Alex Emilio Fischer

HIV self-testing (HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre- and posttest counseling, reporting results, and linking to care. Digital interventions for HIVST, a type of Software as a Medical Device (SaMD), have been shown to address these challenges, but there is currently no standardized system for regulating or approving these interventions. The World Health Organization Prequalification Program (WHOPQ) is an international regulatory body that approves vaccines, medications, and in vitro diagnostics (IVDs) for low- and middle-income countries that do not have the capacity to do their own approvals. This paper explores whether WHOPQ could be used to prequalify digital interventions for HIVST. Over half the World Health Organization (WHO) member states have national regulatory bodies for medical devices, but low- and middle-income countries, especially in Africa, do not have the capacity to regulate medical devices, let alone SaMD. This gap parallels the gap in vaccine regulation that initially led to the development of WHOPQ, and while sophisticated artificial intelligence (AI)–enabled SaMD are being developed, digital interventions for HIVST could be used as a low-risk test case for prequalification of SaMD. The WHOPQ already has a strong history with HIV; over half the WHOPQ funding is from HIV-related funders and half of all prequalified medicines and IVDs are for treatment and diagnosis of HIV; however, only 2% are manufactured in Africa. If digital interventions for HIVST become prequalified, this could improve interoperability and ensure quality, accelerating their adoption at scale. However, care must be taken to remove barriers for African developers and ensure that prequalification does not delay access to people testing for HIV.

Background: In 2022, 3100 adolescent girls and young women in sub-Saharan Africa experienced new HIV infections each week. HIV pre-exposure prophylaxis (PrEP) is effective at preventing HIV but has limited uptake and persistence. Mobile health (mHealth) interventions can improve medication adherence; however, their utility to improve PrEP adherence among adolescent girls and young women is not well established. Objective: This scoping review synthesizes evidence supporting mHealth for PrEP among adolescent girls and young women in sub-Saharan Africa and identifies strategies for further evaluation. Methods: We searched PubMed and Google Scholar databases, expert referrals, and reference lists using the following eligibility criteria: (1) original research study or protocol; (2) English language; (3) publication between January 1, 2012, and August 31, 2023; (4) inclusion of adolescent girls and young women; (5) conducted in sub-Saharan Africa; and (6) use of mHealth tools to promote PrEP uptake, adherence, or persistence. Titles and abstracts were screened by 2 independent researchers. Full-text manuscripts were reviewed against all eligibility criteria to determine the final included studies. The characteristics and results of the included studies were abstracted and synthesized by mHealth tool type. Results: The search identified 482 unique citations. Title and abstract review removed 380 citations primarily for not including adolescent girls and young women or being conducted outside sub-Saharan Africa. The remaining 102 articles underwent full-text review, yielding 31 eligible publications reporting on 21 unique studies. The most common mHealth tool was SMS text message (n=11), followed by app (n=9), telehealth (n=3), website (n=4), and video (n=1). Few publications evaluated effectiveness, and the results were mixed. One study found that SMS text message reminders improved PrEP adherence, and another concluded that SMS text message reminders did not show a significant impact. Two studies found that differentiated service delivery, which included mHealth components, improved PrEP uptake or persistence; however, the findings could not be attributed solely to the mHealth components. Lastly, 1 website was shown to improve PrEP persistence. Several earlier-stage studies focused on values and preferences toward mHealth without reporting the impact on PrEP. Conclusions: We found few rigorously evaluated mHealth interventions for supporting PrEP among adolescent girls and young women, preventing the ability to draw conclusions on its effectiveness. Studies documented high usability and acceptability but limited assessment of the impact on health outcomes. Secondary uses of mHealth were found for data collection and components of the standard of care. There is substantial room for growth in the innovative use of mHealth to support PrEP among adolescent girls and young women. Consideration of the strengths and limitations of mHealth tools in the local setting, review of past lessons learned, and intentional measurement of mHealth exposure and use could help advance this growing field.

