'I understood the texting process well'. Participant perspectives on usability and acceptability of SMS-based telehealth follow-up after voluntary medical male circumcision in South Africa.

Background: Voluntary medical male circumcision (MC) is a biomedical HIV prevention method that requires post-operative follow-up for healing confirmation. Recent research found that a two-way texting (2wT) app providing SMS-based telehealth for MC patients was safe and reduced provider workload. We evaluated 2wT usability among MC clients in South Africa assigned the 2wT intervention within a larger randomized controlled trial (RCT) of 2wT safety and workload. Methods: This quantitative usability study is within an RCT where 547 men used 2wT to interact with an MC provider via SMS. The sub-study involved the first 100 men assigned to 2wT who completed a usability survey 14 days after surgery. Acceptability was assessed through 2wT response rates of the 547 men. Regression models analyzed associations between age, wage, location, potential adverse events (AEs), and 2wT responses. Results: Men assigned to 2wT found it safe, comfortable, and convenient, reporting time and cost savings. High response rates (88%) to daily messages indicated acceptability. Age, wage, and location didn't affect text responses or potential AEs. Conclusion: 2wT for post-MC follow-up was highly usable and acceptable, suggesting its viability as an alternative to in-person visits. It enhanced confidence in wound self-management. This SMS-based telehealth can enhance MC care quality and be adapted to similar contexts for independent healing support, particularly for men.

"It reminds me and motivates me": Human-centered design and implementation of an interactive, SMS-based digital intervention to improve early retention on antiretroviral therapy: Usability and acceptability among new initiates in a high-volume, public clinic in Malawi.

BACKGROUND: Early retention of people living with HIV (PLHIV) in antiretroviral therapy (ART) programs is critical to improve individual clinical outcomes and viral load suppression. Although many mobile health (mHealth) interventions aim to improve retention in care, there is still lack of evidence on mHealth success or failure, including from patient's perspectives. We describe the human-centered design (HCD) process and assess patient usability and acceptability of a two-way texting (2wT) intervention to improve early retention among new ART initiates at Lighthouse Trust clinic in Lilongwe, Malawi. METHODS: An iterative HCD approach focused on patient and provider users' needs, incorporating feedback from multidisciplinary teams to adapt 2wT for the local, public clinic context. We present mixed-methods usability and acceptability results from 100 participants, 50 at 3-months and 50 at 6-months, post 2wT enrollment, and observations of these same patients completing core tasks of the 2wT system. RESULTS: Among the 100 usability respondents, 95% were satisfied with visit reminders, and 88% would recommend reminders and motivational messages to friends; however, 17% were worried about confidentiality. In observation of participant task completion, 94% were able to successfully confirm visit attendance and 73% could request appointment date change. More participants in 4-6 months group completed tasks correctly compared to 1-3 months group, although not significantly different (78% vs. 66%, p = 0.181). Qualitative results were overwhelmingly positive, but patients did note confusion with transfer reporting and concern that 2wT would not reach patients without mobile phones or with lower literacy. CONCLUSION: The 2wT app for early ART retention appears highly usable and acceptable, hopefully creating a solid foundation for lifelong engagement in care. The HCD approach put the local team central in this process, ensuring that both patients' and Lighthouse's priorities, policies, and practices were forefront in 2wT optimization, raising the likelihood of 2wT success in other routine program contexts.

Expanding the Evidence on the Safety and Efficiency of 2-Way Text Messaging-Based Telehealth for Voluntary Medical Male Circumcision Follow-up Compared With In-Person Reviews: Randomized Controlled Trial in Rural and Urban South Africa.

