Preliminary Acceptability of a Home-Based Peripheral Blood Collection Device for Viral Load Testing in the Context of Analytical Treatment Interruptions in HIV Cure Trials: Results from a Nationwide Survey in the United States (original) (raw)
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AIDS, 2000
Gross d , for the HIV Early Detection Study Group Objective: To assess the feasibility and acceptability of bimonthly home oral¯uid (OF) and dried blood spot (DBS) collection for HIV testing among high-risk individuals. Design: A total of 241 participants [including men who have sex with men (MSM), injecting drug users (IDU), and women at heterosexual risk] were recruited from a randomly selected subset of study participants enrolled at four sites in the HIV Network for Prevention Trials (HIVNET) cohort, and assigned at random to bimonthly home collection of OF or DBS specimens over a 6 month interval. Participants could select telephone calls or clinic visits to receive HIV test results. Methods: Bimonthly specimens were tracked for adherence to the schedule, were evaluated for adequacy for testing, and tested using antibody assays and polymerase chain reaction (PCR) for DBS. The acceptability of bimonthly home OF and DBS collection and telephone counseling was assessed in an end-of-study questionnaire. Results: The laboratory received 96 and 90% of expected OF and DBS specimens, respectively; 99% of each specimen type was adequate for testing. Almost all (95%) participants chose results disclosure by telephone. The majority of participants (85%) reported that bimonthly testing did not make them worry more about HIV, and almost all (98%) judged that with bimonthly testing their risk behavior remained the same (77%) or became less risky (21%).
2020
Background: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test.Results: Primary efficacy analysis on 678 completed...
Utilizing Alternative Testing Technology for Human Immunodeficiency Virus (HIV) in the COVID era
Current Emergency and Hospital Medicine Reports, 2021
Purpose of Review With the onset of the Coronavirus disease 2019 (COVID-19) pandemic, in-person human immunodeficiency virus (HIV) testing is no longer easily accessible. Therefore, alternative testing technologies must be considered and implemented on a large scale to continue prevention efforts. This review seeks to describe the benefits of utilizing at-home HIV testing technologies, traditionally deemed an alternative form of testing. Recent Findings Utilizing at-home testing technology during the COVID-19 pandemic overcomes novel and previously identified barriers to HIV testing. Summary Ensuring access to HIV testing is imperative to long-term prevention goals. With the Ending the HIV Epidemic (EHE) initiative in the USA targeting achievement by 2030, obstacles to HIV testing must be addressed to ensure its success. Implementing alternative testing technology more broadly allows for continued prevention efforts for HIV in light of COVID era restrictions.
At-home HIV self-testing during COVID: implementing the GetaKit project in Ottawa
Canadian Journal of Public Health
Setting In March 2020, COVID-19 shuttered access to many healthcare settings offering HIV testing and there is no licensed HIV self-test in Canada. Intervention A team of nurses at the University of Ottawa and Ottawa Public Health and staff from the Ontario HIV Treatment Network (OHTN) obtained Health Canada’s Special Access approval on April 23, 2020 to distribute bioLytical’s INSTI HIV self-test in Ottawa; we received REB approval on May 15, 2020. As of July 20, 2020, eligible participants (≥18 years old, HIV-negative, not on PrEP, not in an HIV vaccine trial, living in Ottawa, no bleeding disorders) could register via www.GetaKit.ca to order kits. Outcomes In the first 6 weeks, 637 persons completed our eligibility screener; 43.3% (n = 276) were eligible. Of eligible participants, 203 completed a baseline survey and 182 ordered a test. These 203 participants were an average of 31 years old, 72.3% were white, 60.4% were cis-male, and 55% self-identified as gay. Seventy-one percent...
BMC Public Health, 2021
Background Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. Methods The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo tes...
Will Patients “Opt In” to Perform Their Own Rapid HIV Test in the Emergency Department
Annals of Emergency Medicine, 2011
Objective: We evaluate the feasibility and accuracy of existing point-of-care HIV tests performed by an untrained patient compared with the routinely used HIV point-of-care test offered to patients in 2 urban emergency departments (EDs). , patients who had completed a standard HIV oral fluid test performed by a trained health care professional and who were unaware of their results were recruited to perform a rapid point-of-care HIV test. Patients were given a choice of the oral fluid or the fingerstick blood point-of-care test. Evaluation of acceptability to perform the mechanics of the test was accessed by questionnaire. For the "self-test," the participant obtained his or her own sample and performed the test. The patient's results were compared with standard oral fluid results obtained by the health care professional.
