Self-test Kits Research Articles

Assessing Whether Providing Regular, Free HIV Self-Testing Kits Reduces the Time to HIV Diagnosis: An Internet-Based, Randomized Controlled Trial in Men Who Have Sex With Men.

The risk of onward HIV transmission is strongly influenced by the interval between HIV infection and its diagnosis. The SELPHI trial examined whether this interval could be reduced by offering free HIV self-testing kits to men who have sex with men (MSM). Internet-based RCT of MSM aged ≥16 years, resident in England/Wales, recruited through sexual and social networking sites. The second-stage randomization of SELPHI was open to participants who used an initial free HIV self-test kit, were HIV seronegative, and reported recent condomless anal sex. They were randomized to receive a free HIV self-test kit every 3 months (repeat testing [RT] group) versus no such offer (nRT group). The primary outcome was time from randomization to a confirmed HIV diagnosis, determined from linkage to national HIV surveillance databases. The key secondary outcome was the frequency of HIV testing regardless of test modality. In total, 2308 eligible participants (1161 RT, 1147 nRT) were randomized between April 2017 and June 2018, and followed for 15-27 months. The proportion of participants reporting an HIV test in the previous 3 months was much higher in the RT group (86%) than in the nRT group (39%). Overall, 16 (9 RT, 7 nRT) confirmed HIV diagnoses were observed (0.35/100 person-years), with no difference between the groups (hazard ratio = 1.27 [95% CI: 0.47 to 3.41], P = 0.63). Providing regular free self-testing kits to sexually active MSM was highly acceptable and markedly increased HIV testing. However, in this low incidence cohort, it did not result in a demonstrably more rapid diagnosis of incident infections.

P-513. Recruitment Challenges for Youth HIV Pre-exposure Prophylaxis (PrEP) Research

Abstract Background Recruitment for youth-focused PrEP studies among sexual and gender minority (SGM) youth is a challenge. We report on recruitment strategies and lessons learned from a youth TelePrEP study in Colorado.Table 1:Recruitment strategies used for youth PrEP study Methods Youth assigned male at birth, ages 18-24 years, eligible for PrEP using FTC/TAF, and at risk for HIV in Colorado were recruited to participate in a pilot feasibility trial of PrEP services provided via telehealth. Participants agreed to be seen via telehealth and to obtain initial lab testing at one of seven sites located throughout the state. PrEP medications were offered free for up to 12 months via in-person pick up or mail delivery. Youth were able to enroll and receive clinical care regardless of insurance type. HIV self-test kits were available via mail for follow up testing. Participants received $25 at time of enrollment. Recruitment methods were informed by two electronic youth surveys (N= 375 total), student young adult advisors, youth PrEP providers, and research team experience in youth HIV treatment and prevention studies.Figure 1:Recruitment Flow Chart Results A total of 319 individuals completed an online recruitment survey of which 44 (14%) were eligible and 21 (48%) of those enrolled between January 2023 and March 2024 out of a target of 100 study participants. (Figure 1) An estimated 107,500 individuals received at least one form of study recruitment. (Table 1) Direct recruitment occurred through adolescent clinics (including family planning/STI, transgender care, adolescent primary care, and youth HIV clinics) and pediatric primary care offices via primary care provider referral (N=4 enrolled). Community recruitment was done through SGM youth-serving organizations, community events, during community HIV education sessions (N=4 enrolled). On-line recruitment utilized social media (including targeted ads and sponsored influencers), dating apps, and survey outreach (N=6 enrolled). (Figure 2) Dating apps and social media were the most common recruitment strategies among eligible participants.Figure 2:Examples of Youth TelePrEP Recruitment Materials Conclusion Despite a multipronged approach to recruitment of SGM youth for a study on youth TelePrEP, recruitment was below targets. Additional innovation and evaluation of strategies are needed to not only increase recruitment to youth PrEP studies but also youth PrEP services. Disclosures Lisa Abuogi, MD, MS, Gilead Sciences: Grant/Research Support Alexander Limas, MSW, Gilead Sciences: Grant/Research Support AJ De La Garza, BSW, Gilead Sciences: Grant/Research Support Katherine Leonard, MSN, FNP-BC, Gilead Sciences: Grant/Research Support Sam Gallegos, BS, Gilead Sciences: Grant/Research Support

Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial

IntroductionAdolescents and young adults (AYA, 14–24 years) bear a disproportionate burden of new HIV infections in Nigeria and are more likely to have worse HIV outcomes compared to other age groups. However, little is known about their access to recommended sexual health care services, including HIV self-testing (HIVST), sexually transmitted infections (STI) testing, sexual behavior patterns, awareness and or access to pre-exposure prophylaxis (PrEP), and overall risk for HIV. MethodsWe present a baseline analysis of the 4 Youth by Youth randomized controlled trial aimed to evaluate the uptake and sustainability of crowdsourced HIVST strategies led by and for young people across 14 states in Nigeria. None of the participants had received intervention at the time of completing this self-reported behavioral survey. We conducted a descriptive analysis to summarize participants' characteristics, sexual behavior, HIV testing, STI testing, and knowledge of PrEP and use across the study sample of the AYAs. We conducted a chi-square test, and the level of significance was set at ≤0.05. ResultsA total of 1551 participants completed the baseline survey comprising males (777, 50.1 %) and females (774, 49.9 %). The majority (77 %) of the participants were students at enrollment. Very few of the participants had ever tested for syphilis, 47 (3.1 %), gonorrhea, 49 (3.2 %), chlamydia, 31 (2.0 %), and hepatitis B, 106 (6.9 %). 678 (43.8 %) of the participants reported to be sexually active at the time of enrolment into the study, of which about 38 % of them engaged in condomless sex. Paying for sex, alcohol use, and drug use are all significant sexual behaviors (p < 0.01). Only 14 (1 %) have ever used PrEP. 481 (31.4 %) have ever tested for HIV, and 104 (6.8 %) have ever used an HIV self-testing kit at baseline. 457 (38.6 %) were eligible for PrEP. ConclusionsHIVST and STI uptake were low at baseline among the AYA in this study. Most AYAs also do not receive recommended sexual health care services, including STI testing services. This underlines the need for interventions to increase the uptake of HIV/STI prevention services among Nigerian AYA.

Variations in sexually transmitted infection self-testing response rates and self-sampling submission rates among men who have sex with men recruited via different approaches: A Multi-Center Observational Study

Objective: Self-collection, self-testing, and telemedicine among high-risk population were important strategies in increase the accessibility of STI services and facilitate their expansion. However, many previous studies have showed that the self-test kit usage and response rates are not high in the MSM population. Different routes of recruitment may affect their response rates. To analyze the differences in response rates of sexually transmitted infection (STI) self-testing and submission rates of self-acquired samples from men who have sex with men recruited through an online platform, STI clinics, and non-governmental organizations (NGOs). Methods: Participants were enrolled in this observational study via three different recruitment methods from July to December 2022. Self-testing kits for human immunodeficiency virus (HIV), Treponema pallidum, and hepatitis C virus, and self-sampling kits for Chlamydia trachomatis and Neisseria gonorrhea were provided to recruited men who have sex with men. The participant’s basic information were collected by using the questionnaire and the resluts of self-testing for HIV/ syphylis and HCV and self-sampling for Chlamydia trachomatis and Neisseria gonorrhea were collected. Multivariate logistic regression analysis was used to identify factors associated with self-test response rate and sample submission rates. Results: A total of 764 participants were recruited from 28 Chinese provinces. In the final analysis data, 670 participants reported their HIV self-testing results, while 644 participants mailed their self-acquired samples to the laboratory. Among the 670 participants, there were 51 patients infected with HIV, 31 infected with syphilis, and 2 infected with the hepatitis C virus. The total prevalences of C. trachomatis and N. gonorrhea were 23.0% (176/637) and 7.6% (58/636), respectively. There were no significantly difference among the willingness of self-test among paticipants recriuted from three rouitines , while the HIV self-test response rate was significantly higher among participants recruited in STI clinics than among participants recruited through the “Aiyijian” platform (adjusted odds ratio [AOR] 0.018, 95% confidence interval [CI] 0.002–0.136) or NGOs (AOR 0.054, 95% CI 0.007 – 0.401). Comparing to the participantd recruited from STI clinics, the willingness of self-sample was significantly higher among participants recruited through the “Aiyijian” platform (AOR 4.557,95% CI 1.445-14.271) and NGO (AOR 2.391, 95% CI 1.136-5.034), but the rectal sample submission rates were significantly lower among participants recruited by the “Aiyijian” platform (AOR 0.014, 95% CI 0.003 – 0.062) or NGOs (AOR 0.062, 95% CI 0.014 – 0.262). Conclusion: MSM recriuted from Aiyijian online paltform and NGO were more willing to self sample, while participants recruited from STI clinics had a greater test result response rate and self-sample submission rate than those recruited via the “Aiyijian” online platform and NGOs. In addition to STI clinics, online platform and NGOs will play a very important role in recommending self-sampling for STIs among MSM population.

Never tested for HIV among men who have sex with men, Hanoi, Vietnam: correlates and missed opportunities.