BACKGROUND In 2022, 3100 adolescent girls and young women in sub-Saharan Africa experienced new HIV infections each week. HIV pre-exposure prophylaxis (PrEP) is effective at preventing HIV but has limited uptake and persistence. Mobile health (mHealth) interventions can improve medication adherence; however, their utility to improve PrEP adherence among adolescent girls and young women is not well established. OBJECTIVE This scoping review synthesizes evidence supporting mHealth for PrEP among adolescent girls and young women in sub-Saharan Africa and identifies strategies for further evaluation. METHODS We searched PubMed and Google Scholar databases, expert referrals, and reference lists using the following eligibility criteria: (1) original research study or protocol; (2) English language; (3) publication between January 1, 2012, and August 31, 2023; (4) inclusion of adolescent girls and young women; (5) conducted in sub-Saharan Africa; and (6) use of mHealth tools to promote PrEP uptake, adherence, or persistence. Titles and abstracts were screened by 2 independent researchers. Full-text manuscripts were reviewed against all eligibility criteria to determine the final included studies. The characteristics and results of the included studies were abstracted and synthesized by mHealth tool type. RESULTS The search identified 482 unique citations. Title and abstract review removed 380 citations primarily for not including adolescent girls and young women or being conducted outside sub-Saharan Africa. The remaining 102 articles underwent full-text review, yielding 31 eligible publications reporting on 21 unique studies. The most common mHealth tool was SMS text message (n=11), followed by app (n=9), telehealth (n=3), website (n=4), and video (n=1). Few publications evaluated effectiveness, and the results were mixed. One study found that SMS text message reminders improved PrEP adherence, and another concluded that SMS text message reminders did not show a significant impact. Two studies found that differentiated service delivery, which included mHealth components, improved PrEP uptake or persistence; however, the findings could not be attributed solely to the mHealth components. Lastly, 1 website was shown to improve PrEP persistence. Several earlier-stage studies focused on values and preferences toward mHealth without reporting the impact on PrEP. CONCLUSIONS We found few rigorously evaluated mHealth interventions for supporting PrEP among adolescent girls and young women, preventing the ability to draw conclusions on its effectiveness. Studies documented high usability and acceptability but limited assessment of the impact on health outcomes. Secondary uses of mHealth were found for data collection and components of the standard of care. There is substantial room for growth in the innovative use of mHealth to support PrEP among adolescent girls and young women. Consideration of the strengths and limitations of mHealth tools in the local setting, review of past lessons learned, and intentional measurement of mHealth exposure and use could help advance this growing field.

Background: In South Africa, diabetes is a leading cause of morbidity and mortality, which was exacerbated during the COVID-19 pandemic. Most education and counseling activities were stopped during the lockdown, and the GREAT4Diabetes WhatsApp Chatbot was innovated to fill this gap. Objective: This study aimed to evaluate the implementation of the chatbot in Cape Town, South Africa, between May and October 2021. Methods: Convergent mixed methods were used to evaluate the implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, cost, coverage, effects, and sustainability. Quantitative data were derived from the chatbot and analyzed using the SPSS. Qualitative data were collected from key informants and analyzed using the framework method assisted by Atlas-ti. The chatbot provided users with 16 voice messages and graphics in English, Afrikaans, or Xhosa. Messages focused on COVID-19 infection and self-management of type 2 diabetes. Results: The chatbot was adopted by the Metro Health Services to assist people with diabetes who had restricted health care during the lockdown and were at a higher risk of hospitalization and death from COVID-19 infection. The chatbot was disseminated via health care workers in primary care facilities and local nonprofit organizations and via local media and television. Two technical glitches interrupted the dissemination but did not substantially affect user behavior. Minor changes were made to the chatbot to improve its utility. Many patients had access to smartphones and were able to use the chatbot via WhatsApp. Overall, 8158 people connected with the chatbot and 4577 (56.1%) proceeded to listen to the messages, with 12.56% (575/4577) of them listening to all 16 messages, mostly within 32 days. The incremental setup costs were ZAR 255,000 (US $16,876) and operational costs over 6 months were ZAR 462,473 (US $30,607). More than 90% of the users who listened to each message found them useful. Of the 533 who completed the whole program, 351 (71.1%) said they changed their self-management a lot and 87.6% (369/421) were more confident. Most users changed their lifestyles in terms of diet (315/414, 76.1%) and physical activity (222/414, 53.6%). Health care workers also saw benefits to patients and recommended that the service continues. Sustainability of the chatbot will depend on the future policy of the provincial Department of Health toward mobile health and the willingness to contract with Aviro Health. There is the potential to go to scale and include other languages and chronic conditions. Conclusions: The chatbot shows great potential to complement traditional health care approaches for people with diabetes and assist with more comprehensive patient education. Further research is needed to fully explore the patient’s experience of the chatbot and evaluate its effectiveness in our context.

