Operationalizing Equity, Inclusion, and Access in Research Practice at a Large Academic Institution.

INTRODUCTION: Healthcare advances are hindered by underrepresentation in prospective research; sociodemographic, data, and measurement infidelity in retrospective research; and a paucity of guidelines surrounding equitable research practices. OBJECTIVE: The Joint Research Practices Working Group was created in 2021 to develop and disseminate guidelines for the conduct of inclusive and equitable research. METHODS: Volunteer faculty and staff from two research centers at the University of Pennsylvania initiated a multi-pronged approach to guideline development, including literature searches, center-level feedback, and mutual learning with local experts. RESULTS: We developed guidelines for (1) participant payment and incentives; (2) language interpretation and translation; (3) plain language in research communications; (4) readability of study materials; and (5) inclusive language for scientific communications. Key recommendations include (1) offer cash payments and multiple payment options to participants when required actions are completed; (2) identify top languages of your target population, map points of contact, and determine available interpretation and translation resources; (3) assess reading levels of materials and simplify language, targeting 6th- to 8th-grade reading levels; (4) improve readability through text formatting and style, symbols, and visuals; and (5) use specific, humanizing terms as adjectives rather than nouns. CONCLUSIONS: Diversity, inclusion, and access are critical values for research conduct that promotes justice and equity. These values can be operationalized through organizational commitment that combines bottom-up and top-down approaches and through partnerships across organizations that promote mutual learning and synergy. While our guidelines represent best practices at one time, we recognize that practices evolve and need to be evaluated continuously for accuracy and relevance. Our intention is to bring awareness to these critical topics and form a foundation for important conversations surrounding equitable and inclusive research practices.

Officer-Involved Killings of Unarmed Black People and Racial Disparities in Sleep Health.

Importance: Racial disparities in sleep health may mediate the broader health outcomes of structural racism. Objective: To assess changes in sleep duration in the Black population after officer-involved killings of unarmed Black people, a cardinal manifestation of structural racism. Design, Setting, and Participants: Two distinct difference-in-differences analyses examined the changes in sleep duration for the US non-Hispanic Black (hereafter, Black) population before vs after exposure to officer-involved killings of unarmed Black people, using data from adult respondents in the US Behavioral Risk Factor Surveillance Survey (BRFSS; 2013, 2014, 2016, and 2018) and the American Time Use Survey (ATUS; 2013-2019) with data on officer-involved killings from the Mapping Police Violence database. Data analyses were conducted between September 24, 2021, and September 12, 2023. Exposures: Occurrence of any police killing of an unarmed Black person in the state, county, or commuting zone of the survey respondent's residence in each of the four 90-day periods prior to interview, or occurence of a highly public, nationally prominent police killing of an unarmed Black person anywhere in the US during the 90 days prior to interview. Main Outcomes and Measures: Self-reported total sleep duration (hours), short sleep (<7 hours), and very short sleep (<6 hours). Results: Data from 181 865 Black and 1 799 757 White respondents in the BRFSS and 9858 Black and 46 532 White respondents in the ATUS were analyzed. In the larger BRFSS, the majority of Black respondents were between the ages of 35 and 64 (99 014 [weighted 51.4%]), women (115 731 [weighted 54.1%]), and college educated (100 434 [weighted 52.3%]). Black respondents in the BRFSS reported short sleep duration at a rate of 45.9%, while White respondents reported it at a rate of 32.6%; for very short sleep, the corresponding values were 18.4% vs 10.4%, respectively. Statistically significant increases in the probability of short sleep and very short sleep were found among Black respondents when officers killed an unarmed Black person in their state of residence during the first two 90-day periods prior to interview. Magnitudes were larger in models using exposure to a nationally prominent police killing occurring anywhere in the US. Estimates were equivalent to 7% to 16% of the sample disparity between Black and White individuals in short sleep and 13% to 30% of the disparity in very short sleep. Conclusions and Relevance: Sleep health among Black adults worsened after exposure to officer-involved killings of unarmed Black individuals. These empirical findings underscore the role of structural racism in shaping racial disparities in sleep health outcomes.

Public Views on Medicaid Work Requirements and Mandatory Premiums in Kentucky.

