Introduction African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of ‘treat all’ to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initiation, requiring multiple clinic visits over a several-week period. Methods and analysis The Simplified Algorithm for Treatment Eligibility (SLATE) study is an individually randomised evaluation of a simplified clinical algorithm for clinicians to reliably determine a patient’s eligibility for immediate ART initiation without waiting for laboratory results or additional clinic visits. SLATE will enrol and randomise (1:1) 960 adult, HIV-positive patients who present for HIV testing or care and are not yet on ART in South Africa and Kenya. Patients randomised to the standard arm will receive routine, standard of care ART initiation from clinic staff. Patients randomised to the intervention arm will be administered a symptom report, medical history, brief physical exam and readiness assessment. Patients who have positive (satisfactory) results for all four components of SLATE will be dispensed ARVs immediately, at the same clinic visit. Patients who have any negative results will be referred for further clinical investigation, counselling, tests or other services prior to being dispensed ARVs. After the initial visit, follow-up will be by passive medical record review. The primary outcomes will be ART initiation ≤28 days and retention in care 8 months after study enrolment. Ethics and dissemination Ethics approval has been provided by the Boston University Institutional Review Board, the University of the Witwatersrand Human Research Ethics Committee (Medical) and the KEMRI Scientific and Ethics Review Unit. Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents. Trial registration NCT02891135
Background: Evidence-based HIV interventions often fail to reach anticipated impact due to insufficient utilization in real-world health systems. Human-centered design (HCD) represents a novel approach in tailoring innovations to fit end-users, narrowing the gap between efficacious interventions and impact at scale. Methods: We combined a narrative literature review of HCD in HIV programs with our experience using HCD to redesign an intervention promoting patient-centered care (PCC) practices among health care workers (HCW) in Zambia. We summarize the use and results of HCD in the global HIV response and share case study insights to advance conceptualization of HCD applications. Results: The literature review identified 13 articles (representing 7 studies) on the use of HCD in HIV. All studies featured HCD hallmarks including empathy development, user-driven inquiry, ideation, and iterative refinement. HCD was applied to mHealth design, a management intervention and pre-exposure prophylaxis delivery. Our HCD application addressed a behavioral service delivery target: changing HCW patient-centered beliefs, attitudes, and practices. Through in-depth developer–user interaction, our HCD approach revealed specific HCW support for and resistance to PCC, suggesting intervention revisions to improve feasibility and acceptability and PCC considerations that could inform implementation in transferable settings. Conclusions: As both a research and implementation tool, HCD has potential to improve effective implementation of the HIV response, particularly for product development; new intervention introduction; and complex system interventions. Further research on HCD application strengths and limitations is needed. Those promoting PCC may improve implementation success by seeking out resonance and anticipating the challenges our HCD process identified.
The aim of the study was to assess the median time between HIV diagnosis and entry into primary HIV medical care in a large urban area and to assess the potential individual, diagnosing facility, and community level factors influencing entry into care. One thousand two hundred and sixty-six individuals diagnosed with HIV in Philadelphia between 1 July 2005 and 30 June 2006 were followed until entry into care through 15 June 2007. Time to entry into care was calculated as a survival time variable and was defined as the time in months between the date of HIV diagnosis and the date more than 3 weeks after diagnosis when a CD4 cell count or percentage and/or HIV viral load were obtained. The median time to entry into care for all individuals was 8 months, with a range of 1–26 months. Factors associated with delayed entry into care included age more than 40 years [hazard ratio (HR) = 0.85; 95% confidence interval (CI) = 0.75–0.97] and diagnosis as an inpatient in the hospital (HR = 0.37; 95% CI = 0.37–0.57). Factors associated with earlier entry into care included Hispanic ethnicity (HR = 1.39; 95% CI = 1.05–1.84), male sex with men as HIV transmission risk factor (HR = 1.27; 95% CI = 1.03–1.56), and residence in a census tract with a high poverty rate (HR = 1.68; 95% CI = 1.22–2.30). Individuals newly diagnosed with HIV in Philadelphia demonstrated marked delays in accessing care highlighting the tremendous need for interventions to improve overall linkage. These interventions should especially be targeted at those aged more than 40 years and those diagnosed in the hospital.
