stapes velocity, for sound drive and light drive using the Earlens. RESULTS: The baseline sound-driven measurements are consistent with previous reports. The average MEPO (n = 4) varies from 116 to 128 dB SPL in the 0.7 to 10 kHz range, with the peak occurring at 7.6 kHz. From 0.1 to 0.7 kHz, it varies from 83 to 121 dB SPL. For the average MSG, a broad minimum of about 10 dB occurs in the 1 to 4 kHz range, above which it rises as high as 42 dB at 7.6 kHz. From 0.2 to 1 kHz, the MSG decreases linearly from approximately 40 dB to 10 dB. CONCLUSION: With high output and high gain margins, the Earlens may offer broader-spectrum amplification for treatment of mild-to-severe hearing impairment.

Preliminary evaluation of a light-based contact hearing device for the hearing impaired.

OBJECTIVE: To assess the safety, stability, and performance of the broad-spectrum, light-based contact hearing device (CHD) on listeners with hearing impairment. STUDY DESIGN: Feasibility study. SETTING: Single-site research and development facility. PARTICIPANTS: Thirteen participants with symmetric mild-to-severe sensorineural hearing impairment had the CHD placed bilaterally. INTERVENTION: A custom-molded light-activated tympanic contact actuator (TCA) was placed into each ear by a physician, where it stayed in contact with the umbo and a portion of the medial wall of the ear canal for 4 months. Each CHD was calibrated and programmed to provide appropriate broad-spectrum amplification. MAIN OUTCOME MEASURES: Safety was determined through routine otologic examinations. Aided and pre-TCA-insertion unaided audiometric thresholds (functional gain), maximum gain before feedback, tympanic membrane damping, Reception Threshold for Sentences (RTS), and Abbreviated Profile of Hearing Aid Benefit (APHAB) measurements were made to characterize system performance as well as the benefits of amplification via the CHD. RESULTS: The TCAs remained on participants' ears for an average total of 122 days, without causing signs of inflammation or infection, and there were no serious device-related adverse events. Measured average maximum output of 90 to 110 dB SPL in the range of 0.25 to 10 kHz, average maximum gain before feedback of 40 dB, and functional gain through 10 kHz show extended-bandwidth broad-spectrum output and gain. RTS results showed significant aided improvements of up to 2.8 dB, and APHAB results showed clinically significant aided benefits in 92% of participants (11/12). CONCLUSION: The safety, stability, and performance demonstrated in this initial 4-month study suggest that the CHD may offer a feasible way of providing broad-spectrum amplification appropriate to treat listeners with mild-to-severe hearing impairment.

How reliable is self-testing for gonorrhea and chlamydia among men who have sex with men?

BACKGROUND: Recent studies have demonstrated a high prevalence of pharyngeal (P) and rectal (R) Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) infections among men who have sex with men (MSM). Guidelines by the Centers for Disease Control and Prevention recommend testing at least annually. But surveys of medical providers suggest that adherence to these guidelines is minimal as a result of limited time and staff. Because of these concerns, we evaluated the feasibility and accuracy of patient self-testing. METHODS: Three-hundred seventy-four patients at a Washington, DC clinic who identified themselves as MSM and requested testing for sexually transmitted infections (STIs) participated in the study. Patients performed self-screening using the Gen-Probe APTIMA Combo 2 (AC2) kit after viewing written and pictorial instructions. Trained providers also screened patients. We randomized the order in which patients or providers performed testing. RESULTS: Among those receiving specific tests, 8% of patients tested positive for R-GC, 9.3% for P-GC, 12.7% for R-CT, and 1.3% for P-CT. We performed McNemar tests, stratified by infection type and anatomic site to evaluate concordance. Self-administered testing was significantly better at identifying P-GC (discordant: 3%) and R-GC (discordant: 2.9%) (P ≤.01), and had results similar to provider- administered testing for P-CT (discordant: 0.5%) and R-CT (discordant: 1.1%) detection. CONCLUSIONS: The equivalent or better detection rates for rectal and oral gonorrhea and chlamydia among patients suggest that patients are capable of performing their own screening for STIs, which may increase infection detection and treatment.

The EarLens system: new sound transduction methods.