BACKGROUND: There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries. We previously conducted a randomized controlled trial (RCT) in Zimbabwe, demonstrating that 2-way texting (2wT) was safe and effective for follow-up after adult voluntary medical male circumcision (VMMC). OBJECTIVE: To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Africa to determine whether 2wT improves adverse event (AE) ascertainment and, therefore, the quality of follow-up after VMMC while reducing health care workers' workload. METHODS: A prospective, unblinded, noninferiority RCT was conducted among adult participants who underwent VMMC with cell phones randomized in a 1:1 ratio between 2wT and control (routine care) in North West and Gauteng provinces. The 2wT participants responded to a daily SMS text message with in-person follow-up only if desired or an AE was suspected. The control group was requested to make in-person visits on postoperative days 2 and 7 as per national VMMC guidelines. All participants were asked to return on postoperative day 14 for study-specific review. Safety (cumulative AEs ≤day 14 visit) and workload (number of in-person follow-up visits) were compared. Differences in cumulative AEs were calculated between groups. Noninferiority was prespecified with a margin of -0.25%. The Manning score method was used to calculate 95% CIs. RESULTS: The study was conducted between June 7, 2021, and February 21, 2022. In total, 1084 men were enrolled (2wT: n=547, 50.5%, control: n=537, 49.5%), with near-equal proportions of rural and urban participants. Cumulative AEs were identified in 2.3% (95% CI 1.3-4.1) of 2wT participants and 1.0% (95% CI 0.4-2.3) of control participants, demonstrating noninferiority (1-sided 95% CI -0.09 to ∞). Among the 2wT participants, 11 AEs (9 moderate and 2 severe) were identified, compared with 5 AEs (all moderate) among the control participants-a nonsignificant difference in AE rates (P=.13). The 2wT participants attended 0.22 visits, and the control participants attended 1.34 visits-a significant reduction in follow-up visit workload (P<.001). The 2wT approach reduced unnecessary postoperative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among the 2wT participants, 94% (514/547) responded to ≥1 daily SMS text messages over 13 days. CONCLUSIONS: Across rural and urban contexts in South Africa, 2wT was noninferior to routine in-person visits for AE ascertainment, demonstrating 2wT safety. The 2wT approach also significantly reduced the follow-up visit workload, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of the 2wT telehealth approach to other acute follow-up care contexts could extend these gains beyond VMMC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04327271; https://www.clinicaltrials.gov/ct2/show/NCT04327271.

Political economy analysis of subnational health management in Kenya, Malawi and Uganda.

The need to bolster primary health care (PHC) to achieve the Sustainable Development Goal (SDG) targets for health is well recognized. In Eastern and Southern Africa, where governments have progressively decentralized health decision-making, health management is critical to PHC performance. While investments in health management capacity are important, so is improving the environment in which managers operate. Governance arrangements, management systems and power dynamics of actors can have a significant influence on health managers' ability to improve PHC access and quality. We conducted a problem-driven political economy analysis (PEA) in Kenya, Malawi and Uganda to explore local decision-making environments and how they affect management and governance practices for health. This PEA used document review and key informant interviews (N = 112) with government actors, development partners and civil societies in three districts or counties in each country (N = 9). We found that while decentralization should improve PHC by supporting better decisions in line with local priorities from community input, it has been accompanied by thick bureaucracy, path-dependent and underfunded budgets that result in trade-offs and unfulfilled plans, management support systems that are less aligned to local priorities, weak accountability between local government and development partners, uneven community engagement and insufficient public administration capacity to negotiate these challenges. Emergent findings suggest that coronavirus disease 2019 (COVID-19) not only resulted in greater pressures on health teams and budgets but also improved relations with central government related to better communication and flexible funding, offering some lessons. Without addressing the disconnection between the vision for decentralization and the reality of health managers mired in unhelpful processes and politics, delivering on PHC and universal health coverage goals and the SDG agenda will remain out of reach.

Political economy analysis of sub-national health sector planning and budgeting: A case study of three counties in Kenya.