Background: HIV testing is the first step for linkage to HIV prevention or treatment services. Facility-based HIV testing is the most utilised method, but faces challenges such as limited work space and human resources. Digitally supported HIV self-testing (HIVST) provided in clinics shifts testing to the client, potentially empowering the client, and addresses such constraints.Objectives: The study primary objective was to determine the feasibility of integrating digitally supported HIVST into the clinic. Secondary objectives were to describe HIV testing volume, populations reached, and antiretroviral treatment (ART) initiation.Method: We conducted an analysis of prospectively collected data during implementation of digitally supported HIVST in two healthcare facilities based in South Africa from June 2019 to September 2019. We described implementation and client characteristics using HIVST and compared testing before and during implementation.Results: During the 4-month implementation period there were 35 248 client visits. A total of 6997 (19.9%) of these visits involved HIV testing. Of those testing, 2278 (32.5%) used HIVST. Of the 2267 analysed, 264 (11.6%) were positive: 182 (12%) women and 82 (11%) men. Of those, 230 (95.4%) were confirmed HIV positive and 150 (65%) initiated ART within 14 days. During a four-month pre-implementation period, 14.5% of the clients tested for HIV. Compared to the pre-implementation period, we observed a 25% increase in HIV testing.Conclusion: Digitally supported HIVST increased the number of clients completing HIV testing in the health facility, without a need to significantly increase staff or space. Facility-based digitally assisted HIVST has the potential to increase HIV testing in high HIV prevalence clinic populations.

Objectives Cardiovascular disease (CVD) is a major problem globally. Truck drivers have an increased risk of CVD due to a sedentary lifestyle, irregular working hours and behavioural choices. We aimed to get insight into the contribution of night shift work to CVD risk in long-distance truck drivers in South Africa. Design A cross-sectional study. Setting Enrolment took place at three South African truck stop locations in two provinces; Bloemfontein (Free State), Pomona Road (Gauteng) and Soweto (Gauteng). Participants 607 males aged ≥18 years with full-time employment as a long-distance truck driver were included. The criteria for inclusion were willingness and being able to provide informed consent and to complete the study procedures. Primary and secondary outcome measures Information was collected on sociodemographics, occupational and health characteristics. Physical measurements, an ECG and carotid intima–media thickness (CIMT) measurements were taken. A night shift was defined as working at least 3 hours between 22:00 and 6:00 hours once a week. CVD risk was defined with the Framingham Risk Score (FRS), the Atherosclerotic Cardiovascular Disease (ASCVD) risk algorithm, left ventricular hypertrophy (LVH) and CIMT. Results In total, 607 truck drivers were included of which 305 (50.2%) worked in day shifts only and 302 (49.8%) worked day and night shifts. There was a high prevalence of CVD risk factors in both groups as 33% were hypertensive, 28% obese and 37% had abnormal lipid levels. Working day and night shifts compared with working only day shifts did not result in differences in FRS, ASCVD risk or LVH. No difference was found in CIMT measurements, except for the maximum bulb thickness which was higher in day shift workers. Conclusions CVD risk factors are considerably present in male truck drivers in South Africa. CVD risk does not differ between dayshift and day–night shift workers in this cross-sectional analysis.

