Clinic-based Testing Research Articles

Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research

BackgroundIn Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services.MethodsWe conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA).ResultsBetween May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit.ConclusionsSemiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Perceptions of a community-based HIV/STI testing program among Black gay, bisexual, and other MSM in Baltimore: a qualitative analysis

ABSTRACT Black gay, bisexual, and other men who have sex with men (GBM) are disproportionately affected by HIV and STIs. Safe Spaces 4 Sexual Health (SS4SH), a community-informed, status-neutral HIV/STI testing intervention combines online outreach via geo-social networking apps and social media with mobile van testing. During 2018–2019, we recruited 25 participants for interviews about their perceptions of SS4SH compared to clinic-based testing. Participants were aged 21–65 years (mean 35); 22 (88%) identified as Black/African American; 20 (80%) identified as gay; and 10 (40%) were living with HIV. Interviews were transcribed, coded, and analyzed using a modified thematic constant comparative approach. Five themes emerged; two related to perceptions of online outreach materials (participants were drawn to eye-catching and to-the-point messages and desired more diversity and representation in messages), and three related to preference for the mobile van (participants found SS4SH provided more comfort, more privacy/confidentiality, and increased accessibility and efficiency). GBM is increasingly using geo-social networking apps to meet sexual partners, and tailored online outreach has the potential to reach historically underserved populations. SS4SH is a barrier-reducing strategy that may serve as an entry to a status-neutral approach to services and help reduce stigma and normalize accessing HIV services.

Results of the Sukuma Ndoda ("Stand up, Man") HIV Self-Screening and Assisted Linkage to Care Project in Johannesburg: A Quasi-Experimental Pre-Post Evaluation.

HIV testing rates among South African men lag behind rates for women and national targets. Community-based HIV self-screening (HIVSS) distribution and follow-up by community health workers (CHWs) is a scalable option to increase testing coverage, diagnosis, and treatment initiation. We provided HIVSS and assisted linkage to care to men not recently tested (within the past 12 months) residing in high-HIV-burden areas of Johannesburg. CHWs distributed HIVSS in 6 clinic catchment areas. Follow-up to encourage confirmatory testing and antiretroviral therapy initiation was conducted through personal support (PS) or an automated short message service (SMS) follow-up and linkage system in 3 clinic areas each. Using a quasi-experimental pre-post design, we compared differences in the proportion of men testing in the clinic catchment areas during the HIVSS campaign (June-August 2019) to the 3 months prior (March-May 2019) and compared treatment initiations by assisted linkage strategy. Among 4793 participants accepting HIVSS, 62% had never tested. Among 3993 participants with follow-up data, 90.6% reported using their HIVSS kit. Testing coverage among men increased by 156%, from under 4% when only clinic-based HIV testing services were available to 9.5% when HIVSS and HIV testing services were available (z = -11.6; P < 0.01). Reported test use was higher for men followed through PS (99% vs. 68% in SMS); however, significantly more men reported reactive self-test results in the SMS group compared with PS (6.4% vs. 2.0%), resulting in more antiretroviral therapy initiations in the SMS group compared with PS (23 vs. 9; P < 0.01). CHW HIVSS distribution significantly increases testing among men. While PS enabled personalized follow-up, reporting differences indicate SMS is more acceptable and better aligned with expectations of privacy associated with HIVSS.

Service user experiences of using internet-based testing for sexually transmitted infections (STIs): a qualitative study

ObjectivesInternet-based testing for sexually transmitted infections allows individuals to order a self-sampling kit online, send samples to a central laboratory and receive their results electronically, reducing the need to attend...

In-home TB Testing Using GeneXpert Edge is Acceptable, Feasible, and Improves the Proportion of Symptomatic Household Contacts Tested for TB: A Proof-of-Concept Study.