Devolution represented a concerted attempt to bring decision making closer to service delivery in Kenya, including within the health sector. This transformation created county governments with independent executive (responsible for implementing) and legislative (responsible for agenda-setting) arms. These new arrangements have undergone several growing pains that complicate management practices, such as planning and budgeting. Relatively little is known, however, about how these functions have evolved and varied sub-nationally. We conducted a problem-driven political economy analysis to better understand how these planning and budgeting processes are structured, enacted, and subject to change, in three counties. Key informant interviews (n = 32) were conducted with purposively selected participants in Garissa, Kisumu, and Turkana Counties; and national level in 2021, with participants drawn from a wide range of stakeholders involved in health sector planning and budgeting. We found that while devolution has greatly expanded participation in sub-national health management, it has also complicated and politicized decision-making. In this way, county governments now have the authority to allocate resources based on the preferences of their constituents, but at the expense of efficiency. Moreover, budgets are often not aligned with priority-setting processes and are frequently undermined by disbursements delays from national treasury, inconsistent supply chains, and administrative capacity constraints. In conclusion, while devolution has greatly transformed sub-national health management in Kenya with longer-term potential for greater accountability and health equity, short-to-medium term challenges persist in developing efficient systems for engaging a diverse array of stakeholders in planning and budgeting processes. Redressing management capacity challenges between and within counties is essential to ensure that the Kenya health system is responsive to local communities and aligned with the progressive aspirations of its universal health coverage movement.

Centering Frontline Health Care Workers in Digital Innovation Design to Inform the Optimization of an App for Improved Male Circumcision Follow-up in South Africa: Qualitative Usability Study.

BACKGROUND: Voluntary medical male circumcision (VMMC) is a safe and effective HIV prevention strategy. However, adherence to recommended in-person, postoperative follow-up is inefficient for procedures with few adverse events. Two-way texting (2wT)-based follow-up appears to be a safe and an efficient alternative to scheduled clinic visits for low-risk patients who underwent VMMC. To ensure that 2wT responds to the needs of health care workers (HCWs) and patients, HCWs were closely involved in app design using a human-centered design (HCD) approach. OBJECTIVE: Embedded within an ongoing randomized controlled trial of 2wT in South Africa and complementary HCD processes of 2wT app optimization, this qualitative study aimed to use key informant interviews (KIIs) to explore the thoughts, suggestions, and opinions on and perceptions of 2wT's usability and acceptability among HCWs involved in 2wT implementation in both urban and rural South Africa. METHODS: A total of 7 HCWs using 2wT in Gauteng and the North West province participated in KIIs regarding the usability and acceptability of 2wT. HCWs were asked for their opinions on 2wT as a viable, useful, appropriate, and accessible method of postoperative VMMC care. They were also asked about 2wT-related working, exploring areas where 2wT could add to or reduce their daily tasks. The KII data were explored, coded, and analyzed by 3 qualitative researchers using thematic content analysis and the ATLAS.ti (ATLAS.ti Scientific Software Development GmbH) software. RESULTS: Most HCWs felt confident, comfortable, satisfied, and well supported using a 2wT-based follow-up as an alternative to in-person clinical reviews. They felt that 2wT was easy to use and required little technical support after initial mentoring on how to use the 2wT system. Few noted safety concerns, as men can receive clinical guidance, reassurance, and referral via 2wT. Although fewer in-person visits reduced the in-person review workload and eased clinical flow, HCWs noted the added burden of having to interact with clients via SMS text messages on evenings or weekends. HCWs reinforced the need for enhanced postoperative counseling to ensure that 2wT patients could recognize and understood how to respond to early signs of complications. HCWs suggested a rotation to spread the evening and weekend workload and ensure swift patient responses. CONCLUSIONS: In this formative qualitative study focused on HCWs, 2wT was a highly usable alternative to in-person postoperative reviews for patients who underwent VMMC in South Africa. The HCD processes likely improved the usability and acceptability of 2wT for HCWs. HCWs supported the scale-up of 2wT given the distance from the clinic to the men's homes and the potential for reducing workload. To ensure success, providers urged sensitizing patients to the fact that 2wT augments, but does not replace, the existing after-hours and emergency care services.

The expanding movement of primary care physicians operating at the first line of healthcare delivery systems in sub-Saharan Africa: A scoping review.

