Power, data and social accountability: defining a community-led monitoring model for strengthened health service delivery.

INTRODUCTION: Despite international commitment to achieving the end of HIV as a public health threat, progress is off-track and existing gaps have been exacerbated by COVID-19's collision with existing pandemics. Born out of models of political accountability and historical healthcare advocacy led by people living with HIV, community-led monitoring (CLM) of health service delivery holds potential as a social accountability model to increase the accessibility and quality of health systems. However, the effectiveness of the CLM model in strengthening accountability and improving service delivery relies on its alignment with evidence-based principles for social accountability mechanisms. We propose a set of unifying principles for CLM to support the impact on the quality and availability of health services. DISCUSSION: Building on the social accountability literature, core CLM implementation principles are defined. CLM programmes include a community-led and independent data collection effort, in which the data tools and methodology are designed by service users and communities most vulnerable to, and most impacted by, service quality. Data are collected routinely, with an emphasis on prioritizing and protecting respondents, and are then be used to conduct routine and community-led advocacy, with the aim of increasing duty-bearer accountability to service users. CLM efforts should represent a broad and collective community response, led independently by impacted communities, incorporating both data collection and advocacy, and should be understood as a long-term approach to building meaningful engagement in systems-wide improvements rather than discrete interventions. CONCLUSIONS: The CLM model is an important social accountability mechanism for improving the responsiveness of critical health services and systems to communities. By establishing a collective understanding of CLM principles, this model paves the way for improved proliferation of CLM with fidelity of implementation approaches to core principles, rigorous examinations of CLM implementation approaches, impact assessments and evaluations of CLM's influence on service quality improvement.

The long wait for long-acting HIV prevention and treatment formulations.

Large randomised studies of new long-acting medications for the prevention and treatment of HIV have shown high effectiveness and acceptability. Although modelling studies indicate these agents could be fundamental in HIV elimination, coordination of their entry into health-care markets is crucial, especially in low-income and middle-income countries with high HIV prevalence, where coordination is low despite UNAIDS flagging that global HIV targets will not be met. Research and implementation projects are tightly controlled by originator pharmaceutical companies, with only a small percentage of eligible people living with or affected by HIV benefiting from these projects. WHO, financial donors, manufacturers, and governments need to consider urgent coordinated action from stakeholders worldwide, akin to the successful introduction of dolutegravir into treatment programmes across low-income and middle-income countries. Without this immediate coordination, large-scale access to long-acting agents for HIV will be delayed, potentially extending into the 2030s. This delay is unacceptable considering the established global HIV targets.

Facilitators and barriers to community-led monitoring of health programs: Qualitative evidence from the global implementation landscape.

Achieving the global HIV, tuberculosis, and malaria targets will require innovative strategies to deliver high quality and person-centered health services. Community-led monitoring (CLM) is a rapidly proliferating health systems strengthening intervention for improving healthcare services and documenting human rights violations, through social empowerment and political accountability. Driven in part by increasing financial support from donors, a growing number of countries are implementing CLM programs. This study aimed to identify early challenges and lessons learned from CLM implementation, with the aim of informing and improving the implementation of CLM programs and ultimately achieving greater impact on the delivery of services. Twenty-five CLM implementors representing 21 countries participated in an interview. Early generation of buy-in from diverse stakeholders was noted as critical for CLM success. Leveraging existing networks of service users and community organizations to implement CLM also helped to maximize program reach and resources. Uncertainty around CLM's purpose and roles among CLM stakeholders resulted in challenges to community leadership and ownership of programs. Respondents also described challenges with underfunded programs, especially advocacy components, and inflexible donor funding mechanisms. Critical capacity gaps remain around advocacy and electronic data collection and use. With the rapid expansion of CLM, this study serves as an important first step in characterizing challenges and successes in the CLM landscape. Successful implementation of CLM requires prioritizing community ownership and leadership, donor commitment to sustainable and reliable funding, and strengthened support of programs across the data collection and advocacy lifecycle.

Current allocations and target apportionment for HIV testing and treatment services for marginalized populations: characterizing PEPFAR investment and strategy.