Understanding patient-reported reasons for lapses of retention in human immunodeficiency virus (HIV) treatment can drive improvements in the care cascade. A systematic assessment of outcomes among a random sample of patients lost to follow-up (LTFU) from 32 clinics in Zambia to understand the reasons for silent transfers and disengagement from care was undertaken.
BackgroundCommunity-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.MethodsWe did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.FindingsBetween May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07–1·29; psuperiority=0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98–1·19; pnon-inferiority=0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16–1·55; psuperiority<0·0001) as did the hybrid approach (66%, RR 1·19, 1·02–1·40; psuperiority=0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275–452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.InterpretationIn high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.FundingThe Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.
Introduction: Point-of-care (POC) technologies in resource-limited settings can circumvent challenges of centralized laboratory testing, improving clinical management. However, higher device costs and uncertain indications for use have inhibited scaling up POC modalities. To address this gap, we investigated the feasibility and cost of targeted near-POC viral load (VL) testing in 2 large HIV clinics in Lilongwe, Malawi. Methods: VL testing using GeneXpert was targeted for patients suspected of treatment failure or returning to care after a previously elevated VL (>1000 copies/mL). Descriptive analysis of retrospective clinical and cost data is presented. Results: Two thousand eight hundred thirteen near-POC VL tests were conducted. One thousand five hundred eleven (54%) tests were for patients for whom results and reason for the test were documented: 57% (794/1389) of tests were to confirm a previously high VL, and 33% (462/1389) were due to clinical indications. Sixty-one percent (926/1511) of patients had a high VL, of whom 78% (719/926) had a recorded clinical action: 77% (557/719) switched to second line antiretroviral therapy, and 15% (194/719) were referred for intensive adherence counseling. Eighty-two percent (567/687) of patients received a clinical action on the same day as testing. The “all-in” cost was $33.71 for a valid POC VL test, compared with an international benchmark for a centralized VL test of $28.62. Conclusion: Targeted, near-POC VL testing was feasible and consistently enabled prompt clinical action. The difference between the “all-in” cost of near-POC VL and centralized testing of $5.09 could be further reduced in an optimized national program by combining targeted near-POC testing and centralized testing.
Postexposure prophylaxis (PEP) is a World Health Organisation-endorsed approach to prevent HIV acquisition from a recent sexual exposure by initiating an antiretroviral drug regimen, within 72 h after the exposure, but ideally within 24 h, and continuing for 28 days [1]. Nonhuman primate studies suggest that PEP may reduce the risk of acquiring HIV by around 90% [2], with the efficacy likely to be higher the earlier PEP is initiated after sexual exposure. The current recommended regimen for PEP includes TLD (tenofovir/lamivudine/dolutegravir), the same as the recommended first line regimen for treatment of people with HIV. Countries have policies to provide PEP, but these usually require a clinic visit and PEP use is generally low. We hypothesize that providing easy, local PEP access would have a beneficial effect on HIV incidence which outweighs any negative effects. Our proposal is to consider making PEP (in the form of TLD) widely and freely available without prescription, along with a step change in levels of community education about all aspects of HIV to increase knowledge, limit stigma, increase awareness of PEP and thereby increase population-level motivation to access it when needed. Wherever we distribute free condoms (e.g. free from vending machines in public places such as shops, bars, toilets, workplaces, and through pharmacies and peer outreach workers), we would have 28-day packs of TLD PEP available. The aim would be to ensure that everyone can access PEP within at most 24 h of a sexual HIV risk. Oral contraceptives and postcoital contraception for women would ideally be distributed through the same mechanisms. This would require community ownership with education resources that explain potential benefits and possible harms. The approach is not intended to replace existing clinic services, but rather a complement to those services. Encouraging use of TLD for prevention presents challenges for HIV testing, as has been seen in some cases with cabotegravir used as pre-exposure prophylaxis (PrEP) (e.g. Maxmen [3]), and access to advice on testing and interpretation of test results would be important. The message would be essentially as follows: 'Condom use is the most effective means of prevention of transmission of sexual infections. If any sex that you have is not protected from HIV risk by a condom or by you taking PrEP, make sure it is protected by starting TLD PEP within 24 h, unless you know the partner not to have HIV or to have HIV viral suppression. You should continue PEP for a full 28 days. You may want to consider taking TLD PEP continuously afterwards so you are prepared if you have (another) risk, or you may wish to enrol for PrEP. You are