This section will help you understand the epidemic profile of target countries, identify key populations and testing gaps and map HIVST-relevant policies and regulations.
Since HIVST is likely to be a new approach to testing in the country context programs are being designed for, there are several crucial preparatory activities that need to be completed before implementation can begin to ensure that there are no impediments to the program’s rollout and scale-up.
It is particularly important to address the legal and regulatory issues that might cause delays further down the line or lead to legal issues if any rare adverse events arise. This section is based on our experience with the STAR Initiative and highlights the core preparatory processes that might need to be completed before implementation can begin.
Before HIV Self-Testing implementation can start, it is crucial to carry out an in-depth situational analysis of how current HIV testing services are organized and performing, so that it is possible to make informed decisions on the most effective way to adapt these structures to improve health outcomes.
Situational analysis should include a review of national HIV epidemiological data, programmatic data, and legal and policy documents. It should be done in collaboration with key stakeholders, such as government departments, communities, implementing partners, donors, health workers and lay or community providers who may have unpublished information that is valuable for program planning. The analysis should also cover any informal availability of HIVST as unregulated or unregistered products sold by pharmacies or on the internet.
This analysis process should also include mapping exercises to identify relevant stakeholders who should be informed about the program and can be engaged in implementation; to look at the regulatory environment and whether new regulations might be required; to identify testing gaps and define the target population; and finally to understand where more research is required to answer key program design questions.
There should also be a component of the analysis that focuses on data to inform demand creation and communications strategies. Click here for a list of useful questions to include in a situational analysis.
When evaluating HIV testing services specifically, the analysis should examine progress and gaps across national and sub-national HIV epidemiology and programmatic data, including HIV testing coverage, testing frequency/retesting, knowledge of status among people with HIV, number of persons testing HIV-positive (positivity rate), linkage to prevention and treatment, and HIV testing costs (disaggregated by sex, age, population group, testing approaches and geography). In addition, existing demand creation efforts as well as capacity, resources and quality assurance systems should be considered. Information and statistics on past and current HIVST projects and pilots, both nationally and globally, should be reviewed to identify good practices.
Tool: WHO Consolidated Strategic Information Guidelines for HIV in the Health Sector
An HIVST Technical Working Group or Task Force should be established as early as possible in the program planning process to help inform and guide the development of national policies, strategic plans (including sustainability), standard operating procedures, guidelines, monitoring and reporting tools, investment cases, communication materials and research agendas.
Many countries may already have established HIV testing working groups from which you can recruit an HIVST project team. If so, it is often more efficient to add HIVST to the terms of reference of an existing group and/or to establish an HIVST-focused subgroup than to try to form a new, separate group for HIVST.
Stakeholders whose involvement should be considered include:
The terms of reference for the group should define clear roles and responsibilities for all participants (ie, Who will be directly involved in project work? Who will be limited to an advisory capacity?) and members of the group should be aware of what is expected of them. Resources should be identified and budgeted appropriately to support the group’s activities. There should also be an administrative contact or secretariat for the group that will make sure minutes of meetings are recorded and that decisions taken are documented and circulated. All key decision-points in the program planning and implementation process should involve the stakeholders represented in the working group, if wider consultation is not required. If formal consultations are needed, for example on draft regulations or policy decisions, the mechanism for informing all stakeholders and coordinating their feedback should be clear.
The working group also has an important function to advocate for the program, to raise issues that might affect implementation, and to connect the program team to the perspectives and information a diverse group of stakeholders can bring.
Once implementation begins, the group could also routinely review programmatic data; examine reports of product misuse or failure, or social harm; provide updates on ongoing research; convene necessary consultations to maintain community engagement; and coordinate partners and broader HIVST scale-up.
HIVST is not intended as a replacement for conventional HIV testing, so programs should be focused on populations who are unable or unwilling to access other forms of HIV testing. The situational analysis (see above) should have identified important information about the groups missed by current testing programs, or segments of the population where HIV risk is particularly high and testing needs to be done frequently.
WHO identifies a number of populations as generally high priority for HIVST:
These populations will be covered in greater detail in the Implementation section of this guide.
Additionally, there may be country-specific populations of interest to your donor or that you identify in your research and situational analysis who could also benefit from HIVST. Prior to starting HIVST implementation, it is recommended that programs conduct a baseline assessment to identify which populations will most benefit from self-testing using existing routine indicators for HIV testing and linkage to prevention and treatment (refer to the Situational Analysis section above and the WHO Consolidated Guidelines for Strategic Information in the Health Sector for specific information on these assessments).
