The document discusses HIV self-testing in South Africa. It notes that from 2005-2015 there was a sharp increase in HIV diagnoses in Africa, and from 2010-2014 over 600 million people received HIV testing services in low- and middle-income countries, nearly half of all tests in Africa. However, there remains a testing gap as only 45% of people living with HIV know their status. HIV self-testing is proposed as an innovative way to help close this gap and reach key populations by making testing more accessible and private. The document outlines several HIV self-testing implementation and research programs currently underway in South Africa, and barriers to introducing HIV self-testing in the country such as regulatory issues.
This presentation on research about HIV self-testing in Australia was given by A/Prof Rebecca Guy, The Kirby Institute, at the AFAO Members Forum - May 2015.
Optimal HIV testing strategies to achieve high levels of HIV diagnosis in Sou...Carmen Figueroa
This document discusses optimal HIV testing strategies to achieve high levels of HIV diagnosis in South Africa. It summarizes that while South Africa has made progress towards diagnosing 90% of HIV cases by 2020, testing gaps remain, particularly for men, youth, and key populations. The document outlines using an agent-based model to assess the efficiency and cost-effectiveness of various testing strategies, such as home-based testing, mobile testing, and targeted testing of sex workers and partners of diagnosed individuals. Preliminary findings suggest strategies like assisted partner notification and testing sex workers and men who have sex with men could be highly cost-effective in increasing diagnoses and reducing undiagnosed cases.
Cost of testing per new HIV diagnosis as a metric for monitoring cost-effecti...Carmen Figueroa
This document analyzes the cost-effectiveness of additional HIV testing programs in southern Africa beyond core testing through mathematical modeling. It finds that using the cost-per-new-HIV-diagnosis as a metric, additional testing programs for men are likely cost-effective if the cost is below $585 per diagnosis. However, additional testing programs for women are unlikely to be cost-effective. The analysis is based on simulating 1000 scenarios of HIV epidemics and testing programs in southern Africa to examine outcomes and costs over 50 years.
The document discusses the design of a survey to evaluate innovation in healthcare centers. It aims to assess factors associated with process innovation, in order to propose innovative programs. The survey design considers three categories: human resources technological capacity, technological procedures, and infrastructure/equipment. It was validated qualitatively through background analysis and expert judgment. The survey seeks to improve health outcomes, though full participation may be difficult and distort results. Further research is needed on the instrument's quantitative validity, descriptive construct validity, explanatory reliability, and applicative efficiency.
The document discusses Theranos and its business model. It summarizes Theranos' claims of being faster, less intrusive through fingerstick samples, widely available through Walgreens partnerships, and cheaper pricing. However, it notes Theranos has not published data to support these claims and an operational reality check finds some limitations, such as turnaround times being longer than advertised and an unproven approach to significant use of fingerstick samples. The document critically assesses Theranos' ability to achieve its goals and disrupt the clinical laboratory market.
Racing for results: lessons learnt in improving the efficiency of HIV VL and ...SystemOne
This document discusses strategies for improving the efficiency of delivering HIV viral load and early infant diagnosis test results from laboratories to clinics. Traditional paper-based reporting systems can result in delays and lost results. Newer electronic and mobile health platforms show promise in reducing turnaround times, but also face challenges from limited infrastructure in low-resource settings. Specifically, laboratory information systems, SMS messaging, and SMS printers are being used to deliver results digitally, with some programs reporting up to 50% reductions in turnaround times. However, merely delivering results is not enough - systems also need to ensure results are received and acted upon to improve patient outcomes.
This presentation on research about HIV self-testing in Australia was given by A/Prof Rebecca Guy, The Kirby Institute, at the AFAO Members Forum - May 2015.
Optimal HIV testing strategies to achieve high levels of HIV diagnosis in Sou...Carmen Figueroa
This document discusses optimal HIV testing strategies to achieve high levels of HIV diagnosis in South Africa. It summarizes that while South Africa has made progress towards diagnosing 90% of HIV cases by 2020, testing gaps remain, particularly for men, youth, and key populations. The document outlines using an agent-based model to assess the efficiency and cost-effectiveness of various testing strategies, such as home-based testing, mobile testing, and targeted testing of sex workers and partners of diagnosed individuals. Preliminary findings suggest strategies like assisted partner notification and testing sex workers and men who have sex with men could be highly cost-effective in increasing diagnoses and reducing undiagnosed cases.
Cost of testing per new HIV diagnosis as a metric for monitoring cost-effecti...Carmen Figueroa
This document analyzes the cost-effectiveness of additional HIV testing programs in southern Africa beyond core testing through mathematical modeling. It finds that using the cost-per-new-HIV-diagnosis as a metric, additional testing programs for men are likely cost-effective if the cost is below $585 per diagnosis. However, additional testing programs for women are unlikely to be cost-effective. The analysis is based on simulating 1000 scenarios of HIV epidemics and testing programs in southern Africa to examine outcomes and costs over 50 years.
The document discusses the design of a survey to evaluate innovation in healthcare centers. It aims to assess factors associated with process innovation, in order to propose innovative programs. The survey design considers three categories: human resources technological capacity, technological procedures, and infrastructure/equipment. It was validated qualitatively through background analysis and expert judgment. The survey seeks to improve health outcomes, though full participation may be difficult and distort results. Further research is needed on the instrument's quantitative validity, descriptive construct validity, explanatory reliability, and applicative efficiency.
The document discusses Theranos and its business model. It summarizes Theranos' claims of being faster, less intrusive through fingerstick samples, widely available through Walgreens partnerships, and cheaper pricing. However, it notes Theranos has not published data to support these claims and an operational reality check finds some limitations, such as turnaround times being longer than advertised and an unproven approach to significant use of fingerstick samples. The document critically assesses Theranos' ability to achieve its goals and disrupt the clinical laboratory market.
Racing for results: lessons learnt in improving the efficiency of HIV VL and ...SystemOne
This document discusses strategies for improving the efficiency of delivering HIV viral load and early infant diagnosis test results from laboratories to clinics. Traditional paper-based reporting systems can result in delays and lost results. Newer electronic and mobile health platforms show promise in reducing turnaround times, but also face challenges from limited infrastructure in low-resource settings. Specifically, laboratory information systems, SMS messaging, and SMS printers are being used to deliver results digitally, with some programs reporting up to 50% reductions in turnaround times. However, merely delivering results is not enough - systems also need to ensure results are received and acted upon to improve patient outcomes.
Introduction of self-testing for HIV in low-income countries could provide value by increasing testing rates and reducing costs compared to standard testing by healthcare workers alone. A model was developed to evaluate the potential impact and cost-effectiveness of introducing self-testing in Zimbabwe. The analysis found that self-testing was cost-effective across a range of thresholds and sensitive parameters included the cost of self-tests, the level of substitution of healthcare worker tests with self-tests, and linkage to care after self-testing.