INTRODUCTION: The United States President's Emergency Plan for AIDS Relief (PEPFAR) is a large bilateral funder of the global HIV response whose policy decisions on key populations (KPs) programming determine the shape of the key populations' response in many countries. Understanding the size and relative share of PEPFAR funds going to KPs and the connection between PEPFAR's targets and resulting programming is crucial for successfully serving key populations. METHODS: Publicly available PEPFAR budgets for key populations' services were assessed by country and geographical region for all 52 countries with budget data in fiscal year (FY) 2020. For the 23 countries which completed a full planning process in FY 2018 and 2019, PEPFAR targets for HIV testing and treatment initiation for key populations were assessed. Expenditures for KP programming were calculated to determine whether shifts in targets translated into programming. Implementing partners were characterized by the level of specialization using the share of assigned targets made up by KPs. The average target per year and implementing partner was calculated for each KP group and indicator. RESULTS: PEPFAR country KP budgets ranged from US$35,000 to $15.2 million, and the proportion of funding to key populations varied by region, with Eastern and Southern African countries having the lowest proportion. Between FY 2018 and 2019, the KP targets for HIV testing and treatment among KPs increased, whereas expenditures on key populations decreased from US$115.4 to $111.0 million. Of the 11 countries with an increase in HIV testing targets, seven had a decrease in KP expenditures. Of the nine countries with an increase in treatment initiation targets, five had a decrease in KP expenditures. The proportion of targets assigned to partners which do not specialize in key populations increased from FY 2018 to 2019. CONCLUSIONS: Current key population policies have not resulted in a tight connection between targets and expenditures. This includes assigning a large proportion of key populations programming to partners who do not specialize in key populations, which may weaken the performance management role of the targets. These results signal that a new approach to key populations programming is needed.

The role of contraception in preventing HIV-positive births: global estimates and projections.

BACKGROUND: Meeting the contraceptive needs of women living with HIV (WLHIV) has primary health benefits for women, in addition to being a key element to prevent mother-to-child HIV transmission. This analysis will estimate the current number of infant HIV infections prevented by contraception in the era of increased HIV treatment coverage and; 2) model the additional HIV benefits of preventing unintended births to WLHIV. METHODS: Secondary data analysis was conducted using publicly available data from the United Nations Programme on HIV/AIDS (UNAIDS) and Population Division, Demographic Health Surveys, and peer-review literature. National data from 70 countries, that had a UNAIDS estimate for the number of WLHIV nationally, were combined into country-level models. Models estimated the current number of infant HIV infections averted by contraception annually and potentially averted if unintended births to WLHIV were prevented. Estimates take into account pregnancy and live birth rates, contraceptive coverage, contraceptive method mix and failure rates, and HIV treatment coverage during pregnancy to prevent mother to child transmission. RESULTS: Contraception use among WLHIV prevents an estimated 43,559 new infant HIV infections annually across 70 countries. Countries with the largest number of infant infections averted by contraception included South Africa (9441), Nigeria (4195), Kenya (3508), Zimbabwe (2586), and India (2145). Preventing unintended births to WLHIV could avert an additional 43,768 new infant infections per year, with the greatest potential gains to be made in South Africa (12,036), Nigeria (2770), Uganda (2552), and the Democratic Republic of the Congo (2324). CONCLUSIONS: Contraception continues to play an integral role in global HIV prevention efforts in the era of increasing HIV treatment coverage, especially in sub-Saharan Africa. Broad contraceptive availability, increased contraceptive voluntarism and method mix are key components to preventing unintended births and ending new infant HIV infections worldwide.

Restrictions On US Global Health Assistance Reduce Key Health Services In Supported Countries.

The 2017 expanded Mexico City Policy prohibits non-US-based nongovernmental organizations from receiving US global health assistance if they either perform or refer for abortion services. We study the effects of the expanded policy on implementing partners of US-funded HIV programming by the President's Emergency Plan for AIDS Relief (PEPFAR) via a primary survey in all recipient countries and key-informant interviews in South Africa and the Kingdom of Eswatini (May-November 2018). Survey results showed that 28 percent (56 of 198) of organizations reported stopping or reducing at least one service in response to the policy. Reported service reductions included reducing the delivery of information about sexual and reproductive health, pregnancy counseling, contraception provision, and HIV testing and counseling. Interview data highlighted how these reductions were often a result of decreased patient flows or implementation of the expanded policy beyond what is required. Reductions disproportionately harmed pregnant women, youth, and key populations such as sex workers and men who have sex with men. Reduced delivery of sexual and reproductive health services has the potential to negatively affect many intended beneficiaries of PEPFAR funding, especially in areas with high HIV prevalence. Policy makers must respond to disruptions in service delivery and end any implementation that undermines US investment in high-quality HIV and sexual and reproductive health services.

White Counties Stand Apart: The Primacy of Residential Segregation in COVID-19 and HIV Diagnoses.