Properly understanding your target populations is critical for making decisions about selecting an appropriate combination of HIVST products and distribution models for your program that meets their needs, is adapted to population preferences and meets any legal or regulatory requirements for the country.
Tool: WHO Consolidated Guidelines on HIV Testing Services
Tool: WHO Guidelines on Self-Testing and Partner Notification
Once target populations and products have been identified and selected, it is important to identify the most appropriate method of delivery of HIVST kits based on the population you are trying to reach. The STAR Initiative did considerable research on different types of delivery models, which models are suited to which target populations, how to mobilize clients with each approach, and the best mechanisms for linking clients to HIV prevention or treatment services after they receive their results.
Detailed descriptions of how to operationalize these models are included in the Implementation Section of this guide (SECTION 3); however, the following table summarizes the key features of the most common distribution models and their appropriateness for different contexts and populations. This summary should serve as a useful guide for narrowing down the options at the preparation stage. Please click on the expandable sections below to see the key features of each type of model.
HIVST Integrated into Mobile Services or HIVST Fixed Sites | |
Description | ·Distribution at urban and rural community hotspots. Confirmatory testing and in some cases ART on site ·People can test themselves in a cubicle at the distribution point or HTS clinic (with assistance available) or take the kit home ·HIVST kit offered to those who test positive (index case) to take home to their sexual partner(s). Follow-up with index or partner for confirmatory testing ·HIVST kit is offered to all pregnant women regardless of HIV status to take to male partner |
Priority Populations | ·High-risk adults, adult men, adolescents, especially girls and young women ·Sexual partners of HIV positive people diagnosed at testing sites (secondary distribution) |
Mobilization Strategy | ·Mobilization and demand creation for HIVST at community level ·Index clients offer HIVST to sexual partners ·Pregnant women offer HIVST to sexual partners |
Linkage Strategy | ·Confirmatory testing offered at site; referral to treatment with referral note after confirmed HIV positive status ·Referral form included in information materials when HIVST kit is handed to sexual partner. Referral information provided via index client |
Rationale | ·Fast-track pre-screening, triaging out those who self-test HIV negative unless confirmatory testing desired ·Providers can shift attention to those most in need, for example, index testing and assisted partner notification, confirmatory testing, initiation of ART. ·Increase in demand for HTS if mobile or fixed HTS clinic services are promoted as outlets for HIVST kits ·Increases likelihood of sexual partner testing. (A high proportion of sexual partners of positive indexes test positive.) |
HIVST Offered at Men’s Workplaces | |
Description | ·HIVST kits are offered to employees at workplaces employing mostly men after buy-in and agreement by employer. Employees can perform HIVST in a private space provided at the workplace where assistance is available or take the HIVST kit home. |
Priority Population | ·High-risk adults, men |
Mobilization Strategy | ·Peer educators and counsellors at workplaces promote HIVST |
Linkage Strategy | ·Referral form included in information materials given when HIVST kit |
Rationale | ·Increases testing in populations that would otherwise not seek testing services. Rapidly and greatly increases testing coverage. |
Integrated with Public Sector Facility | |
Description | ·Facility-based counsellors and health care workers directly promote HIVST at entry points of the health delivery system, for example, outpatients, in-patients ·HIVST kit offered to HIV positive clients to take to sexual partner(s). Follow-up with index or partner for confirmatory testing. ·HIVST kit is offered to all pregnant women regardless of HIV status to take to male partner |
Priority Population | ·Individuals accessing health-care facilities in both urban and rural areas ·Sexual partners of HIV positive index diagnosed at HTS (secondary distribution) ·Partners of pregnant women using public sector maternity services (secondary distribution) |
Mobilization Strategy | ·Health-care providers actively promote HIVST at health facilities, option of individuals to take test kit for partner home testing ·Index clients offer HIVST to sexual partners ·Pregnant women offer HIVST to sexual partners |
Linkage Strategy | ·Self-testers with reactive result receive confirmatory testing on site, initiation on ART (test and treat). ·Referral form included in information materials when HIVST is handed to sexual partner. Referral information provided via index client ·Referral form included in information materials when HIVST is handed to sexual partner. Referral information provided via index client |
Rationale | ·Test-for-triage approach. HTS clinic can shift attention to other tasks ·Increases numbers tested and more targeted provider-initiated testing to maximize HIV positive diagnoses, ART initiation and uptake of prevention service. ·Increases likelihood that sexual partner will test ·Increases opportunity for partners of pregnant women to test for HIV and link to care, treatment or prevention |
Integrated with Voluntary Medical Male Circumcision Services (VMMC) | |
Description | ·HIVST offered to men mobilized for VMMC to use at home before VMMC |
Priority Population | ·Men considering VMMC services |
Mobilization Strategy | ·Mobilizers for VMMC offer HIVST as option to conduct pre-screening before VMMC |
Linkage Strategy | ·VMMC mobilizers may directly follow up with clients on successful referral for HIVST |
