Expanding access to parasite-based malaria diagnosis through retail drug shops in Tanzania: evidence from a randomized trial and implications for treatment.

BACKGROUND: Tanzania has seen a reduction in the fraction of fevers caused by malaria, likely due in part to scale-up of control measures. While national guidelines require parasite-based diagnosis prior to treatment, it is estimated that more than half of suspected malaria treatment-seeking in Tanzania initiates in the private retail sector, where diagnosis by malaria rapid diagnostic test (RDT) or microscopy is illegal. This pilot study investigated whether the introduction of RDTs into Accredited Drug Dispensing Outlets (ADDOs) under realistic market conditions would improve case management practices. METHODS: Dispensers from ADDOs in two intervention districts in Tanzania were trained to stock and perform RDTs and monitored quarterly. Each district was assigned a different recommended retail price to evaluate the need for a subsidy. Malaria RDT and artemisinin-based combination therapy (ACT) uptake and availability were measured pre-intervention and 1 year post-intervention through structured surveys of ADDO owners and exiting customers in both intervention districts and one contiguous control district. Descriptive analysis and logistic regression were used to compare the three districts and identify predictive variables for testing. RESULTS AND DISCUSSION: A total of 310 dispensers from 262 ADDOs were trained to stock and perform RDTs. RDT availability in intervention ADDOs increased from 1% (n = 172) to 73% (n = 163) during the study; ACT medicines were available in 75% of 260 pre-intervention and 68% of 254 post-intervention ADDOs. Pre-treatment testing performed within the ADDO increased from 0 to 65% of suspected malaria patients who visited a shop (95% CI 60.8-69.6%) with no difference between intervention districts. Overall parasite-based diagnosis increased from 19 to 74% in intervention districts and from 3 to 18% in the control district. Prior knowledge of RDT availability (aOR = 1.9, p = 0.03) and RDT experience (aOR = 1.9, p = 0.01) were predictors for testing. Adherence data indicated that 75% of malaria positives received ACT, while 3% of negatives received ACT. CONCLUSIONS: Trained and supervised ADDO dispensers in rural Tanzania performed and sold RDTs under real market conditions to two-thirds of suspected malaria patients during this one-year pilot. These results support the hypothesis that introducing RDTs into regulated private retail sector settings can improve malaria testing and treatment practices without an RDT subsidy. Trial registration ISRCTN ISRCTN14115509.

Rapid diagnostic tests for malaria.

Maintaining quality, competitiveness and innovation in global health technology is a constant challenge for manufacturers, while affordability, access and equity are challenges for governments and international agencies. In this paper we discuss these issues with reference to rapid diagnostic tests for malaria. Strategies to control and eliminate malaria depend on early and accurate diagnosis. Rapid diagnostic tests for malaria require little training and equipment and can be performed by non-specialists in remote settings. Use of these tests has expanded significantly over the last few years, following recommendations to test all suspected malaria cases before treatment and the implementation of an evaluation programme to assess the performance of the malaria rapid diagnostic tests. Despite these gains, challenges exist that, if not addressed, could jeopardize the progress made to date. We discuss recent developments in rapid diagnostic tests for malaria, highlight some of the challenges and provide suggestions to address them.

Le maintien de la qualité, de la compétitivité et de l'innovation dans les technologies de la santé au niveau mondial représente un défi constant pour les fabricants, tandis que l'accessibilité économique, l'accès et l'équité constituent un défi pour les gouvernements et les organismes internationaux. Nous abordons ces questions dans le présent rapport en ce qui concerne les tests de diagnostic rapide du paludisme. Les stratégies visant à enrayer et à éradiquer le paludisme reposent sur un diagnostic précoce et précis. Les tests de diagnostic rapide du paludisme nécessitent peu de formation et de matériel et peuvent être réalisés par des non-spécialistes dans des endroits isolés. L'utilisation de ces tests s'est considérablement répandue au cours des dernières années suite aux recommandations préconisant d'examiner tous les cas présumés de paludisme avant la mise en route d'un traitement et de mettre en œuvre un programme d'évaluation pour mesurer les performances des tests de diagnostic rapide du paludisme. Il demeure, malgré ces avancées, des défis, qui, s'ils ne sont pas surmontés, risquent de compromettre les progrès accomplis jusqu'à présent. Le présent rapport fait état des améliorations récemment apportées aux tests de diagnostic rapide du paludisme, souligne un certain nombre de défis et propose des solutions pour les surmonter.

Mantener la calidad, competitividad e innovación en la tecnología de salud mundial es un desafío constante para los fabricantes, mientras que la asequibilidad, el acceso y la equidad son desafíos para los gobiernos y las agencias internacionales. En este artículo se debaten estas cuestiones con relación a las pruebas de diagnóstico rápido del paludismo. Las estrategias para controlar y eliminar el paludismo dependen de un diagnóstico temprano y preciso. Las pruebas de diagnóstico rápido del paludismo requieren muy poco entrenamiento y equipo y pueden ser llevadas a cabo por no especialistas en lugares apartados. La utilización de estas pruebas se ha expandido significantemente durante los últimos años, tras las recomendaciones de hacer una prueba en todos los casos de posible paludismo antes del tratamiento y la implementación de un programa de evaluación para examinar el rendimiento de las pruebas de diagnóstico rápido del paludismo. A pesar de estos avances, todavía existen desafíos que, si no se abordan, podrían poner en peligro el progreso hecho hasta la fecha. Se debaten los recientes desarrollos de las pruebas de diagnóstico rápido del paludismo, se destacan algunos de los desafíos y se proporcionan sugerencias para tratarlos.

Introducing malaria rapid diagnostic tests in private medicine retail outlets: A systematic literature review.

BACKGROUND: Many patients with malaria-like symptoms seek treatment in private medicine retail outlets (PMR) that distribute malaria medicines but do not traditionally provide diagnostic services, potentially leading to overtreatment with antimalarial drugs. To achieve universal access to prompt parasite-based diagnosis, many malaria-endemic countries are considering scaling up malaria rapid diagnostic tests (RDTs) in these outlets, an intervention that may require legislative changes and major investments in supporting programs and infrastructures. This review identifies studies that introduced malaria RDTs in PMRs and examines study outcomes and success factors to inform scale up decisions. METHODS: Published and unpublished studies that introduced malaria RDTs in PMRs were systematically identified and reviewed. Literature published before November 2016 was searched in six electronic databases, and unpublished studies were identified through personal contacts and stakeholder meetings. Outcomes were extracted from publications or provided by principal investigators. RESULTS: Six published and six unpublished studies were found. Most studies took place in sub-Saharan Africa and were small-scale pilots of RDT introduction in drug shops or pharmacies. None of the studies assessed large-scale implementation in PMRs. RDT uptake varied widely from 8%-100%. Provision of artemisinin-based combination therapy (ACT) for patients testing positive ranged from 30%-99%, and was more than 85% in five studies. Of those testing negative, provision of antimalarials varied from 2%-83% and was less than 20% in eight studies. Longer provider training, lower RDT retail prices and frequent supervision appeared to have a positive effect on RDT uptake and provider adherence to test results. Performance of RDTs by PMR vendors was generally good, but disposal of medical waste and referral of patients to public facilities were common challenges. CONCLUSIONS: Expanding services of PMRs to include malaria diagnostic services may hold great promise to improve malaria case management and curb overtreatment with antimalarials. However, doing so will require careful planning, investment and additional research to develop and sustain effective training, supervision, waste-management, referral and surveillance programs beyond the public sector.