Emerging epidemiological data suggest that white Americans have a lower risk of acquiring COVID-19. Although many studies have pointed to the role of systemic racism in COVID-19 racial/ethnic disparities, few studies have examined the contribution of racial segregation. Residential segregation is associated with differing health outcomes by race/ethnicity for various diseases, including HIV. This commentary documents differing HIV and COVID-19 outcomes and service delivery by race/ethnicity and the crucial role of racial segregation. Using publicly available Census data, we divide US counties into quintiles by percentage of non-Hispanic white residents and examine HIV diagnoses and COVID-19 per 100,000 population. HIV diagnoses decrease as the proportion of white residents increase across US counties. COVID-19 diagnoses follow a similar pattern: Counties with the highest proportion of white residents have the fewest cases of COVID-19 irrespective of geographic region or state political party inclination (i.e., red or blue states). Moreover, comparatively fewer COVID-19 diagnoses have occurred in primarily white counties throughout the duration of the US COVID-19 pandemic. Systemic drivers place racial minorities at greater risk for COVID-19 and HIV. Individual-level characteristics (e.g., underlying health conditions for COVID-19 or risk behavior for HIV) do not fully explain excess disease burden in racial minority communities. Corresponding interventions must use structural- and policy-level solutions to address racial and ethnic health disparities.

Risk for COVID-19 infection and death among Latinos in the United States: examining heterogeneity in transmission dynamics.

PURPOSE: The purpose of this study was to ascertain COVID-19 transmission dynamics among Latino communities nationally. METHODS: We compared predictors of COVID-19 cases and deaths between disproportionally Latino counties (≥17.8% Latino population) and all other counties through May 11, 2020. Adjusted rate ratios (aRRs) were estimated using COVID-19 cases and deaths via zero-inflated binomial regression models. RESULTS: COVID-19 diagnoses rates were greater in Latino counties nationally (90.9 vs. 82.0 per 100,000). In multivariable analysis, COVID-19 cases were greater in Northeastern and Midwestern Latino counties (aRR: 1.42, 95% CI: 1.11-1.84, and aRR: 1.70, 95% CI: 1.57-1.85, respectively). COVID-19 deaths were greater in Midwestern Latino counties (aRR: 1.17, 95% CI: 1.04-1.34). COVID-19 diagnoses were associated with counties with greater monolingual Spanish speakers, employment rates, heart disease deaths, less social distancing, and days since the first reported case. COVID-19 deaths were associated with household occupancy density, air pollution, employment, days since the first reported case, and age (fewer <35 yo). CONCLUSIONS: COVID-19 risks and deaths among Latino populations differ by region. Structural factors place Latino populations and particularly monolingual Spanish speakers at elevated risk for COVID-19 acquisition.

Assessing differential impacts of COVID-19 on black communities.

Purpose: Given incomplete data reporting by race, we used data on COVID-19 cases and deaths in U.S. counties to describe racial disparities in COVID-19 disease and death and associated determinants. Methods: Using publicly available data (accessed April 13, 2020), predictors of COVID-19 cases and deaths were compared between disproportionately (≥13%) black and all other (<13% black) counties. Rate ratios were calculated, and population attributable fractions were estimated using COVID-19 cases and deaths via zero-inflated negative binomial regression model. National maps with county-level data and an interactive scatterplot of COVID-19 cases were generated. Results: Nearly 90% of disproportionately black counties (656/677) reported a case and 49% (330/677) reported a death versus 81% (1987/2465) and 28% (684/2465), respectively, for all other counties. Counties with higher proportions of black people have higher prevalence of comorbidities and greater air pollution. Counties with higher proportions of black residents had more COVID-19 diagnoses (Rate Ratio (RR): 1.24, 95% confidence interval: 1.17-1.33) and deaths (RR: 1.18, 95% confidence interval: 1.00-1.40), after adjusting for county-level characteristics such as age, poverty, comorbidities, and epidemic duration. COVID-19 deaths were higher in disproportionally black rural and small metro counties. The population attributable fraction of COVID-19 diagnosis due to lack of health insurance was 3.3% for counties with less than 13% black residents and 4.2% for counties with greater than or equal to 13% black residents. Conclusions: Nearly 20% of U.S. counties are disproportionately black, and they accounted for 52% of COVID-19 diagnoses and 58% of COVID-19 deaths nationally. County-level comparisons can both inform COVID-19 responses and identify epidemic hot spots. Social conditions, structural racism, and other factors elevate risk for COVID-19 diagnoses and deaths in black communities.