Rationale | ·May reduce fear of testing that discourages men from taking up VMMC services |
HIVST integrated with HTS services for key populations (eg, female sex workers, MSM) | |
Description | ·HIVST offered as alternative to HTS to clients accessing sex worker clinics or health services for men who have sex with men ·HIVST distribution through social networks of female sex workers or men who have sex with men |
Priority Population | ·Female sex workers and men who have sex with men |
Mobilization Strategy | ·Health-care providers actively promote HIVST at health facilities ·Peers of key populations promote HIVST |
Linkage Strategy | ·Self-testers with reactive result receive confirmatory testing on site, initiation on ART (test and treat). ·Referral form included in information materials given with HIVST kit |
Rationale | ·Test-for-triage approach. HTS clinic can shift attention to other tasks. Increases numbers tested and more targeted provider-initiated testing to maximize HIV positive diagnoses, ART initiation and uptake of prevention service. ·Increases uptake and frequency of testing among key populations |
When initiating a program to bring HIVST kits into new markets, it is essential to secure proper regulatory approval so that all stakeholders will have confidence in the quality and effectiveness of the products used and to mitigate against risks of legal liability for the program managers. However, you may find that the country you are working in does not have appropriate regulations in order to approve and register new IVDs or, if regulations are in place, there is no system to monitor compliance or implement legal sanctions, including removal from the market, for violations.
Your situational analysis (see above) should have involved mapping of the regulatory landscape to identify whether there are appropriate systems in place already.
Countries with well-developed medical device regulatory systems will have regulations and guidelines in place that require the listing of medical devices. This is so the country knows what medical devices are in clinical use. Guidelines and regulations apply to kits which are available in both the public and private sectors. For countries that have well-developed medical device regulatory systems, these regulations must be followed for HIVST.
However, many low- and middle-income countries do not regulate medical devices. This situation poses a problem for ensuring that only safe, well performing devices are used for self-testing by the population. Public procurement systems can be used to control devices that are used in the public sector, but these do not reach into the private sector market. Therefore, the establishment of the proper regulation of IVDs – of all types, not just HIVST – is the most efficient way to ensure that only good quality HIVST devices are available for clinical use in-country and that they are appropriately used. This is an important part of preparing for the roll-out of an HIVST program and one of the ways in which it can contribute to broad health system strengthening.
Process for Developing New Country-Based Regulation
STAR’s experience of establishing regulations in project countries led to the development of a 5-stage process that other countries can follow:
The whole process is estimated to take around 2 years. Ideally, you should develop regulations that are as convergent (ie, as similar as possible) with existing medical device regulations established by regional and international organizations and/or neighboring countries. We were fortunate to have been able to do this in the STAR countries. Convergent regulations will increase the number of good quality HIVST devices available on the market and the lessen the administrative burden for manufacturers to list devices.
Substitutes for Country-Based Regulation
You may decide that it is not feasible to go through the entire regulatory development process in your country and therefore need an alternative system to ensure product quality and effectiveness.
The WHO Prequalification (WHO PQ) system was designed to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy. The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers. This information, in conjunction with other procurement criteria, is used by the UN and other procurement agencies to make purchasing decisions regarding diagnostics, medicines and/or vaccines. can be used as an indicator of safety and effectiveness for a country while regulations are being developed.
Many countries and donors use this WHO system, or the decisions made my other regulatory authorities known to apply stringent processes and standards, as a pre-requisite or substitution for device listing and/or procurement.
WHO PQ is recognized as an important indication of safety and performance for countries that have not yet developed and implemented medical device regulations. In most countries, the absence of medical device regulations will mainly impact procurement choices made by the public sector; there will not be a legal imperative for the private sector to choose tests that have underdone WHO PQ because there is no consequence for violating non-existent regulations. Also, not all diseases are covered by WHO PQ, which is limited to IVDs of the greatest public health importance. This leaves a regulatory gap for many IVDs that are still necessary for individual health.
Stringent Regulatory Authority (SRA) approval is used by some countries as an indicator of safety and performance of a device. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the body responsible for maintaining the global list of which countries’ regulators qualify for the status of SRAs. However, the differences between the applicability to low and middle-income countries of WHO PQ tests and those approved by SRA needs to be clearly understood by program designers, so that the suitability of the respective types of assessment can be understood.
