Screening and treatment of malaria in pregnancy in West Africa

The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach. The study conducted an open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp in 5,354 primi- or secundigravidae in The Gambia, Mali, Burkina Faso and Ghana

A randomised controlled trial of three drug regimes for the treatment of malaria in pregnancy in Ghana

A thesis presented on a clinical trial of amodiaquine (AQ) and sulphadoxine-pyrimethamine (SP) used singly and in combination (AQ+SP) compared with chloroquine (CQ) for the treatment of 900 pregnant women who had falciparum malaria infection detected by a screening programme using OptiMAL antigen dipsticks during routine antenatal clinic sessions at the St. Theresa's hospital. Enrolment into the study began in March 2003 and ended in September 2004 but follow up of treated women continued to March 2005

Dihydroartemisinin-piperaquine versus artesunate-amodiaquine for treatment of malaria infection in pregnancy in Ghana: an open-label, randomized, non-inferiority trial.

To determine whether dihydroartemisinin-piperaquine (DHA-PPQ) is non-inferior to artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria infection in pregnancy. 417 second/ third trimester pregnant women with confirmed asymptomatic Plasmodium falciparum parasitaemia were randomized to receive DHA-PPQ or ASAQ over 3 days. Women were followed up on days 1, 2, 3, 7, 14, 28 and 42 after treatment start and at delivery for parasitological, haematological, birth outcomes and at 6-weeks post-partum to ascertain the health status of the babies. Parasitological efficacy (PE) by days 28 and 42 were co-primary outcomes. Analysis was per-protocol (PP) and modified intention-to-treat (ITT). Non-inferiority was declared if the two-sided 95% confidence interval for PE at the endpoints excluded 5% lower efficacy for DHA-PPQ. Secondary outcomes were assessed for superiority. In PP analysis, PE was 91.6% for DHA-PPQ and 89.3% for ASAQ by day 28 and 89.0% and 86.5% respectively by day 42. DHA-PPQ was non-inferior to ASAQ with respect to uncorrected PE {adjusted difference by day 28 (DHA-PPQ-ASAQ); 3.5% (95%CI: -1.5, 8.5) and day 42: 3.9% (95%CI: -2.7, 10.4)}. ITT analysis gave similar results. PCR to distinguish recrudescence and reinfection was unsuccessful. DHA-PPQ recipients had fewer adverse events of vomiting, dizziness and general weakness compared to ASAQ. Both drugs were well-tolerated and there was no excess of adverse birth outcomes. DHA-PPQ was non-inferior to ASAQ for treatment of malaria infection during pregnancy. No safety concerns were identified. Our findings contribute to growing evidence that DHA-PPQ is useful for control of malaria in pregnancy. This article is protected by copyright. All rights reserved

Performance of the OptiMAL® dipstick in the diagnosis of malaria infection in pregnancy

The accuracy of OptiMAL® dipsticks was compared with that of microscopy in the diagnosis of malaria infection in pregnancy. During the course of a clinical trial of antimalarial drugs in pregnancy, we screened 4500 pregnant women of all parities who accessed antenatal clinic services at St. Theresa’s Hospital’s in Nkoranza, Ghana, between March 2003 and December 2004 with OptiMAL® dipsticks and confirmed the diagnosis of malaria with microscopy. We determined the sensitivity, specificity, positive and negative predictive values, and the area under receiver operating characteristic (ROC) curve for the OptiMAL® antigen test compared to microscopy for the diagnosis of malaria infection in pregnancy. OptiMAL® dipsticks had a sensitivity of 96.6%, specificity of 85.4%, a positive predictive value of 92.7%, a negative predictive value of 92.6%, and an area under the ROC curve of 0.91 (95% CI of 0.90–0.92). The diagnostic accuracy of the OptiMAL® dipstick is high and the test may have practical use in the diagnosis of malaria infection in pregnancy in malaria endemic countries

Improving the effectiveness of point of care tests for malaria and anaemia: a qualitative study across three Ghanaian antenatal clinics