Calculating indirect costs from international PEPFAR implementing partners.

BACKGROUND: UNAIDS estimates global HIV investment needs in low- and middle-income countries (LMICs) at $26 billion per year in 2020. Yet international financing for HIV programs has stagnated amidst despite the increasing number of people requiring and accessing treatment. Despite increased efficiencies in HIV service delivery, evaluating programs for greater efficiencies remains necessary. While HIV budgets have been under scrutiny in recent years, indirect costs have not been quantified for any major global HIV program, but may constitute an additional avenue to identify program efficiencies. This analysis presents a method for estimating indirect costs in the President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: Utilizing PEPFAR country operational plan (COP) funding data from 2007 to 2016 for international organizations (IOs) and universities and standard regulatory cost bases, we calculated modified total direct costs on which indirect cost rates may be applied by partner and funding agency. We then apply a series of plausible indirect cost rates (10%-36.28%) to develop a range for total indirect costs that have accrued over the period. FINDINGS: Of $37.01 billion in total COP funding between 2007 and 2016, $22.24 billion (60.08%) was identifiably allocated to IOs ($17.95B) and universities ($4.29B). After excluding funding for sub-awards ($1.92B) and other expenses ($3.89B) to which indirect rates cannot be applied, $16.44B remained in combined direct and indirect costs. From this, we estimate that between $1.85B (8.30% of total international partner funding) and $4.34B (19.51%) has been spent on indirect costs from 2007-2016, including $157-$369 million in 2016. INTERPRETATION: To our knowledge, this is the first analysis to quantify the indirect costs of major implementing partners of a global HIV funder. However, lack of transparency in the indirect cost rates of non-University international partners creates an opaque layer of programmatic costs. Given the current funding environment and evolution of HIV programming in PEPFAR countries, the findings motivate a re-examination of the current policies and the return on investment in indirect cost recovery across the PEPFAR program.

Mapping the impact of the expanded Mexico City Policy for HIV/ family planning service integration in PEPFAR-supported countries: a risk index.

BACKGROUND: The previously-named Mexico City Policy (MCP) - which prohibited non U.S.-based non-governmental organizations (NGOs) from receiving U.S. family planning (FP) funding if they advocated, provided, counseled, or referred clients for abortions, even with non-U.S. funds - was reinstated and expanded in 2017. For the first time, the expanded MCP (EMCP) applies to HIV funding through the President's Emergency Plan for AIDS Relief (PEPFAR) in addition to FP funding. Previous, and more limited, iterations of the policy forced clinic closures and decreased contraceptive access, prompting the need to examine where and how the EMCP may impact FP/HIV service integration. METHODS: The likelihood of FP/HIV service de-integration under the EMCP was quantified using a composite risk index for 31 PEPFAR-funded countries. The index combines six standardized indicators from publically available sources organized into three sub-indexes: 1) The importance of PEPFAR for in-country service delivery of HIV and FP services; 2) The susceptibility of implementing partners to the EMCP; and 3) The integration of FP/HIV funds and programming through PEPFAR and USAID. RESULTS: Countries with the highest overall risk scores included Zambia (3.3) Cambodia (3.2), Uganda (3.1), South Africa (2.9), Haiti (2.8), Lesotho (2.8), Swaziland (2.1), and Burundi (1.5). Zambia's risk score is driven by sub-index 1, having a high proportion of country HIV expenditures provided by PEPFAR (86.3%). Cambodia and Uganda's scores are driven sub-index 3, with both countries reporting 100% of PEPFAR supported HIV delivery sites were providing integrated FP services in 2017. South Africa's risk score is driven by sub-index 2, where roughly 60% of PEPFAR funding is to non U.S.-based NGOs. Of the countries with the highest risk scores, Swaziland, Lesotho, and South Africa, are also in the top quartile of PEPFAR countries for HIV prevalence and unintended pregnancies among young women. CONCLUSION: This analysis highlights where and why the EMCP may have the greatest impact on FP/HIV service integration. The possible disruption of service integration in countries with generalized HIV epidemics highlights significant risks. Researchers, national governments, and non-U.S. funders can consider these risk factors to help target their responses to the EMCP and mitigate potential harms of the policy.

Impact of Medicaid Expansion on Access to Opioid Analgesic Medications and Medication-Assisted Treatment.

