Clinic-based Testing Research Articles

COVID-19 AND NEUROMUSCULAR DISEASES: EP.24 COVID-19 mitigation strategies for outcome measure assessments, training, and endpoint collection in clinic, clinical trials and natural history studies

Functional motor performance outcome measures (OM), assessed by Physiotherapists, are commonly used as primary or secondary endpoints in clinical trials, natural history studies and within clinics for children and adults with neuromuscular disorders (NMD). The impact of COVID-19 globally on the ability to assess patients within the clinic, especially those considered clinically vulnerable and advised to shield at home, necessitated rapid development of COVID-19 mitigation strategies. Here we explore the feasibility of adapting current standard outcomes to remote testing, considerations for a remote assessment, methods utilised for clinical evaluator training and future work on validation of the home assessments. In March 2020, with several trials and natural history studies underway, including trials that were due to collect primary endpoints during lockdowns, a fast response and alternative strategies to in person clinic-based assessments were required to protect study efficacy endpoints and ensure ongoing patient evaluations. Remote testing of existing outcome measures had not yet been validated in the population of patients with NMD and most clinical trials did not include remote assessments. Exploring feasibility and suitability of adapting current OMs for remote assessments was critical to ensuring ongoing data collection in clinical trials, natural history studies and for clinic. A group of expert Physiotherapists in NMD, working across clinics, countries, and clinical trials developed initial guidelines for the suitability and feasibility of performing OMs commonly used in clinical trials. A number of sponsors introduced amendments to enable remote evaluations, supported by video streaming of the assessment to their local clinical evaluators, which has raised discussions around the validity and reliability of remote assessments and their correlation to clinic-based testing. Additionally, the model of clinical evaluator training used for industry trials was adapted to meet COVID-19 restrictions to ensure trained staff were available for clinical evaluations. Future directions and validation efforts will be presented.

Glaucoma Screening Using an iPad-Based Visual Field Test in a West African Population

To investigate the performance of the Melbourne Rapid Fields (MRF) for use in clinic-based visual field testing in a low-resource setting. Prospective cross-sectional study. One hundred and three participants (66 patients with glaucoma and 37 control participants) attending a clinical appointment at the Tema Eye Center, Tema, Ghana. Patients with glaucoma and control participants underwent MRF and Humphrey Field Analyzer (HFA) testing. Mean deviation (MD), pattern standard deviation (PSD), reliability parameters, sensitivity, specificity, and area under the receiver operating characteristic curve. Mean MD was less negative and mean PSD was more positive on the MRF than the HFA in both groups (all P < 0.001). False-positive and false-negative rates were comparable between methods (P= 0.09 and P= 0.35, respectively). In patients with glaucoma, MD and PSD from the 2 devices were correlated strongly (r= 0.84; P < 0.001) and moderately (r= 0.61; P < 0.001), respectively. Agreement analysis revealed that MRF tended to generate significantly higher MD (bias, 3.3 ± 4.1 dB; P= 0.03) and PSD (bias, 1.9 ± 2.8 dB; P= 0.03) with wide limits of agreement. For detecting moderate to advanced glaucoma, the sensitivity was 60.9% for the MRF and 78.3% for the HFA (P= 0.10); respective specificities were 86.5% and 83.8% (P= 0.76). The MRF underestimated MD and overestimated PSD values compared with the HFA. Agreement biases were significant, suggesting a weak agreement between the 2 devices. However, the MRF showed potential for screening in a low-resource setting, particularly for detecting moderate to advanced glaucoma.

Screening Programs for SARS-CoV-2 Infections on a University Campus - Austin, Texas, September 30-November 30, 2020.