Household contact investigations are effective for finding tuberculosis (TB) cases but are hindered by low referral uptake for clinic-based evaluation and testing. We assessed the acceptability and feasibility of in-home testing of household contacts (HHC) using the GeneXpert Edge platform. We conducted a 2-arm, randomized study in Eastern Cape, South Africa. HHCs were verbally assessed using the World Health Organization-recommended 4-symptom screen. Households with ≥1 eligible symptomatic contact were randomized. Intervention households received in-home GeneXpert MTB/RIF molecular testing. GeneXpert-positive HHCs were referred for clinic-based treatment. Standard-of-care households were referred for clinic-based sputum collection and testing. We defined acceptability as agreeing to in-home testing and feasibility as generation of valid Xpert MTB/RIF results. The proportion and timeliness of test results received was compared between groups. Eighty-four households were randomized (n = 42 per arm). Of 100 eligible HHCs identified, 98/100 (98%) provided consent. Of 51 HHCs allocated to the intervention arm, all accepted in-home testing; of those, 24/51 (47%) were sputum productive and 23/24 (96%) received their test results. Of 47 HCCs allocated to standard-of-care, 7 (15%) presented for clinic-based TB evaluation, 6/47 (13%) were tested, and 4/6 (67%) returned for their results. The median (interquartile range) number of days from screening to receiving test results was 0 (0) and 16.5 (11-15) in the intervention and standard-of-care arms, respectively. In-home testing for TB was acceptable, feasible, and increased HHCs with a molecular test result. In-home testing mitigates a major limitation of household contact investigations (dependency on clinic-based referral), revealing new strategies for enhancing early case detection.

Real-world walking behaviors are associated with early-stage heart failure: a Project Baseline Health Study

BackgroundData collected via wearables may complement in-clinic assessments to monitor subclinical heart failure (HF). ObjectivesEvaluate the association of sensor-based digital walking measures with HF stage and characterize their correlation with in-clinic measures of physical performance, cardiac function and participant reported outcomes (PROs) in individuals with early HF. MethodsThe analyzable cohort included participants from the Project Baseline Health Study (PBHS) with HF stage 0, A, or B, or adaptive remodeling phenotype (without risk factors but with mild echocardiographic change, termed RF-/ECHO+) (based on available first-visit in-clinic test and echocardiogram results) and with sufficient sensor data. We computed daily values per participant for 18 digital walking measures, comparing HF subgroups vs stage 0 using multinomial logistic regression and characterizing associations with in-clinic measures and PROs with Spearman's correlation coefficients, adjusting all analyses for confounders. ResultsIn the analyzable cohort (N=1265; 50.6% of the PBHS cohort), one standard deviation decreases in 17/18 walking measures were associated with greater likelihood for stage-B HF (multivariable-adjusted odds ratios [ORs] vs stage 0 ranging from 1.18-2.10), or A (ORs vs stage 0, 1.07-1.45), and lower likelihood for RF-/ECHO+ (ORs vs stage 0, 0.80-0.93). Peak 30-minute pace demonstrated the strongest associations with stage B (OR vs stage 0=2.10; 95% CI:1.74-2.53) and A (OR vs stage 0=1.43; 95% CI:1.23-1.66). Decreases in 13/18 measures were associated with greater likelihood for stage-B HF vs stage A. Strength of correlation with physical performance tests, echocardiographic cardiac-remodeling and dysfunction indices and PROs was greatest in stage B, then A, and lowest for 0. ConclusionsDigital measures of walking captured by wearable sensors could complement clinic-based testing to identify and monitor pre-symptomatic HF.

"It Soothes Your Heart": A Multimethod Study Exploring Acceptability of Point-of-Care Viral Load Testing among Ugandan Pregnant and Postpartum Women Living with HIV.