OBJECTIVES: To assess the impact of the expansion of Medicaid eligibility in the United States on the opioid epidemic, as measured through increased access to opioid analgesic medications and medication-assisted treatment. METHODS: Using Medicaid enrollment and reimbursement data from 2011 to 2016 in all states, we evaluated prescribing patterns of opioids and the 3 Food and Drug Administration-approved medications used in treating opioid use disorders by using 2 statistical models. We used difference-in-differences and interrupted time series models to measure prescribing rates before and after state expansions. RESULTS: Although opioid prescribing per Medicaid enrollee increased overall, we observed no statistical difference between expansion and nonexpansion states. By contrast, per-enrollee rates of buprenorphine and naltrexone prescribing increased more than 200% after states expanded eligibility, while increasing by less than 50% in states that did not expand. Methadone prescribing decreased in all states in this period, with larger decreases in expansion states. CONCLUSIONS: The Medicaid expansion enrolled a population no more likely to be prescribed opioids than the base Medicaid population while significantly increasing uptake of 2 drugs used in medication-assisted treatment.

Population Size Estimation of Gay and Bisexual Men and Other Men Who Have Sex With Men Using Social Media-Based Platforms.

BACKGROUND: Gay, bisexual, and other cisgender men who have sex with men (GBMSM) are disproportionately affected by the HIV pandemic. Traditionally, GBMSM have been deemed less relevant in HIV epidemics in low- and middle-income settings where HIV epidemics are more generalized. This is due (in part) to how important population size estimates regarding the number of individuals who identify as GBMSM are to informing the development and monitoring of HIV prevention, treatment, and care programs and coverage. However, pervasive stigma and criminalization of same-sex practices and relationships provide a challenging environment for population enumeration, and these factors have been associated with implausibly low or absent size estimates of GBMSM, thereby limiting knowledge about the dynamics of HIV transmission and the implementation of programs addressing GBMSM. OBJECTIVE: This study leverages estimates of the number of members of a social app geared towards gay men (Hornet) and members of Facebook using self-reported relationship interests in men, men and women, and those with at least one reported same-sex interest. Results were categorized by country of residence to validate official size estimates of GBMSM in 13 countries across five continents. METHODS: Data were collected through the Hornet Gay Social Network and by using an a priori determined framework to estimate the numbers of Facebook members with interests associated with GBMSM in South Africa, Ghana, Nigeria, Senegal, Côte d'Ivoire, Mauritania, The Gambia, Lebanon, Thailand, Malaysia, Brazil, Ukraine, and the United States. These estimates were compared with the most recent Joint United Nations Programme on HIV/AIDS (UNAIDS) and national estimates across 143 countries. RESULTS: The estimates that leveraged social media apps for the number of GBMSM across countries are consistently far higher than official UNAIDS estimates. Using Facebook, it is also feasible to assess the numbers of GBMSM aged 13-17 years, which demonstrate similar proportions to those of older men. There is greater consistency in Facebook estimates of GBMSM compared to UNAIDS-reported estimates across countries. CONCLUSIONS: The ability to use social media for epidemiologic and HIV prevention, treatment, and care needs continues to improve. Here, a method leveraging different categories of same-sex interests on Facebook, combined with a specific gay-oriented app (Hornet), demonstrated significantly higher estimates than those officially reported. While there are biases in this approach, these data reinforce the need for multiple methods to be used to count the number of GBMSM (especially in more stigmatizing settings) to better inform mathematical models and the scale of HIV program coverage. Moreover, these estimates can inform programs for those aged 13-17 years; a group for which HIV incidence is the highest and HIV prevention program coverage, including the availability of pre-exposure prophylaxis (PrEP), is lowest. Taken together, these results highlight the potential for social media to provide comparable estimates of the number of GBMSM across a large range of countries, including some with no reported estimates.

Consequences of a changing US strategy in the global HIV investment landscape.

OBJECTIVE: The global fight against HIV/AIDS in Africa has long been a focus of US foreign policy, but this could change if the federal budget for 2018 proposed by the US Office of Management and Budget is adopted. We aim to inform public and Congressional debate around this issue by evaluating the historical and potential future impact of US investment in the African HIV response. DESIGN/METHODS: We use a previously published mathematical model of HIV transmission to characterize the possible impact of a series of financial scenarios for the historical and future AIDS response across Sub-Saharan Africa. RESULTS: We find that US funding has saved nearly five million adults in Sub-Saharan Africa from AIDS-related deaths. In the coming 15 years, if current numbers on antiretroviral treatment are maintained without further expansion of programs (the proposed US strategy), nearly 26 million new HIV infections and 4.4 million AIDS deaths may occur. A 10% increase in US funding, together with ambitious domestic spending and focused attention on optimizing resources, can avert up to 22 million HIV infections and save 2.3 million lives in Sub-Saharan Africa compared with the proposed strategy. CONCLUSION: Our synthesis of available evidence shows that the United States has played, and could continue to play, a vital role in the global HIV response. Reduced investment could allow more than two million avoidable AIDS deaths by 2032, whereas continued leadership by the United States and other countries could bring UNAIDS targets for ending the epidemic into reach.