Colleges and universities in the United States have relied on various measures during the COVID-19 pandemic to prevent transmission of SARS-CoV-2, the virus that causes COVID-19, including implementing testing programs (1-3). These programs have permitted a safer return to campus for students by identifying infected persons and temporarily isolating them from the campus population (2,3). The University of Texas at Austin (UT Austin) implemented COVID-19 prevention measures in Fall 2020* including the following testing programs: clinic-based diagnostic testing, voluntary community screening, and targeted screening (testing of specific student populations in situations of increased transmission risk). During September 30-November 30, 2020, UT Austin students participated in tests for SARS-CoV-2, which resulted in the detection of 401 unique student cases of COVID-19 from among 32,401 tests conducted.† Among students who participated in one targeted screening program for students attending campus events, 18 (37.5%) of 48 infected students were asymptomatic at the time of their positive test result compared with 45 (23%) of 195 students identified through community testing and nine (5.8%) of 158 students identified through clinic-based testing. Targeted screening also identified a different population of students than did clinic-based and community testing programs. Infected students tested through targeted screening were more likely to be non-Hispanic White persons (chi square=20.42; p<0.03), less likely to engage in public health measures, and more likely to have had interactions in settings where the risk for SARS-CoV-2 transmission is higher, such as restaurants, gyms, and residence halls. In addition to clinic-based SARS-CoV-2 testing at colleges and universities, complementary testing programs such as community and targeted screening might enhance efforts to identify and control SARS-CoV-2 transmission, especially among asymptomatic persons and disproportionately affected populations that might not otherwise be reached.

Laboratory Reflex and Clinic-Based Point-of-Care Cryptococcal Antigen Screening for Preventing Meningitis and Mortality Among People Living With HIV.

Cryptococcosis remains a leading cause of meningitis and mortality among people living with HIV (PLHIV) worldwide. We sought to evaluate laboratory-based cryptococcal antigen (CrAg) reflex testing and a clinic-based point-of-care (POC) CrAg screening intervention for preventing meningitis and mortality among PLHIV in South Africa. We conducted a prospective pre-post intervention study of adults presenting for HIV testing in Umlazi township, South Africa, over a 6-year period (2013-2019). Participants were enrolled during 3 phases of CrAg testing: CrAg testing ordered by a clinician (clinician-directed testing, 2013-2015); routine laboratory-based CrAg reflex testing for blood samples with CD4 ≤100 cells/mm3 (laboratory reflex testing, 2015-2017); and a clinic-based intervention with POC CD4 testing and POC CrAg testing for PLHIV with CD4 ≤200 cells/mm3 with continued standard-of-care routine laboratory reflex testing among those with CD4 ≤100 cells/mm3 (clinic-based testing, 2017-2019). The laboratory and clinical teams performed serum CrAg by enzyme immunoassay and lateral flow assay (Immy Diagnostics, Norman, OK). We followed up participants for up to 14 months to compare associations between baseline CrAg positivity, antiretroviral therapy and fluconazole treatment initiation, and outcomes of cryptococcal meningitis, hospitalization, and mortality. Three thousand one hundred five (39.4%) of 7877 people screened were HIV-positive, of whom 908 had CD4 ≤200 cells/mm3 and were included in the analyses. Laboratory reflex and clinic-based testing increased CrAg screening (P < 0.001) and diagnosis of CrAg-positive PLHIV (P = 0.011). When compared with clinician-directed testing, clinic-based CrAg testing showed an increase in the number of PLHIV diagnosed with cryptococcal meningitis (4.5% vs. 1.5%; P = 0.059), initiation of fluconazole preemptive therapy (7.2% vs. 2.5%; P = 0.010), and initiation of antiretroviral therapy (96.8% vs. 91.3%; P = 0.012). Comparing clinic-based testing with laboratory reflex testing, there was no significant difference in the cumulative incidence of cryptococcal meningitis (4.5% vs. 4.1%; P = 0.836) or mortality (8.1% vs. 9.9%; P = 0.557). Laboratory reflex and clinic-based CrAg testing facilitated the diagnosis of HIV-associated cryptococcosis and fluconazole initiation but did not reduce cryptococcal meningitis or mortality. In this nonrandomized cohort, clinical outcomes were similar between laboratory reflex testing and clinic-based POC CrAg testing.

Diagnosis and treatment of sexually transmitted infections in male partners of pregnant women in Brazil.