INTRODUCTION: In sub-Saharan Africa (SSA), the physicians' ratio is increasing. There are clear indications that many of them have opted to work at the first-line of healthcare delivery systems, i.e. providing primary care. This constitutes an important change in African healthcare systems where the first line has been under the responsibility of nurse-practitioners for decades. Previous reviews on primary care physicians (PCPs) in SSA focused on the specific case of family physicians in English-speaking countries. This scoping review provides a broader mapping of the PCPs' practices in SSA, beyond family physicians and including francophone Africa. For this study, we defined PCPs as medical doctors who work at the first-line of healthcare delivery and provide generalist healthcare. METHODS: We searched five databases and identified additional sources through purposively selected websites, expert recommendations, and citation tracking. Two reviewers independently selected studies and extracted and coded the data. The findings were presented to a range of stakeholders. FINDINGS: We included 81 papers, mostly related to the Republic of South Africa. Three categories of PCPs are proposed: family physicians, "médecins généralistes communautaires", and general practitioners. We analysed the functioning of each along four dimensions that emerged from the data analysis: professional identity, governance, roles and activities, and output/outcome. Our analysis highlighted several challenges about the PCPs' governance that could threaten their effective contribution to primary care. More research is needed to investigate better the precise nature and performance of the PCPs' activities. Evidence is particularly needed for PCPs classified in the category of GPs and, more generally, PCPs in African countries other than the Republic of South Africa. CONCLUSIONS: This review sheds more light on the institutional, organisational and operational realities of PCPs in SSA. It also highlighted persisting gaps that remain in our understanding of the functioning and the potential of African PCPs.

Examining the Implementation of the Free Maternity Services Policy in Kenya: A Mixed Methods Process Evaluation.

BACKGROUND: Kenya introduced a free maternity policy in 2013 to address the cost barrier associated with accessing maternal health services. We carried out a mixed methods process evaluation of the policy to examine the extent to which the policy had been implemented according to design, and positive experiences and challenges encountered during implementation. METHODS: We conducted a mixed methods study in 3 purposely selected counties in Kenya. Data were collected through in-depth interviews (IDIs) with policy-makers at the national level, health managers at the county level, and frontline staff at the health facility level (n=60), focus group discussions (FGDs) with community representatives (n=10), facility records, and document reviews. We analysed the data using a framework approach. RESULTS: Rapid implementation led to inadequate stakeholder engagement and confusion about the policy. While the policy was meant to cover antenatal visits, deliveries, and post-natal visits, in practice the policy only covered deliveries. While the policy led to a rapid increase in facility deliveries, this was not matched by an increase in health facility capacity and hence compromised quality of care. The policy led to an improvement in the level of revenues for facilities. However, in all three counties, reimbursements were not made on time. The policy did not have a system of verifying health facility reports on utilization of services. CONCLUSION: The Kenyan Ministry of Health (MoH) should develop a formal policy on the free maternity services, and provide clear guidelines on its content and implementation arrangements, engage with and effectively communicate the policy to stakeholders, ensure timeliness of payment disbursement to healthcare facilities, and introduce a mechanism for verifying utilization reports prepared by healthcare providers. User fee removal policies such as free maternity programmes should be accompanied by supply side capacity strengthening.

Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya.

There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential 'solutions' to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications.

Tracking implementation and (un)intended consequences: a process evaluation of an innovative peripheral health facility financing mechanism in Kenya.