Setting Targets for HIV: An Evaluation of Indicator Quality and Target Achievement in National Strategic Plans.

BACKGROUND: National Strategic Plans (NSPs) for HIV have become foundational documents that frame responses to HIV. Both Global Fund and PEPFAR require coordination with NSPs as a component of their operations. Despite the role of NSPs in country planning, no rigorous assessment of NSP targets and performance outcomes exists. We performed a quantitative analysis of the quality of NSP indicators and targets and assessed whether historical NSP targets had been achieved. METHODS: All targets and indicators from publicly available NSPs from 35 countries are coded as structural, input, output, or impact indicators. Targets were evaluated for specificity, measurability, achievability, relevance, and being time-bound. In addition, progress toward achieving targets was evaluated using historical NSPs from 4 countries. RESULTS: NSPs emphasized output indicators, but inclusion of structural, input, or impact indicators was highly variable. Most targets lack specificity in target population, numeric baselines or targets, and a data source for monitoring. Targets were, on average, 205% increases or decreases relative to baselines. Alignment with international indicators was variable. Metrics of indicator quality were not associated with NSP funding needs. Monitoring of historical NSP targets was limited by a lack of defined targets and available data. CONCLUSIONS: Country NSPs are limited by a lack of specific, measurable, and achievable targets. The low achievement of targets in historical NSPs corroborates that targets are often poorly defined and aspirational, and not linked to available data sources. NSP quality may be improved through better use of programmatic data and greater inclusion of targets for process measures.

Use of expenditure analysis to enhance returns on investments in HIV services.

PURPOSE OF REVIEW: Globally, the response to the HIV epidemic is at a crisis point. International investments in the HIV response have been essentially flat for 8 years and domestic budgets in low and middle-income countries - still recovering from the global recession - have not been able to fill the resource gap to drive a full-fledged HIV response. Still, efficiencies and prioritization of evidence-based interventions enable a significant scale-up of treatment, but millions more people remain without treatment. This review looks at recent data and research to evaluate interventions that may help close gaps in service provision that undermine testing and treatment programs. RECENT FINDINGS: The President's Emergency Plan for AIDS Relief recently began publicly releasing vast programmatic and expenditure data. These data reveal potential efficiency gaps in testing and treatment programs, particularly in the area of linkage and retention. Interventions such as HIV self-testing have been proposed to help, but whether they can deliver better results remains unclear. Same-day initiation on treatment improves initiation, retention, and viral suppression rates. SUMMARY: Near real-time analysis of data and active response is critical in improving efficiencies in programs. More investment in implementation research is necessary to improve linkage to care and treatment to reach 90-90-90 goals.

Cyclists' helmet usage and characteristics in central and southern Malawi: a cross-sectional study.

The objective of this study was to determine the prevalence of, and factors associated with, bicycle helmet usage in southern and central Malawi. This study was across-sectional observation of public behaviour. The urban and rural roadways in southern and central Malawi were studied during the dry season. In total, 1900 bicyclists were observed along the roadways of southern and central Malawi over a four-day period. Observer ascertainment of cyclists' helmet status, approximate age, sex and bicycle operator or passenger status were measured. Of the 1900 cyclists observed, no cyclist was identified as wearing a helmet (exact 95% CI: 0.0-0.2%). There was no variation by age, sex or operator/passenger status. Nearly, 91.5% of observed cyclists were males and 87.7% were operating the bicycle. The sizeable majority of male cyclists were classified as young adults from adolescence to 25 years old (47.2%) or adults over age 25 (44.9%); 7.9% of male cyclists were pre-adolescent. Passengers were more likely to be female than operators (39.1% versus 4.2%), though, even for passengers, a higher proportion were males than females (p < 0.001). In Malawi, helmet usage is so rare as to be non-existent. This suggests an opportunity for significant improvement. Based on the observed cyclists' characteristics, interventions should be targeted to adult and young adult males.