Meaningful Use encompasses multiple stages, each with specific timeline and measure requirements that continue to be a moving target. This can be a confusing process, sending providers in a tailspin in their attempts to stay current. This webinar focuses on the overall details of Meaningful Use and provides a nice outline of all of its details.
Theranos presented to investors with the goal of becoming the standard for improving drug therapies. Its initial market is phase IV clinical trials, using a product platform of cartridges, readers, and informatics services. Founded in 2003 with 50 employees, Theranos aims to generate $120-300M in revenue over 1.5 years through deals with pharmaceutical companies. The company's system allows for simultaneous quantitative measurement of drugs and biomarkers from small blood samples, returning results comparable to gold standards within 30 minutes. Theranos' value proposition is improving drug labels and safety by enabling real-time pharmacokinetic and pharmacodynamic monitoring during trials and treatment.
OVC_HIVSTAT and Linkages to Care for Strengthened Collection, Analysis, and U...MEASURE Evaluation
This webinar focused on explaining the HIV Risk Assessment cascade and how it is related to OVC_HIVSTAT disaggregates. The presenters also provided guidance for how OVC_HIVSTAT data can be analyzed to enhance program outcomes.
The document discusses anti-retroviral drug resistance in HIV. It notes that drug resistance is a major reason why HIV drugs stop being effective over time. It outlines steps India is taking to monitor and prevent drug resistance, including establishing a national committee on HIV drug resistance to develop surveillance strategies. Pilot sites for initial threshold surveys and drug resistance monitoring are proposed to provide initial data on transmission levels and resistance in patients on antiretroviral therapy.
WorldOne is an international research agency specializing in healthcare data collection with one of the largest healthcare panels in the industry. They answered ESOMAR's 26 questions to provide details on their panel recruitment process, data quality validation policies, and compliance with industry standards. Their healthcare panel consists of over 1.6 million medical professionals recruited through telephone and in-person verification to ensure high quality data.
Point of Care Diagnostics: Revenue Growth, New Entrants, InvestmentBruce Carlson
The document discusses point-of-care (POC) testing, which involves diagnostic tests performed near patients outside of centralized laboratories. It estimates the global POC diagnostics market was $17 billion in 2014 and is projected to grow to $18.7 billion by 2016. Key drivers of growth include rapid results to inform immediate treatment decisions, expanded test menus, and advances enabling quantitative lab-quality results. Major diseases addressed by POC solutions discussed are colorectal cancer, cardiovascular disease, and diabetes.
Launch of Policy Cures: Improving Access to Diagnostics in the Developing Wor...LIDC
This document discusses improving access to diagnostics in developing countries. It notes that there is a lack of investment in diagnostic R&D for diseases prevalent in developing areas, as well as a lack of access to diagnostic services and laboratories. Regulatory processes for approving diagnostic tests are often lengthy and not quality-based. Diagnostics are undervalued in healthcare decision making. The document advocates for fast-tracking the translation of evidence on effective new diagnostic technologies into healthcare policies to improve access and outcomes in developing nations.
Roche Diagnostics conducted customer satisfaction surveys to better understand customer needs and identify areas for improvement. They established new customer service initiatives like a toll-free hotline and dedicated customer support teams. Linking customer satisfaction to profits allows Roche to focus on enhancing the customer experience which drives customer loyalty and future sales.
This document provides an overview of direct access testing (DAT) also known as direct-to-consumer testing. It defines DAT as consumers ordering lab tests directly from a lab without a physician consultation. The document discusses why consumers use DAT, lists major players in the DAT market, and outlines considerations for understanding the costs and value of DAT including downstream costs. It also provides guidance on developing educational programs and assessing learning needs related to DAT.
10 most trusted clinical laboratories in 2021Merry D'souza
To honor the diligent services of clinical laboratories, we came up with this edition of Insights Care - 10 Most Trusted Clinical Laboratories in 2021.
The document proposes a mobile health application for Medical Attendant Community Health Workers (MA-CHWs) in Tanzania. It summarizes that [1] current rural health systems rely heavily on MA-CHWs but lack standardized monitoring, [2] the proposed application would provide a standardized checklist for MA-CHW home visits to improve quality of care. It then outlines how the application [3] impacts CHWs, supervisors, patients, and decision-making through collection and use of standardized data.
The document discusses patient engagement requirements under Meaningful Use Stage 2, Accountable Care Organizations, and the Patient-Centered Medical Home model. It outlines 7 proposed core measures for Stage 2 that focus on clinical summaries, education resources, secure messaging, and reminders. It also lists 7 patient experience measures required by ACOs and notes the 66 factors assessed by NCQA for medical homes. The document emphasizes that meaningful patient engagement requires real change by both providers and patients through improved experiences and patient involvement.
This presentation discusses innovative solutions to improving access to orphan drugs outside of Canada and examines their potential implications for Canada. It summarizes key developments in the US and Europe, including natural history studies, new approval pathways focusing on surrogate endpoints, value demonstration programs, reference networks, early dialogues, and proposals for cross-country price negotiations. The presentation concludes that Canada is at an inflection point and could consider a new, more flexible model incorporating value demonstration across the product lifecycle, real-world evidence generation, iterative approvals, and pan-Canadian decision-making for products treating small populations.
Using HIV Surveillance Data to Evaluate Outcomes of Site Randomized Intervent...CDC NPIN
The document describes the design of the HPTN 065 study which tested the efficacy of financial incentives to improve linkage to care and viral suppression outcomes across HIV testing and care sites in the Bronx, New York and Washington D.C. using aggregate HIV surveillance data from local health departments. The study involved randomizing sites to either receive financial incentives or standard of care and then measuring aggregate linkage to care and viral suppression outcomes using surveillance data to compare the two study arms.
Dr. Peter Davies - Perceptions About Raising Food Animals Without AntibioticsJohn Blue
Perceptions About Raising Food Animals Without Antibiotics - Dr. Peter Davies, from the 2018 Allen D. Leman Swine Conference, September 15-18, 2018, St. Paul, Minnesota, USA.
More presentations at http://www.swinecast.com/2018-leman-swine-conference-material
2014 Berlin_ Operational Excellence in Clinical TrailsKaren Radley
The document summarizes an upcoming two-day conference on operational excellence in clinical trials taking place March 12-13, 2014 in Berlin, Germany. It outlines the conference agenda, topics, and speakers. Over 20 speakers are listed from pharmaceutical and clinical research organizations who will address topics like study feasibility, patient recruitment and retention, social media in recruitment, clinical project management, and conducting global clinical trials. The document provides an overview of the conference objectives, sessions, and opportunities for networking and discussion between professionals in clinical operations and research.
