Study protocol for a cluster-randomized controlled trial of an NCD access to medicines initative: Evaluation of Novartis Access in Kenya

INTRODUCTION: Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private nonprofit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme. METHODS: This study will be a cluster randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis. ETHICS AND DISSEMINATION: This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders

Effect of Novartis Access on availability and price of non-communicable disease medicines in Kenya: A cluster-randomised controlled trial

Novartis Access is a Novartis programme that offers a portfolio of non-communicable disease medicines at a wholesale price of US$1 per treatment per month in low-income and middle-income countries. We evaluated the effect of Novartis Access in Kenya, the first country to receive the programme.Methods We did a cluster-randomised controlled trial in eight counties in Kenya. Counties (clusters) were randomly assigned to the intervention or the control group with a covariate-constrained randomisation procedure that maximised balance on a set of demographic and health variables. In intervention counties, public and non-profit health facilities were allowed to purchase Novartis Access medicines from the Mission for Essential Drugs and Supplies (MEDS). Data were collected from all facilities served by MEDS and a sample of households in study counties. Households were eligible if they had at least one adult patient who had been diagnosed and prescribed medicines for one of the non-communicable diseases targeted by the programme: hypertension, heart failure, dyslipidaemia, type 2 diabetes, asthma, or breast cancer. Primary outcomes were availability and price of portfolio medicines at health facilities, irrespective of brand; and availability of medicines at patient households. Impacts were estimated with intention-to-treat analysis. This trial is registered with ClinicalTrials.gov (NCT02773095)

SARS-CoV-2 seroprevalence in three Kenyan health and demographic surveillance sites, December 2020-May 2021

Background Most of the studies that have informed the public health response to the COVID-19 pandemic in Kenya have relied on samples that are not representative of the general population. We conducted population-based serosurveys at three Health and Demographic Surveillance Systems (HDSSs) to determine the cumulative incidence of infection with SARS-CoV-2. Methods We selected random age-stratified population-based samples at HDSSs in Kisumu, Nairobi and Kilifi, in Kenya. Blood samples were collected from participants between 01 Dec 2020 and 27 May 2021. No participant had received a COVID-19 vaccine. We tested for IgG antibodies to SARS-CoV-2 spike protein using ELISA. Locally-validated assay sensitivity and specificity were 93% (95% CI 88–96%) and 99% (95% CI 98–99.5%), respectively. We adjusted prevalence estimates using classical methods and Bayesian modelling to account for the sampling scheme and assay performance. Results We recruited 2,559 individuals from the three HDSS sites, median age (IQR) 27 (10–78) years and 52% were female. Seroprevalence at all three sites rose steadily during the study period. In Kisumu, Nairobi and Kilifi, seroprevalences (95% CI) at the beginning of the study were 36.0% (28.2–44.4%), 32.4% (23.1–42.4%), and 14.5% (9.1–21%), and respectively; at the end they were 42.0% (34.7–50.0%), 50.2% (39.7–61.1%), and 24.7% (17.5–32.6%), respectively. Seroprevalence was substantially lower among children (&lt;16 years) than among adults at all three sites (p≤0.001). Conclusion By May 2021 in three broadly representative populations of unvaccinated individuals in Kenya, seroprevalence of anti-SARS-CoV-2 IgG was 25–50%. There was wide variation in cumulative incidence by location and age. </jats:sec

Facteurs qui influent sur le rôle du mâle dans la santé de reproduction et sexuelle à l&apos;ouest de Kenya : une étude qualitative.

This study explored factors that influence male involvement in reproductive health in western Kenya. Qualitative study design was used. From December 2008 to February 2009, data were collected via in-depth interviews and focus group discussions (FGDs) at three provinces of western Kenya. Twelve in-depth interviews and eight FGDs were conducted. Five participants in in-depth interviews were female, seven were male. Four of the FGDs had all-male participants, four all-female. The factors that influence male involvement in reproductive health emerged in two themes, namely gender norms and the traditional approaches used to implement reproductive health and family planning programs. Any strategy taken to involve men in reproductive health must therefore consider addressing these two factors. A review of the traditional approaches of implementing reproductive health is necessary to make them more male-friendlyCette étude a exploré les facteurs qui influent sur le rôle du mâle dans la santé de reproduction é l&apos;ouest du Kenya. On a employé l&apos;organisation d&apos;une étude qualitative. A partir du mois du décembre 2008 jusqu&apos;au février 2009, nous avons recueilli des données à travers des interviews en profondeur et les discussions à groupe cible (DGC) dans trois provinces du Kenya de l&apos;ouest. Nous avons recueilli douze interviews en profondeur et avons organise huit DGCs. Parmi les participants aux interviews en profondeur, cinq étaient des femelles, sept étaient des mâles. Quatre parmi les DGCs étaient composés entièrement de mâles et quatre étaient composés entièrement de femelles. Les facteurs qui influent sur la participation des mâles à la santé de reproduction ont émergé en deux thèmes : 1) les normes du genre et 2) les approches traditionnelles dont on se sert pour mettre en œuvre les programme de santé de reproduction et de planification familiale. Toute stratégie adoptée pour assurer la participation des hommes à la santé de reproduction doit donc penser à s&apos;occuper de ces deux facteurs. Une révision des approches traditionnelles de la mise en application de santé de la reproduction est nécessaire pour les rendre plus favorables aux homme

Is polygyny a risk factor in the transmission of HIV in sub- Saharan Africa? a systematic review

