Dataset Information

Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.

ABSTRACT: 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 non-profit 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.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.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.NCT02773095.

SUBMITTER: Rockers PC

PROVIDER: S-EPMC5168521 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.

Rockers Peter C PC Wirtz Veronika J VJ Vian Taryn T Onyango Monica A MA Ashigbie Paul G PG Laing Richard R

BMJ open 20161125 11

<h4>Introduction</h4>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 non-profit 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.<h4>Methods and analysis</h4>This study will be a cluster-ran ...[more]

PMID: 27888177

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Project description:BackgroundGlobally, eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services; in addition, specialist services are over-utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smartphone-based screening algorithm (Peek Community Screening App). The application (App) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteers (CV) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualising service delivery. We hypothesise that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches.Study designA single masked, cluster randomised controlled trial design will be used. The unit of randomisation will be the 'community unit', defined as a dispensary or health centre with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitisation, where attendance will be ascertained. During triage, participants will be assessed and treated and, if necessary, referred onwards to Kitale Eye Unit.DiscussionWe aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level.Trial registrationThe Pan African Clinical Trials Registry (PACTR), 201807329096632 . Registered on 8 June 2018.

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Dataset Information

Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.

Publications

Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya.

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