Sexually transmitted infections (STIs) can adversely affect a woman's pregnancy and the health of the developing fetus. The source of these infections may be the male sexual partner who remains under-diagnosed and un-treated due to a combination of lack of symptoms, decreased access to health care, and poor health-seeking behaviors. From September 2018 to November 2019, we offered a cohort of pregnant women (gestational age range: 4.6-41 weeks) clinic-based STI testing for HIV and syphilis (via lateral flow assay rapid tests) and for Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, and Trichomonas (T.) vaginalis (via PCR-based testing) at Santa Casa Hospital and 10 affiliated prenatal clinics in Porto Alegre, Brazil. 400 women between the ages of 18 and 46years (mean age: 27years) enrolled and 24% were diagnosed with an STI. Each woman enrolled agreed to invite their male partners to clinic for the same panel of STI testing, and 255 men (64%) between the ages of 18 and 64years (mean age: 29years) attended clinic and all accepted full intervention. In these male partners, 40 (16%) were diagnosed with an STI including 22 (8.7%) testing positive for C. trachomatis, 15 (6%) for treponemal antibody (syphilis), 7 (2.8%) for T. vaginalis, 3 (1.2%) for N. gonorrhoeae, and 1 (0.4%) for HIV antibody. In our multivariate analysis, having symptoms of an STI (AOR 4.5, 95% CI 1.3-15.2) and arguing about jealousy (AOR 3.1, 95% CI 1.2-8.2) remained significantly associated with male diagnosis of an STI. Sexually transmitted infections are common in sexual partners of pregnant women in Brazil and should be addressed to prevent reinfection of pregnant women.

Prevalence and risk factors for hypertension and diabetes among those screened in a refugee settlement in Uganda

BackgroundDiabetes and hypertension are increasingly prevalent in low and middle income countries, but they are not well documented in refugee settlements in these settings. We sought to estimate the prevalence and associated characteristics of diabetes and hypertension among adults presenting for clinic-based HIV testing in Nakivale Refugee Settlement in Uganda.MethodsHIV-negative adults presenting to outpatient clinics for HIV testing at three health centers in Nakivale Refugee Settlement were enrolled from January 2019 through January 2020. Multi-lingual research assistants administered questionnaires aloud to ascertain medical history and sociodemographic information. The research assistants used standardized procedures to measure participants’ blood pressure to detect hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg), and conduct a point-of-care blood glucose test for diabetes (random blood glucose ≥11.1 mmol/L with self-reported frequent urination or thirst, or fasting blood glucose ≥7.0 mmol/L regardless of symptoms), as per Uganda Ministry of Health guidelines. We used χ-square or Fisher’s exact test to test for differences in disease prevalence by refugee status and log-binomial or Poisson regression models to estimate associations of immigration status and country of origin, respectively, with hypertension and diabetes while controlling for age, sex, education level, and body mass index.ResultsAmong 2127 participants, 1379 (65%) were refugees or asylum seekers and 748 (35%) were Ugandan nationals. Overall, 32 participants met criteria for diabetes (1.5%, 95% CI 1.1–2.1%) and the period prevalence was 2.3% (95% CI 1.7–3.0). There were 1067 (50%, 95% CI 48.0–52.2%) who met the criteria for pre-hypertension and 189 (9%, 95% CI 7.7–10.1%) for hypertension. These proportions did not vary by immigration status or country of origin in univariate tests or multivariable regression models.ConclusionsHypertension was common and diabetes was uncommon among those screened in a Ugandan refugee settlement. Routine blood pressure screening should be considered in this setting. Additional research could develop diabetes screening criteria to help identify at risk individuals in this limited resource setting.

Peer Mobilization and Human Immunodeficiency Virus (HIV) Partner Notification Services Among Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women in Coastal Kenya Identified a High Number of Undiagnosed HIV Infections.