strongly advised to make use of our online counsellors or visit a clinic or a pharmacy to get advice, but if you cannot do this within 24 h of your sexual risk start PEP in any case and then seek advice thereafter. This will include advice on HIV testing. It is important to have an HIV test to check that you did not already have HIV at the time of the sexual exposure – a negative test result while taking PEP does not mean you did not acquire HIV as a result of the exposure. You would not know if you got HIV from a certain exposure until a test at about 12 weeks after'. Several countries have policies to provide PrEP consisting of tenofovir/FTC but it can be difficult for people to predict their condomless sex and to negotiate access to PrEP and continue with its use, including due to pill size, concern over adverse effects as well as inability to attend clinic on a routine basis to receive an HIV test and renewed PrEP drug supply [4–6]. If the proposed PEP approach is implemented, it could provide a relatively safe bridge to tenofovir/FTC PrEP for individuals who might not consider themselves high risk until a sexual exposure occurs. It would also raise the question of whether existing PrEP services might adapt to also offer continuous TLD PEP as an additional PrEP option for people with recurrent sexual exposures over time. If drugs for HIV prevention are to be widely available without prescription as we describe, the critical advantage of TLD compared with tenofovir/FTC PrEP is that drug resistance risk is much lower and the antiviral effect much greater when a person with HIV takes the drugs [7,8]. The primary potential benefit of this approach is that it provides a realistic means for people to protect themselves from HIV when a sexual risk was unanticipated and it was not possible for them to use a condom. However, we hypothesize that wide TLD availability would also be of benefit people with HIV who have difficulty accessing care, and could decrease late presentation with advanced HIV disease. It would give the opportunity for people with HIV who run out of drug to have access to an emergency supply. It could also lead to some people who suspect they may have HIV, but are afraid to test for it [9], to take TLD to treat their HIV while avoiding the real or perceived stigma they fear with engaging with healthcare, which could be of net benefit, particularly if this leads them subsequently to engage in care. On the other hand, the approach could have a negative effect on engagement with clinical services, including for sexual and reproductive health. Further, while dolutegravir is generally a safe drug, and a similar drug, cabotegravir, is approved as PrEP [10,11], some toxicities do occur. There would also be a risk that some people with HIV who have been under care may default from that care as they know they can access their antiretroviral drugs locally and easily; thus they would be unmonitored. Further, if the approach is introduced in one area and not others there is the possibility of a black market for drugs. We propose that the approach is studied in implementation science projects. Considerations for such studies and thoughts on cost-effectiveness are provided in Table 1. Table 1 - Additional considerations for proposal on easy access TLD PEP. Studying the approach in communities Net benefits are most likely in settings where the population prevalence of unsuppressed HIV is highest. One way to study the effect of the approach would be to select one or more relatively self-contained communities with high HIV incidence and with an inclusive community leadership who are motivated to pilot the approach. A random sample survey would be conducted at baseline (along the lines of the PHIA surveys) [12]. The approach would then be introduced. There would be active surveillance for incidence of drug toxicity. There would follow a second independent (i.e. a new sample) random sample survey after a period of time to study differences from baseline in PEP, PrEP and ART use, viral suppression levels, HIV diagnosis coverage, and other key measures. Any evaluation would need to be accompanied by extensive process evaluation work to monitor acceptability, accessibility, feasibility and unintended consequences of the programme. Cost-effectiveness considerations A 28 day course of TLD costs approximately $5, which is similar to the cost of tenofovir/FTC. Risk-informed PrEP has been shown to be likely to be cost-effective [13–15], so this approach is likely to be cost-effective, although assumptions would require verification in pilot implementation and further modelling conducted. There would be a cost to time spent by clinical and pharmacist staff on providing advice, but this would likely be less than in a context where such staff are responsible for managing access as is currently the case for PrEP. Similar approaches to condom distribution could be used for TLD pack distribution. Costs of widespread community education will need to be considered. If moving PrEP entirely to TLD there would be price benefits of extending procurement of TLD compared with separate procurement of tenofovir/FTC PrEP. If PEP could be distributed along with postcoital contraception this would increase the scope of benefits. PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; TLD, tenofovir/lamivudine/dolutegravir. Acknowledgements Author contributions: A.P. wrote the first draft. All authors contributed with ideas and suggestions. Conflicts of interest There are no conflicts of interest.
