Stakeholder-engaged development of a rapid test for detection of acute HIV infection.

Background/Objective: The utilization of rapid HIV tests has been effective at reducing transmission rates in high-risk populations by allowing individuals to receive diagnosis in as little as one minute and begin treatment. However, no current rapid tests can detect HIV immediately after infection in the acute HIV infection (AHI) phase, when the virus is at its most infectious, and instead require a waiting period of up to 90 days after exposure. Rapid HIV tests to detect AHI are currently under development. Investigation of stakeholder perspectives and context-specific needs are critical to ensure successful translation of novel AHI tests. The objectives of this study were to 1) understand context-specific factors such as barriers to HIV testing in Indiana, a state with one of 48 prioritized counties for HIV elimination; 2) assess the acceptability of a novel rapid AHI test, and 3) identify key implementation considerations for such a device, including ideal end-users. Methods: Semi-structured in-depth interviews were conducted with staff (n = 14) and clients (n = 5) of Indiana-based organizations that conduct HIV testing, including syringe service programs. Utilizing human-centered design frameworks, interview guides were developed and tailored to each participant group to understand their experiences with HIV testing, perspectives on a novel rapid AHI test in development, and preferences for self-testing versus testing by a community health worker (CHW) or a peer recovery coach. Thematic analysis was conducted to identify major themes, including barriers to HIV testing and perceived benefits and concerns of the proposed AHI test. Results: Overall acceptability for a novel AHI rapid test was high with a greater preference for CHW/Peerled testing. While self-testing was not a preferred modality, it was still seen as a potential tool to reach and address key barriers among high-risk individuals. Key considerations for implementation emphasized accuracy, cost-effectiveness, ease of use, ensuring access to counseling, education, and navigation to care while maintaining a human element to self-testing. Conclusion: Stakeholder engagement is meaningfully informing the design, development, and implementation of rapid AHI testing in order to facilitate adoption among populations at high-risk for HIV.

Feasibility and anticipated acceptability of community health worker-facilitated HPV self-sampling for cervical cancer screening around Lake County, Indiana.

Background/Objective: In light of calls to engage community health workers (CHWs) in the delivery of cervical cancer screening innovations, this study explores CHW perspectives on i) barriers to cervical cancer screening in a predominantly Hispanic community in Lake County, Indiana, the county with the highest cervical mortality in the state; and ii) the acceptability and feasibility of CHW-facilitated human papillomavirus (HPV) self-sampling as a means of reducing screening disparities. Methods: In 2021, in-depth interviews were conducted with 15 CHWs employed by Lake County community-based organizations including clinics, schools, and faith-based organizations. Results: Harnessing CHWs' voices as insiders with knowledge of their communities' health landscape, our analysis identified multilevel barriers to screening that spanned individual, interpersonal, and community levels of the socio-ecological model. CHW-facilitated HPV self-sampling shows promise of mitigating several barriers to cervical cancer screening. Privacy, time saved, and comfort were perceived to be facilitators for acceptability, with concerns about the novelty of this approach and trust in provider (as opposed to CHW) expertise emerging as key barriers. In terms of feasibility, synergies with existing CHW work, and some community members' prior experience with self-sampling were found to be facilitators, while CHW's time limitations and self-efficacy in providing adequate medical support were areas of concern. Considerations for adoption included CHW training, gender concordance, safety, and respect, among others. Conclusion: This study provides critical insights from CHWs as key stakeholders on a screening model that directly engages them, which can inform implementation to increase screening in medically-underserved communities in the US.

Leveraging COVID-era innovation for cervical cancer screening: Clinician awareness and attitudes toward self-sampling and rapid testing for HPV detection.