In many African countries, user fees have failed to achieve intended access and quality of care improvements. Subsequent user fee reduction or elimination policies have often been poorly planned, without alternative sources of income for facilities. We describe early implementation of an innovative national health financing intervention in Kenya; the health sector services fund (HSSF). In HSSF, central funds are credited directly into a facility's bank account quarterly, and facility funds are managed by health facility management committees (HFMCs) including community representatives. HSSF is therefore a finance mechanism with potential to increase access to funds for peripheral facilities, support user fee reduction and improve equity in access. We conducted a process evaluation of HSSF implementation based on a theory of change underpinning the intervention. Methods included interviews at national, district and facility levels, facility record reviews, a structured exit survey and a document review. We found impressive achievements: HSSF funds were reaching facilities; funds were being overseen and used in a way that strengthened transparency and community involvement; and health workers' motivation and patient satisfaction improved. Challenges or unintended outcomes included: complex and centralized accounting requirements undermining efficiency; interactions between HSSF and user fees leading to difficulties in accessing crucial user fee funds; and some relationship problems between key players. Although user fees charged had not increased, national reduction policies were still not being adhered to. Finance mechanisms can have a strong positive impact on peripheral facilities, and HFMCs can play a valuable role in managing facilities. Although fiduciary oversight is essential, mechanisms should allow for local decision-making and ensure that unmanageable paperwork is avoided. There are also limits to what can be achieved with relatively small funds in contexts of enormous need. Process evaluations tracking (un)intended consequences of interventions can contribute to regional financing and decentralization debates.

Implementation of patient charges at primary care facilities in Kenya: implications of low adherence to user fee policy for users and facility revenue.

With user fees now seen as a major hindrance to universal health coverage, many countries have introduced fee reduction or elimination policies, but there is growing evidence that adherence to reduced fees is often highly imperfect. In 2004, Kenya adopted a reduced and uniform user fee policy providing fee exemptions to many groups. We present data on user fee implementation, revenue and expenditure from a nationally representative survey of Kenyan primary health facilities. Data were collected from 248 randomly selected public health centres and dispensaries in 2010, comprising an interview with the health worker in charge, exit interviews with curative outpatients, and a financial record review. Adherence to user fee policy was assessed for eight tracer conditions based on health worker reports, and patients were asked about actual amounts paid. No facilities adhered fully to the user fee policy across all eight tracers, with adherence ranging from 62.2% for an adult with tuberculosis to 4.2% for an adult with malaria. Three quarters of exit interviewees had paid some fees, with a median payment of US dollars (USD) 0.39, and a quarter of interviewees were required to purchase additional medical supplies at a later stage from a private drug retailer. No consistent pattern of association was identified between facility characteristics and policy adherence. User fee revenues accounted for almost all facility cash income, with average revenue of USD 683 per facility per year. Fee revenue was mainly used to cover support staff, non-drug supplies and travel allowances. Adherence to user fee policy was very low, leading to concerns about the impact on access and the financial burden on households. However, the potential to ensure adherence was constrained by the facilities' need for revenue to cover basic operating costs, highlighting the need for alternative funding strategies for peripheral health facilities.

Are Health Facility Management Committees in Kenya ready to implement financial management tasks: findings from a nationally representative survey.

BACKGROUND: Community participation in peripheral public health facilities has in many countries focused on including community representatives in Health Facility Management Committees (HFMCs). In Kenya, HFMC roles are being expanded with the phased implementation of the Health Sector Services Fund (HSSF). Under HSSF, HFMCs manage facility funds which are dispersed directly from central level into facility bank accounts. We assessed how prepared HFMCs were to undertake this new role in advance of HSSF roll out, and considered the implications for Kenya and other similar settings. METHODS: Data were collected through a nationally representative sample of 248 public health centres and dispensaries in 24 districts in 2010. Data collection included surveys with in-charges (n = 248), HFMC members (n = 464) and facility users (n = 698), and record reviews. These data were supplemented by semi-structured interviews with district health managers in each district. RESULTS: Some findings supported preparedness of HFMCs to take on their new roles. Most facilities had bank accounts and HFMCs which met regularly. HFMC members and in-charges generally reported positive relationships, and HFMC members expressed high levels of motivation and job satisfaction. Challenges included users' low awareness of HFMCs, lack of training and clarity in roles among HFMCs, and some indications of strained relations with in-charges. Such challenges are likely to be common to many similar settings, and are therefore important considerations for any health facility based initiatives involving HFMCs. CONCLUSION: Most HFMCs have the basic requirements to operate. However to manage their own budgets effectively and meet their allocated roles in HSSF implementation, greater emphasis is needed on financial management training, targeted supportive supervision, and greater community awareness and participation. Once new budget management roles are fully established, qualitative and quantitative research on how HFMCs are adapting to their expanded roles, especially in financial management, would be valuable in informing similar financing mechanisms in Kenya and beyond.