Importance: Federal and state policymakers continue to pursue work requirements and premiums as conditions of Medicaid participation. Opinion polling should distinguish between general policy preferences and specific views on quotas, penalties, and other elements. Objective: To identify views of adults in Kentucky regarding the design of Medicaid work requirements and premiums. Design, Setting, and Participant: A cross-sectional survey was conducted via telephone and the internet from June 27 through July 11, 2019, of 1203 Kentucky residents 9 months before the state intended to implement Medicaid work requirements and mandatory premiums. Statistical analysis was performed from October 2019 to August 2023. Main Outcomes and Measures: Agreement, disagreement, or neutral views on policy components were the main outcomes. Recruitment for the survey used statewide random-digit dialing and an internet panel to recruit residents aged 18 years or older. Findings were weighted to reflect state demographics. Of 39 110 landlines called, 209 reached an eligible person (of whom 150 participated), 8654 were of unknown eligibility, and 30 247 were ineligible. Of 55 305 cell phone lines called, 617 reached an eligible person (of whom 451 participated), 29 951 were of unknown eligibility, and 24 737 were ineligible. Internet recruitment (602 participants) used a panel of adult Kentucky residents maintained by an external data collector. Results: Percentages were weighted to resemble the adult population of Kentucky residents. Of the participants in the study, 52% (95% CI, 48%-55%) were women, 80% (95% CI, 77%-82%) were younger than 65 years, 41% (95% CI, 38%-45%) were enrolled in Medicaid, 36% (95% CI, 32%-39%) were Republican voters, 32% (95% CI, 29%-36%) were Democratic voters, 14% (95% CI, 11%-16%) were members of racial and ethnic minority groups (including but not limited to American Indian or Alaska Native, Asian, Black, Hispanic or Latinx, and Native Hawaiian or Pacific Islander), and 48% (95% CI, 44%-52%) were employed. Most participants supported work requirements generally (69% [95% CI, 66%-72%]) but did not support terminating benefits due to noncompliance (43% [95% CI, 39%-46%]) or requiring quotas of 20 or more hours per week (34% [95% CI, 31%-38%]). Support for monthly premiums (34% [95% CI, 31%-38%]) and exclusion penalties for premium nonpayment (22% [95% CI, 19%-25%]) was limited. Medicaid enrollees were significantly less supportive of these policies than nonenrollees. For instance, regarding work requirements, agreement was lower (64% [95% CI, 59%-69%] vs 72% [95% CI, 68%-77%]) and disagreement higher (26% [95% CI, 21%-31%] vs 20% [95% CI, 16%-24%]) among current Medicaid enrollees compared with nonenrollees (P = .04). Among Medicaid enrollees, some beliefs about work requirements varied significantly by employment status but not by political affiliation. Among nonenrollees, beliefs about work requirements, premiums, and Medicaid varied significantly by political affiliation but not by employment. Conclusions and Relevance: This study suggests that even when public constituencies express general support for Medicaid work requirements or premiums, they may oppose central design features, such as quotas and termination of benefits. Program participants may also hold significantly different beliefs than nonparticipants, which should be understood before policies are changed.

Effects Of An Employee COVID-19 Vaccination Mandate At A Long-Term Care Network.

We assessed COVID-19 vaccination and employment status among employees of a long-term care network that announced an employee vaccination mandate on July 29, 2021. The day before the announcement, 1,208 employees were unvaccinated; of these workers, 56.2 percent subsequently were vaccinated, whereas 20.9 percent (3.7 percent of active employees) were terminated because of noncompliance with the mandate.

The effects of cash transfers on adult and child mortality in low- and middle-income countries.

Poverty is an important social determinant of health that is associated with increased risk of death1-5. Cash transfer programmes provide non-contributory monetary transfers to individuals or households, with or without behavioural conditions such as children's school attendance6,7. Over recent decades, cash transfer programmes have emerged as central components of poverty reduction strategies of many governments in low- and middle-income countries6,7. The effects of these programmes on adult and child mortality rates remains an important gap in the literature, however, with existing evidence limited to a few specific conditional cash transfer programmes, primarily in Latin America8-14. Here we evaluated the effects of large-scale, government-led cash transfer programmes on all-cause adult and child mortality using individual-level longitudinal mortality datasets from many low- and middle-income countries. We found that cash transfer programmes were associated with significant reductions in mortality among children under five years of age and women. Secondary heterogeneity analyses suggested similar effects for conditional and unconditional programmes, and larger effects for programmes that covered a larger share of the population and provided larger transfer amounts, and in countries with lower health expenditures, lower baseline life expectancy, and higher perceived regulatory quality. Our findings support the use of anti-poverty programmes such as cash transfers, which many countries have introduced or expanded during the COVID-19 pandemic, to improve population health.