BackgroundHuman immunodeficiency virus (HIV) partner notification services (HPN), peer mobilization with HIV self-testing, and acute and early HIV infection (AEHI) screening among gay, bisexual, and other men who have sex with men (GBMSM) and transgender women (TGW) were assessed for acceptability, feasibility, and linkage to antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) services.MethodsBetween April and August 2019, peer mobilizers mobilized clients by offering HIV oral self-tests and immediate clinic referral for clients with AEHI symptoms. Mobilized participants received clinic-based rapid antibody testing and point-of-care HIV RNA testing. Newly diagnosed participants including those derived from HIV testing services were offered immediate ART and HPN. Partners were recruited through HPN.ResultsOf 772 mobilized clients, 452 (58.5%) enrolled in the study as mobilized participants. Of these, 16 (3.5%) were HIV newly diagnosed, including 2 (0.4%) with AEHI. All but 2 (14/16 [87.5%]) initiated ART. Thirty-five GBMSM and TGW were offered HPN and 27 (77.1%) accepted it. Provider referral identified a higher proportion of partners tested (39/64 [60.9%] vs 5/14 [35.7%]) and partners with HIV (27/39 [69.2%] vs 2/5 [40.0%]) than index referral. Of 44 enrolled partners, 10 (22.7%) were newly diagnosed, including 3 (6.8%) with AEHI. All 10 (100%) initiated ART. PrEP was initiated among 24.0% (103/429) mobilized participants and 28.6% (4/14) partners without HIV.ConclusionsHPN, combined with a peer mobilization–led self-testing strategy and AEHI screening for GBMSM and TGW, appears to be acceptable and feasible. These strategies, especially HPN provider referral, effectively identified undiagnosed HIV infections and linked individuals to ART and PrEP services.

Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial

BackgroundCervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.MethodsWe designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.DiscussionOur trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.Trial registrationClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

Telemedicine with a Cell-Free DNA Based Monitoring Approach Maintains Lung Allograft Function While Reducing Frequency of Invasive Bronchoscopy

Purpose The need to reduce in-person clinic visits during the COVID-19 pandemic necessitated a significant reduction in traditional lung transplant surveillance with bronchoscopy and clinic-based pulmonary function testing (PFT). We hypothesized that a screening strategy that utilized cell free DNA (CareDx: Allosure), a non-invasive marker of molecular allograft injury, to determine the need for for-cause diagnostics would yield equivalent lung function stability as traditional monitoring using surveillance bronchoscopy and clinic performed PFTs in lung transplant recipients. Methods We compared the change in FEV1, the prevalence of donor-specific HLA antibodies (DSA), and frequency of hospitalization over parallel 6-month timespans in 2 cohorts of LTRs assessed during the 1st 3 years of their transplant. The 1st cohort (N=65) was monitored from 3/2019 to 9/2019 by in-clinic PFT, surveillance bronchoscopy, DSA, and the 2nd cohort (N=73) was monitored from 3/2020-9/2020 with telemedicine, home spirometry, surveillance dd-cfDNA, and DSA testing every 1-3 months. In cohort 2, patients with >10% decline in home FEV1, and/or dd-cfDNA>1% underwent for-cause bronchoscopy and/or further diagnostic evaluation. Surveillance PFTs were conducted once between 7/20 and 9/20 in cohort 2 to assess the stability of lung function. For both cohorts, a minimum interval of 150 days and a maximum interval of 200 days was used for analysis of spirometric change. Results There were significantly fewer bronchoscopies/patient (pt) in cohort 2 vs cohort 1 (0.91 vs 1.8, p Conclusion The use of non-invasive cell-free DNA testing with home spirometry screening appears to yield comparable medium-term allograft outcomes, as compared to conventional clinic-based PFTs and surveillance bronchoscopy. Further multi-center studies are warranted to determine if this approach can reduce invasive procedures while maintaining equivalent outcomes in clinically meaningful parameters.

"I got tested at home, the help came to me": acceptability and feasibility of home-based TB testing of household contacts using portable molecular diagnostics in South Africa.