High adherence to antiretroviral therapy (ART) is critical for achieving viral suppression and preventing onward HIV transmission. ART continuation can be challenging for pregnant women living with HIV (PWLHIV), which has critical implications for risk of vertical HIV transmission. Point-of-care viral load (POC VL) testing has been associated with improved treatment and retention outcomes. We sought to explore acceptability of POC VL testing among Ugandan PWLHIV during pregnancy and postpartum. This multimethod analysis drew on quantitative and qualitative data collected between February and December 2021. Quantitatively, we used an intent-to-treat analysis to assess whether randomization to clinic-based POC VL testing during pregnancy and infant testing at delivery was associated with improved viral suppression (≤50 copies/mL) by 3 months postpartum compared to standard-of-care (SOC) VL testing through a central laboratory, adjusting for factorial randomization for the male partner testing strategy. Additionally, a subset of 22 PWLHIV in the POC VL arm participated in in-depth qualitative interviews. We inductively analyzed transcripts to develop categories representing concepts that characterized women's perceptions of POC VL testing during pregnancy and at delivery and ways that POC VL testing may have impacted their ART adherence and viral suppression. Key themes around women's perceptions of POC VL testing were then organized into main categories. Overall, 151 PWLHIV were enrolled into the study, 77 (51%) of whom were randomized to receive POC VL testing during pregnancy and at delivery. Women reported in qualitative interviews that POC VL testing had (1) motivated their ART adherence during pregnancy and postpartum and that they felt this testing method had (2) helped them protect their infants from acquiring HIV and (3) improved their emotional wellbeing. POC VL testing was highly acceptable among Ugandan PWLHIV and was viewed as an important tool that women believed improved their ART adherence, gave them information necessary to protect their infants from vertical HIV acquisition, and improved their emotional wellbeing. These findings support the global scale-up of POC VL testing in settings with high HIV burden, especially for PWLHIV who may be at risk of treatment disruptions or loss to follow-up.

Evaluating the acceptability, usability, and feasibility of a clinic-based genetic testing risk assessment intervention in Black women with breast cancer.

436 Background: Black women diagnosed with breast cancer utilize genetic counseling and testing services less often than White women despite these services having the potential to personalize medical management of breast cancer and identify family members for cascade testing. Lower rates of provider recommendations may be a driver of these disparities, as uptake does not appear to differ by race. The objective of this study was to evaluate the acceptability, usability, and feasibility of a clinic-based genetic risk assessment to facilitate provider recommendations for genetic testing in Black women diagnosed with breast cancer. Methods: A clinic-embedded, race-concordant, trained navigator administered a 15-minute screening tool based on National Comprehensive Cancer Network genetic testing criteria to English-speaking, Black women ≥18 and newly diagnosed with breast cancer. A copy of the results were given to the treating surgeon to facilitate consideration of genetic testing for the patient. However, the decision to recommend genetic testing was left to discretion of the surgeon. After enrollment completion, we conducted semi-structured interviews with a subsample of patients and surgeons who participated in the intervention to elicit their perspectives and experiences. We also used medical record data to determine if surgeons recommended genetic testing to participating patients, and if so, whether they completed it. Results: Between January 2022 and April 2023, 37 patients with a median age of 56.9 years (IQR 15.0-37.5) consented to participate. Surgeons recommended genetic testing to 25/37 patients and 5/37 additional patients were referred outside of this intervention (81.1% total). 12/37 patients (including those who were and were not recommended genetic testing) and 4/4 surgeons completed follow-up interviews. For clinician usability and acceptability, surgeons reported little to no negative impact on their clinic flow. While some found the intervention to be a helpful reminder, others shared it made no discernible impact on their practice, as they reported already incorporating a similar system into their clinic flow. For patient usability and acceptability, some patients found questions on the screening tool difficult to answer and expressed feeling overwhelmed at the time it was administered but the navigator was comforting, reassuring, and informative. Patients, surgeons, and the navigator recommended administering the screening tool prior to the initial appointment with the surgeon and ensuring follow up with patients regarding results. Conclusions: Participating patients and surgeons found this intervention to be feasible and acceptable. Usability challenges warrant further exploration into the logistics of the intervention, including timing, delivery, and medium.

A community health worker-led program to improve access to gestational diabetes screening in urban slums of Pune, India: Results from a mixed methods study.