Access to Oral Fluid-Based Human Immunodeficiency Virus Self-Tests Increases Testing Among Male Partners of Adolescent Girls in Kenya: A Randomized Controlled Trial.

PURPOSE: The risk of human immunodeficiency virus (HIV) among adolescent girls (AGs) may be reduced if they know the HIV status of their male partners. We assessed the ability of AGs in Siaya County, Kenya, to offer HIV self-tests to their partners to promote partner and couples testing. METHODS: Eligible AGs were 15-19 years old, self-tested HIV-negative, and had a male partner not tested in the past 6 months. Participants were randomly assigned to receive two oral fluid-based self-tests (intervention arm) or a referral coupon for facility-based testing (comparison arm). The intervention included counseling on ways to safely introduce self-tests to partners. Follow-up surveys were conducted within 3 months. RESULTS: Among 349 AGs enrolled, median age was 17 years (interquartile range 16-18), 88.3% of primary partners were noncohabiting boyfriends, and 37.5% were unaware if their partner had ever tested. At 3 months, 93.9% of the intervention arm and 73.9% of the comparison arm reported that partner testing occurred. Compared to the comparison arm, partner testing was more likely in the intervention arm (risk ratio = 1.27; 95% confidence interval 1.15-1.40; p < .001). Among participants whose partners got tested, 94.1% and 81.5% in the intervention and comparison arms, respectively, reported that couples testing occurred; couples testing was more likely in the intervention than comparison arm (risk ratio = 1.15; 95% confidence interval 1.15-1.27; p = .003). Five participants reported partner violence, one study-related. DISCUSSION: Provision of multiple self-tests to AGs for the purpose of promoting partner and couples testing should be considered in Kenya and other settings where AGs face a high risk of HIV acquisition.

Routine child immunizations in India during the COVID-19 pandemic.

Disruptions in health service delivery and utilization during the COVID-19 pandemic may have caused many children worldwide to not receive vital preventative health services. We investigate the pandemic's effects on routine childhood vaccinations in India, which has the world's largest child immunization program. Using data from the Government of India's health management information system and interrupted time series analyses, we estimate district-level changes in routine child vaccinations during the pandemic relative to typical monthly vaccinations in the pre-pandemic period. Our results indicate there were significant reductions in child vaccinations during the pandemic, with declines being extremely large in April 2020 when a strict national lockdown was in place. For example, district-level administration of the final required dose in the polio series declined by about 60% in April 2020 relative to the typical monthly vaccination levels observed prior to the pandemic. Vaccinations subsequently increased but largely remained below levels observed before the outbreak of COVID-19. Additional declines in vaccinations occurred in 2021 during the second wave of COVID-19 infections in India. Heterogeneity analyses suggest that vaccinations declined the most in districts with the strictest lockdowns and in districts with low health system capacity at baseline. There is a vital need for corrective actions, such as catch-up vaccination campaigns, to limit the deleterious consequences that will arise for the children who missed routine immunizations during the COVID-19 pandemic.

A savings intervention to reduce men's engagement in HIV risk behaviors: study protocol for a randomized controlled trial.

BACKGROUND: In much of eastern and southern Africa, the incidence of HIV and other sexually transmitted infections (STIs) remains high despite the scale-up of promising biomedical and behavioral interventions. Studies have documented the crucial role of transactional sex-the exchange of money, material support, or goods, in sexual relationships-and heavy alcohol use in contributing to men's and women's health outcomes. Existing policy responses to this challenge have largely focused on women, through the provision of pre-exposure prophylaxis (PrEP) or structural interventions such as education subsidies and cash transfers. However, the effectiveness of these interventions has been hindered by the relative lack of interventions and programs targeting men's behavior. We describe the protocol for a study that will test an economic intervention designed to reduce men's engagement in HIV/STI-related risk behaviors in Kenya. METHODS: We will conduct a randomized controlled trial among income-earning men in Kenya who are aged 18-39 years and self-report alcohol use and engagement in transactional sex. The study will enroll 1500 participants and randomize them to a control group or savings group. The savings group will receive access to a savings account that includes lottery-based incentives to save money regularly, opportunities to develop savings goals/strategies, and text message reminders about their savings goals. The control group will receive basic health education. Over a period of 24 months, we will collect qualitative and quantitative data from participants and a subset of their female partners. Participants will also be tested for HIV and other STIs at baseline, 12, and 24 months. DISCUSSION: The findings from this study have the potential to address a missing element of HIV/STI prevention efforts in sub-Saharan Africa by promoting upstream and forward-looking behavior and reducing the risk of acquiring HIV/STIs in a high HIV/STI burden setting. If this study is effective, it is an innovative approach that could be scaled up and could have great potential for scientific and public health impact in Kenya. TRIAL REGISTRATION: ClinicalTrials.gov NCT05385484 . Registered on May 23, 2022.