The effectiveness of household contact investigations is limited by low referral uptake for clinic-based TB testing by symptomatic household contacts. We qualitatively investigated the acceptability and perceived benefits of home-based TB testing using a portable GeneXpert-I instrument (GX-I) in an urban South African township. In-depth interviews were conducted with household contacts tested and those that observed testing. Semi-structured interviews explored household contact's understanding of TB, perceptions of the GX-I device and testing procedures, confidentiality, willingness to refer others, and views on home- vs. clinic-based testing. Focus group discussions with home-based TB testing implementing staff assessed operational considerations for scale-up. Data were analysed using a constant comparison approach to qualitatively evaluate the acceptability and feasibility of home-based TB testing. Thirty in-depth interviews and two focus group discussions were conducted. Observing one's own sputum being tested resulted in an emergent trust in home-based TB testing, the GX-I device and one's test results. Home-based TB testing was considered convenient, helped to overcome apathy towards testing and mitigated barriers to clinic-based testing. Perceptions that home-based TB testing contributes to improved household and community health resulted in an emergent theme of alleviation of health insecurities. Operational concerns regarding inadvertent disclosure of one's diagnosis to household members and time spent in people's homes were identified. Home-based TB testing was acceptable and feasible. Individuals expressed belief in the machine by being able to witness the testing process. Though most themes mirrored qualitative studies of home-based HIV testing, the alleviation of health insecurities theme is unique to home-based TB testing. Future research must evaluate the impact of home-based TB testing on case finding yield, time-to-treatment initiation and household outcomes.

Development of a proxy-reported scale to assess motor function in infants and young children with early-onset neuromuscular disorders.

To develop a novel proxy-reported scale of motor function in infants and young children with early-onset neuromuscular disorders (NMD), entitled the Proxy Motor Outcome Measure (PMOM). A mixed method design was employed, applying both qualitative and quantitative research. A framework technique using sensitivity analyses guided the development of the most appropriate and relevant subset of items, modelled after 30 neuromuscular disease instruments/scales. The PMOM was designed based on semi-structured interviews with 16 proxies; a focus group of 11 experts in neuromuscular diseases and scale development, 10 of whom also gave quantitative data using a two-round Delphi method survey; and cognitive interviews with five proxies. These processes were conducted between January 2014-March 2019. Nine themes and 32 subthemes were derived from the semi-structured interviews. Five domains and three subdomains of potential items were identified by the focus group. An initial version of the PMOM scale was created with 121 items. Using the two-round Delphi method, 43 items met agreement on pre-defined requirements. The second version of the PMOM scale included these 43 and two additional items based on expert feedback. Proxies gave 114 suggestions on cognitive interviews, 99 of which were successfully addressed by the research team. The final version of the PMOM scale included 43 items. We developed a preliminary proxy-reported instrument, the PMOM, to evaluate motor function in infants and young children with early-onset NMD. Proxies hold a wealth of knowledge on their child's motor function during early development, which may complement clinic-based motor function testing. However, there is no validated measure of motor function that incorporates the observation of proxies of infants and young children with NMD. Future work will be focused on assessing the reliability, validity and responsiveness of the PMOM scale and implementing this tool in clinical studies.

Using individual stated-preferences to optimize HIV self-testing service delivery among men who have sex with men (MSM) in Malaysia: results from a conjoint-based analysis