Introduction: Understanding levels of HIV testing among populations at risk for acquisition is essential to meeting the goal of the United Nations that 95% of individuals living with HIV know their status. This study assessed HIV testing prevalence among men who had sex with men (MSM), characteristics of MSM who have never tested for HIV, and missed testing opportunities in Hanoi, Vietnam.Methods: We measured the prevalence of never testing for HIV and missed opportunities for testing in the baseline data of a cohort study of MSM recruited in 2017-2019 in Hanoi. Logistic regression analysis characterized MSM who had never tested prior to cohort participation.Results: Of 1,893 MSM enrolled in the cohort, 39.4% had never previously tested for HIV. MSM with children (aOR 1.75, 95% CI 1.09-2.82) and those who did not know or remember having a male partner living with HIV (aOR 1.41, 95% CI 1.07-1.84) were more likely to have never tested. Older age, university education, higher income, and having a male partner living with HIV were associated with a lower likelihood of never having been tested. The most common missed testing opportunities to test MSM who had never been tested were when receiving free condoms from health educators (35.3%), testing for other sexually transmitted infections (STIs) (23.3%), reporting their MSM status to healthcare workers (16.4%), and receiving an STI diagnosis (13.0%). The most common barriers identified by MSM who had never tested were fear of seeking health care due to their sexual orientation (82.7%) and having been refused healthcare due to their sexual oreitnation (76.2%).Conclusions: Facilitating provider-initiated HIV testing in STI clinics and other healthcare services, community-based testing, and HIV self-test kits should enhance HIV testing options for young MSM, especially those with lower education and income.

Assessment of the acceptability and detection rate of HIV self-testing in Nigeria: a systematic review and meta-analysis

BackgroundHIV remains a major public health challenge in Nigeria, with significant gaps in testing coverage caused by stigma, limited healthcare access, and logistical issues, highlighting the need for enhanced HIV control efforts. HIV self-testing presents a promising solution to overcome these barriers; however, there is a lack of systematic review and meta-analysis on its effectiveness within Nigeria for evidence-based medicine decision.ObjectivesTo systematically assess the acceptability and detection rate of HIV self-testing in Nigeria.MethodsStudies conducted in Nigeria on HIV self-testing with or without comparison to other HIV tests were included. The primary outcomes were the detection rate of new HIV cases and acceptability (uptake) rate for HIV self-testing. Electronic databases (PubMed/Medline, Web of Science, Scopus, CINAHL, and Cochrane Library) and Google Scholar were searched. Pooled estimates were calculated using a random-effects model. Heterogeneity was analyzed using the I2 test, and risk of bias was assessed with the Hoy and colleagues’ scale. The PROSPERO registration number: CRD42023479752).ResultsEight studies, encompassing 7556 participants, met the inclusion criteria. The overall risk of bias was low. The detection rate of HIV self-testing for new HIV cases was 25.78% (95% CI 0.90–50.66, I2:100.0), acceptability (uptake) rate was 56.92% (95% CI: 26.54–87.30, I2:100.0), and repeat testing rate was 20.10% (95% CI − 11.44–51.65, I2:100.0).ConclusionsThe use of HIV self-testing test kits in Nigeria showed a high detection rate of new HIV cases, moderate acceptability, but low repeat testing rates. Larger, higher-quality studies are essential to explore the broader impact of HIV self-testing on reducing HIV incidence in Nigeria.

Training Social Network-Central Fishermen in Western Kenya to Distribute HIV Self-Test Kits and Health Facility Referral Vouchers

Low HIV testing among men, particularly highly mobile fishermen, is a persistent challenge. The Owete study (NCT#04772469) used social network-central men (Promoters) to promote testing and linkage to HIV services among social networks of fishermen in western Kenya. The Promoters and fishermen networks were randomised to intervention or control arms. We describe Owete’s interactive training approach and Promoters’ training experiences for implementation insights. The 146 Promoters trained (balanced across arms) were highly engaged, eager learners, and supportive of targeted health training sessions for men. Promoters felt the knowledge gained improved their understanding of health matters and elevated their social status. Promoters felt empowered knowing how to interpret self-testing results and how to address pre-exposure prophylaxis use questions and correct misconceptions. Offering capacity building for social network-central men to spearhead campaigns on health issues affecting fishermen can leverage established relationships and trust, expand knowledge, and help increase health-seeking practices among underserved, highly mobile men.

"There is no need to leave the beach to test": A qualitative study of HIV self-testing knowledge and acceptability of HIV self-test kit distribution among social networks of fishermen in western Kenya.