BACKGROUND In South Africa, diabetes is a leading cause of morbidity and mortality, which was exacerbated during the COVID-19 pandemic. Most education and counseling activities were stopped during the lockdown, and the GREAT4Diabetes WhatsApp Chatbot was innovated to fill this gap. OBJECTIVE This study aimed to evaluate the implementation of the chatbot in Cape Town, South Africa, between May and October 2021. METHODS Convergent mixed methods were used to evaluate the implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, cost, coverage, effects, and sustainability. Quantitative data were derived from the chatbot and analyzed using the SPSS. Qualitative data were collected from key informants and analyzed using the framework method assisted by Atlas-ti. The chatbot provided users with 16 voice messages and graphics in English, Afrikaans, or Xhosa. Messages focused on COVID-19 infection and self-management of type 2 diabetes. RESULTS The chatbot was adopted by the Metro Health Services to assist people with diabetes who had restricted health care during the lockdown and were at a higher risk of hospitalization and death from COVID-19 infection. The chatbot was disseminated via health care workers in primary care facilities and local nonprofit organizations and via local media and television. Two technical glitches interrupted the dissemination but did not substantially affect user behavior. Minor changes were made to the chatbot to improve its utility. Many patients had access to smartphones and were able to use the chatbot via WhatsApp. Overall, 8158 people connected with the chatbot and 4577 (56.1%) proceeded to listen to the messages, with 12.56% (575/4577) of them listening to all 16 messages, mostly within 32 days. The incremental setup costs were ZAR 255,000 (US $16,876) and operational costs over 6 months were ZAR 462,473 (US $30,607). More than 90% of the users who listened to each message found them useful. Of the 533 who completed the whole program, 351 (71.1%) said they changed their self-management a lot and 87.6% (369/421) were more confident. Most users changed their lifestyles in terms of diet (315/414, 76.1%) and physical activity (222/414, 53.6%). Health care workers also saw benefits to patients and recommended that the service continues. Sustainability of the chatbot will depend on the future policy of the provincial Department of Health toward mobile health and the willingness to contract with Aviro Health. There is the potential to go to scale and include other languages and chronic conditions. CONCLUSIONS The chatbot shows great potential to complement traditional health care approaches for people with diabetes and assist with more comprehensive patient education. Further research is needed to fully explore the patient’s experience of the chatbot and evaluate its effectiveness in our context.