The Centers for Disease Control and Prevention (CDC) recommends routine human immunodeficiency virus (HIV) screening of emergency department (ED) patients aged 13 to 64 years. The study objectives were to determine the accessibility of rapid HIV testing in academic EDs, to identify factors that influence an ED's adoption of testing, and to describe current HIV testing practices.Online surveys were sent to EDs affiliated with emergency medicine (EM) residency programs (n = 128), excluding federal hospitals and facilities in U.S. territories. Eighty percent (n = 102) responded. Most e-mail recipients (n = 121) were Emergency Medicine Network (EMNet) investigators; remaining contacts were obtained from residency-related Web sites.Most academic EDs (n = 58; 57%; 95% confidence interval (CI) = 47% to 66%) offer rapid HIV testing. Among this group, 26 (45%) allow providers to order tests without restrictions. Of the other 32 EDs, 100% have policies allowing for rapid HIV testing following occupational exposures, but less than 10% have guidelines for testing in other clinical situations. Forty-seven percent expect to routinely offer HIV testing in the next 2 to 3 years. Only 59% of the EDs that offered rapid tests in any situation could link an HIV-positive patient to subspecialty care. The facility characteristic most important to availability of rapid HIV testing was the presence of on-site HIV counselors.Most academic EDs now offer rapid HIV testing (57%), but few use it in situations other than occupational exposure. Less than half of academic EDs expect to implement CDC guidelines regarding routine screening within the next few years. The authors identified facility characteristics (e.g., counseling, ability to refer) that may influence adoption of rapid HIV testing.
Several models of differentiated care for stable HIV patients on antiretroviral therapy (ART) in Malawi have been introduced to ensure that care is efficient and patient-centered. Three models have been prioritized by the government for a deeper and broader understanding: adjusted appointment spacing through multi-month scripting (MMS); fast-track drug refills (FTRs) on alternating visits; and community ART groups (CAGs) where rotating group members collect medications at the facility for all members. This qualitative study aimed to understand the challenges and successes of implementing these models of care and of the process of patient differentiation.A qualitative study was conducted as a part of a broader process evaluation in 30 purposefully selected ART facilities between February and May 2016. Semi-structured, in-depth interviews with 32 health workers that managed and coordinated ART clinics and 30 focus groups were held with 216 ART patients. Interviews and focus groups were audio recorded, transcribed, and coded thematically.Participants reported that the models of differentiated care have yielded key benefits, including: reduced patients' travel and visit time, decongestion of facilities, and enhanced social support. Participants suggested that these benefits could lead to improved HIV treatment outcomes for patients. At the same time, some challenges were reported, such as inconsistent stocks of drugs, which can inhibit implementation of MMS. For CAGs, the group-based nature of the model presented some unique problems, such as conflicts within groups or concerns about privacy. Health workers also described some of the reasons why eligible patients may not receive the models or conversely why ineligible patients sometimes get the models.Documenting patient and health worker perspectives on models of differentiated care is critical to understanding and improving these models. While these models can offer important benefits, the models may not be appropriate for all sites or patients, and patient status and needs may change over time. Key challenges should be recognized and addressed for optimal utilization of the models.
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