HIV self-testing (HIVST) can improve HIV testing uptake by offering convenience and privacy. Yet HIVST accessibility and uptake remain limited in Lake Victorias beach communities where HIVST holds promise to address many barriers highly mobile populations of men in fishing communities face. We assessed HIVST knowledge and acceptability among highly mobile fishermen, a high priority population for HIV prevention and treatment, participating in a social network-based study ("Owete"; NCT04772469) to promote HIV testing, prevention, and treatment in Kenya. Sixty-five in-depth baseline interviews (IDIs) and two focus group discussions (FGDs) were conducted at study baseline from December 2021 to June 2022 with fishermen, including 30 who were social network-central men recruited as HIVST "promoters" from three fishing communities along Lake Victoria, Kenya. Fishermen were purposively-sampled based on study arm, community and age (18-34 and 35+) for interviews exploring HIVST knowledge, perceived benefits, and concerns. IDIs and FGDs were audio-recorded, translated/transcribed into English and inductively-coded and analyzed by six researchers using a framework approach. Nearly all participants had heard about HIVST and expressed willingness to self-test. Almost half reported learning about HIVST for the first time through the Owete study. Perceived benefits of self-testing included privacy, convenience, and being able to learn one's status with the freedom to choose when and where to test, which minimized stigma and work interruptions. Few participants had used HIVST prior to joining Owete, all of whom reported ease of use. Potential barriers to HIVST included fear of HIV-seropositive results, feeling unsure about how to use HIVSTs, and fear of stigma if a HIVST was discovered. Nearly all Owete promoters indicated willingness to distribute HIVST to help their peers know their status. Promoters stressed the importance of approaching HIVST discussions strategically and thoughtfully to garner trust and engagement, and felt they needed training to answer HIVST questions. While few fishermen had ever used HIVST, this study found high awareness, positive perceptions, and substantial willingness to use and distribute HIVST to other men. The "promoter" model, with known peers engaged in disseminating HIVST information and test kits, shows promise for engaging men in testing.

Willingness to Be Contacted via a Patient Portal for Health Screening, Research Recruitment, and at-Home Self-Test Kits for Health Monitoring: Pilot Quantitative Survey.

Patient portals are being increasingly used by health systems in the United States. Although some patients use portals for clinical use, patient perspectives on using portals for research-related activities, to complete health screenings, and to request at-home self-test kits are unclear. We aimed to understand patient perspectives on using electronic health portals for research; health-related screenings; and patient-initiated, home-based self-testing. Patients (N=105) from the Patient Engaged Research Center at a large, urban, midwestern health system completed a 23-item web-based survey on patient portal (MyChart) use and willingness to use the patient portal for research, risk assessments, and self-test kits. Frequencies and percentages were generated. Almost all participants (102/105, 97.1%) had accessed MyChart at least once, with most (44/102, 43.1%) indicating they logged in at least once per month. Participants indicated logging into MyChart to check laboratory results or other health data (89/105, 84.8%), because they received a message to log in (85/105, 81%), and to message their health care professional (83/105, 79%). Fewer participants logged in to see what medications they had been prescribed (16/105, 15.2%) and to learn more about their health conditions (29/105, 27.6%). Most participants indicated logging into MyChart on a computer via a website (70/105, 66.7%) or on a smartphone via an app (54/105, 51.4%). When asked about how likely they would be to participate in different types of research if contacted via MyChart, most (90/105, 85.7%) said they would be likely to answer a survey, fill out a health assessment (87/105, 82.9%), or watch a video (86/105, 81.9%). Finally, participants would be willing to answer risk assessment questions on MyChart regarding sleep (74/101, 73.3%), stress (65/105, 61.9%), diabetes (60/105, 57.1%), anxiety (59/105, 56.2%), and depression (54/105, 51.4%) and would be interested in receiving an at-home self-test kit for COVID-19 (66/105, 62.9%), cholesterol (63/105, 60%), colon cancer (62/105, 59%), and allergies (56/105, 53.3%). There were no significant demographic differences for any results (all P values were >.05). Patient portals may be used for research recruitment; sending research-related information; and engaging patients to answer risk assessments, read about health information, and complete other clinical tasks. The lack of significant findings based on race and gender suggests that patient portals may be acceptable tools for recruiting research participants and conducting research. Allowing patients to request self-test kits and complete risk assessments in portals may help patients to take agency over their health care. Future research should examine if patient portal recruitment may help address persistent biases in clinical trial recruitment to increase enrollment of women and racial minority groups.

Acceptability and feasibility of HIV self-testing distribution modes among key populations in Morocco.

HIV self-testing was introduced to enhance HIV testing uptake, especially among key populations. Despite the benefits, its use remains relatively low in the WHO Eastern Mediterranean Region. To assess the acceptability, usability and feasibility of HIV self-testing among key populations in Morocco. We assessed the usability and acceptability, as well as the feasibility of ordering online and picking up in pharmacies and of distribution by people living with HIV of an oral HIV self-testing kit among 3465 female sex workers, men having sex with men, and partners of newly diagnosed people living with HIV in Morocco. Data were collected using 4 questionnaires administered online anonymously and analysed using Stata version 14.0. A total of 3465 individuals received the HIV self-testing kits, 54.4% male, 43.7% female and 1.9% transgender. High acceptability rates of 90.2%, 86.2% and 80.4% were reported among the female sex workers, men having sex with men, and partners of newly diagnosed people living with HIV, respectively. HIV positivity rates were 1.2% among the female sex workers and men having sex with men, and 4.3% among partners of people living with HIV. Between 44.0% and 73.4% of the participants had never been tested for HIV. Our findings highlight the value of extending HIV self-testing services to key populations in Morocco and possibly other countries in the Middle East and North Africa.