The hypothesis is tested that an open-canal hearing device, with a microphone in the ear canal, can be designed to provide amplification over a wide bandwidth and without acoustic feedback. In the design under consideration, a transducer consisting of a thin silicone platform with an embedded magnet is placed directly on the tympanic membrane. Sound picked up by a microphone in the ear canal, including sound-localization cues thought to be useful for speech perception in noisy environments, is processed and amplified, and then used to drive a coil near the tympanic-membrane transducer. The perception of sound results from the vibration of the transducer in response the electromagnetic field produced by the coil. Sixteen subjects (ranging from normal-hearing to moderately hearing-impaired) wore this transducer for up to a 10-month period, and were monitored for any adverse reactions. Three key functional characteristics were measured: (1) the maximum equivalent pressure output (MEPO) of the transducer; (2) the feedback gain margin (GM), which describes the maximum allowable gain before feedback occurs; and (3) the tympanic-membrane damping effect (D(TM)), which describes the change in hearing level due to placement of the transducer on the eardrum. Results indicate that the tympanic-membrane transducer remains in place and is well tolerated. The system can produce sufficient output to reach threshold for those with as much as 60 dBHL of hearing impairment for up to 8 kHz in 86% of the study population, and up to 11.2 kHz in 50% of the population. The feedback gain margin is on average 30 dB except at the ear-canal resonance frequencies of 3 and 9 kHz, where the average was reduced to 12 dB and 23 dB, respectively. The average value of D(TM) is close to 0 dB everywhere except in the 2-4 kHz range, where it peaks at 8dB. A new alternative system that uses photonic energy to transmit both the signal and power to a photodiode and micro-actuator on an EarLens platform is also described.

Attitudes, beliefs and values of students in undergraduate medical, nursing and pharmacy programs.

First and final year students in medicine, nursing and pharmacy programs at the University of Auckland completed a questionnaire used in studies of professional subcultures. Before entering training, students differed in how they believed clinical work should be organised. The collectivist attitude of pharmacy students was greater among those completing their studies than it was among those commencing study. Doctors, nurses, pharmacists and other professional groups are expected to work in multidisciplinary teams to deliver high quality health services. This study suggests that the individualistic attitudes of medical students may need to be addressed during training if medical students are to graduate with a commitment to working in teams, an expectation of clinical governance.

Malleus-to-footplate ossicular reconstruction prosthesis positioning: cochleovestibular pressure optimization.

AIMS: To determine 1) the best position for hydroxylapatite malleus-to-footplate (MFP), ossicular replacement prosthesis (ORP) in reconstructed ears, and 2) whether preserving the stapes superstructure (SS), when present, has acoustic advantages. BACKGROUND: Positioning of the MFP-ORP head beneath the neck of the malleus may produce maximal force, whereas positioning beneath the manubrium of the malleus may produce the greatest displacement. It is not clear which is the optimal placement position. In addition, we look at the effect of the SS on sound transmission to the inner ear in ossicular reconstruction. METHODS: The ear-canal air pressure and vestibular hydro-pressure were measured in human cadaver temporal bones with incus intact, removed, and replaced with the MFP-ORP; the ORP head was placed at three different positions on the malleus (head, mid-manubrium, and umbo) while keeping its base at the center of stapes footplate with intact or removed stapes SS. The vestibular pressure ratio between the ear with intact incus and MFP-ORP reconstructed ear is defined as Lmfp, the loss caused by the prosthesis in relation to the normal ossicular chain. RESULTS: The mean magnitude of Lmfp, averaged in the important speech frequency region of 0.5 to 3 kHz, is approximately 7.8 dB at the neck with stapes SS. In comparison, mean magnitude of Lmfp for mid-manubrium without stapes SS is 15 dB (p = 0.04), and with the stapes SS it is 16 dB (p = 0.05), whereas at the umbo without SS it is 15 dB (p = 0.03). In the 8 kHz region, the mean magnitude of Lmfp is approximately 1 dB with the stapes SS intact and approximately 8.5 dB when it was removed (p < 0.09). CONCLUSION: There are significant physiologic advantages to placing the hydroxylapatite MFP-ORP beneath the neck of the malleus and preserving the SS.