Another option for program designers is to rely on approval of devices by the UNITAID/Global Fund Expert Review Panel mechanism, which can also be used as an indicator of safety and performance, but the time-limited nature of these approvals must be considered.
The adoption of products from regulatory authorities other than WHO PQ, for example the US Food and Drug Administration or the European Union’s CE process, must be done with caution, since the assessment schedules for those products were designed for use in populations and countries that may not be consistent with situations encountered in low and middle income countries (environmental conditions, unrelated medical conditions, etc.). WHO PQ, on the other hand, takes many of these variables into account.
Tool: WHO Global Model Regulatory Framework for Medical Devices
There is a large volume of research available on HIVST, and you should be able to obtain most of the information you need for program planning from secondary sources. However, there might be specific areas where new research is required, for example, your target users’ preferences for self-testing and culturally specific risk factors/potential harms.
The following list of questions should help focus program designers’ minds on what needs to be done in order to ensure that sufficient information for decision-making is available and incorporated into the preparation process:
DOWNLOAD RESOURCE Since the release of the WHO consolidated guidelines in 2015, new evidence has emerged. Consequently, in an effort to further support countries, programme
DOWNLOAD RESOURCE The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable
DOWNLOAD RESOURCE This guidance consolidates, prioritizes and describes key indicators to monitor the national and global response of the health sector to HIV. Its goal
DOWNLOAD RESOURCE The Consolidated guidelines on HIV testing services bring together existing guidance relevant to the provision of HIV testing services (HTS) and addresses issues and elements
DOWNLOAD RESOURCE HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to
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Join us in this illuminating session as we explore the evolution of the STAR self-testing project, sharing insights, challenges, and successes that have emerged over the years. By examining the lessons learned and considering the implications for future healthcare strategies, we hope to foster a deeper understanding of the transformative potential of self-testing in improving healthcare accessibility and patient-centric services.
This enlightening session promises to provide updates from WHO guidelines and share insights on the journey toward viral hepatitis elimination. It will also showcase outcomes from the STAR hepatitis C self-testing research and discuss how these findings could potentially inform hepatitis B antigen self-testing and the use of multiplex test kits in the context of triple elimination. Join us in this crucial discussion as we work together to fast-track the global journey toward a hepatitis-free world by 2030.
In this two-part session, the Bill & Melinda Gates Foundation, PSI, and Population Solutions for Health will share lessons and best practices from rigorous research and hands-on implementation experience in Zimbabwe. The session will cover important topics like client-centered, community-led demand creation, differentiated service delivery, sustainable financing, and digital solutions. The sessions will also cover lessons in the program.
In this session, PSI and PSH will share lessons for optimizing access to comprehensive, culturally sensitive HIV and sexual and reproductive health services. Topics will include enhancing the accuracy and reliability of sex worker population data, improving HIV case finding among men who have sex with men (MSM) through reverse index case testing, and scaling differentiated service delivery models. The session will also cover integrating mental health and substance abuse in key populations (KP) programming and lessons in public sector strengthening.
Additionally, the session will showcase solutions that MSMs have co-designed, highlighting how this collaboration has improved the consumer care experience. It will demonstrate the critical role of KP communities in establishing strong and sustainable HIV responses, including amplifying KP voices, strengthening community-led demand, and establishing safe spaces at national and subnational levels for KP communities to shape and lead the HIV response.
This enlightening session promises to provide updates from WHO guidelines and share insights on the journey toward viral hepatitis elimination. It will also showcase outcomes from the STAR hepatitis C self-testing research and discuss how these findings could potentially inform hepatitis B antigen self-testing and the use of multiplex test kits in the context of triple elimination. Join us in this crucial discussion as we work together to fast-track the global journey toward a hepatitis-free world by 2030.
In this two-part session, the Bill & Melinda Gates Foundation, PSI, and PSH will share lessons and best practices from rigorous research and hands-on implementation experience in Zimbabwe. The session will cover important topics like client-centered, community-led demand creation, differentiated service delivery, sustainable financing, and digital solutions. The sessions will also cover lessons in program management. These insights are applicable beyond Zimbabwe and can be used to scale up HIV prevention efforts in the region.
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Private sector pharmacies and drug shops play an important role in improving access to essential health services and products for millions of people living in low- and middle-income countries (LMICs), where healthcare resources are often limited. However, the way in which these outlets are, or are not, integrated into health systems holds significant importance. Do they serve as facilitators of affordable, high-quality care? Or have they become sources of substandard health services and products?