The World Health Organization recommends all pregnant women receive screening for gestational diabetes (GDM) with a fasting oral glucose tolerance test (OGTT). However, very few women receive recommended screening in resource-limited countries like India. We implemented a community health worker (CHW)-delivered program to evaluate if home-based, CHW-delivered OGTT would increase GDM screening in a low-resource setting. We conducted a mixed methods study in two urban slum communities in Pune, India. CHWs were trained to deliver home-based, point-of-care fasting OGTT to women in their third trimester of pregnancy. The primary outcome was uptake of CHW-delivered OGTT. Secondary outcomes included GDM prevalence and linkage to GDM care. Individual interviews were conducted with purposively sampled pregnant women, CHWs, and local clinicians to assess barriers and facilitators of this approach. From October 2021-June 2022, 248 eligible pregnant women were identified. Of these, 223 (90%) accepted CHW-delivered OGTT and 31 (14%) were diagnosed with GDM. Thirty (97%) women diagnosed with GDM subsequently sought GDM care; only 10 (33%) received lifestyle counseling or pharmacologic therapy. Qualitative interviews indicated that CHW-delivered testing was considered highly acceptable as home-based testing saved time and was more convenient than clinic-based testing. Inconsistent clinical management of GDM was attributed to providers' lack of time to deliver counseling, and perceptions that low-income populations are not at risk for GDM. Convenience and trust in a CHW-delivered GDM screening program resulted in high access to gold-standard OGTT screening and identification of a high GDM prevalence among pregnant women in two urban slum communities. Appropriate linkage to care was limited by clinician time constraints and misperceptions of GDM risk. CHW-delivered GDM screening and counseling may improve health education and access to preventive healthcare, offloading busy public clinics in high-need, low-resource settings.

Self-sampled multi-anatomic site testing for uncovering the community burden of undiagnosed Chlamydia trachomatis and Neisseria gonorrhoeae infection in men who have sex with men.

To detect otherwise undiagnosed asymptomatic sexually transmitted infection (STI), and for estimating prevalence among men who have sex with men (MSM). In this community-based study in Hong Kong, adult MSM were recruited. After completion of an online survey, free multi-anatomic sites self-sampling kits (urine specimens, pharyngeal and rectal swabs) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) tests were delivered to requesting participants. Factors associated with STI positivity were analyzed in logistic regression. From September 2021 to October 2022, 712 MSM were recruited, with 86% aged 18-39, and 16% reported history of chemsex engagement. A majority (81%) had previously undergone HIV testing, 68% had ever tested for STI, and 35% previously diagnosed with STI. Totally 428 (60%) had requested self-sampling kits, and 276 (39%) returned collected samples. Among participants who returned the samples, about half had never been tested in the past and had no history of STI. Overall 21% tested positive for CT and/or NG (CT/NG)-CT positive 16% and NG positive 7%. By anatomic site, 16% of rectal swabs, 7% of pharyngeal swabs, but just 3% of urine specimens were CT/NG positive. The prevalence of CT/NG was not significantly different by history of STI diagnosis and testing. Self-sampled STI testing is a potentially useful means for enhancing uptake of screening in MSM in the community, which could uncover otherwise undiagnosed asymptomatic infections. Internet-based self-sampling for STI testing could complement the current clinic-based STI testing for supporting epidemiologic evaluation of STI control in the community.

User perceptions of COVID-19 telemedicine testing services, disease risk, and pandemic preparedness: findings from a private clinic in Hong Kong.

During the coronavirus disease 2019 (COVID-19) pandemic, telemedicine has been regarded as a method for providing safe access to healthcare. Here, we explored the experiences of individuals using telemedicine in Hong Kong during the COVID-19 pandemic to understand their risk perceptions and preparedness measures. We conducted a cross-sectional online survey of telemedicine users of private clinic-based COVID-19 testing services from 6 April to 11 May 2020. All users were invited to complete an anonymous online survey regarding COVID-19 risk perception and preparedness measures. The results of the survey were compared with the findings of a previous territory-wide survey. In total, 141 of 187 telemedicine users agreed to participate; the response rate was 75.4%. Of the participants, 95.1% (116/122) believed that telemedicine consultations were useful. Nearly half of the participants (49.0%) agreed or strongly agreed that telemedicine consultations were appropriate during the COVID-19 pandemic. Most participants believed that telemedicine consultations could perform the functions of 'health protection, promotion and disease prevention' (73.6%) and 'diagnosis' (64.0%). Concerning the choice of telemedicine provider, almost all participants (99.2%) were willing to consult medical doctors; more than half of the participants (54.1%) were willing to consult registered nurses, but only 13.1% were willing to consult non-clinical staff who had been trained to provide telemedicine services. The use of telemedicine for screening and patient education can be encouraged during the COVID-19 pandemic in Hong Kong.