BackgroundHIV self-testing (HIVST) has the potential to improve HIV testing uptake and frequency for key populations like MSM who experience multiple barriers accessing clinic-based HIV testing. In the absence of HIVST in Malaysia, there is no guidance to inform HIVST delivery. This study investigated the acceptability of HIVST and preferences about the HIVST service delivery approaches using a standardized stated preference method.MethodsA cross-sectional online survey conducted between January and April 2019 assessed the interest in HIVST in 544 MSM in Malaysia. Participants ranked eight hypothetical HIVST service delivery program elements with varied combinations of six, two-level HIVST service delivery program attributes (cost, privacy, accuracy, kit collection site, kit type, and testing support). SPSS conjoint procedure was used to estimate the relative importance of each attribute and preference across eight possible HIVST service delivery programs.ResultsOverall, 70.4% had previously tested for HIV, and of those, 64.0% had done so in the past 6 months (45.0% of all participants). Of all the participants, 25.2% reported having used HIVST previously. The acceptability for HIVST service delivery models ranged from 44.9 to 77.1%, with mean acceptability of 56.2% across the eight hypothetical HIVST distribution scenarios. The HIVST service delivery scenario with the highest acceptability had the following attributes: no cost (free), anonymity (name not required), 99–100% accuracy, home-delivered, fingerstick, and testing support using telephone hotline or texting. HIVST cost was the most important attribute (relative importance score: RIS = 19.30) associated with acceptability, followed by anonymity (RIS = 18.41), accuracy (RIS = 17.33), kit delivery (RIS = 16.99), fingerstick kit (RIS = 15.86), and support (RIS = 12.08).ConclusionsAcceptability for HIVST in Malaysian MSM was high but differed markedly by a number of HIVST delivery scenarios and attributes. These findings could be relevant as the Malaysian Ministry of Health is in the process of developing a regulatory framework for ensuring the quality of kits, as well as policies supporting safe use while broader implementation under national AIDS programs.

Home-Based Testing for Sexually Transmitted Infections: Leveraging Online Resources During the COVID-19 Pandemic.

Home-Based Testing for Sexually Transmitted Infections: Leveraging Online Resources During the COVID-19 Pandemic.

Unintended uses, meanings, and consequences: HIV self-testing among female sex workers in urban Uganda

ABSTRACT Female sex workers (FSWs) are at increased risk of HIV and face significant barriers to clinic-based HIV testing, including provider stigma and privacy constraints. HIV self-testing (HIVST) has been proven to significantly increase HIV testing among FSWs. Less is known, however, about how FSWs make meaning of oral-fluid HIV self-tests, and the unintended ways they use and understand this novel technology. From October 2016 to March 2017, we conducted 61 in-depth interviews with FSWs (n = 31) in Kampala, Uganda. Eligible participants were: female, ≥18 years, exchanged sex for money or goods, and had not recently tested for HIV. We used inductive coding to identify emerging themes and re-arranged these into an adapted framework. Unintended desirable ways FSWs described self-testing included as a means to test others, to bolster their reputation as a health-conscious sex worker, and to avoid bearing witness to suffering at health facilities. Unintended undesirable meanings ascribed to self-testing included misunderstandings about how HIV is transmitted (via saliva versus blood) and whether self-tests also test for other infections. HIVST can increase FSWs’ knowledge of their own HIV status and that of their sexual partners, but messaging and intervention design must address misunderstandings and misuses of self-testing. Trial registration: ClinicalTrials.gov identifier: NCT02846402.

Implications of HIV Self-Testing for Other Sexually Transmissible Infection Testing and Broader Sexual Health Needs: A Mixed-Methods Study of Gay and Bisexual Men in Australia.

Although HIV self-tests can support frequent HIV testing, their impact on attending clinics for other sexually transmissible infection (STI) testing and sexual health care is largely unknown. We explored intentions to use HIV self-tests and how this might affect patterns of attending sexual health services among gay, bisexual, and other men who have sex with men (GBM) in Victoria, Australia. Gay, bisexual, and other men who have sex with men self-completed an online survey between March 10 and June 10, 2019. Among GBM reporting lifetime HIV testing and intentions to self-test at least once annually, we used logistic regression to identify correlates of intending to replace clinic-based HIV testing with self-tests. Qualitative interviews with purposively selected survey participants undertaken between May and June 2019 explored the implications of self-testing on clinic-based sexual health care. Of the 279 survey participants, 79 (29%) reported they would replace most or all clinic-based HIV tests with self-tests, with longer time since last testing for HIV and younger age associated with reporting this outcome in the multivariate analysis. Qualitative interviews revealed different perceived roles for self-tests and clinic-based testing, and the importance of integrating HIV self-tests within broader sexual health routines. Although GBM see a distinct role for HIV self-testing, its rollout will likely result in missed opportunities for clinic-based STI testing and education for some GBM, particularly among younger and less-recently tested GBM. Convenient, non-clinic-based approaches to STI testing are needed alongside support platforms to maximize the benefits of HIV self-testing within comprehensive sexual health routines.