For over 50 years, PSI’s social businesses have worked globally to generate demand, design health solutions with our consumers, and work with local partners to bring quality and affordable healthcare products and services to the market. Now consolidating under VIYA, PSI’s first sexual health and wellness brand and social business, our portfolio represents the evolution from traditionally donor–funded projects towards a stronger focus on sustainability for health impact over the long term. Across 26 countries, the VIYA model takes a locally rooted, globally connected approach. We have local staff, partners and providers with a deep understanding of the markets we work in. In 2022, we partnered with over 47,000 pharmacies and 10,000 providers to reach 11 million consumers with products and services, delivering 137 million products. VIYA delivers lasting health impact across the reproductive health continuum, from menstruation to menopause. Consumer insights drive our work from start to finish. Their voices, from product exploration to design, launch, and sales, ensure that products not only meet consumers’ needs but exceed their expectations. The consumer is our CEO.
In 2019, our human-centered design work in East Africa explored ways that our work could support and accompany young women as they navigate the various choices required for a healthy, enjoyable sexual and reproductive life. Harnessing insights from consumers, VIYA is revolutionizing women’s health by addressing the confusion, stigma, and unreliability surrounding sexual wellness. Across five markets – Guatemala, Kenya, South Africa, Uganda and Pakistan – VIYA utilizes technology to provide women with convenient, discreet, and enjoyable tools for making informed choices about their bodies. The platform offers a wealth of high-quality sexual wellness information, covering topics from periods to pleasure in an accessible and relatable manner. Additionally, VIYA fosters a supportive community where users can share experiences and receive guidance from counselors. In 2023, VIYA will begin offering a diverse range of sexual wellness products and connect users with trusted healthcare providers, ensuring comprehensive care tailored to individual needs.
By: Fana Abay, Marketing and Communications Director, PSI Ethiopia
In rural Ethiopia, women and girls often face significant barriers in accessing healthcare facilities, which can be located hours away. Moreover, there is a prevailing stigma surrounding the use of contraception, with concerns about potential infertility or the perception of promiscuity. To address these challenges, the Smart Start initiative has emerged, linking financial well-being with family planning through clear and relatable messaging that addresses the immediate needs of young couples—planning for the lives and families they envision. Smart Start takes a community-based approach, utilizing a network of dedicated Navigators who engage with women in their localities. These Navigators provide counseling and refer interested clients to Health Extension Workers or healthcare providers within Marie Stopes International-operated clinics for comprehensive contraceptive counseling and services.
In a significant development, PSI Ethiopia has digitized the proven counseling messaging of Smart Start, expanding its reach to more adolescent girls, young women, and couples. This approach aligns with the priorities set by the Ethiopian Ministry of Health (MOH) and is made possible through funding from Global Affairs Canada. The interactive and engaging digital messaging has revolutionized counseling services, enabling clients to make informed and confident decisions regarding both their finances and contraceptive choices.
Clients who received counseling with the digital Smart Start tool reported a higher understanding of their options and were more likely to choose contraception (74 percent) compared to those counseled with the manual version of Smart Start (64 percent). Navigators also found the digital tool more effective in connecting with clients, leading to higher ratings for the quality of their counseling.
By December 2023, PSI Ethiopia, working in close collaboration with the MOH, aims to reach over 50 thousand new clients by leveraging the digital counseling tool offered by Smart Start. This innovative approach allows for greater accessibility and effectiveness in providing sexual and reproductive health services, contributing to improved reproductive health outcomes for women and couples across the country.
By: Christopher Lourenço, Deputy Director, Malaria, PSI Global
Community health workers (CHWs) are critical lifelines in their communities. Ensuring they have the training, support, and equipment they need is essential to keep their communities safe from malaria, especially in the hardest to reach contexts.
For example, in Mali, access to formal health services remains challenging, with four in ten people living several miles from the nearest health center, all without reliable transportation or access. In 2009, the Ministry of Health adopted a community health strategy to reach this population. The U.S. President’s Malaria Initiative (PMI) Impact Malaria project, funded by USAID and led by PSI, supports the Ministry with CHW training and supervision to localize health services.
In 2022, 328 thousand malaria cases were recorded by CHWs); 6.5 thousand severe malaria cases were referred to health centers, according to the national health information system.