2014 December 16 - eHI Survey Summary - BLUE AND GRAY LAY OUT BY WARREN - FINALCarrie Bauman
The survey assessed organizations' readiness for ICD-10 implementation focusing on testing, financial impact, and strategic implications. Key findings were that almost half have begun testing but most don't know partners' readiness. There is widespread concern about impacts on systems, workflow, productivity and revenue. Respondents expect increased specificity to improve research, population health, quality and claims accuracy. The compliance extension provides an opportunity for more training and documentation improvement.
This document discusses HIV self-testing (HIVST) in South Africa. It provides an overview of the current HIV testing situation, the potential benefits of HIVST, target product profiles, delivery models, and the current policy environment regarding HIVST. Several demonstration projects in South Africa found HIVST to be highly acceptable, accurate, and able to reach undertested groups like men and youth. Next steps include finalizing implementation guidelines and standards, completing demonstration projects to guide rollout, and targeting initial implementation in specific areas and populations.
Realizing the potential for HIV self-testing - a summary of latest evidenceCheryl Johnson
This document summarizes the latest evidence on HIV self-testing (HIVST). It finds that HIVST is acceptable and increases testing frequency. Sensitivity and specificity of HIVST can be high, though linkage to care needs improvement. While risks like false results exist, clear messaging can mitigate them. Several countries now allow HIVST, and demand is estimated at millions of tests in 2018. The WHO is developing guidelines on HIVST to expand testing and reach undiagnosed populations. In conclusion, HIVST is an additional tool that countries should utilize alongside traditional testing to work towards ending the HIV epidemic.
Introduction of self-testing for HIV in low-income countries could provide value by increasing testing rates and reducing costs compared to standard testing by healthcare workers alone. A model was developed to evaluate the potential impact and cost-effectiveness of introducing self-testing in Zimbabwe. The analysis found that self-testing was cost-effective across a range of thresholds and sensitive parameters included the cost of self-tests, the level of substitution of healthcare worker tests with self-tests, and linkage to care after self-testing.
Meaningful Use encompasses multiple stages, each with specific timeline and measure requirements that continue to be a moving target. This can be a confusing process, sending providers in a tailspin in their attempts to stay current. This webinar focuses on the overall details of Meaningful Use and provides a nice outline of all of its details.
Theranos presented to investors with the goal of becoming the standard for improving drug therapies. Its initial market is phase IV clinical trials, using a product platform of cartridges, readers, and informatics services. Founded in 2003 with 50 employees, Theranos aims to generate $120-300M in revenue over 1.5 years through deals with pharmaceutical companies. The company's system allows for simultaneous quantitative measurement of drugs and biomarkers from small blood samples, returning results comparable to gold standards within 30 minutes. Theranos' value proposition is improving drug labels and safety by enabling real-time pharmacokinetic and pharmacodynamic monitoring during trials and treatment.
OVC_HIVSTAT and Linkages to Care for Strengthened Collection, Analysis, and U...MEASURE Evaluation
This webinar focused on explaining the HIV Risk Assessment cascade and how it is related to OVC_HIVSTAT disaggregates. The presenters also provided guidance for how OVC_HIVSTAT data can be analyzed to enhance program outcomes.
The document discusses anti-retroviral drug resistance in HIV. It notes that drug resistance is a major reason why HIV drugs stop being effective over time. It outlines steps India is taking to monitor and prevent drug resistance, including establishing a national committee on HIV drug resistance to develop surveillance strategies. Pilot sites for initial threshold surveys and drug resistance monitoring are proposed to provide initial data on transmission levels and resistance in patients on antiretroviral therapy.
WorldOne is an international research agency specializing in healthcare data collection with one of the largest healthcare panels in the industry. They answered ESOMAR's 26 questions to provide details on their panel recruitment process, data quality validation policies, and compliance with industry standards. Their healthcare panel consists of over 1.6 million medical professionals recruited through telephone and in-person verification to ensure high quality data.
Point of Care Diagnostics: Revenue Growth, New Entrants, InvestmentBruce Carlson
The document discusses point-of-care (POC) testing, which involves diagnostic tests performed near patients outside of centralized laboratories. It estimates the global POC diagnostics market was $17 billion in 2014 and is projected to grow to $18.7 billion by 2016. Key drivers of growth include rapid results to inform immediate treatment decisions, expanded test menus, and advances enabling quantitative lab-quality results. Major diseases addressed by POC solutions discussed are colorectal cancer, cardiovascular disease, and diabetes.
Launch of Policy Cures: Improving Access to Diagnostics in the Developing Wor...LIDC
This document discusses improving access to diagnostics in developing countries. It notes that there is a lack of investment in diagnostic R&D for diseases prevalent in developing areas, as well as a lack of access to diagnostic services and laboratories. Regulatory processes for approving diagnostic tests are often lengthy and not quality-based. Diagnostics are undervalued in healthcare decision making. The document advocates for fast-tracking the translation of evidence on effective new diagnostic technologies into healthcare policies to improve access and outcomes in developing nations.
Roche Diagnostics conducted customer satisfaction surveys to better understand customer needs and identify areas for improvement. They established new customer service initiatives like a toll-free hotline and dedicated customer support teams. Linking customer satisfaction to profits allows Roche to focus on enhancing the customer experience which drives customer loyalty and future sales.
This document provides an overview of direct access testing (DAT) also known as direct-to-consumer testing. It defines DAT as consumers ordering lab tests directly from a lab without a physician consultation. The document discusses why consumers use DAT, lists major players in the DAT market, and outlines considerations for understanding the costs and value of DAT including downstream costs. It also provides guidance on developing educational programs and assessing learning needs related to DAT.
10 most trusted clinical laboratories in 2021Merry D'souza
To honor the diligent services of clinical laboratories, we came up with this edition of Insights Care - 10 Most Trusted Clinical Laboratories in 2021.
The document proposes a mobile health application for Medical Attendant Community Health Workers (MA-CHWs) in Tanzania. It summarizes that [1] current rural health systems rely heavily on MA-CHWs but lack standardized monitoring, [2] the proposed application would provide a standardized checklist for MA-CHW home visits to improve quality of care. It then outlines how the application [3] impacts CHWs, supervisors, patients, and decision-making through collection and use of standardized data.
The document discusses patient engagement requirements under Meaningful Use Stage 2, Accountable Care Organizations, and the Patient-Centered Medical Home model. It outlines 7 proposed core measures for Stage 2 that focus on clinical summaries, education resources, secure messaging, and reminders. It also lists 7 patient experience measures required by ACOs and notes the 66 factors assessed by NCQA for medical homes. The document emphasizes that meaningful patient engagement requires real change by both providers and patients through improved experiences and patient involvement.