Quasi-experimental evaluation of a financial incentive for first-dose COVID-19 vaccination among adults aged ≥60 years in South Africa.

INTRODUCTION: COVID-19 vaccination coverage in South Africa (RSA) remains low despite increased access to vaccines. On 1 November 2021, RSA introduced the Vooma Voucher programme which provided a small guaranteed financial incentive, a Vooma Voucher redeemable at grocery stores, for COVID-19 vaccination among older adults, a population most vulnerable to serious illness, hospitalisation and death. However, the association of financial incentives with vaccination coverage remains unclear. METHODS: We evaluated the association of the conditional economic incentive programme with first-dose vaccination rates among adults (aged ≥60 years) through a quasi-experimental cohort study. The Vooma Voucher programme was a nationwide vaccination incentive programme implemented for adults aged ≥60 years from 1 November 2021 to 28 February 2022. We ran ITS models to evaluate the Vooma Voucher programme at national and provincial levels. We used data between 1 October 2021 and 27 November 2021 in models estimated at the daily level. Individuals who received their first vaccine dose received a text message to access a ZAR100 ($~7) voucher that was redeemable at grocery stores. RESULTS: The Vooma Voucher programme was associated with a 7.15%-12.01% increase in daily first-dose vaccinations in November 2021 compared with late October 2021. Overall, the incentive accounted for 6476-10 874 additional first vaccine doses from 1 November to 27 November 2021, or 8.31%-13.95% of all doses administered to those aged ≥60 years during that period. This result is robust to the inclusion of controls for the number of active vaccine delivery sites and for the nationwide Vooma vaccination weekend initiative (12 November to 14 November), both of which also increased vaccinations through expanded access to vaccines and demand creation activities. CONCLUSIONS: Financial incentives for COVID-19 vaccination led to a modest increase in first-dose vaccinations among older adults in RSA. Financial incentives and expanded access to vaccines may result in higher vaccination coverage. TRIAL REGISTRATION NUMBER SANCTR: DOH-27-012022-9116.

Adoption of HIV pre-exposure prophylaxis among women at high risk of HIV infection in Kenya.

In 2017, Kenya became one of the first African countries to provide pre-exposure prophylaxis (PrEP) in its national HIV prevention plan. We sought to characterize factors associated with PrEP uptake and persistence among a cohort of women at risk of HIV infection during the early stages of PrEP scale-up in Kenya. HIV-negative women ≥18 years with ≥2 sexual partners in the past 4 weeks were recruited as part of an ongoing cluster randomized trial of an HIV self-testing intervention. PrEP use was assessed at baseline and at 6- and 12-month follow-up visits. Between June 2017 and August 2018, 2,086 were enrolled and had complete baseline data. 138 (6.6%) reported PrEP use during the first year of the study. Although PrEP use increased, persistence on PrEP was low, and less than half of individuals reported continuing PrEP at follow-up visits. In multivariate analyses, PrEP use was associated with recent STIs, having an HIV-positive primary partner, having regular transactional sex in the past 12 months, and being a female sex worker. In the early stages of PrEP scale-up in Kenya, uptake increased modestly among women with risk factors for HIV infection, but overall uptake and persistence was low.

Death by Robots? Automation and Working-Age Mortality in the United States.