HIV testing amid COVID-19: community efforts to reach men who have sex with men in three Kenyan counties.

In comparison to European and American countries, Kenya has been less impacted by the COVID-19 pandemic in terms of reported cases and mortalities. However, everyday life has been dramatically affected by highly restrictive government-imposed measures such as stay-at-home curfews, prohibitions on mobility across national and county boundaries, and strict policing, especially of the urban poor, which has culminated in violence. This open letter highlights the effects of these measures on how three community-based organizations (CBOs) deliver HIV programs and services to highly stigmatized communities of men who have sex with men living in the counties of Kisumu, Kiambu and Mombasa. In particular, emphasis is placed on how HIV testing programs, which are supported by systematic peer outreach, are being disrupted at a time when global policymakers call for expanded HIV testing and treatment targets among key populations. While COVID 19 measures have greatly undermined local efforts to deliver health services to members and strengthen existing HIV testing programs, each of the three CBOs has taken innovative steps to adapt to the restrictions and to the COVID-19 pandemic itself. Although HIV testing in clinical spaces among those who were once regular and occasional program attendees dropped off noticeably in the early months of the COVID-19 lockdown, the program eventually began to rebound as outreach approaches shifted to virtual platforms and strategies. Importantly and unexpectedly, HIV self-testing kits proved to fill a major gap in clinic-based HIV testing at a time of crisis.

Frequent Detection of Undiagnosed HIV Within Emergency Departments in Botswana.

Among 130,161 HIV testing records from unique individuals at 149 programmatic sites in Botswana, frequency of detecting undiagnosed HIV infection within emergency departments (EDs) was 4.7% (455/9695), 2-fold higher than other clinic-based HIV counseling and testing. Men and noncitizens less frequently initiated same-day antiretroviral therapy after testing HIV positive within emergency departments.

High Prevalence of Sexually Transmitted Infections in Pregnant Women Living in Southern Brazil.

Porto Alegre, Brazil, has the highest rates of congenital syphilis and HIV in the country. Other treatable sexually transmitted infections (STIs) are associated with poor pregnancy and neonatal outcomes, but are only diagnosed by syndromic algorithms. Between September 2018 and November 2019, we offered all pregnant women clinic-based STI testing for HIV antibody and treponemal antibody (via lateral flow assay rapid tests provided by the Brazilian Government) and for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis (via polymerase chain reaction-based testing provided by Gene Xpert, Sunnyvale, CA) in 10 public prenatal health clinics in Porto Alegre. Participating women answered a brief survey via audio computer-assisted survey instrument regarding demographics, partnerships, and sexual behaviors. All infected individuals received appropriate treatment and referrals. Of 400 pregnant women recruited, 94 (24%) were diagnosed with an STI, including 2% with HIV, 11% with syphilis, 9% with chlamydia, 1% with gonorrhea, 5% with trichomoniasis, and 3% with more than 1 STI. In our multivariate analysis, younger age (adjusted odds ratio [AOR], 1.1; 95% confidence interval [CI], 1-1.2), being non-White (AOR, 1.8; 95% CI, 1.1-3.1), having less education (AOR, 2; 95% CI, 1.2-3.4), and having a relationship <1 year (AOR, 2; 95% CI, 1.1-3.6) were all independent predictors of women having an STI. Endorsing symptoms of an STI (e.g., vaginal ulcers/lesions and vaginal discharge) was not predictive of having a laboratory-diagnosed STI (OR, 1.1; 95% CI, 0.7-1.7). Etiologic-based screening for STIs was uniformly accepted by women attending both hospital-based and primary health clinics in the south of Brazil and can result in appropriate treatment of pregnant women.