This presentation discusses innovative solutions to improving access to orphan drugs outside of Canada and examines their potential implications for Canada. It summarizes key developments in the US and Europe, including natural history studies, new approval pathways focusing on surrogate endpoints, value demonstration programs, reference networks, early dialogues, and proposals for cross-country price negotiations. The presentation concludes that Canada is at an inflection point and could consider a new, more flexible model incorporating value demonstration across the product lifecycle, real-world evidence generation, iterative approvals, and pan-Canadian decision-making for products treating small populations.
Using HIV Surveillance Data to Evaluate Outcomes of Site Randomized Intervent...CDC NPIN
The document describes the design of the HPTN 065 study which tested the efficacy of financial incentives to improve linkage to care and viral suppression outcomes across HIV testing and care sites in the Bronx, New York and Washington D.C. using aggregate HIV surveillance data from local health departments. The study involved randomizing sites to either receive financial incentives or standard of care and then measuring aggregate linkage to care and viral suppression outcomes using surveillance data to compare the two study arms.
Dr. Peter Davies - Perceptions About Raising Food Animals Without AntibioticsJohn Blue
Perceptions About Raising Food Animals Without Antibiotics - Dr. Peter Davies, from the 2018 Allen D. Leman Swine Conference, September 15-18, 2018, St. Paul, Minnesota, USA.
More presentations at http://www.swinecast.com/2018-leman-swine-conference-material
2014 Berlin_ Operational Excellence in Clinical TrailsKaren Radley
The document summarizes an upcoming two-day conference on operational excellence in clinical trials taking place March 12-13, 2014 in Berlin, Germany. It outlines the conference agenda, topics, and speakers. Over 20 speakers are listed from pharmaceutical and clinical research organizations who will address topics like study feasibility, patient recruitment and retention, social media in recruitment, clinical project management, and conducting global clinical trials. The document provides an overview of the conference objectives, sessions, and opportunities for networking and discussion between professionals in clinical operations and research.
2014 December 16 - eHI Survey Summary - BLUE AND GRAY LAY OUT BY WARREN - FINALCarrie Bauman
The survey assessed organizations' readiness for ICD-10 implementation focusing on testing, financial impact, and strategic implications. Key findings were that almost half have begun testing but most don't know partners' readiness. There is widespread concern about impacts on systems, workflow, productivity and revenue. Respondents expect increased specificity to improve research, population health, quality and claims accuracy. The compliance extension provides an opportunity for more training and documentation improvement.
This document discusses HIV self-testing (HIVST) in South Africa. It provides an overview of the current HIV testing situation, the potential benefits of HIVST, target product profiles, delivery models, and the current policy environment regarding HIVST. Several demonstration projects in South Africa found HIVST to be highly acceptable, accurate, and able to reach undertested groups like men and youth. Next steps include finalizing implementation guidelines and standards, completing demonstration projects to guide rollout, and targeting initial implementation in specific areas and populations.
Realizing the potential for HIV self-testing - a summary of latest evidenceCheryl Johnson
This document summarizes the latest evidence on HIV self-testing (HIVST). It finds that HIVST is acceptable and increases testing frequency. Sensitivity and specificity of HIVST can be high, though linkage to care needs improvement. While risks like false results exist, clear messaging can mitigate them. Several countries now allow HIVST, and demand is estimated at millions of tests in 2018. The WHO is developing guidelines on HIVST to expand testing and reach undiagnosed populations. In conclusion, HIVST is an additional tool that countries should utilize alongside traditional testing to work towards ending the HIV epidemic.
Principles of cost effectiveness webinar: Zimbabwe experienceCarmen Figueroa
Zimbabwe has made progress in HIV prevention through collaboration between the Ministry of Health and partners, piloting new strategies before national rollout, and using data-driven decision making. Testing strategies are evaluated based on yields, costs, and population reach to efficiently meet treatment targets. The national HIV testing strategy considers 19 testing modalities, aiming to maximize high-yield, low-cost strategies like index testing, self-testing, and targeted outreach to increase identification of remaining PLHIV across sub-populations.
Bringing high quality, WHO-approved HIV self-tests to commerical market in So...Cheryl Johnson
This document proposes a developmental program in South Africa to evaluate HIV self-test products for commercial market approval. The objectives are to assess 3 promising self-test candidates' technical and user performance, independently evaluate their accuracy, assist with packaging and materials, and evaluate usage in key populations. It will also establish support services, assess social impacts, and advocate for quality HIV self-testing in South Africa and the region. A multi-phase evaluation approach uses trained and untrained users from the general population and hard to reach groups.
Boldly Using Technology to Change Culture around HIV Testing and Screening…YTH
Boldly using tech and social media to change the culture in LA around HIV testing and HIV screening Sin Verguenza (without shame). English, Spanish. Health Communications. Using social media for public health. Telenovela and soap opera series educating patients about the importance of HIV testing
Rachel Baggaley presented an overview of HIV self-testing at the Bill and Melinda Gates Foundation meeting. There is a large testing gap, with only 45% of people living with HIV knowing their status. HIV self-testing could help close this gap by making testing more convenient and private. Several HIV self-testing products are in development using oral fluid or whole blood samples. Early evidence shows high acceptability of HIV self-testing, though accuracy can vary depending on how it is administered. Linkage to care also seems promising when self-testing is coupled with support services. More research is still needed on self-testing among key populations and in resource-limited settings.
Rachel Baggaley presented an overview of HIV self-testing at the Bill and Melinda Gates Foundation meeting. She discussed that there is a large testing gap globally with only 45% of people living with HIV knowing their status. HIV self-testing could help close this gap by making testing more convenient and private. Several HIV self-testing products are in development using oral fluid or whole blood samples. Early evidence shows high acceptability of HIV self-testing among key populations. Accuracy can be good when supervised but may be poorer without support. Linkage to care also appears promising when coupled with proactive follow up. More research is still needed on HIV self-testing among different populations and in resource-limited settings.
1) Around 1.5 million Kenyans are living with HIV, with about 500,000 not yet initiated on treatment. HIV self-testing (ST) is being implemented to help reach the 90:90:90 goal.
2) ST was included in national guidelines in 2009 but is just now being rolled out. Acceptability studies found 72% of Kenyans would use ST kits. ST can reach populations like men and youth who haven't previously tested.
3) A pilot with 16 pharmacies in major cities will help inform a wider private sector rollout of ST in Kenya, scheduled for the end of April 2017. Procurement of WHO-prequalified ST kits and public sector distribution will then begin.
This chapter discusses key considerations for developing a protocol for population-based surveys measuring HIV. It recommends that surveys be designed based on the epidemic context and objectives of monitoring the impact of HIV. Surveys should return HIV and other biomarker results to participants and measure HIV prevalence among children when adult female HIV prevalence is over 5%. HIV incidence should only be included when adult prevalence is over 5% and incidence over 0.3%. Developing the protocol takes about two years to cover planning, implementation, and release of results.
