BackgroundThe use of mobile communication technologies (mHealth: mobile health) in chronic disease management has grown significantly over the years. mHealth interventions have the potential to decentralize access to health care and make it convenient, particularly in resource-constrained settings. It is against this backdrop that we aimed to codevelop (with potential users) a new generation of mobile phone–connected HIV diagnostic tests and Web-based clinical care pathways needed for optimal delivery of decentralized HIV testing, prevention, and care in low- and middle-income countries.ObjectiveThe aim of this study was to understand ways in which an mHealth intervention could be developed to overcome barriers to existing HIV testing and care services and promote HIV self-testing and linkage to prevention and care in a poor, HIV hyperendemic community in rural KwaZulu-Natal, South Africa.MethodsA total of 54 in-depth interviews and 9 focus group discussions were conducted with potential users (including health care providers) in 2 different communities. Theoretically informed by the candidacy framework, themes were identified from the interview transcripts, manually coded, and thematically analyzed.ResultsParticipants reported barriers, such as fear of HIV identity, stigma, long waiting hours, clinic space, and health care workers’ attitudes, as major impediments to effective uptake of HIV testing and care services. People continued to reassess their candidacy for HIV testing and care services on the basis of their experiences and how they or others were treated within the health systems. Despite the few concerns raised about new technology, mobile phone–linked HIV testing was broadly acceptable to potential users (particularly men and young people) and providers because of its privacy (individual control of HIV testing over health provider–initiated testing), convenience (individual time and place of choice for HIV testing versus clinic-based testing), and time saving.ConclusionsMobile phone–connected HIV testing and Web-based clinical care and prevention pathways have the potential to support access to HIV prevention and care, particularly for young people and men. Although mHealth provides a way for individuals to test their candidacy for HIV services, the barriers that can make the service unattractive at the clinic level will also need to be addressed if potential demand is to turn into actual demand.

Although deep learning algorithms show increasing promise for disease diagnosis, their use with rapid diagnostic tests performed in the field has not been extensively tested. Here we use deep learning to classify images of rapid human immunodeficiency virus (HIV) tests acquired in rural South Africa. Using newly developed image capture protocols with the Samsung SM-P585 tablet, 60 fieldworkers routinely collected images of HIV lateral flow tests. From a library of 11,374 images, deep learning algorithms were trained to classify tests as positive or negative. A pilot field study of the algorithms deployed as a mobile application demonstrated high levels of sensitivity (97.8%) and specificity (100%) compared with traditional visual interpretation by humansexperienced nurses and newly trained community health worker staff-and reduced the number of false positives and false negatives. Our findings lay the foundations for a new paradigm of deep learning-enabled diagnostics in low-and middle-income countries, termed REASSURED diagnostics 1 , an acronym for real-time connectivity, ease of specimen collection, affordable, sensitive, specific, user-friendly, rapid, equipment-free and deliverable. Such diagnostics have the potential to provide a platform for workforce training, quality assurance, decision support and mobile connectivity to inform disease control strategies, strengthen healthcare system efficiency and improve patient outcomes and outbreak management in emerging infections.Rapid diagnostic tests (RDTs) save lives by informing case management, treatment, screening, disease control and elimination programs 1 . Lateral flow tests are among the most common RDTs, and hundreds of millions of these tests are performed worldwide each year. They have the potential to support near-person testing and decentralized management of a range of clinically important diseases (including malaria, HIV, syphilis, tuberculosis, influenza and noncommunicable diseases 2 ), making it convenient for the end user and more affordable for health systems 3 . However, RDTs also present some issues, namely: errors in performing the test and interpreting the result 4,5 , quality control and lack of electronic data capture records of the test and results within health systems and surveillance. Many of these would be overcome with the real-time connectivity associated with REASSURED-the new criterion for an ideal test to reflect the importance of digital connectivity, coined by Peeling and coworkers 1 . Real-time connectivity involves the use of mobile-phone-connected RDTs. To date there have been few peer-reviewed studies or evaluations of the effectiveness of connected lateral flow tests at scale in populations in low-and middle-income countries.