A Web-Based, Mail-Order Sexually Transmitted Infection Testing Program: Qualitative Analysis of User Feedback.

The incidence of sexually transmitted infections (STIs) is increasing in the United States. The COVID-19 pandemic resulted in significant reductions in access to health care services, including STI testing and treatment, leading to underreporting of STI cases and a need for alternatives to clinic-based testing. Moreover, concerns around confidentiality, accessibility, and stigma continue to limit access to clinic-based STI testing, particularly for high-priority populations. IWantTheKit (IWTK) is a web-based platform that mails free, confidential, self-administered sample collection kits for testing for gonorrhea, chlamydia (both genital and extragenital sites), and vaginal trichomonas. Individuals visiting the IWTK website may select genital, pharyngeal, and rectal samples for chlamydia and gonorrhea testing. Vaginal samples are tested for trichomoniasis. Self-collected samples are processed in a College of American Pathologists-accredited laboratory, and results are posted to an individual's secure digital account. This study aimed to (1) describe users' experience with the IWTK service through analysis of routine data and (2) optimize retention among current users and expand reach among high-priority populations by responding to user needs through programmatic and functional changes to the IWTK service. Free-text entries were submitted by IWTK users via a confidential "Contact Us" page on the IWTK website from May 17, 2021, to January 31, 2022. All entries were deidentified prior to analysis. Two independent analysts coded these entries using a predefined codebook developed inductively for thematic analysis. A total of 254 free-text entries were analyzed after removing duplicates and nonsensical entries. Themes emerged regarding the functionality of the website and personal experiences using IWTK's services. Users' submissions included requests related to order status, address changes, replacement of old kits, clinical information (eg, treatment options and symptom reports), and reported risk behaviors. This analysis demonstrates how routine data can be used to propose potential programmatic improvements. IWTK implemented innovations on the website based on the study results to improve users' experience, including a tracking system for orders, address verification for each order, a physical drop box, additional textual information, direct linkage to care navigation, and printable results. Web-based, mail-order STI testing programs can leverage user feedback to optimize implementation and retention among current users and potentially expand reach among high-priority populations. This analysis is supported by other data that demonstrate how comprehensive support and follow-up care for individuals testing positive are critical components of any self-testing service. Additional formal assessments of the IWTK user experience and efforts to optimize posttesting linkage to care may be needed.

Reflex Hepatitis C Virus Viral Load Testing Following an Initial Positive Hepatitis C Virus Antibody Test: A Global Systematic Review and Meta-analysis.

Many people who have a positive hepatitis C virus (HCV) antibody (Ab) test never receive a confirmatory HCV RNA viral load (VL) test. Reflex VL testing may help address this problem. We undertook a systematic review to evaluate the effectiveness of reflex VL testing compared with standard nonreflex approaches on outcomes across the HCV care cascade. We searched 4 databases for studies that examined laboratory-based reflex or clinic-based reflex VL testing approaches, with or without a nonreflex comparator, and had data on the uptake of HCV RNA VL test and treatment initiation and turnaround time between Ab and VL testing. Both laboratory- and clinic-based reflex VL testing involve only a single clinic visit. Summary estimates were calculated using random-effects meta-analyses. Fifty-one studies were included (32 laboratory-based and 19 clinic-based reflex VL testing). Laboratory-based reflex VL testing increased HCV VL test uptake versus nonreflex testing (RR: 1.35; 95% CI: 1.16-1.58) and may improve linkage to care among people with a positive HCV RNA test (RR: 1.47; 95% CI: .81-2.67) and HCV treatment initiation (RR: 1.03; 95% CI: .46-2.32). The median time between Ab and VL test was <1 day for all laboratory-based reflex studies and 0-5 days for 13 clinic-based reflex testing. Laboratory-based and clinic-based HCV reflex VL testing increased uptake and reduced time to HCV VL testing and may increase HCV linkage to care. The World Health Organization now recommends reflex VL testing as an additional strategy to promote access to HCV VL testing and treatment. PROSPERO CRD42021283822.