The document describes a proposed study to evaluate the effectiveness of the SMARTubeTM device in India. The SMARTubeTM is designed to enable earlier detection of HIV and HCV infections by stimulating antibody production in blood samples. The study would involve collecting blood samples from various clinical sites and incubating portions in the SMARTubeTM device before testing for antibodies. The goals are to validate using the SMARTubeTM in Indian settings and to estimate the rate of additional HIV/HCV detections made possible by the technology. Participating organizations would benefit from thought leadership, contributing to medical research, and gaining experience evaluating new diagnostic technologies.
Fast-track the end of AIDS in the EU - practical evidence-based interventions.
Presentation by: Karen Champenois, Maison Blanche Hospital, Paris
In a two-day meeting under the auspices of the Maltese Presidency of the Council of the European Union (30-31 January 2017), HIV experts from across the European Union discussed how to reverse this trend and how to prepare Europe to achieve the set target of ending AIDS by 2030.
Materiovigilance Programme of India (MvPI).pptxChhavi Singh
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Survey included.
This document describes a community-based anonymous counseling, testing and linkage center for men who have sex with men (MSM) in Portugal called CheckpointLX. It provides free, anonymous and confidential HIV, Syphilis, and HCV rapid tests. The number of HIV rapid tests administered has increased each year from 2011 to 2014. Most tests are for MSM, with a positivity rate of around 5%. The majority of those with reactive tests are referred to treatment protocols. The center also participates in research studies and international networking initiatives. It aims to improve testing practices and referrals through community outreach. The document outlines several current and planned projects, including partner notification, acute HIV detection, and PrEP acceptability research
Acceptability of HIV self-testing a systematic literature review.pdfLisa Brewer
The document is a literature review that evaluated 11 studies on the acceptability of HIV self-testing (HST). The studies demonstrated universally high acceptability of HST, ranging from 22% to 87%. The majority of participants accurately performed HST with little support. While participants valued the privacy and confidentiality of HST, they felt counseling support was inadequate. Overall the review found HST to be an acceptable testing option, but identified challenges in linking individuals to counseling and medical care.
Presentation at 2007 Annual Meeting of VA Patient Safety Managers and OfficersNoel Eldridge
This presentation was for 150 or so Dept of VA Patient Safety managers with and for whom I worked at VA Central Office while they worked at the VA Medical Centers and Network offices. The main items of interest are the preliminary work that I was describing from the periphery of the then developing VA MRSA Prevention Program, which was quite successful and led by Dr. Rajiv Jain (and published in NEJM: http://www.nejm.org/doi/full/10.1056/NEJMoa1007474#t=abstract). Also of interest is the wide-ranging work that VA NCPS led on the follow up on an OIG report that identified problems in some of VA's operating rooms. Also of interest is slide 36 where I present some interesting data on VA's reduction in unadjusted inpatient mortality - this hasn't been widely publicized or published to my knowledge. The second to last slide refers to the fact that the day after the meeting I was going to the Grand Canyon and planning to hike to the bottom one day and out the next day. That turned out to be a great experience.
Process validation.pptx_Process validation and inspection method with Exampl...ZerlealemTsegaye2
Process validation, definition and purpose
General principle
Traditional vs new paradigm
Risk assessment as part of process validation
Validation scheme: Monitoring and Sampling
Specific topics: Blend uniformity and validation of compression step
Process validation: other dosage forms
Process validation: sterile products
Process validation : Biological products
Retrospective validation
Summary: How to review protocol and report
List of References used
The WHO has updated its HIV testing services (HTS) guidelines to address gaps in reaching populations still undiagnosed. The updates prioritize key populations like men who have sex with men, partners of PLHIV, and young people. The guidelines recommend high-impact approaches like provider-assisted referral, social network-based testing, and HIV self-testing to diagnose the estimated 21% of PLHIV who are still undiagnosed globally. The strategic mix of HTS approaches should be tailored to each setting's HIV burden level to efficiently reach priority groups and facilitate linkage to care.
Virtual clinical trials utilize emerging technologies like mobile apps, remote monitoring devices, and online platforms to conduct clinical trials remotely with participants in their homes. This allows trials to have more convenient participation, potentially improving enrollment, retention, and compliance. However, virtual trials also face challenges like developing patient trust in internet-based data collection and ensuring appropriate populations are selected. Early case studies provided lessons about balancing technology with human support. Overall, virtual trials may become a more important model as patients expect remote participation options and for certain study types and populations.
Infographic- Improve Clinical Trial Participation with Mobile AppsDiaspark
Mobile apps are pivotal to patient recruitment & retention in clinical trials, we have done research on changing trends &d challenges in clinical trial patient recruitment & retention.
This document discusses the evolution of HIV testing strategies in Malawi over time. It notes that HIV testing was initially delivered primarily through health surveillance assistants but faced challenges from competing tasks. Testing strategies have shifted from periodic campaigns to introducing dedicated lay cadres to provide more sustained testing. While the number of new HIV diagnoses identified each quarter has remained steady, the yield of new diagnoses from testing has declined over time. The document also examines challenges in targeting testing and linkage to care, emerging issues like repeat positives, and difficulties in accurately assessing the costs and impacts of different testing strategies.
An introduction to using cost-effectiveness analysis to inform spending decis...Carmen Figueroa
This document provides an introduction to using cost-effectiveness analysis to inform spending decisions on HIV testing. It discusses how economic evaluation considers both the health outcomes and costs of interventions to determine whether one intervention provides better value for money compared to alternatives. It outlines different types of economic evaluation and how they incorporate costs and outcomes. Health outcomes can be measured generically using QALYs or DALYs, or through disease-specific measures. Economic evaluations are typically conducted through modeling or alongside clinical trials. The results can help decision-makers compare interventions and maximize health given limited budgets.
Costing HIV testing Services Understand and Using Data for decision makingCarmen Figueroa
This document discusses costing and informing policy for HIV testing services in South Africa. It notes that HIV testing is a national priority and gap analysis showed a 25% testing gap. Research was conducted on the feasibility, acceptability, and usability of different testing modalities. Data shows increased testing could help close gaps in reaching the first 90 target of the UNAIDS 90-90-90 goals. Cost-benefit analyses are in progress to show benefits of increased testing outweigh costs. National HIV testing policies and guidelines from 2010 and 2016 outline facility-based and community-based testing modalities, including client-initiated counseling and testing, provider-initiated counseling and testing, and HIV self-screening.