Background: In late March 2020, South Africa implemented a 5-stage COVID-19 Risk Adjusted Strategy, which included a lockdown that required all residents to remain home to prevent the spread of COVID-19. Due to this lockdown, individuals have been forced to find and use alternatives for accomplishing tasks including shopping, socializing, working, and finding information, and many have turned to the internet and their mobile devices. Objective: This study aimed to describe how South Africans consume and internalize information surrounding the COVID-19 outbreak in order to determine whether the COVID-19 lockdown and social isolation have influenced technology behavior, particularly in terms of health communication and information. Methods: From June 24 to August 24, 2020, people in South Africa were invited to complete a survey through the Upinion mobile app, an online data collection resource. The survey collected information on demographics, and technology use during the lockdown, and COVID-19 knowledge. Results: There were 405 participants, of which 296 (73.06%) were female. A total of 320 (79.01%) participants had a tertiary school education, 242 (59.75%) were single, and 173 (42.72%) had full-time employment. The lockdown forced 363 (89.63%) participants to use more technology, especially for work (n=140, 24.05%) and social media/communication (n=133, 22.85%). Security or privacy issues (n=46, 38.98%) and unfamiliarity with technology (n=32, 27.12%) were identified as the most common issues faced by the 127 (31.36%) participants who were unsure about using technology prior to the lockdown. Almost all participants (n=392, 96.79%) stated that they would continue using technology after the lockdown. Multimedia (n=215, 53.09%), mobile phone content (n=99, 24.44%), and health organizations and professionals (n=91, 22.47%) were the main sources of COVID-19 information. Most participants (n=282, 69.63%) felt that they had enough information. Two-thirds (n=275, 67.90%) of participants stated that they had used their mobile phones for health information before the lockdown, with web searches (n=109, 26.91%), social media (n=58, 14.32%), and government and institutional websites (n=52; 12.84%) serving as their main sources of information. Overall, the mean COVID-19 knowledge score was 8.8 (out of 10), and 335 (82.72%) had adequate knowledge (scored ≥8). Males were less likely to identify the correct transmission routes, and single participants were less likely to identify the signs and symptoms of the coronavirus. Tertiary school graduates were 4 times more likely to correctly identify the routes and 2 times more likely to identify how to stop the spread of the virus. People aged 43-56 years were 4 times more likely to identify how the coronavirus can be prevented, and participants ≥57 years were 2.6 times more likely to obtain a knowledge score of 10 when compared to those under 29 years of age. Conclusions: This study has shown that the COVID-19 lockdown has forced people to increase technology use, and people plan to continue using technology after the lockdown is lifted. Increased technology use was seen across a variety of fields; however, barriers including privacy, unfamiliarity, and data costs were identified. This population showed high COVID-19 knowledge, although the use of web searches and social media, instead of government and institutional websites, increases the potential for health misinformation to be spread.

Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval.

Introduction: With over 500 000 infections and nearly 12 000 deaths, South Africa (SA) is the African epicenter of the current Coronavirus (COVID-19) pandemic. SA has implemented a 5-stage Risk-Adjusted Strategy which includes a phased national lockdown, requiring social distancing, frequent hand washing and wearing face masks. Strict adherence to this strategy is crucial to reducing COVID-19 transmission, flattening the curve, and preventing resurgence. As part of the 22-country International Citizens Project COVID-19 (ICPcovid), this study aimed to describe the SA adherence to the Risk-Adjusted Strategy and identify determinants of adherence. Method: During 24 April-15 May 2020, people were electronically invited, through social media platforms and a text blast, to complete an online survey, accessible via www.icpcovid.com. The survey investigated COVID-19 testing and preventative adherence measures, then used logistic regression analysis to identify predictors of adherence. Results: There were 951 participants, with 731(76.9%) 25 to 54 years. Most (672;70.7%) were female, and 705(74.1%) had a university degree. Since the epidemic started, 529(55.6%) and 436(45.9%) participants stated they were eating healthier and taking more vitamins, respectively. Only 82(8.6%) had been COVID-19 tested, and 1(1.2%) tested positive. In public, 905(95.2%) socially distanced, however 99(10.4%) participants had recently attended meetings with over ten people. Regular hand washing was practiced by 907(95.4%) participants, 774(81.4%) wore face masks and 854(89.8%) stayed home when they experienced flu-like symptoms. The odds of adhering to the guidelines were lower among men versus women (AOR 0.72, 95% confidence interval [CI] = 0.528, 0.971) and those who had flu-like symptoms (AOR 0.42, 95% CI = 0.277, 0.628). In contrast, increased odds were reported for those who reported increased vitamin intake (AOR 1.37, 95% CI = 1.044,1.798), and were either cohabiting or married (AOR 1.39, 95% CI = 1.042,1.847). Conclusion: Despite high reported adherence, face mask use and symptomatic individuals not self-isolating, were areas for improvement. However, these factors cannot solely account for SA’s increasing COVID-19 cases. Larger general population studies are needed to identify other adherence predictors for a strengthened SA COVID-19 response. While the government must continue to educate the entire population on preventative measures, provide personal protective equipment and stress the importance of adherence, there also needs to be implementation of prioritised prevention strategies for men and single individuals to address their demonstrated lower adherence.