Realizing the Potential for HIV Self-Testing
HIV self-testing (HIVST), a process in which an individual performs a HIV rapid diagnostic test and interprets the result in private, is an emerging approach that is well accepted, potentially cost-effective and empowering for those who may not otherwise test. To further explore the potential of HIVST, the Liverpool School of Tropical Medicine and World Health Organization held the first global symposium on the legal, ethical, gender, human rights and public health implications of HIVST. The meeting highlighted the potential of HIVST to increase access to and uptake of HIV testing, and emphasized the need to further develop evidence around the quality of HIVST and linkage to post-test services, and to assess the risks and the benefits associated with scale-up. This special issue of AIDS and Behavior links directly to the symposium and presents some of the latest research and thinking on the scale-up of HIV self-testing.
Feasibility of HIV point-of-care tests for resource-limited settings: challenges and solutions
BMC Medicine, 2014
Improved access to anti-retroviral therapy increases the need for affordable monitoring using assays such as CD4 and/or viral load in resource-limited settings. Barriers to accessing treatment, high rates of loss to initiation and poor retention in care are prompting the need to find alternatives to conventional centralized laboratory testing in certain countries. Strong advocacy has led to a rapidly expanding repertoire of point-of-care tests for HIV. point-ofcare testing is not without its challenges: poor regulatory control, lack of guidelines, absence of quality monitoring and lack of industry standards for connectivity, to name a few. The management of HIV increasingly requires a multidisciplinary testing approach involving hematology, chemistry, and tests associated with the management of non-communicable diseases, thus added expertise is needed. This is further complicated by additional human resource requirements and the need for continuous training, a sustainable supply chain, and reimbursement strategies. It is clear that to ensure appropriate national implementation either in a tiered laboratory model or a total decentralized model, clear country-specific assessments need to be conducted.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2023
Barriers continue to limit access to viral load (VL) monitoring across sub-Saharan Africa adversely impacting control of the HIV epidemic. The objective of this study was to determine whether the systems and processes required to realize the potential of rapid molecular technology are available at a prototypical lower-level (i.e., level III) health center in rural Uganda. In this open-label pilot study, participants underwent parallel VL testing at both the central laboratory (i.e., standard of care) and on-site using the GeneXpert HIV-1 assay. The primary outcome was the number of VL tests completed each clinic day. Secondary outcomes included the number of days from sample collection to receipt of result at clinic and the number of days from sample collection to patient receipt of the result. From August 2020 to July 2021, we enrolled a total of 242 participants. The median number of daily tests performed on the Xpert platform was 4, (IQR = 2-7). Time from sample collection to result was 51 days (IQR = 45-62) for samples sent to the central laboratory and 0 days (IQR = 0-0.25) for the Xpert assay conducted at the health center. However, few participants elected to receive results by one of the expedited options, which contributed to similar time-to-patient between testing approaches (89 versus 84 days, p = 0.07). Implementation of a rapid, near point-of-care VL assay at a lowerlevel health center in rural Uganda appears feasible, but interventions to promote rapid clinical response and influence patient preferences about result receipt require further study. Trial registration: ClinicalTrials.gov Identifier: NCT04517825, Registered 18 August 2020.
Tropical medicine & international health : TM & IH, 2018
The HPTN 071 (PopART) trial is examining the impact of a package including universal testing and treatment on community-level HIV incidence in Zambia and South Africa. We conducted a nested case-control study to examine factors associated with acceptance of home-based HIV testing and counselling (HB-HTC) delivered by community HIV-care providers (CHiPs) in PopART intervention communities. Of 295 447 individuals who were offered testing, random samples of individuals who declined HB-HTC (cases) and accepted HB-HTC (controls), stratified by gender and community, were selected. Odds ratios comparing cases and controls were estimated using multivariable logistic regression. Data from 642 participants (313 cases, 329 controls) were analysed. There were no differences between cases and controls by demographic or behavioural characteristics including age, marital or socio-economic position. Participants who felt they could be open with CHiPs (AOR: 0.46, 95% CI: 0.30-0.71, P < 0.001); se...