Costing HIV testing services: understanding and using data for decision makingCarmen Figueroa
This document discusses costing methods for HIV testing services. It aims to present key questions to interrogate cost evidence and support commissioning cost studies. The learning outcomes are to understand why HIV testing costs vary, recognize different cost definitions and analysis methods, and define what type of analyses are needed to address policy questions. It discusses financial vs. economic costs, full vs. incremental costs, project phases, perspectives, and inflation. Real differences in resource use can be due to scale, distribution model, population characteristics, and prevalence. The appropriate costing method depends on the question being asked - economic evaluation focuses on should we do it? while budget impact analysis addresses can we afford it?
Self-testing for HIV: initial experience of the UK’s first kitCarmen Figueroa
This document summarizes the initial experience with the first HIV self-testing kit available in the UK. Over 27,000 kits have been sold since April 2015. Most buyers are male and located outside major cities. About half of buyers had never tested for HIV before. User feedback indicates the test is easy to use and results are easy to read. A small number of false positive and invalid tests were reported. While self-testing is proving popular, more data is still needed on access to care for reactive results and the impact on testing rates and behavior.
HIV Self-Testing in the context of South AfricaCarmen Figueroa
This document discusses HIV self-testing in South Africa. It notes that while South Africa's HIV/AIDS program is doing well overall, movement towards improving testing rates, particularly among men and youth, has been slow. HIV self-testing has the potential to help increase testing among these groups but its introduction in South Africa has also been slow due to various ethical, regulatory, and policy issues. Now that guidelines have been developed, self-testing can be considered as a way to augment South Africa's HIV response by improving testing rates among populations that have been under-tested so far.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
2. Scale-Up of HIV Testing Services
Source: WHO 2015; WHO 2016
From 2005 – 2015, there was a
sharp increase in HIV-positive
diagnoses in Africa
From 2010—2014, > 600 M
people received HTS in 122 low-
and middle-income countries –
nearly half all tests were in Africa.
3. 100%
0%
20%
40%
60%
80%
100%
PLHIV PLHIV who know their
status
PLHIV on ART PLHIV virally surpressed
Covered Not covered
Source: UNAIDS, Gap report 2014
Why are we talking about HIV Self-
Testing (HIVST)?
4. 100%
45% 39%
29%
0%
20%
40%
60%
80%
100%
PLHIV PLHIV who know their
status
PLHIV on ART PLHIV virally surpressed
Covered Not covered
Source: UNAIDS, Gap report 2014
Why are we talking about HIV Self-
Testing (HIVST)?
5. There is a testing gap.
55%
0%
20%
40%
60%
80%
100%
PLHIV PLHIV who know their
status
PLHIV on ART PLHIV virally surpressed
Covered Not covered
Source: UNAIDS, Gap report 2014
6. Proposed UNAIDS “90-90-90”
100%
90% 90% 90%
5%
0%
20%
40%
60%
80%
100%
PLHIV PLHIV who know their
status
PLHIV on ART PLHIV virally surpressed
Covered 2020 Covered 2025 Not Covered
Source: UNAIDS, Ambitious treatment targets, 2014
7. Global Progress Toward the First 90,
2015
Source: UNAIDS, 2016 – based on 2015 measure derived from data reported by 87 countries, which accounted for 73% of people living with HIV worldwide; 2015
measure derived from data reported by 86 countries. Worldwide, 22% of all people on antiretroviral therapy were reported to have received a viral load test during the
reporting period.
40% of PLHIV still remain undiagnosed worldwide
> 80% of all
diagnosed
PLHIV are on
treatment
8. Progress toward the first 90 by region, 2015
Asia & the Pacific
Eastern &
southern Africa
Eastern Europe &
central Asia
Latin America & the
Caribbean
Middle East & North
Africa
Western &
central Africa
Source: UNAIDS, 2016
62%
9. New adult HIV infections globally,
2015
~1.9 M new adult HIV
infections in 2015
44% new HIV
infections are among
key populations and
their partners
Source: UNAIDS, Data is for populations 15 years of age and above.
10. Innovation Needed to Close the Testing Gap
Photo Credit: http://fr.ubergizmo.com/2013/02/15/wifi-gratuit-metro-londonien-fin.html
11. So what is HIV Self-Testing?
• HIVST is a process by which an individual wanting to
know his or her HIV status collects a blood or oral
fluid specimen, performs a HIV test, and interprets
the results by him or herself.
• HIVST is a “screening test” or Test for Triage
• As a new innovation that has significant potential to
extend beyond the limitations of the HIV testing
infrastructure and address existing barriers to testing,
HIVST could play a substantial role in accelerating
progress towards this goal of 90-90-90.
12. HIVST has been touted as a
supplementary strategy to reach
key and under-tested populations
It is a concept that requires
optimization for the ‘lay’ person
out in the community
13. What is HIVST NOT?
• It is not here to replace traditional HTS, and facility
based HTS should continue to be the main modality
through which the majority of the population learn
their status
• It is not a definitive test, but rather the first step
towards learning a status. All POSITIVE results must
be confirmed using the national algorithm and
negatives retested in 3 months. MESSAGING MUST BE
CLEAR
14.
15. Current Wits HSTAR Programme
The HSTAR Programme, currently funded by the BMGF and AIDS Fonds, is evaluating
HIV self-testing in the South African market, actively engaging with policy makers and
communities, to pave the way for several well-tested products to enter the market,
and facilitate the process towards World Health Organisation Pre-Qualification and
National Guidance on ST.
The programme will address access, acceptability, product performance,
implementation, assessment of social harms and linkage-to-care.
The programme has a multi-phased approach for the performance evaluation of
potential devices:
• Phase 1: Usability Assessments of prospective HIV Self-Testing devices including
Instruction for Use comprehension and result interpretation.
• Phase 2: Evaluation of prospective HIVST devices in the hands of Trained Users.
• Phase 3: Evaluation of prospective HIVST devices in the hands of untrained users
from the general population
16. Why WHO Pre-Qualification?
• South Africa does not have a Medical Devices
Regulatory Authority, or evaluation framework
• Yogan Pillay DDG Health “NDOH will not allow HIV
Self-Tests into Public Health which have not been
approved by the WHO PQ process”
24. HSTAR 001 Objectives
The purpose of the Usability Assessment is to document if “lay” people, non-
professional and inexperienced in HIV self-testing, can successfully perform the
steps to use a HIV Self-Test device, without product familiarization
- gain data regarding the usability (IFU comprehension and contrived results
interpretation) of the device including any error[s] that may occur including
modes of error, critical and non-critical errors, in a simulated “private” setting.