The decline of manufacturing employment is frequently invoked as a key cause of worsening U.S. population health trends, including rising mortality due to "deaths of despair." Increasing automation-the use of industrial robots to perform tasks previously done by human workers-is one structural force driving the decline of manufacturing jobs and wages. In this study, we examine the impact of automation on age- and sex-specific mortality. Using exogenous variation in automation to support causal inference, we find that increases in automation over the period 1993-2007 led to substantive increases in all-cause mortality for both men and women aged 45-54. Disaggregating by cause, we find evidence that automation is associated with increases in drug overdose deaths, suicide, homicide, and cardiovascular mortality, although patterns differ by age and sex. We further examine heterogeneity in effects by safety net program generosity, labor market policies, and the supply of prescription opioids.

The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial.

BACKGROUND: HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence. METHODS: We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067. FINDINGS: Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants' median age was 25 years (IQR 22-31) and 1390 (66·6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17·6 months. HIV incidence was not significantly different between the intervention and comparison groups (1·2 vs 1·0 per 100 person-years; hazard ratio 1·2, 95% CI 0·6-2·3, p=0·64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group). INTERPRETATION: Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence. FUNDING: National Institute of Mental Health; Center for Health Incentives and Behavioral Economics; National Institute of Allergies and Infectious Diseases; University of Pennsylvania Center for AIDS Research.

Oral health and oral health care use among able-bodied adults enrolled in Medicaid in Kentucky after Medicaid expansion: A mixed methods study.

BACKGROUND: Oral health care use remains low among adult Medicaid recipients, despite the Patient Protection and Affordable Care Act's expansion increasing access to care in many states. It remains unclear the extent to which low use reflects either low demand for care or barriers to accessing care. The authors aimed to examine factors associated with low oral health care use among adults enrolled in Medicaid. METHODS: The authors conducted a survey from May through September 2018 among able-bodied (n = 9,363) Medicaid recipients who were aged 19 through 65 years and nondisabled childless adults in Kentucky. The survey included questions on perceived oral health care use. Semistructured interviews were also conducted from May through November 2018 among a subset of participants (n = 127). RESULTS: More than one-third (37.8%) of respondents reported fair or poor oral health, compared with 26.2% who reported fair or poor physical health. Although 47.6% of respondents indicated needing oral health care in the past 6 months, only one-half of this group reported receiving all of the care they needed. Self-reported barriers included lack of coverage for needed services and lack of access to care (for example, low provider availability and transportation difficulties). CONCLUSIONS: Low rates of oral health care use can be attributed to a subset of the study population having low demand and another subset facing barriers to accessing care. Although Medicaid-covered services might be adequate for beneficiaries with good oral health, those with advanced dental diseases and a history of irregular care might benefit from coverage for more extensive restorative services. PRACTICAL IMPLICATIONS: These results can inform dentists and policy makers about how to design effective interventions and policies to improve oral health care use and oral health outcomes.

Personalized Cancer Medicine in the Media: Sensationalism or Realistic Reporting?

BACKGROUND: Given that media coverage can shape healthcare expectations, it is essential that we understand how the media frames "personalized medicine" (PM) in oncology, and whether information about unproven technologies is widely disseminated. METHODS: We conducted a content analysis of 396 news reports related to cancer and PM published between 1 January 1998 and 31 December 2011. Two coders independently coded all the reports using a pre-defined framework. Determination of coverage of "standard" and "non-standard" therapies and tests was made by comparing the media print/broadcast date to the date of Federal Drug Administration approval or incorporation into clinical guidelines. RESULTS: Although the term "personalized medicine" appeared in all reports, it was clearly defined only 27% of the time. Stories more frequently reported PM benefits than challenges (96% vs. 48%, p < 0.001). Commonly reported benefits included improved treatment (89%), prediction of side effects (30%), disease risk prediction (33%), and lower cost (19%). Commonly reported challenges included high cost (28%), potential for discrimination (29%), and concerns over privacy and regulation (21%). Coverage of inherited DNA testing was more common than coverage of tumor testing (79% vs. 25%, p < 0.001). Media reports of standard tests and treatments were common; however, 8% included information about non-standard technologies, such as experimental medications and gene therapy. CONCLUSION: Confusion about personalized cancer medicine may be exacerbated by media reports that fail to clearly define the term. While most media stories reported on standard tests and treatments, an emphasis on the benefits of PM may lead to unrealistic expectations for cancer genomic care.

Health and Economic Outcomes Associated With COVID-19 in Women at High Risk of HIV Infection in Rural Kenya.