Home- and Clinic-Based Pediatric HIV Index Case Testing in Kenya: Uptake, HIV Prevalence, Linkage to Care, and Missed Opportunities.

Gaps in HIV testing of children persist, particularly among older children born before the expansion of the prevention of mother-to-child transmission of HIV programs. The Counseling and Testing for Children at Home study evaluated an index-case pediatric HIV testing approach. Caregivers receiving HIV care at 7 health facilities in Kenya (index cases), who had children of unknown HIV status aged 0-12 years, were offered the choice of clinic-based testing (CBT) or home-based testing (HBT). Testing uptake and HIV prevalence were compared between groups choosing HBT and CBT; linkage to care, missed opportunities, and predictors of HIV-positive diagnosis were identified. Among 493 caregivers, 70% completed HIV testing for ≥1 child. Most caregivers who tested children chose CBT (266/347, 77%), with 103 (30%) agreeing to same-day testing of an untested accompanying child. Overall HIV prevalence among 521 tested children was 5.8% (CBT 6.8% vs HBT 2.4%; P = 0.07). Within 1 month of diagnosis, 88% of 30 HIV-positive children had linked to care, and 54% had started antiretroviral treatment. For 851 children eligible for testing, the most common reason for having an unknown HIV status was that the child's mother was not tested for HIV or had tested HIV negative during pregnancy (82%). Testing uptake and HIV prevalence were moderate with nonsignificant differences between HBT and CBT. Standardized offer to test children accompanying caregivers is feasible to scale-up with little additional investment. Linkage to care for HIV-positive children was suboptimal. Lack of peripartum maternal testing contributed to gaps in pediatric testing.

Willingness to Use Home Collection Methods to Provide Specimens for SARS-CoV-2/COVID-19 Research: Survey Study.

BackgroundInnovative laboratory testing approaches for SARS-CoV-2 infection and immune response are needed to conduct research to establish estimates of prevalence and incidence. Self-specimen collection methods have been successfully used in HIV and sexually transmitted infection research and can provide a feasible opportunity to scale up SARS-CoV-2 testing for research purposes.ObjectiveThe aim of this study was to assess the willingness of adults to use different specimen collection modalities for themselves and children as part of a COVID-19 research study.MethodsBetween March 27 and April 1, 2020, we recruited 1435 adults aged 18 years or older though social media advertisements. Participants completed a survey that included 5-point Likert scale items stating how willing they were to use the following specimen collection testing modalities as part of a research study: home collection of a saliva sample, home collection of a throat swab, home finger-prick blood collection, drive-through site throat swab, clinic throat swab, and clinic blood collection. Additionally, participants indicated how the availability of home-based collection methods would impact their willingness to participate compared to drive-through and clinic-based specimen collection. We used Kruskal-Wallis tests and Spearman rank correlations to assess if willingness to use each testing modality differed by demographic variables and characteristics of interest. We compared the overall willingness to use each testing modality and estimated effect sizes with Cohen d.ResultsWe analyzed responses from 1435 participants with a median age of 40.0 (SD=18.2) years and over half of which were female (761/1435, 53.0%). Most participants agreed or strongly agreed that they would be willing to use specimens self-collected at home to participate in research, including willingness to collect a saliva sample (1259/1435, 87.7%) or a throat swab (1191/1435, 83.1%). Willingness to collect a throat swab sample was lower in both a drive-through setting (64%) and clinic setting (53%). Overall, 69.0% (990/1435) of participants said they would be more likely to participate in a research study if they could provide a saliva sample or throat swab at home compared to going to a drive-through site; only 4.4% (63/1435) of participants said they would be less likely to participate using self-collected samples. For each specimen collection modality, willingness to collect specimens from children for research was lower than willingness to use on oneself, but the ranked order of modalities was similar.ConclusionsMost participants were willing to participate in a COVID-19 research study that involves laboratory testing; however, there was a strong preference for home specimen collection procedures over drive-through or clinic-based testing. To increase participation and minimize bias, epidemiologic research studies of SARS-CoV-2 infection and immune response should consider home specimen collection methods.