- Stratified for Age, Gender, Education level
Primary Objectives are to document and record:
• Label comprehension (understanding of Instructions for Use, test limitations,
test goal, inspection of test components)
• Usability / user interaction with the devices [effectiveness and efficiency] and
accuracy of testing process
• Results interpretation (contrived results, no actual diagnosis will be made)
29. Other Notable UA in SA pops
Dong et al in KZN, showed 95% usability accuracy in a
rural KZN population (35km out of PMB)
Deville et al demonstrated high usability, sensitivity
(99%) and specificity (95%) in Moetse region in
Groblersdal
31. HSTAR 003 Objectives
Primary Objectives
• The primary objective of this study is to evaluate the ability of untrained
users to obtain accurate HIV test results using the XXXXX Rapid HIV Self-Test
when compared to professional users and ELISA
Secondary Objectives
• To evaluate the untrained users’ interaction with the device in terms of
effectiveness and efficiency, i.e. successful / unsuccessful completion and
difficulty of the critical steps as per the Instructions for Use
• To assess the ability of the untrained users to correctly comprehend key
messaging from device packaging and labelling, including the Instructions for
Use
• Participants will be surveyed for user experience, and satisfaction with the
overall process; in addition, users will be asked for comments and
recommended improvements for test process
32. HSTAR 003 Progress
• Commenced 22 March 2017
• Orasure OF HIVST
• 147 participants completed to date
• Important study for OR PQ submission
33. Visual Stability Study
• Embedded substudy of 003 where we are looking at
the visual stability of the test line on the test kits are
D1 – 7, wk 1 – 4, Mo 2 – 6.
• With Liverpool School Tropical Medicine
• Duncombe, Watson, Taegetmayer
34. Where are we with HIVST in SA currently?
• Constraints/Barriers to Market Entry
• Target Product Profile
• Product Pipeline
• WHO Pre-Qualification
• Normative Guidance
• Regulatory pathways
• Clinical Research and Implementation Programmes
• SA TWG and Guidelines
36. Constraints/Barriers to Market Entry
• Barrier 1: Undefined Regulatory landscapeⱡ
• Barrier 2: High cost of risk and uncertaintyⱡ
• Barrier 3: Lack of demand for quality-assured HIVST
translating into concrete purchase orders~
• Barrier 4: Price pressure form donors and
governments~
• Barrier 5: Lack of incentives to innovate for further
product development~
• Barrier 6: Lack of ownership of and investment in key
market functionsⱡ ~
ⱡ Majam (2016), ~ PSI (2016)
41. HIVST Target Product Profile (PATH, 2014)
• Unlike HIV RDTs for professional-use, HIV RDTs for self-
testing are often employed by lay users who must collect
a whole-blood or oral fluid specimen, perform the test,
and interpret the results, potentially with little to no
assistance.
• This requires that products be designed for ease of use to
achieve accuracy, to facilitate interpretation of results,
and to support linkage to care.
42. TPP…cont
• High clinical and analytical sensitivity and specificity
• Low invalid and test failure rates
• Pictorial instructions for use with any text-based
instruction translated into local languages
• Low number of test steps which could be achieved
through integrated systems to deliver buffer or other
such innovations
• Simple to interpret test results which require little
instruction
• Reduction in time to result to 5 minutes or less (time
from test performance to interpretation)
• Increased stability of test results
43. ST manufacturers have brought
innovation to a stagnant industry
All in one test
Flow through technology
Results in seconds
44. On-going research into ST
• STAR Project
• Choko et al - Malawi
• Australia, Thailand, Brazil, Kenya programmes
• HSTAR programme (FDA studies, and WHO PQ)
46. South African ST data
• Ndlovu Health (Limpopo)
• High usability, concordance, Sens and Spec in rural
population
• HSTAR (Gauteng)
• High usability in Oral Fluid and Finger stick products in Inner
City Johannesburg
• iTEACH (Gauteng, Mpumalanga, KZN)
• High concordance, but low LTC in Truck Drivers
• UCT (Western Cape)
• High acceptability in MSM, and demonstrated utility of
online platforms for sale and distribution
• Anova (North West)
• High acceptability in MSM
49. WHO Guidelines on HIVST
5 RCTs directly comparing HIVST to
HIV testing by a provider as of July
2016
25 studies on HIV RDT for self-
testing performance as of April 2016
• 125 studies on
acceptability/feasibility (including user
values preferences) as of July 2016
• 4 studies on cost/cost-effectiveness
50. HIVST Doubled Uptake & Frequency
Moderate quality evidence that HIVST
doubled overall HIV testing uptake
compared to standard HTS
Study or Subgroup
Gichalgi 2016 3.08 [2.58, 3.69]
Thirumurthy 2016 1.77 [1.57, 2.00]
Wang 2016 1.77 [1.57, 2.00]
2.12 [1.51, 2.98]
Risk Ratio
M-H, Random, 95% CI
Favours standard of care Favours HIV self-testing
105210.50.2
Study or Subgroup
Katz 2015 1.70 [0.94, 2.46]
Jamil 2016 2.30 [2,27, 2.33]
2.13 [1.59, 2.66]
Mean Difference
IV, Random, 95% CI
Favours standard of care Favours HIV self-testing
1050-5-10
Low quality evidence that HIVST resulted in 2
more tests in a 12-15 month period compared to
standard HTS
Effect also shown for increase uptake of
couples testing in Gichangi et al &
Thirumurthy et al.
Jamil et al also showed HIVST increased
the frequency of testing among non-
recent testers compared to standard HTS
51. • Studies generally report HIVST can be empowering
• Social harm due to HIVST was not identified in RCTs
• Reports from other studies were limited and did not
suggest HIVST increased risk of harm
• In Malawi, two-years of implementing HIVST found no
suicides, no self-harm and no cases of IPV.
• Reports of coercion identified were
mostly among men who also reported
that they would recommend HIVST
• In Kenya 4 cases of IPV identified - unclear if due to
HIVST. (41% of participants reported IPV 12 months prior
to intervention).
No identifiable increased risk of
social harm & adverse events
52. However, Social Harms remain a
concern and will be continually
assessed through current and on-
going research
• STAR Phase 1: Over 300 000 tests distributed through
various modalities with no incidence of GBV, IPV or
Suicide
• Malawi unobserved, unassisted study (n = 14000), no
reports of social harm
• Much of the concern regarding suicide after a positive
HIV test comes from speculation and anecdotal
reports on the Internet. These remain a concern but
no evidence to support the link.
53. • HIVST is highly acceptable among many different groups and across
different settings – but some concern about potential lack of counselling
and support, accuracy of test results, and related costs
• Individuals surveyed about HIVST had concerns about possible harm,
but most had not self-tested, and concerns were not founded in
evidence –despite concern most still found HIVST acceptable
• Many users prefer oral HIVST (e.g. painless) – but many studies did not
inform respondents about performance.
• Some studies show when participants are informed they may actually
prefer fingerprick/whole blood-based HIVST.
• Preferences across service delivery approaches vary
• Key populations, in particular, reported preferences for pharmacies, the
Internet, and over-the-counter approaches more appealing because they
are more discreet and private
Summary of Values & Preferences
The picture can't be displayed.