Modeling the impact of different PrEP targeting strategies combined with a clinic-based HIV-1 nucleic acid testing intervention in Kenya

BackgroundUp to 69% of adults who acquire HIV in Kenya seek care for acute retroviral symptoms, providing an important opportunity for early diagnosis and HIV care engagement. The Tambua Mapema Plus (TMP) trial tested a combined HIV-1 nucleic acid testing, linkage, treatment, and partner notification intervention for adults with symptoms of acute HIV infection presenting to health facilities in coastal Kenya. We estimated the potential impact on the Kenyan HIV epidemic of providing PrEP to individuals testing negative in TMP, if scaled up. MethodsWe developed an agent-based simulation of HIV-1 transmission using TMP data and current Kenyan statistics. PrEP interventions were layered onto a model of TMP as standard of care, to estimate additional potential population-level impact of enrolling HIV-negative individuals identified through TMP on PrEP over 10 years. Four scenarios were modeled: PrEP for uninfected individuals in disclosed serodiscordant couples; PrEP for individuals with concurrent partnerships; PrEP for all uninfected individuals identified through TMP; and PrEP integrated into the enhanced partner services component of TMP. FindingsProviding PrEP to both individuals with concurrent partnerships and uninfected partners identified through enhanced partner services reduced new HIV infections and was efficient based on numbers needed to treat (NNT). The mean percent of infections averted was 2.79 (95%SI:−10.83, 15.24) and 4.62 (95%SI:−9.5, 16.82) when PrEP uptake was 50% and 100%, respectively, and median NNT was 22.54 (95%SI:not defined, 6.45) and 27.55 (95%SI:not defined, 11.0), respectively. Providing PrEP for all uninfected individuals identified through TMP averted up to 12.68% (95%SI:0.17, 25.19) of new infections but was not efficient based on the NNT: 200.24 (95%SI:523.81, 123.23). ConclusionsProviding PrEP to individuals testing negative for HIV-1 nucleic acid after presenting to a health facility with symptoms compatible with acute HIV adds value to the TMP intervention, provided PrEP is targeted effectively and efficiently. FundingNational Institutes of Health, Sub-Saharan African Network for TB/HIV Research Excellence.

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months

Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of -10% or greater was interpreted as noninferior. A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, -0.33%, 95% CI LB, -7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, -3.25%; 95% CI LB, -10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, -2.46%). No HIV seroconversions were observed over the follow-up period. In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. ClinicalTrials.gov Identifier: NCT03593629.

Associations Between Clinic-Based HIV Testing Guidelines and Population-Level HIV Testing Rates in the United States.

Between 2005 and 2006, the United States Preventive Services Task Force and the Centers for Disease Control and Prevention revised their risk-based HIV testing guidelines to include universal HIV testing in routine health care. We examined trends in HIV testing and associations with changing policy recommendations using the 2000-2017 National Health Interview Surveys. Multivariable logistic regression and difference-in-difference approach were used to assess rates and correlates of HIV testing before and after the policy changes. Changes in recommendations had minimal effects on overall HIV testing rates but had significant effects on selected subpopulations. The odds of HIV testing increased disproportionately among African Americans, Hispanics, individuals with some college education, low perceived HIV risks, and those who were never married but decreased among those with no regular source of care. A strategy combining risk-based and routine opt-out testing holds promise to rapidly link recently infected individuals to care while reaching individuals who have never been tested.

Challenges and opportunities related to penicillin allergy in the Veterans Health Administration: a narrative review.

The presence of a penicillin allergy label in a patient's medical chart is associated with negative clinical and economic outcomes. Given that less than 10% of reported reactions are truly immunoglobulin E-mediated, removal of unverified penicillin allergy labels is a public health priority and an area of ongoing implementation research. The Veterans Health Administration (VHA) is the largest integrated healthcare system in the United States, with almost 9 million veterans currently enrolled. However, studies analyzing the impact of the penicillin allergy label in this population are limited to single facilities and largely focus on short-term outcomes of allergy documentation correction, usage of β-lactams, and avoidance of antibiotic-related side effects. Broader, national VHA studies focusing on health outcomes and costs are lacking. As with non-VHA facilities, penicillin allergy evaluations are limited owing to the absence of formal allergy/immunology services at most VHA facilities. Pharmacy-driven screening and referral for clinic-based penicillin skin testing is a promising and frequently discussed modality in the literature, but its scalability within the VHA is not yet proven. Broader, evidence-based strategies that can be adapted to the available resources of individual VHA facilities, including those without on-site access to allergy providers, are needed.