During that time, the PMI Impact Malaria project (IM) designed and supported two rounds of supportive supervision of 123 CHWs in their workplaces in the IM-supported regions of Kayes and Koulikoro. This included developing and digitizing a standardized supervision checklist; and developing a methodology for selecting which CHWs to visit. Once a long list of CHW sites had been determined as accessible to supervisors for a day trip (including security reasons), the supervisors telephoned the CHWs to check when they would be available to receive a visit [as being a CHW is not a full-time job, and certain times of the year they are busy with agricultural work (planting, harvesting) or supporting health campaigns like mosquito net distribution].
Supervisors directly observed how CHWs performed malaria rapid diagnostic tests (RDTs) and administered artemisinin-based combination therapy (ACT). They recorded CHW performance using the digitized checklist, interviewed community members, reviewed records, and provided on-the-spot coaching. They also interviewed the CHWs and tried to resolve challenges they expressed, including with resupply of commodities or equipment immediately or soon afterwards.
Beyond the observed interactions with patients, supervisors heard from community members that they were pleased that CHWs were able to provide essential malaria services in the community. And the data shows the impact.
In IM-supported areas of Mali, 36% of CHWs in the first round were competent in performing the RDT, which rose to 53% in the second. 24% of CHWs in the first round compared to 38% in the second were competent in the treatment of fever cases and pre-referral counseling. Between both rounds, availability of ACT increased from 80 percent to 90 percent.
Supportive supervision with interviews and observations at sites improved the basic competencies of CHWs between the first and second rounds, and additional rounds will help to understand the longer-term programmatic benefits.
By: Dr. Dorothy Balaba, Country Representative, PSI Ethiopia
In Ethiopia, PSI leads the implementation of USAID Transform WASH (T/WASH) activity with consortium partners, SNV and IRC WASH. Contrary to traditional models that rely on distribution of free or heavily subsidized sanitation products, T/WASH utilizes a market-based sanitation approach. This approach creates sustainable and affordable solutions, by integrating market forces and supporting businesses to grow, while creating demand at the household level.
During the last six years, T/WASH has worked alongside the private sector and government (Ethiopia’s Ministry of Health, Ministry of Water and Energy, and Ministry of Labor and Skills), among other stakeholders, to increase household access to affordable, quality sanitation products and services. For example, more than 158 thousand households have invested in upgraded sanitation solutions with rapid expansion to come as the initiative scales and market growth accelerates.
T/WASH has successfully trained more than 500 small businesses, including community masons and other construction-related enterprises, with technical know-how in sanitation product installation, operational capacities, and marketing and sales skills needed to run successful, growing businesses. The Ethiopian government is now scaling the approach to all districts through various national, regional, and local institutions with requisite expertise. T/WASH has also worked the One WASH National Program, Ministry of Health, Ministry of Water and Energy, and Ministry of Labor and Skills to examine policies that influence increased household uptake of basic WASH services, such as targeted sanitation subsidies, tax reduction to increase affordability, and increased access to loan capital for business seeking to expand and households needing help to improve their facilities.
To share the journey to market-based sanitation, representatives of the Ethiopian Ministry of Health and the USAID Transform WASH team took to the stage at the UN Water Conference in 2023.
“Rather than relying on traditional aid models that often distribute free or heavily subsidized sanitation products, market-based sanitation creates sustainable and affordable solutions, integrating market forces and supporting businesses to grow.”
— Michael Negash, Deputy Chief Party of T/WASH
By: Dr Karin Hatzold, Associate Director HIV/TB/Hepatitis
Building upon the success and insights gained from our work with HIV self-testing (HIVST), PSI is actively applying this approach to better integrate self-care, more broadly, in the health system beginning with Hepatitis C and COVID-19. Self-testing has emerged as a powerful tool to increase access to integrated, differentiated, and decentralized health services, accelerating prevention, care, and treatment for various diseases, while also increasing health system resilience against COVID-19.
Here’s how we got there.
Seven years ago, the landscape of HIV self-testing lacked global guidelines, and only the U.S., the UK and France had policies in place that allowed for HIV self-testing. High disease burdened countries in low-and-middle-income-countries (LMICs) lacked evidence and guidance for HIVST despite major gaps in HIV diagnosis.
However, through the groundbreaking research from the Unitaid-funded HIV Self-Testing Africa (STAR) initiative led by PSI, we demonstrated that HIVST is not only safe and acceptable but also cost-effective for reaching populations at high risk with limited access to conventional HIV testing. This research played a pivotal role in informing the normative guidelines of the World Health Organization (WHO) and shaping policies at the country level. As a result, more than 108 countries globally now have reported HIVST policies, with an increasing number of countries implementing and scaling up HIVST to complement and partially replace conventional testing services. This became especially significant as nations tried to sustain HIV services amidst the disruptions caused by the COVID-19 pandemic.