54. Results of HIV RDTs performed by self-tester were
similar to those performed by trained health worker
Measured using kappa statistic – 16 studies
55. Generally acceptable levels of sensitivity
and specificity were achieved
Sensitivity
as high as 98.8% (95% CI 96.6 – 99.5%)
Specificity
as high as 100% (95% CI 99.9 – 100 %)
Figueroa et al Poster AIDS 2016, WEPEC207; HIVST.org
n = 18 studies
57. South African Guidance Document
SA TWG:
SAHIVSOC
Wits RHI
NHLS
NICD
MRC
MSF
iTEACH
NDLOVU
… others
58. SA Specific Guidance
• Guidance for Implementation
• Guidance to Manufacturers
• Implementation Messaging
• Provision for access to information through various
mechanisms in the absence of counselling
• Support systems
• Websites
• Apps
• Helpline
• Social Media
• Post Marketing Surveillance
60. HSTAR004
HIV Self-Testing: A supplementary strategy towards
achieving the first 90 in inner city Johannesburg
• This programme addresses the following two
interlinked problems:
• Inadequate HIV testing options, with poor linkage to care
• Inadequate testing of men, transgender, discordant
couples and other key and under-tested populations
• Using innovative Health Communication Platforms
• Opportunity to pilot in proposed STAR populations
Distribution of HIV Prevention Packages that include:
HIV Self-test, Male and Female Condoms, Prevention pamphlets
61. So who are the under-tested and
high risk pop that we want to target
MEN
AGYW
KEY POPS: FSW, MSM,
IDU, TRANSG
62. What would a Distribution Model
look like? Men
Men
Community
Based
Peer
referral
VMMC
Sport
Events
Internet
Based
Partner
Delivery
63. What would a Distribution Model
look like? Adolescent Girls Young
Women
AGYW
Community
Based
Peer referral
Vending
Machines
Social clubs
Internet
Based
Reproductive
Health
Centers
64. Where to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV Self----TestingTestingTestingTesting
Know your epidemic
& testing gap
Approaches
Couples & Partners
Men
Key populations
Young people
Other
At risk populations
(SDC, partners of PLHIV, migrants etc.)
Community-based
(outreach, door-to-door)
Facility-based
(PITC, drop-in centres)
VMMC programmes Workplace programmes
Pharmacies & Kiosks
Integrated in KP
Programmes
Internet & Apps
Integrated in RHS &
Contraceptive Services
Vending machines Partner-delivered
Considerations
Benefits & Risks to
Populations
Support tools
Linkage
Increased access
Increased coverage
65. Where to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV Self----TestingTestingTestingTesting
Know your
epidemic
& testing gap
Approaches
Couples & Partners
Men
Key populations
Young people
Other
At risk populations
(SDC, partners of PLHIV, migrants etc.)
Community-based
(outreach, door-to-door)
Facility-based
(PITC, drop-in centres)
VMMC programmes Workplace programmes
Pharmacies & Kiosks
Integrated in KP
Programmes
Internet & Apps
Integrated in RHS &
Contraceptive Services
Vending machines Partner-delivered
Consideratio
ns
Benefits & Risks to
Populations
Support tools
Linkage
Increased access
Increased coverage
Know your epidemic
& testing gap
Approaches Considerations
66. Where to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV Self----TestingTestingTestingTesting
Know your
epidemic
& testing gap
Approaches
Couples & Partners
Men
Key populations
Young people
Other
At risk populations
(SDC, partners of PLHIV, migrants etc.)
Community-based
(outreach, door-to-door)
Facility-based
(PITC, drop-in centres)
VMMC programmes Workplace programmes
Pharmacies & Kiosks
Integrated in KP
Programmes
Internet & Apps
Integrated in RHS &
Contraceptive Services
Vending machines Partner-delivered
Consideratio
ns
Benefits & Risks to
Populations
Support tools
Linkage
Increased access
Increased coverage
Know your epidemic
& testing gap
Approaches Considerations
67. Where to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV SelfWhere to Begin with HIV Self----TestingTestingTestingTesting
Know your
epidemic
& testing gap
Approaches
Couples & Partners
Men
Key populations
Young people
Other
At risk populations
(SDC, partners of PLHIV, migrants etc.)
Community-based
(outreach, door-to-door)
Facility-based
(PITC, drop-in centres)
VMMC programmes Workplace programmes
Pharmacies & Kiosks
Integrated in KP
Programmes
Internet & Apps
Integrated in RHS &
Contraceptive Services
Vending machines Partner-delivered
Consideratio
ns
Benefits & Risks to
Populations
Support tools
Linkage
Increased access
Increased coverage
Know your epidemic
& testing gap
Approaches Considerations
68. Policy and Advocacy
• South African Guidelines and TWG
• Final Draft with WHO HIV Dept for review
• WHO TWG
• Engagement with Pharmacy Council and Pharmacy
Groups
• TAC
• SANAC
• South African Stakeholder Symposium
71. Link to Prevention
DIRECT IMPACT
Link to Treatment
Triaged out of Health
System
Health for PLHIV: Reduced
Morbidity & Mortality
Reduced HIV Transmission &
Infections Averted
Cost and Time Savings (Health
System & Users)
Efficiency
Expanded Coverage
Equity of Health
Health Systems
Social & Economic
Population
Productivity & Growth
Social Benefit
Social Harm
+
-
ADDITIONAL
IMPACT
DIRECT
ACTION
DIFFERENT
POPULATIONS
DIFFERENT
CONTEXTS
DIFFERENT
GEOGRAPHIES
HIVST
PREP
Acceptability
Usability
Willingness
to Pay
Evidence Available
72. To do list!
• Learn what distribution model works in which
populations
• LINKAGE TO CARE!
• How do measure impact of HIVST on National
numbers?
• Is this modality cost effective?
• Have we adequately addressed all the concerns of
social harm?
73. STAR Phase 2
• Wits RHI, SFH, PSI and CHAI
• 2.2 million HIVST Kits over 3 years
• Test and research distribution models over the next
three years to make both investment and operational
implementation recommendations to NDOH
74. Finally
We don’t have all the answers yet, and we
don’t profess a perfect science, but we are
moving forward in a responsible and
inclusive manner in the hopes of achieving
a positive public health impact
75. Acknowledgements
• Dr Yogan Pillay and Dr Thato Chidarikire
• Prof Francois Venter
• Wits RHI Colleagues
• SA HIV Clinicians Society and the Guidelines TWG
• WHO HIV Dept: Cheryl Johnson and Rachel Baggaley
• Funders: BMGF and Aids Fonds
• UNITAID
• STAR Consortium
MOHAMMED MAJAM – Technical Head
Wits RHI; mmajam@wrhi.ac.za. 082 826 0180