Understanding the impact of subsidizing artemisinin-based combination therapies (ACTs) in the retail sector--results from focus group discussions in rural Kenya.

BACKGROUND: There is considerable interest in the potential of private sector subsidies to increase availability and affordability of artemisinin-based combination therapies (ACTs) for malaria treatment. A cluster randomized trial of such subsidies was conducted in 3 districts in Kenya, comprising provision of subsidized packs of paediatric ACT to retail outlets, training of retail staff, and community awareness activities. The results demonstrated a substantial increase in ACT availability and coverage, though patient counselling and adherence were suboptimal. We conducted a qualitative study in order to understand why these successes and limitations occurred. METHODOLOGY/PRINCIPAL FINDINGS: Eighteen focus group discussions were conducted, 9 with retailers and 9 with caregivers, to document experiences with the intervention. Respondents were positive about intervention components, praising the focused retailer training, affordable pricing, strong promotional activities, dispensing job aids, and consumer friendly packaging, which are likely to have contributed to the positive access and coverage outcomes observed. However, many retailers still did not stock ACT, due to insufficient supplies, lack of capital and staff turnover. Advice to caregivers was poor due to insufficient time, and poor recall of instructions. Adherence by caregivers to dosing guidelines was sub-optimal, because of a wish to save tablets for other episodes, doses being required at night, stopping treatment when the child felt better, and the number and bitter taste of the tablets. Caregivers used a number of strategies to obtain paediatric ACT for older age groups. CONCLUSIONS/SIGNIFICANCE: This study has highlighted that important components of a successful ACT subsidy intervention are regular retailer training, affordable pricing, a reliable supply chain and community mobilization emphasizing patient adherence and when to seek further care.

Analyzing the equity of public primary care provision in Kenya: variation in facility characteristics by local poverty level.

INTRODUCTION: Equitable access to health care is a key health systems goal, and is a particular concern in low-income countries. In Kenya, public facilities are an important resource for the poor, but little is known on the equity of service provision. This paper assesses whether poorer areas have poorer health services by investigating associations between public facility characteristics and the poverty level of the area in which the facility is located. METHODS: Data on facility characteristics were collected from a nationally representative sample of public health centers and dispensaries across all 8 provinces in Kenya. A two-stage cluster randomized sampling process was used to select facilities. Univariate associations between facility characteristics and socioeconomic status (SES) of the area in which the facility was located were assessed using chi-squared tests, equity ratios and concentration indices. Indirectly standardized concentration indices were used to assess the influence of SES on facility inputs and service availability while controlling for facility type, province, and remoteness. RESULTS: For most indicators, we found no indication of variation by SES. The clear exceptions were electricity and laboratory services which showed evidence of pro-rich inequalities, with equity ratios of 3.16 and 3.43, concentration indices of 0.09 (p<0.01) and 0.05 (p=0.01), and indirectly standardized concentration ratios of 0.07 (p<0.01) and 0.05 (p=0.01). There were also some indications of pro-rich inequalities for availability of drugs and qualified staff. The lack of evidence of inequality for other indicators does not imply that availability of inputs and services was invariably high; for example, while availability was close to 90% for water supply and family planning services, under half of facilities offered delivery services or outreach. CONCLUSIONS: The paper shows how local area poverty data can be combined with national health facility surveys, providing a tool for policy makers to assess the equity of input and service availability. There was little evidence of inequalities for most inputs and services, with the clear exceptions of electricity and laboratory services. However, efforts are required to improve the availability of key inputs and services across public facilities in all areas, regardless of SES.