Background Despite effective biomedical tools, HIV remains the largest cause of morbidity/mortality in South Africa – especially among adolescents and young people. We used community-based participatory research (CBPR), informed by principles of social justice, to develop a peer-led biosocial intervention for HIV prevention in KwaZulu-Natal (KZN). Methods Between March 2018 and September 2019 we used CBPR to iteratively co-create and contextually adapt a biosocial peer-led intervention to support HIV prevention. Men and women aged 18–30 years were selected by community leaders of 21 intervention implementation areas (izigodi) and underwent 20 weeks of training as peer-navigators. We synthesised quantitative and qualitative data collected during a 2016–2018 study into 17 vignettes illustrating the local drivers of HIV. During three participatory intervention development workshops and community mapping sessions, the peer-navigators critically engaged with vignettes, brainstormed solutions and mapped the components to their own izigodi. The intervention components were plotted to a Theory of Change which, following a six-month pilot and process evaluation, the peer-navigators refined. The intervention will be evaluated in a randomised controlled trial (NCT04532307). Results Following written and oral assessments, 57 of the 108 initially selected participated in two workshops to discuss the vignettes and co-create the Thetha Nami (`talk to me’). The intervention included peer-led health promotion to improve self-efficacy and demand for HIV prevention, referrals to social and educational resources, and aaccessible youth-friendly clinical services to improve uptake of HIV prevention. During the pilot the peer-navigators approached 6871 young people, of whom 6141 (89%) accepted health promotion and 438 were linked to care. During semi-structured interviews peer-navigators described the appeal of providing sexual health information to peers of a similar age and background but wanted to provide more than just “onward referral”. In the third participatory workshop 54 peer-navigators refined the Thetha Nami intervention to add three components: structured assessment tool to tailor health promotion and referrals, safe spaces and community advocacy to create an enabling environment, and peer-mentorship and navigation of resources to improve retention in HIV prevention. Conclusion Local youth were able to use evidence to develop a contextually adapted peer-led intervention to deliver biosocial HIV prevention.

BackgroundGaps in maternal and child health services can slow progress towards achieving the Sustainable Development Goals. The Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care (MONARCH) study will evaluate a Continuous Quality Improvement (CQI) intervention targeted at improving antenatal and postnatal health service outcomes in rural South Africa where HIV prevalence among pregnant women is extremely high. Specifically, it will establish the effectiveness of CQI on viral load (VL) testing in pregnant women who are HIV-positive and repeat HIV testing in pregnant women who are HIV-negative.MethodsThis is a stepped-wedge cluster-randomised controlled trial (RCT) of 7 nurse-led primary healthcare clinics to establish the effect of CQI on selected routine antenatal and postnatal services. Each clinic was a cluster, with the exception of the two smallest clinics, which jointly formed one cluster. The intervention was applied at the cluster level, where staff received training on CQI methodology and additional mentoring as required. In the control exposure state, the clusters received the South African Department of Health standard of care. After a baseline data collection period of 2 months, the first cluster crossed over from control to intervention exposure state; subsequently, one additional cluster crossed over every 2 months. The six clusters were divided into 3 groups by patient volume (low, medium and high). We randomised the six clusters to the sequences of crossing over, such that both the first three and the last three sequences included one cluster with low, one with medium, and one with high patient volume.The primary outcome measures were (i) viral load testing among pregnant women who were HIV-positive, and (ii) repeat HIV testing among pregnant women who were HIV-negative. Consenting women ≥18 years attending antenatal and postnatal care during the data collection period completed outcome measures at delivery, and postpartum at three to 6 days, and 6 weeks. Data collection started on 15 July 2015. The total study duration, including pre- and post-exposure phases, was 19 months. Data will be analyzed by intention-to-treat based on first booked clinic of study participants.DiscussionThe results of the MONARCH trial will establish the effectiveness of CQI in improving antenatal and postnatal clinic processes in primary care in sub-Saharan Africa. More generally, the results will contribute to our knowledge on quality improvement interventions in resource-poor settings.Trial registrationThis trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351.Electronic supplementary materialThe online version of this article (10.1186/s12913-018-3404-3) contains supplementary material, which is available to authorized users.

Background Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa. Methods and findings We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinicscombined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools

IntroductionA cluster randomised controlled trial (cRCT) to determine whether HIV self-testing (HIVST) delivered by peers either directly or through incentivised peer-networks, could increase the uptake of antiretroviral therapy and pre-exposure prophylaxis (PrEP) among young women (18 to 24 years) is being undertaken in an HIV hyperendemic area in KwaZulu-Natal, South Africa.Methods and analysisA three-arm cRCT started mid-March 2019, in 24 areas in rural KwaZulu-Natal. Twenty-four pairs of peer navigators working with ~12 000 young people aged 18 to 30 years over a period of 6 months were randomised to: (1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs and HIV prevention information to peers within their social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health information and provide barcoded clinic referral slips to facilitate linkage to HIV testing, prevention and care services. The primary outcome is the difference in linkage rate between arms, defined as the number of women (18 to 24 years) per peer-navigators month of outreach work (/pnm) who linked to clinic-based PrEP eligibility screening or started antiretroviral, based on HIV-status, within 90 days of receiving the clinic referral slip.Ethics and disseminationThis study was approved by the Institutional Review Boards at the WHO, Switzerland (Protocol ID: STAR CRT, South Africa), London School of Hygiene and Tropical Medicine, UK (Reference: 15 990–1), University of KwaZulu-Natal (BFC311/18) and the KwaZulu-Natal Department of Health (Reference: KZ_201901_012), South Africa. The findings of this trial will be disseminated at local, regional and international meetings and through peer-reviewed publications.Trial registration numberNCT03751826; Pre-results.