Remote vision testing of central retinal acuity and comparison with clinic-based Snellen acuity testing in patients followed for retinal conditions.

The unmet need for remote monitoring of visual function with home-based, patient-centric technologies became increasingly palpable during the COVID-19 pandemic. Many patients with chronic eye conditions lack access to office-based examinations. Here, we evaluate the efficacy of the Accustat® test, a virtual application for measuring near visual acuity on any portable electronic device via telehealth. Thirty-three adult subjects from the telehealth remote monitoring service of a retina practice performed the Accustat® acuity testing at home. All patients underwent in-office general eye examination with additional fundoscopic examination and optical coherence tomography retina imaging. Best corrected visual acuity assessment using a Snellen chart was compared with remote visual acuity assessment with the Accustat® test. Visual acuity was analyzed and compared between the best-corrected near visual acuity potential achieved on the Accustat® and in-office distance best-corrected Snellen visual acuity. The mean logarithm of the minimum angle of resolution (logMAR) visual acuities of all eyes tested using the Accustat test was 0.19 ± 024 and for the office Snellen test 0.21 ± 0.21. A linear regression model with 95% confidence intervals reveals that there is a strong linear relationship between Accustat logMAR and office Snellen logMAR. Bland-Altman analysis demonstrated 95.2% significant agreement between Accustat and Office Snellen's best corrected visual acuity. Intraclass correlation coefficient (ICC = 0.94) demonstrated a strong positive correlation between at home versus office visual acuity. There was a high correlation between the visual acuity measured with the Accustat near vision digital self-test and the office Snellen acuity test, suggesting the potential utility of scalable remote monitoring of central retinal function via telehealth.

Acceptability of an existing online sexually transmitted and blood-borne infection testing model among gay, bisexual and other men who have sex with men in Ontario, Canada.

Gay, bisexual and other men who have sex with men (GBM) are disproportionately affected by sexually transmitted and blood-borne infections (STBBI) due to stigma and other factors such as structural barriers, which delay STBBI testing in this population. Understanding acceptability of online testing is useful in expanding access in this population, thus we examined barriers to clinic-based testing, acceptability of a potential online testing model, and factors associated with acceptability among GBM living in Ontario. Sex Now 2019 was a community-based, online, bilingual survey of GBM aged ≥15. Prevalence ratios (PR) and 95% confidence intervals (95%CI) were calculated using modified Poisson regression with robust variances. Multivariable modelling was conducted using the Hosmer-Lemeshow-Sturdivant approach. Among 1369 participants, many delayed STBBI testing due to being too busy (31%) or inconvenient clinic hours (29%). Acceptability for online testing was high (80%), with saving time (67%) as the most common benefit, and privacy concerns the most common drawback (38%). Statistically significant predictors of acceptability for online testing were younger age (PR = 0.993; 95%CI: 0.991-0.996); a greater number of different sexual behaviours associated with STBBI transmission (PR = 1.031; 95%CI: 1.018-1.044); identifying as an Indigenous immigrant (PR = 1.427; 95%CI: 1.276-1.596) or immigrant of colour (PR = 1.158; 95%CI: 1.086-1.235) compared with white non-immigrants; and currently using HIV pre-exposure prophylaxis (PrEP) compared to not currently using PrEP (PR = 0.894; 95%CI: 0.828-0.965). Acceptability of online testing was high among GBM in Ontario. Implementing online STBBI testing may expand access for certain subpopulations of GBM facing barriers to current in-person testing.

Impact of rapid near-patient STI testing on service delivery outcomes in an integrated sexual health service in the United Kingdom: a controlled interrupted time series study

ObjectivesTo evaluate the impact of a new clinic-based rapid sexually transmitted infection testing, diagnosis and treatment service on healthcare delivery and resource needs in an integrated sexual health service.DesignControlled interrupted...