Intention to Use Leucorrheea Self-Test Innovation Kit and Collection Data through Mobile Application in Bangkok

Leukorrhea, or abnormal vaginal discharge (fungi, bacteria, and protozoa), can be indicated bacterial vaginosis or STIs. If not treated, these infections may lead to complications impacted fertility such as pelvic inflammatory disease (PID). Therefore, the goal is to develop a self-test kit for vaginal discharge detecting all three pathogens in one device. This study examines the acceptance of innovative technologies and factors affecting the intention to self-administered leucorrhoea test kits (SALTK) with results presentation and data transmission via mobile phones. Factors influencing such intention included technology acceptance (Technology Acceptance Model: TAM), facilitating conditions, social influence, and perceived privacy risk. The data were collected using an online Google Form questionnaire. A total of 450 valid questionnaires were used for analysis. The descriptive statistics employed in this study included percentage, means, and standard deviation, and the hypothesis was tested using multiple regression analysis. It was found that the factors impacting the intention to use SALTK with a statistical significance level of .05 were facilitating condition, social influence, perceived privacy risk, and three key technology acceptance components, namely perceived usefulness, perceived ease of use, and attitude toward using, respectively. SALTK modulates the beneficial for public health policies in Thailand and government agencies, the Food and Drug Administration and the Department of Disease Control, establishing prevention to reach the international standards.

Combined interventions for the testing and treatment of HIV and schistosomiasis among fishermen in Malawi: a three-arm, cluster-randomised trial

Undiagnosed HIV and schistosomiasis are highly prevalent among fishermen in the African Great Lakes region. We aimed to evaluate the efficacy of lakeside interventions integrating services for HIV and male genital schistosomiasis on the prevalence of schistosomiasis, uptake of antiretroviral therapy (ART) for HIV, and voluntary male medical circumcision (VMMC) among fishermen in Malawi. We conducted a three-arm, cluster-randomised trial in 45 lakeshore fishing communities (clusters) in Mangochi, Malawi. Clusters were defined geographically by their home community as the place where fishermen leave their boats (ie, a landing site). Eligible participants were male fishermen (aged ≥18 years) who resided in a cluster. Clusters were randomly allocated (1:1:1) through computer-generated random numbers to either enhanced standard of care (SOC), which offered invitation with information leaflets to a beach clinic offering HIV testing and referral, and presumptive treatment for schistosomiasis with praziquantel; peer education (PE), in which a nominated fisherman was responsible for explaining the study leaflet to promote services to his boat crew; or peer distribution education (PDE), in which the peer educator explained the leaflet and distributed HIV self-test kits to his boat crew. The beach clinic team and fishermen were not masked to intervention allocation; however, investigators were masked until the final analysis. Coprimary composite outcomes were the proportion of participants who had at least one Schistosoma haematobium egg observed on light microscopy from 10 mL of urine filtrate and the proportion who had self-reported initiating ART or scheduling VMMC by day 28. Outcomes were analysed by intention to treat; multiple imputation for missing outcomes was done; random-effect binomial models adjusting for baseline imbalance and clustering were used to compute unadjusted and adjusted risk differences, risk ratios (RRs) and 95% CIs, and intracluster correlation coefficients for each outcome. This trial is registered with ISRCTN, ISRCTN14354324. Between March 1, 2022, and Jan 29, 2023, 45 (65·2%) of 69 clusters assessed for eligibility were enrolled in the trial, with 15 clusters per arm. Of the 6036 fishermen screened at baseline, 5207 (86·3%) were eligible for participation: 1745 (87·6%) of 1991 in the enhanced SOC group, 1687 (81·9%) of 2061 in the PE group, and 1775 (89·5%) of 1984 in the PDE group. Compared with the prevalence of active schistosomiasis in the enhanced SOC group (292 [16·7%] of 1745), 241 (13·6%) of 1775 fishermen in the PDE group (adjusted RR 0·80 [95% CI 0·69-0·94]; p=0·0054) and 263 (15·6%) of 1687 fishermen in the PE group (0·92 [0·79-1·07]; p=0·28) had schistosomiasis at day 28. 230 (13·2%) in the enhanced SOC group, 281 (16·7%) in the PE group, and 215 (12·1%) in the PDE group initiated ART or were scheduled for VMMC. ART initiation or VMMC scheduling was not significantly increased with the PDE intervention (0·88 [0·74-1·05); p=0·15) and was marginally increased with the PE intervention (1·16 [0·99-1·37]; p=0·069) when compared with the enhanced SOC group. No serious adverse events were reported in this trial. We found weak evidence for the use of peer education to increase uptake of ART and VMMC, but strong evidence for the added distribution of HIV self-test kits to promote high engagement with services and reduce the prevalence of active schistosomiasis, suggesting a high potential for scale-up in hard-to-reach communities across Malawi. Wellcome Trust and the UK National Institute for Health Research.