Importance: COVID-19 lockdowns may affect economic and health outcomes, but evidence from low- and middle-income countries remains limited. Objective: To assess the economic security, food security, health, and sexual behavior of women at high risk of HIV infection in rural Kenya during the COVID-19 pandemic. Design, Setting, and Participants: This survey study of women enrolled in a randomized trial in a rural county in Kenya combined results from phone interviews, conducted while social distancing measures were in effect between May 13 and June 29, 2020, with longitudinal, in-person surveys administered between September 1, 2019, and March 25, 2020. Enrolled participants were HIV-negative and had 2 or more sexual partners within the past month. Surveys collected information on economic conditions, food security, health status, and sexual behavior. Subgroup analyses compared outcomes by reliance on transactional sex for income and by educational attainment. Data were analyzed between May 2020 and April 2021. Main Outcomes and Measures: Self-reported income, employment hours, numbers of sexual partners and transactional sex partners, food security, and COVID-19 prevention behaviors. Results: A total of 1725 women participated, with a mean (SD) age of 29.3 (6.8) years and 1170 (68.0%) reporting sex work as an income source before the COVID-19 pandemic. During the pandemic, participants reported experiencing a 52% decline in mean (SD) weekly income, from $11.25 (13.46) to $5.38 (12.51) (difference, -$5.86; 95% CI, -$6.91 to -$4.82; P < .001). In all, 1385 participants (80.3%) reported difficulty obtaining food in the past month, and 1500 (87.0%) worried about having enough to eat at least once. Reported numbers of sexual partners declined from a mean (SD) total of 1.8 (1.2) partners before COVID-19 to 1.1 (1.0) during (difference, -0.75 partners; 95% CI, -0.84 to -0.67 partners; P < .001), and transactional sex partners declined from 1.0 (1.1) to 0.5 (0.8) (difference, -0.57 partners; 95% CI, -0.64 to -0.50 partners; P < .001). In subgroup analyses, women reliant on transactional sex for income were 18.3% (95% CI, 11.4% to 25.2%) more likely to report being sometimes or often worried that their household would have enough food than women not reliant on transactional sex (P < .001), and their reported decline in employment was 4.6 hours (95% CI, -7.9 to -1.2 hours) greater than women not reliant on transactional sex (P = .008). Conclusions and Relevance: In this survey study, COVID-19 was associated with large reductions in economic security among women at high risk of HIV infection in Kenya. However, shifts in sexual behavior may have temporarily decreased their risk of HIV infection.

Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study.

BACKGROUND: Interventions to promote medication adherence and viral suppression are needed among HIV-positive individuals. We aimed to determine the feasibility, acceptability, and preliminary impact of daily financial incentives linked to real-time adherence monitoring among treatment-experienced individuals. METHODS: At an HIV clinic in Philadelphia, we conducted a pilot randomized trial among treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/mL). Participants randomized to the intervention group were eligible for daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle. Participants also received a financial incentive for achieving viral suppression at 3 months. The control group received the standard of care. We measured acceptance and feasibility through follow-up survey at 3 months, viral suppression at 3 months, and adherence. RESULTS: Among 29 participants, 28 (93%) completed 3-month follow-up, and 24 (83%) completed a 3-month laboratory visit. Electronic pill bottles were highly acceptable to participants, with most strongly agreeing that they worked well, were reliable, and easy to use. Among those who received the intervention, 77% were very satisfied with their experience. Among those who completed the 3-month laboratory visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group. ART adherence ≥80% was achieved by 36% and 25% in the intervention and control groups, respectively. CONCLUSIONS: Daily financial incentives coupled with real-time adherence monitoring are a promising strategy to support ART adherence among HIV-positive individuals who are not virally suppressed. This novel approach warrants testing in a larger trial.

The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.

Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.

Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial.

INTRODUCTION: Without significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self-tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial. METHODS: We examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya. HIV-negative women ≥18 years who self-reported ≥2 partners in the past month were eligible. Participants received self-tests at enrolment and three-monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self-test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self-test distribution. RESULTS: From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self-tests over six months, a median of eight per participant. Participants offered a median three self-tests to sexual partners. Of participants with a primary partner, 94% offered them a self-test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self-test. When offered self-tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV-negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self-test (56.3% vs. 62.0%, p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). CONCLUSIONS: Providing women with multiple self-tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential. Clinical Trial Number: NCT03135067.