Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S.

BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as "sex workers." This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs' unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of "PrEPare for Work,"- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the "PrEPare for Work Stage 1 intervention" (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the "PrEPare for Work Stage 2 intervention" (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs' unique life circumstances are urgently needed. In this study, we are evaluating whether "PrEPare for Work" can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Clinician confidence and practices for evaluating bone health in male and female adolescents and young adults with an eating disorder.

Extensive literature exists on bone health in females with an eating disorder, yet few have studied males. Our study assessed clinician confidence and current practices for assessing bone health in patients with an eating disorder. We also aimed to identify any differences in practice based on patient sex. Our 31-item survey, distributed to adolescent clinicians in the United States via the Society for Adolescent Health and Medicine (SAHM) listserv, assessed clinician confidence and practices for assessing bone mineral density in both male and female adolescents with an eating disorder. Findings showed that clinicians (n = 104) were less confident in assessing bone mineral density in males compared to females (p < .001), yet there was no significant difference in rates of obtaining a DXA (p = .390). Although clinicians are less confident assessing bone health in males with an eating disorder than females, this does not appear to result in screening differences.

Clinician practices assessing hypothalamic-pituitary-gonadal axis suppression in adolescents with an eating disorder.

OBJECTIVE: Although extensive literature exists on hypothalamic-pituitary-gonadal (HPG) axis suppression in females with an eating disorder, there are few studies in males. Our study aimed to determine clinician practices for the assessment of HPG axis suppression and to identify differences in practice based on the sex of the patient. METHOD: Our 31-item survey queried clinicians about confidence level and practices for assessing HPG suppression in male compared to female patients. RESULTS: Findings showed that clinicians (n = 104) were less likely to evaluate HPG suppression in males compared to females, including assessment of sexual maturity rating (p < .050), screening of decreased libido compared to amenorrhea (p < .001) and lab assessment (luteinizing hormone and follicular-stimulating hormone: p < .001; estradiol/testosterone: p < .010; TSH: p < .050). Participants also felt less confident evaluating male patients (p < .001) and requested better screening tools for males (p < .001). DISCUSSION: Our data suggest that clinician practices differ based on patient sex and that clinicians request tools for HPG suppression assessment in males. This is the first study examining specific practices and comfort levels of clinicians when assessing HPG axis suppression. Findings suggest that more guidance on the management of male patients may be needed to standardize care and to prevent short and long-term sequela of malnutrition.

The Influence of Age, Health Literacy, and Affluence on Adolescents' Capacity to Consent to Research.

While adults are assumed to have the capacity to consent to medical research, and young children to have no capacity, adolescents' capacity to consent is not well described. Adapting the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), we describe adolescents' capacity to consent to medical research and factors influencing that capacity. Our pilot study included a community-based sample of 30 adolescents, 14 to 21 years of age, who completed the MacCAT-CR after undergoing a simulated informed consent process. We found that adolescents' capacity to consent to research was associated with age, health literacy, and family affluence. These findings suggest that investigators and institutional review boards should be aware that factors other than age may influence capacity to consent, and, for modifiable factors, such as health literacy, consent processes for medical research with adolescents can be modified.

Noise reduction technologies implemented in head-worn preprocessors for improving cochlear implant performance in reverberant noise fields.

The purpose of this study was to investigate whether a multichannel adaptive directional microphone and a modulation-based noise reduction algorithm could enhance cochlear implant performance in reverberant noise fields. A hearing aid was modified to output electrical signals (ePreprocessor) and a cochlear implant speech processor was modified to receive electrical signals (eProcessor). The ePreprocessor was programmed to flat frequency response and linear amplification. Cochlear implant listeners wore the ePreprocessor-eProcessor system in three reverberant noise fields: 1) one noise source with variable locations; 2) three noise sources with variable locations; and 3) eight evenly spaced noise sources from 0° to 360°. Listeners' speech recognition scores were tested when the ePreprocessor was programmed to omnidirectional microphone (OMNI), omnidirectional microphone plus noise reduction algorithm (OMNI + NR), and adaptive directional microphone plus noise reduction algorithm (ADM + NR). They were also tested with their own cochlear implant speech processor (CI_OMNI) in the three noise fields. Additionally, listeners rated overall sound quality preferences on recordings made in the noise fields. Results indicated that ADM+NR produced the highest speech recognition scores and the most preferable rating in all noise fields. Factors requiring attention in the hearing aid-cochlear implant integration process are discussed.

Modulation-based digital noise reduction for application to hearing protectors to reduce noise and maintain intelligibility.

OBJECTIVE: The objective of this study was to test the effects of modulation-based digital noise reduction (MB-DNR) on noise levels, speech intelligibility, and listening preference in four real-world noises. BACKGROUND: A significant challenge in hearing protection device (HPD) design is to reduce ambient noise levels while maintaining users' ability to understand speech. MB-DNR technology, currently employed in hearing aids, potentially could be used to achieve these objectives. METHODS: Speech and noise calibrated to signal-to-noise ratios (SNRs) of 0, -5, and -10 dB in the sound field were recorded at the outputs of two digital hearing aids in the ears of a Knowles Electronic Manikin for Acoustic Research with and without MB-DNR activated (i.e., NR and noNR, respectively). Listeners' speech intelligibility scores and sound quality preferences were evaluated while they listened to the recordings presented via ER-3A insert earphones at 85 dB SPL. RESULTS: MB-DNR reduced the overall noise level by approximately 4 to 7 dB. Listeners obtained significantly higher speech intelligibility scores in the NR condition at an SNR of -10 dB in two noises and similar scores in the noNR and NR conditions in all other cases. They preferred the NR condition in all cases. CONCLUSION: MB-DNR reduced overall noise level, enhanced sound quality, and maintained or improved speech intelligibility in the four military noises tested. APPLICATIONS: MB-DNR algorithms potentially could be incorporated into HPDs to enhance performance and increase user acceptance.