Cervical cancer screening rates are declining in the US, with persistent disparities among vulnerable populations. Strategies to better reach under-screened communities are needed. The COVID pandemic sparked major shifts in healthcare delivery, including the accelerated development and adoption of rapid diagnostic testing, broadened access to remote care, and growing consumer demand for self-testing, which could be leveraged for cervical cancer. Rapid tests for the detection of Human Papillomavirus (HPV) have the potential to improve cervical cancer screening coverage, and if coupled with patient-collected cervicovaginal samples, create an opportunity for self-testing. The objectives of this study were: 1) to examine whether COVID influenced clinician perspectives of rapid testing as a screening modality; and 2) to assess clinician awareness, perceived benefits and limitations, and willingness to adopt point-of-care HPV testing, patient self-sampling, and rapid HPV self-testing with self-collected samples. The methodology adopted consisted of an online cross-sectional survey (n = 224) and in-depth interviews (n = 20) were conducted with clinicians who perform cervical cancer screening in Indiana, ranked in the top ten states for cervical cancer mortality and with marked disparities across socio-demographic groups. The main findings show that about half the clinicians reported that the COVID pandemic had influenced their views on rapid testing as a screening modality both positively (greater public acceptability of rapid testing and impact on patient care) and negatively (concerns regarding accuracy of rapid tests). The majority of clinicians (82%) were willing to adopt rapid HPV testing at the point-of-care, while only 48% were willing to adopt rapid HPV self-testing with self-collected samples. In-depth interviews revealed provider concerns around patients' ability to collect their own sample, report results correctly, and return to the clinic for follow-up and other preventive care. Addressing clinician concerns about self-sampling and rapid HPV testing, such as ensuring that rapid tests include sample adequacy controls, is necessary to mitigate barriers to adoption for cervical cancer screening.

Clinician practices, knowledge, and attitudes regarding primary human papillomavirus testing for cervical cancer screening: A mixed-methods study in Indiana.

Primary human papillomavirus (HPV) testing, in which a high-risk HPV test is administered without cytology, was first included in 2018 US cervical cancer screening guidelines. Subsequent guidelines endorsed primary HPV testing as the preferred method for cervical cancer screening following evidence of its clinical and economic benefits, although many sources still indicate it as an option along with cytology and HPV/Pap co-testing. Primary HPV testing could be key to improving the declining cervical cancer screening rates in the US; however its adoption has been slow as clinicians are hesitant to make the change. Indiana ranks in the top ten states for cervical cancer mortality, with marked race-ethnic disparities in cervical cancer screening and low HPV vaccination rates. To examine clinician practices, knowledge, and attitudes regarding primary HPV testing, in 2021 we conducted an online cross-sectional survey (n = 224) and in-depth interviews (n = 20) with Indiana clinicians practicing cervical cancer screening. Only 3 % reported using primary HPV testing for eligible patients, and only 50 % were willing to adopt it as the preferred cervical cancer screening method for the recommended patient group. In a multivariable logistic regression model, knowledge of the effectiveness (aOR 2.58 [1.41-4.72]) and perceived benefit (aOR 7.35 [3.65-14.81]) of primary HPV testing predicted willingness to adopt. In-depth interviews revealed knowledge gaps, uncertainty, and perceived limitations of this method as the reasons for limited uptake of primary HPV testing. Targeted messages about the benefits and effectiveness may enhance clinician knowledge, acceptance, and adoption.

Human-centered design of a smartphone-based self-test for HIV viral load monitoring.

Background/Objective: HIV viral load self-testing could enable people living with HIV (PLHIV) to monitor their viral suppression status more easily, potentially facilitating medication adherence and safe behavior decision-making. Smartphone-based viral load testing innovations have the potential to reach resource-limited and vulnerable communities to address inequities in access to HIV care. However, successful development and translation of these tests requires meaningful investigation of end-user contexts and incorporation of those context-specific needs early in the design process. The objective of this study is to engage PLHIV and HIV healthcare providers in human-centered design research to inform key design and implementation considerations for a smartphone-based HIV viral load self-testing device prototype in development. Methods: Semi-structured in-depth interviews were conducted with PLHIV (n = 10) and HIV providers (n = 4) in Indiana, a state with suboptimal viral suppression rates and marked disparities in access to HIV care. Interview guides were developed based on contextual investigation and human-centered design frameworks and included a demonstration of the device prototype with feedback-gathering questions. Results: Thematic analysis of interview transcripts revealed important benefits, concerns, and user requirements for smartphone-based HIV VL self-testing within the context of PLHIV lived experience, knowledge, and barriers to care in Indiana. Conclusion: End-user needs and preferences were identified as key design specifications and implementation considerations to facilitate the acceptability and inform ongoing development and ultimately real-world translation of the HIV VL monitoring device prototype.