By leveraging our expertise, PSI is conducting research to identify specific areas and populations where the adoption of Hepatitis C and COVID-19 self-testing could significantly enhance testing uptake and coverage. This research serves as the foundation for developing targeted strategies and interventions to expand access to self-testing, ensure that individuals have convenient and timely options for testing for these diseases, and are linked to care, treatment and prevention services through differentiated test and treat approaches.
By: Shawn Malone, Project Director, HIV/AIDS Gates Project in South Africa, PSI Global
In South Africa, where the HIV response has lagged in reaching men, PSI’s Coach Mpilo model has transformed the role of an HIV counselor or case manager into that of a coach and mentor who provides empathetic guidance and support based on his own experience of living with HIV. Coaches are men who are not just stable on treatment but also living proudly and openly with HIV. Situated within the community and collaborating closely with clinic staff, they identify and connect with men struggling with barriers to treatment and support them in overcoming those barriers, whether that means navigating the clinic or disclosing their HIV status to their loved ones.
PSI and Matchboxology first piloted the model in 2020 with implementing partners BroadReach Healthcare and Right to Care as well as the Department of Health in three districts of South Africa. Since then, the model has been rolled out by eight implementing partners in South Africa, employing more than 300 coaches and reaching tens of thousands of men living with HIV. To date, the model has linked 98 percent of clients to care and retained 94 percent of them, in sharp contrast to the estimated 70 percent of men with HIV in South Africa who are currently on treatment.
Given the success of the program, South Africa’s Department of Health and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) have each embraced the Coach Mpilo model in their health strategy and are embedding it in their strategies and programs.
“The men we spoke to [while I was traveling to South Africa for a PrEP project with Maverick Collective by PSI] were not only decidedly open to the idea of taking a daily pill…many were willing to spread the word and encourage friends to get on PrEP too. We were able to uncover and support this new way forward because we had flexible funding to focus on truly understanding the community and the root barriers to PrEP adoption. This is the philanthropic funding model we need to effectively fight the HIV epidemic, and it’s beneficial for all sorts of social challenges.”
– Anu Khosla, Member, Maverick Collective by PSI
By: Hoa Nguyen, Country Director, PSI Vietnam
In late 2022, with funding from the Patrick J. McGovern Foundation, PSI and Babylon partnered to pilot AIOI in Vietnam. By combining Babylon’s AI symptom checker with PSI’s health provider locator tool, this digital health solution analyzes symptoms, recommends the appropriate level of care, and points them to health providers in their local area. The main goal is to support people in low-income communities to make informed decisions about their health and efficiently navigate the healthcare system, while reducing the burden on the healthcare workforce. The free 24/7 service saves people time and subsequent loss of income from taking time off work and from having to pay unnecessary out-of-pocket expenses. Under our global partnership with Meta, PSI launched a digital campaign to put this innovative product in the hands of people in Vietnam. By the end of June 2023 (in the nine months since product launch), 210 thousand people accessed the AIOI platform; 2.4 thousand people created personal accounts on the AIOI website, 4.8 thousand triages to Symptom Checker and linked 2.2 thousand people to health facilities.
Babylon’s AI symptom checker and PSI’s health provider locator tool captures real-time, quality data that supports health systems to plan, monitor and respond to consumer and provider needs. But for this data to be effective and useable, it needs to be available across the health system. Fast Healthcare Interoperability Resources (FHIR) standard provides a common, open standard that enables this data exchange.
PSI’s first consumer-facing implementation of FHIR was launched in September 2022 as part of the Babylon Symptom Checker project in Vietnam, enabling rapid alignment between PSI and Babylon’s FHIR-enabled client records systems. PSI already has several other consumer health FHIR implementations under active development in 2023, including PSI’s collaboration with the Kenya MOH to launch a FHIR-enabled WhatsApp national health line for COVID-19 health information. PSI will also look to adopt and scale health workforce-facing FHIR-enabled tools, such as OpenSRP2, which will be piloted in an SRH-HIV prevention project in eSwatini in partnership with Ona by the end of 2023.