Improving the Efficiency of Luminescent Zn(II)-Modified N-Doped GOQD Nanomaterials in Parkinson's Disease Treatment: A Theoretical Mechanistic Framework Exploring Doping Effect.

Levodopa, a widely prescribed drug in Parkinson's disease treatment, stands as the foremost prodrug of dopamine. An affordable self-testing kit is utilized to monitor levodopa content in anti-parkinson drugs in human serum. A photoluminescent trinuclear Zn(II) complex [Zn3(L)2(κ1-OAc)2(κ2-OAc)2] has been synthesized, which cleaves into mononuclear ZC in aqueous solution. ZC was found to detect L-Dopa in Tris-HCl buffer, exhibiting a moderate decrease in PL-emission. The real-life utility of the ZC probe is limited, for its lower sensitivity (LOD 35.3 μM) and separation challenges. Therefore, an interface between homogeneous and heterogeneous supports has been explored, leading to the strategic development of NGOZC, where ZC was grafted onto NGOQD (Graphene oxide quantum dots). This material enables naked- eye detection under both ambient and UV light with color change from bright cyan to green, followed by dark. The nitrogen doping effect was investigated by several comparative investigations involving the synthesis of ZC-grafted GOQD, leading to enhanced quenching performance. Steady-state and time-resolved fluorescence titration study, morphological analysis, and computational calculations have been performed to get insights into the sensing mechanism. To the best of our knowledge, this as-synthesized NGOZC (LOD 1.78 nM) represents a promising strategy and platform for applications in biosensors, especially for Parkinson's and Alzheimer's diseases.

CUREMA project: a further step towards malaria elimination among hard-to-reach and mobile populations

BackgroundIn most countries engaged on the last mile towards malaria elimination, residual transmission mainly persists among vulnerable populations represented by isolated and mobile (often cross-border) communities. These populations are sometimes involved in informal or even illegal activities. In regions with Plasmodium vivax transmission, the specific biology of this parasite poses additional difficulties related to the need for a radical treatment against hypnozoites to prevent relapses. Among hard-to-reach communities, case management, a pillar of elimination strategy, is deficient: acute malaria attacks often occur in remote areas, where there is limited access to care, and drugs acquired outside formal healthcare are often inadequately used for treatment, which typically does not include radical treatment against P. vivax. For these reasons, P. vivax circulation among these communities represents one of the main challenges for malaria elimination in many non-African countries. The objective of this article is to describe the protocol of the CUREMA study, which aims to meet the challenge of targeting malaria in hard-to-reach populations with a focus on P. vivax.ResultsCUREMA is a multi-centre, international public health intervention research project. The study population is represented by persons involved in artisanal and small-scale gold mining who are active and mobile in the Guiana Shield, deep inside the Amazon Forest. The CUREMA project includes a complex intervention composed of a package of actions: (1) health education activities; (2) targeted administration of treatment against P. vivax after screening against G6PD deficiency to asymptomatic persons considered at risk of silently carrying the parasite; (3) distribution of a self-testing and self-treatment kit (malakit) associated with user training for self-management of malaria symptoms occurring while in extreme isolation. These actions are offered by community health workers at settlements and neighbourhoods (often cross-border) that represent transit and logistic bases of gold miners. The study relies on hybrid design, aiming to evaluate both the effectiveness of the intervention on malaria transmission with a pre/post quasi-experimental design, and its implementation with a mixed methods approach.ConclusionsThe purpose of this study is to experiment an intervention that addresses both Plasmodium falciparum and P. vivax malaria elimination in a mobile and isolated population and to produce results that can be transferred to many contexts facing the same challenges around the world.

Development of aptamer-based lateral flow devices for rapid detection of SARS-CoV-2 S protein and uncertainty assessment

The outbreak and spread of COVID-19 have highlighted the urgent need for early diagnosis of SARS-CoV-2. Nucleic acid testing as an authoritative tool, is cumbersome, time-consuming, and easy to cross-infect, while the available antibody self-testing kits are deficient in sensitivity and stability. In this study, we developed competitive aptamer-based lateral flow devices (Apt-LFDs) for the quantitative detection of SARS-CoV-2 spike (S) protein. Molecular docking simulation was used to analyze the active binding sites of the aptamer to S protein, guiding complementary DNA (cDNA) design. Then a highly efficient freezing strategy was applied for the conjugation of gold nanoparticles (AuNPs) and DNA probes. Under optimal conditions, the linear range of the constructed Apt-LFDs was 0.1–1 μg/mL, and the limit of detection (LOD) was 51.81 ng/mL. The cross-reactivity test and stability test of the Apt-LFDs showed good specificity and reliability. The Apt-LFDs had recoveries ranging from 89.45 % to 117.12 % in pharyngeal swabs. Notably, the uncertainty of the analytical result was evaluated using a “bottom-up” approach. At a 95 % confidence level, the uncertainty report of (453.37±54.86) ng/mL with k = 2 was yielded. Overall, this study provides an important reference for the convenient and reliable detection of virus proteins based on LFDs.