Background: Despite effective biomedical tools, HIV remains the largest cause of morbidity/mortality in South Africa – especially among adolescents and young people. We used community-based participatory research (CBPR) informed by principles of social justice, to develop a peer-led biosocial intervention for HIV prevention in rural KwaZulu-Natal (KZN). Methods: Between March 2018 and September 2019 we used CBPR to iteratively co-create and contextually adapt a biosocial peer-led intervention to support HIV prevention. Men and women aged 18-30 years were selected by community leaders of 21 intervention implementation areas (izigodi) and underwent 20 weeks of training as peer-navigators. We synthesised quantitative and qualitative data collected during a 2016-2018 study into 17 vignettes illustrating the local drivers of HIV. During three participatory intervention development workshops and community mapping sessions, the peer-navigators critically engaged with vignettes, brainstormed solutions and mapped the components to their own izigodi. The intervention components were plotted to a Theory of Change which, following a six-month pilot and process evaluation, the peer-navigators refined. The intervention will be evaluated in a randomised controlled trial (NCT04532307).Results: Following written and oral assessments, 57 of the 108 initially selected participated in two workshops to discuss the vignettes and co-create the Thetha Nami (`talk to me’). The intervention. included peer-led health promotion to improve self-efficacy and demand for HIV prevention, referrals to social and educational resources, and aaccessible youth-friendly clinical services to improve uptake of HIV prevention. During the pilot the peer-navigators approached 6871 young people, of whom 6141 (89%) accepted health promotion and 438 linked to care. During semi-structured interviews peer-navigators described the appeal of providing sexual health information to peers of a similar age and background but wanted to provide more than just “onward referral”. In the third participatory workshop 54 peer-navigators refined the Thetha Nami intervention to add three components structured assessment tool to tailor health promotion and referrals; safe spaces and community advocacy to create an enabling environment; peer-mentorship and navigation of resources to improve retention in HIV prevention. Conclusion: Local youth were able to use evidence to develop a contextually adapted peer-led intervention to deliver biosocial HIV prevention.

Objective:We investigate how risk of sexually acquiring or transmitting HIV in adolescent girls and young women (AGYW) changed following the real-world implementation of DREAMS (Determined, Resilient, Empowered, AIDS free, Mentored and Safe) HIV prevention programme.Design:A representative population-based prospective cohort study of AGYW living in rural KwaZulu-Natal.Methods:Between 2017 and 2019, we interviewed a random sample of AGYW aged 13–22 years annually. We measured exposure to DREAMS as self-reported receipt of an invitation to participate and/or participation in DREAMS activities that were provided by DREAMS implementing organizations. HIV and herpes simplex virus type 2 (HSV-2) statuses were ascertained through blood tests on Dried Blood Spot (DBS). We used multivariable regression analysis to assess the association between exposure to DREAMS and risk of acquiring HIV: measured as incident HSV-2 (a proxy of sexual risk) and incident HIV;and the risk of sexually transmitting HIV: measured as being HIV positive with a detectable HIV viral load (≥50 copie/ml) on the last available DBS. We adjusted for sociodemographic, sexual relationship, and migration.Results:Two thousand one hundred and eighty-four (86.4%) of those eligible agreed to participate and 2016 (92.3%) provided data for at least one follow-up time-point. One thousand and thirty (54%) were exposed to DREAMS;HIV and HSV-2 incidence were 2.2/100 person-years [95% confidence interval (CI) 1.66–2.86] and 17.3/100 person-years (95% CI 15.5–19.4), respectively. There was no evidence that HSV-2 and HIV incidence were lower in those exposed to DREAMS: adjusted rate ratio (aRR) 0.96 (95% CI 0.76–1.23 and 0.83 (95% CI 0.46–1.52), respectively. HIV viral load was detectable for 169 (8.9%) respondents;there was no evidence this was lower in those exposed to DREAMS with an adjusted risk difference, compared with those not exposed to DREAMS, of 0.99% (95% CI–1.52 to 3.82]. Participants who lived in peri-urban/ urban setting were more likely to have incident HIV and transmissible HIV. Both HSV-2 incidence and the transmissible HIV were associated with older age and ever having sex. Findings did not differ substantively by respondent age group.Conclusion:DREAMS exposure was not associated with measurable reductions in risk of sexually acquiring or transmitting HIV amongst a representative cohort of AGYW in rural South Africa