— Martin Dale, Director, Digital Health and Monitoring, PSI
By: Dr. Zayar Kyaw, Head of Health Security & Innovation, PSI Myanmar
Under a three-year investment from the Indo-Pacific Center for Health Security under Australia’s Department for Foreign Affairs and Trade (DFAT), PSI is enhancing disease outbreak surveillance and public health emergency preparedness and response capacities in Myanmar, Cambodia, Laos, and Vietnam. When PSI conducted a review of existing disease surveillance systems in Myanmar, it identified several gaps: although the Ministry of Health had systems in place for HIV, tuberculosis, malaria and other communicable diseases, they were fragmented, with different reporting formats and reliance on paper-based reporting. In addition, private sector case surveillance data were not routinely captured, yet private clinics and pharmacies are the dominant health service delivery channel in the country. This hindered effective disease prevention and control efforts.
Building on our extensive private sector malaria surveillance work under the BMGF-funded GEMS project in the Greater Mekong Subregion, PSI implemented a case-based disease notification system using social media channels to overcome the limitations of paper-based and custom-built mobile reporting tools. These chatbots, accessible through popular social media platforms like Facebook Messenger and Viber, proved to be user-friendly and required minimal training, maintenance, and troubleshooting. The system was implemented in more than 550 clinics of the Sun Quality Health social franchise network as well as nearly 470 pharmacies. The captured information flows to a DHIS2 database used for real-time monitoring and analysis, enabling rapid detection of potential outbreaks. Local health authorities receive instant automated SMS notifications, enabling them to promptly perform case investigation and outbreak response.
In 2022, private clinics reported 1,440 malaria cases through the social media chatbots, while community mobilizers working with 475 private providers and community-based malaria volunteers reported more than 5,500 cases, leading to the detection of two local malaria outbreaks. Local health authorities were instantly notified, allowing them to take action to contain these surges in malaria transmission. During the same time, pharmacies referred 1,630 presumptive tuberculosis cases for confirmatory testing – a third of which were diagnosed as tuberculosis and enrolled into treatment programs.
By: Anya Fedorova, Country Representative, PSI Angola
The shortage of skilled health workers is widely acknowledged as a significant barrier to achieving Universal Health Coverage. To address this challenge, PSI supported ministries of health to develop a digital ecosystem that brings together stewardship, learning, and performance management (SLPM). The ecosystem enhances training, data-driven decision-making, and the efficiency of healthcare delivery.
Here’s what it looks like in practice.
In July 2020, PSI Angola, alongside the Angolan digital innovation company Appy People, launched Kassai, an eLearning platform that targets public sector health workers in Angola. Through funding from USAID and the President’s Malaria Initiatve (PMI), Kassai features 16 courses in malaria, family planning, and maternal and child health – with plans to expand learning topic areas through funding from ExxonMobil Foundation and private sector companies. A partnership with UNITEL, the largest telecommunication provider in Angola, provides all public health providers in Angola free internet access to use Kassai.
Kassai’s analytics system to follow learners’ success rate and to adjust the course content to learners’ performance and needs. Kassai analytics are integrated with DHIS2 – the Health Management Information System (HMIS) of Angolan MOH, to be able to link learners’ knowledge and performance with the health outcomes in the health facilities. The analytics track learners’ performance by course and gives visibility by health provider, health facility, municipality, and province. Each course has pre-and post-evaluation tests to track progress of learning, too.
By the end of 2022, there were 6,600 unique users on the Kassai platform and 31,000 course enrollments. PSI Angola’s partnership with UNITEL, the largest telecommunication provider in Angola, allows for free internet access to learn on the Kassai for all public health providers in Angola. Building on its success for malaria training, Kassai now also provides courses in family planning, COVID-19, and maternal and child health. This reduces training silos and provides cross-cutting benefits beyond a single disease.
Implementing the SLPM digital ecosystem brings numerous benefits to health systems. It allows for more strategic and efficient workforce training and performance management, enabling ministries of health to track changes in health workers’ knowledge, quality of care, service utilization, and health outcomes in real time. The ecosystem also supports better stewardship of mixed health systems by facilitating engagement with the private sector, aligning training programs and standards of care, and integrating private sector data into national HMIS. Furthermore, it enables the integration of community health workers into the broader health system, maximizing their impact and contribution to improving health outcomes and strengthening primary healthcare.
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With overarching commitments to flexibility in our work, and greater wellbeing for our employees, we want to ensure PSI is positioned for success with a global and holistic view of talent. Under our new “work from (almost) anywhere,” or “WFAA” philosophy, we are making the necessary investments to be an employer of record in more than half of U.S. states, and consider the U.S. as one single labor market for salary purposes. Globally, we recognize the need to compete for talent everywhere; we maintain a talent center in Nairobi and a mini-hub in Abidjan. PSI also already works with our Dutch-based European partner, PSI Europe, and we’re creating a virtual talent center in the UK.
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