Using a systematic literature review approach, this paper focused on the role of polygyny in the spread of HIV/AIDS in sub-Saharan Africa (SSA) countries. The widespread practice of polygyny is one feature of many SSA contexts that may be relevant to understanding patterns of HIV prevalence. Building on the conflicting studies on the importance of polygyny, this study investigated whether or not polygyny is a conduit for elevating HIV transmission in SSA countries. Findings showed that polygyny as an institution is perhaps less of a concern; rather the implication that men and women who are in polygamous relationships are also more likely to engage in extra-marital sex - raises secondary questions about their patterns of sexual networking and concurrent sexual partnerships. The findings however show that polygyny amplifies risky sexual behaviours such as sexual networking and concurrent sexual partnerships, all of which were found to be significantly associated with the risk of HIV transmission. This demonstrates that targeting risky sexual behaviours in a broader marital context may be more important for HIV risk reduction than targeting polygyny as an institution

The impact of ICT-enabled extension campaign on farmers' knowledge and management of fall armyworm in Uganda.

This study evaluates the unique and combined effects of three complementary ICT-based extension methods - interactive radio, mobile SMS messages and village-based video screenings - on farmers' knowledge and management of fall armyworm (FAW), an invasive pest of maize that is threatening food security in sub-Saharan Africa and Asia. Building on a survey of maize farmers in western Uganda and using various selection-on-observables estimators, we find consistent evidence that participation in the ICT-based extension campaigns significantly increases farmers' knowledge about FAW and stimulates the adoption of agricultural technologies and practices for the management of the pest. We also show that exposure to multiple campaign channels yields significantly higher outcomes than exposure to a single channel, with some evidence of additive effects. These results are robust to alternative estimators and also to hidden bias. Results further suggest that among the three ICT channels, radio has greater reach, video exerts a stronger impact on the outcome measures, and greater gains are achieved when video is complemented by radio. Our findings imply that complementary ICT-based extension campaigns (particularly those that allow both verbal and visual communication) hold great potential to improve farmers' knowledge and trigger behavioural changes in the identification, monitoring and sustainable management of a new invasive pest, such as FAW

Exploring HIV risk perception mechanisms among youth in a test-and-treat trial in Kenya and Uganda

Understanding risk perception and risk-taking among youth can inform targeted prevention efforts. Using a health beliefs model-informed framework, we analysed 8 semi-structured, gender-specific focus group discussions with 93 youth 15-24 years old (48% male, 52% female), drawn from the SEARCH trial in rural Kenya and Uganda in 2017-2018, coinciding with the widespread introduction of PrEP. Highly connected social networks and widespread uptake of antiretrovirals shaped youth HIV risk perception. Amid conflicting information about HIV prevention methods, youth felt exposed to multiple HIV risk factors like the high prevalence of HIV, belief that people with HIV(PWH) purposefully infect others, dislike of condoms, and doubts about PrEP efficacy. Young women also reported minimal sexual autonomy in the context of economic disadvantages, the ubiquity of intergenerational and transactional sex, and peer pressure from other women to have many boyfriends. Young men likewise reported vulnerability to intergenerational sex, but also adopted a sexual conquest mentality. Comprehensive sexuality education and economic empowerment, through credible and trusted sources, may moderate risk-taking. Messaging should leverage youth's social networks to spread fact-based, gender- and age-appropriate information. PrEP should be offered alongside other reproductive health services to address both pregnancy concerns and reduce HIV risk

"I was still very young": agency, stigma and HIV care strategies at school, baseline results of a qualitative study among youth in rural Kenya and Uganda.

IntroductionAdolescents and young adults living with HIV (AYAH) have the lowest rates of retention in HIV care and antiretroviral therapy (ART) adherence, partly due to the demands of school associated with this life stage, to HIV-related stigma and to fears of serostatus disclosure. We explore the implications of school-based stigma and disclosure on the development of agency during a critical life stage in rural Kenya and Uganda.MethodsWe conducted a qualitative study in the baseline year of the SEARCH Youth study, a combination intervention using a life-stage approach among youth (15-24 years old) living with HIV in western Kenya and southwestern Uganda to improve viral load suppression and health outcomes. We conducted in-depth, semi-structured interviews in 2019 with three cohorts of purposively selected study participants (youth [n = 83], balanced for sex, life stage and HIV care status; recommended family members of youth [n = 33]; and providers [n = 20]). Inductive analysis exploring contextual factors affecting HIV care engagement revealed the high salience of schooling environments.ResultsStigma within school settings, elicited by non-consensual serostatus disclosure, medication schedules and clinic appointments, exerts a constraining factor around which AYAH must navigate to identify and pursue opportunities available to them as young people. HIV status can affect cross-generational support and cohort formation, as AYAH differ from non-AYAH peers because of care-related demands affecting schooling, exams and graduation. However, adolescents demonstrate a capacity to overcome anticipated stigma and protect themselves by selectively disclosing HIV status to trusted peers and caregivers, as they develop a sense of agency concomitant with this life stage. Older adolescents showed greater ability to seek out supportive relationships than younger ones who relied on adult caregivers to facilitate this support.ConclusionsSchool is a potential site of HIV stigma and also a setting for learning how to resist such stigma. School-going adolescents should be supported to identify helpful peers and selectively disclose serostatus as they master decision making about when and where to take medications, and who should know. Stigma is&nbsp;avoided&nbsp;by fewer visits to the clinic; providers should consider longer refills, discreet packaging and long-acting, injectable ART for students