Effectiveness of Using Additional HIV Self-Test Kits as an Incentive to Increase HIV Testing Within Assisted Partner Services.

Incentives have shown mixed results in increasing HIV testing rates in low-resource settings. We investigated the effectiveness of offering additional self-tests (HIVSTs) as an incentive to increase testing among partners receiving assisted partner services (APS). Western Kenya. We conducted a single-crossover study nested within a cluster-randomized controlled trial. Twenty-four facilities were randomized 1:1 to (1) control: provider-delivered testing or (2) intervention: offered 1 HIVST or provider-delivered testing for 6 months (pre-implementation), then switched to offering 2 HIVSTs for 6 months (post-implementation). A difference-in-differences approach using generalized linear mixed models, accounting for facility clustering and adjusting for age, sex, and income, was used to estimate the effect of the incentive on HIV testing and first-time testing among partners in APS. March 2021-June 2022, 1127 index clients received APS and named 8155 partners, among whom 2333 reported a prior HIV diagnosis and were excluded from analyses, resulting in 5822 remaining partners: 3646 (62.6%) and 2176 (37.4%) in the pre-implementation and post-implementation periods, respectively. Overall, 944/2176 partners (43%) were offered a second HIVST during post-preimplementation, of whom 34.3% picked up 2 kits, of whom 71.7% reported that the second kit encouraged HIV testing. Comparing partners offered 1 vs. two HIVSTs showed no difference in HIV testing (relative risk: 1.01, 95% confidence interval: 0.951 to 1.07) or HIV testing for the first time (relative risk: 1.23, 95% confidence interval: 0.671 to 2.24). Offering a second HIVST as an incentive within APS did not significantly impact HIV testing or first-time testing, although those opting for 2 kits reported it incentivized them to test.

Caregiver-assisted testing with HIV self-test kits for children 18 months and older: A GRADE systematic review.

Caregiver-assisted testing using HIV self-test (CG-HIVST) kits has been proposed to enhance paediatric HIV case finding and contribute toward ending paediatric HIV/AIDS by 2030. We conducted a systematic review to assess the risks and benefits of CG-HIVST. We searched nine electronic databases and consulted experts to identify relevant articles through 5 February, 2022. Studies comparing CG-HIVST to other testing services among children over 18-months, or to no intervention, were included. Outcomes included uptake, acceptability, diagnostic accuracy, feasibility, HIV positivity, linkage to care, social harm, values and preferences, costs, and cost-effectiveness. Risk of bias was assessed using relevant Cochrane tools and certainty of evidence was evaluated with GRADE. Among 2203 screened articles, nine observational studies from sub-Saharan Africa were included. All studies used and assessed caregiver-assisted testing using oral fluid-based HIVST. In one non-randomized intervention study of 6062 children, overall CG-HIVST uptake was lower than other standard testing services (3.30% vs. 56.71%). In the same study, HIV positivity following CG-HIVST appeared lower or comparable to standard testing (RR = 0.44; 95% CI: 0.06, 3.20). Two single-arm studies reported high linkage to confirmatory testing (97.48%) and treatment initiation (97.7%) among children reported positive with CG-HIVST. Pooled positive predictive value was 36.72% across three non-randomized intervention studies. Reported social harms were rare, and acceptability appeared high among caregivers taking up the intervention, but feasibility was unclear as some reported anxiety in relation to reactive results. Evidence was appraised very low certainty. Average CG-HIVST costs varied widely and were consistently higher than standard testing services. CG-HIVST may be acceptable, but feasibility remains uncertain with potential higher costs. Current evidence favours standard testing for uptake and positivity. Low positive predictive values raise concerns about false positives and potential harm. Programmes should prioritize evidence-based approaches for paediatric case-finding, while research to fully evaluate this approach continues.

Acceptability, usability, and willingness to pay for HIV self-test kits distributed through community-based, PLHIV network-led and private practitioners models in India: Results from the STAR III Initiative.

HIV self-testing (HIVST) has been shown to increase the uptake of HIV testing and help achieve the UNAIDS 95-95-95 targets. This study assessed the acceptability, usability (ease of use and result interpretation) and the willingness to pay for HIVST kits distributed through three distribution models, namely the community-based, PLHIV network-led and private practitioners models, in India. This cross-sectional study was implemented across 14 states in India between September 2021 and June 2022. All participants could choose between blood-based or oral-fluid-based test kits. Participants were shown a test-kit usage demonstration video, and pre- and post-test counselling was provided for all. Participants were followed-up after testing, and if reported reactive, were further supported for linkage to confirmatory testing and antiretroviral therapy (ART) initiation. Among the 90,605 participants found eligible, 88,080 (97%) accepted an HIVST kit. Among the 87,976 who reported using an HIVST kit, 45,207 (51%) preferred a blood-based kit, and 42,120 (48%) reported testing for the first time. For future testing, 77,064 (88%) reported preferring HIVST over other HIV testing methods. Among those who used the kit, 83,308 (95%) found the kit easy to use, and 83,237 (95%) reported that the test results were easy to interpret. Among those who preferred HIVST for future use, 52,136 (69%) were willing to pay for the kit, with 35,854 (69%) of those willing to pay less than US$ 1.20. Only one instance of social harm was reported, with a participant reporting suicidal tendencies due to discord with their partner. Out of 328 participants (0.4%) who tested reactive with HIVST, 291 (89%) were linked to confirmatory testing; of these, 254 were confirmed HIV positive, and 216 (85%) successfully initiated ART. Overall, we report that nearly all participants were willing to accept HIVST, found the test kits easy to use and interpret, and about two-thirds were willing to pay for HIVST. Given the high levels of acceptance and the ability to reach a large proportion of first-time testers, HIVST in India could contribute to achieving the UNAIDS first 95 and ending the HIV epidemic.

Potential population-level effects of HIV self-test distribution among key populations in Côte d'Ivoire, Mali, and Senegal: a mathematical modelling analysis

During 2019-21, the AutoTest VIH, Libre d'accéder à la connaissance de son Statut (ATLAS) programme distributed around 380 000 HIV self-testing kits to key populations, including female sex workers, men who have sex with men, and their partners, in Côte d'Ivoire, Mali, and Senegal. We aimed to estimate the effects of the ATLAS programme and national scale-up of HIV self-test distribution on HIV diagnosis, HIV treatment coverage, HIV incidence, and HIV-related mortality. We adapted a deterministic compartmental model of HIV transmission in Côte d'Ivoire, parameterised and fitted to country-specific demographic, behavioural, HIV epidemiological, and intervention data in Côte d'Ivoire, Mali, and Senegal separately during 1980-2020. We simulated dynamics of new HIV infections, HIV diagnoses, and HIV-related deaths within scenarios with and without HIV self-test distribution among key populations. Models were separately parameterised and fitted to country-specific sets of epidemiological and intervention outcomes (stratified by sex, risk, age group, and HIV status, if available) over time within a Bayesian framework. We estimated the effects on the absolute increase in the proportion of people with HIV diagnosed at the end of 2021 for the ATLAS-only scenario and at the end of 2028 and 2038 for the HIV self-testing scale-up scenario. We estimated cumulative numbers of additional HIV diagnoses and initiations of antiretroviral therapy and the proportion and absolute numbers of new HIV infections and HIV-related deaths averted during 2019-21 and 2019-28 for the ATLAS-only scenario and during 2019-28 and 2019-38 for the HIV self-testing scale-up scenario. Our model estimated that ATLAS could have led to 700 (90% uncertainty interval [UI] 500-900) additional HIV diagnoses in Côte d'Ivoire, 500 (300-900) in Mali, and 300 (50-700) in Senegal during 2019-21, a 0·4 percentage point (90% UI 0·3-0·5) increase overall by the end of 2021. During 2019-28, ATLAS was estimated to avert 1900 (90% UI 1300-2700) new HIV infections and 600 (400-800) HIV-related deaths across the three countries, of which 38·6% (90% UI 31·8-48·3) of new infections and 70·1% (60·4-77·3) of HIV-related deaths would be among key populations. ATLAS would avert 1·5% (0·8-3·1) of all HIV-related deaths across the three countries during this period. Scaling up HIV self-testing would avert 16·2% (90% UI 10·0-23·1) of all new HIV infections during 2019-28 in Senegal, 5·3% (3·0-8·9) in Mali, and 1·6% (1·0-2·4) in Côte d'Ivoire. HIV self-testing scale-up among key populations was estimated to increase HIV diagnosis by the end of 2028 to 1·3 percentage points (90% UI 0·8-1·9) in Côte d'Ivoire, 10·6 percentage points (5·3-16·8) in Senegal, and 3·6 percentage points (2·0-6·4) in Mali. Scaling up HIV self-test distribution among key populations in western Africa could attenuate disparities in access to HIV testing and reduce infections and deaths among key populations and their partners. Unitaid, Solthis, the UK Medical Research Council Centre for Global Infectious Disease Analysis, the EU European & Developing Countries Clinical Trials Partnership programme, and the Wellcome Trust. For the French translation of the abstract see Supplementary Materials section.

Feasibility of wearable sensor signals and self-reported symptoms to prompt at-home testing for acute respiratory viruses in the USA (DETECT-AHEAD): a decentralised, randomised controlled trial

Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor. DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020. Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events. In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation. Janssen Pharmaceuticals.