Background: Anaemia and malaria are both major contributors to maternal and child mortality, and morbidity, with some of the worst outcomes occurring in sub-Saharan Africa. Point of care tests (POCT), if used appropriately, provide a simple, inexpensive form of diagnostic testing, as a reliable alternative when laboratory tests are not readily available. In such resource limited settings, clinical staff tend to rely on symptom-based diagnosis and presumptive treatment. This study uses qualitative methods to identify the current practice of POCT use for malaria and anaemia, to explore the enablers and barriers to effective implementation of these POCT, and to determine how relationships between each of the stakeholder groups may impact on POCT use. Methods: Staff (clinical and laboratory) and patients (pregnant women) at three antenatal care facilities within the Ashanti Region of Ghana participated in interviews and focus group discussions (FGDs). An initial coding framework was developed based on the pre-defined objectives of the study. Thematic analysis was used to identify subthemes and categories within each of the key themes. Results: At the time data were collected all three facilities used malaria POCT either as an adjunct to microscopy, or as their only form of malaria testing. Although all three facilities were familiar with haemoglobin colour scale (HCS), none of the facilities used them routinely. Clinical staff perceived symptom-based diagnosis was a quick way to diagnosis because access to POCT during consultations was unreliable, but recognized disadvantages associated with symptom-based diagnosis. Perceived advantages of malaria and anaemia POCT were user-friendliness, improved diagnosis and opportunity for patient engagement, as well as lower cost implication for patients. Perceived disadvantages included likelihood of missed diagnosis of mild anaemia, as well as likelihood of human error leading to in accurate diagnosis which could impact on patient trust. Poor communication and lack of trust between staff groups was also identified as a barrier to effective uptake of POCT. Conclusions: Consistent supply of POCT as well as staff training and staff and patient engagement, are fundamental to successful uptake of POCT for effective malaria and anaemia management. Keywords: Antenatal care, Malaria and anaemia in pregnancy, Active participation, Rapid diagnostic test, Haemoglobin colour scale, LMIC, Ghan

Qualitative study to develop processes and tools for the assessment and tracking of African institutions’ capacity for operational health research

Objectives Research is key to achieving global development goals. Our objectives were to develop and test an evidence-informed process for assessing health research management and support systems (RMSS) in four African universities and for tracking interventions to address capacity gaps. Setting Four African universities. Participants 83 university staff and students from 11 cadres. Intervention/methods A literature-informed ‘benchmark’ was developed and used to itemise all components of a university’s health RMSS. Data on all components were collected during site visits to four African universities using interview guides, document reviews and facilities observation guides. Gaps in RMSS capacity were identified against the benchmark and institutional action plans developed to remedy gaps. Progress against indicators was tracked over 15 months and common challenges and successes identified. Results Common gaps in operational health research capacity included no accessible research strategy, a lack of research e-tracking capability and inadequate quality checks for proposal submissions and contracts. Feedback indicated that the capacity assessment was comprehensive and generated practical actions, several of which were no-cost. Regular follow-up helped to maintain focus on activities to strengthen health research capacity in the face of challenges. Conclusions Identification of each institutions’ strengths and weaknesses against an evidence-informed benchmark enabled them to identify gaps in in their operational health research systems, to develop prioritised action plans, to justify resource requests to fulfil the plans and to track progress in strengthening RMSS. Use of a standard benchmark, approach and tools enabled comparisons across institutions which has accelerated production of evidence about the science of research capacity strengthening. The tools could be used by institutions seeking to understand their strengths and to address gaps in research capacity. Research capacity gaps that were common to several institutions could be a ‘smart’ investment for governments and health research funders

Qualitative study to develop processes and tools for the assessment and tracking of African institutions’ capacity for operational health research

Objectives Research is key to achieving global development goals. Our objectives were to develop and test an evidence-informed process for assessing health research management and support systems (RMSS) in four African universities and for tracking interventions to address capacity gaps. Setting Four African universities. Participants 83 university staff and students from 11 cadres. Intervention/methods A literature-informed ‘benchmark’ was developed and used to itemise all components of a university’s health RMSS. Data on all components were collected during site visits to four African universities using interview guides, document reviews and facilities observation guides. Gaps in RMSS capacity were identified against the benchmark and institutional action plans developed to remedy gaps. Progress against indicators was tracked over 15 months and common challenges and successes identified. Results Common gaps in operational health research capacity included no accessible research strategy, a lack of research e-tracking capability and inadequate quality checks for proposal submissions and contracts. Feedback indicated that the capacity assessment was comprehensive and generated practical actions, several of which were no-cost. Regular follow-up helped to maintain focus on activities to strengthen health research capacity in the face of challenges. Conclusions Identification of each institutions’ strengths and weaknesses against an evidence-informed benchmark enabled them to identify gaps in in their operational health research systems, to develop prioritised action plans, to justify resource requests to fulfil the plans and to track progress in strengthening RMSS. Use of a standard benchmark, approach and tools enabled comparisons across institutions which has accelerated production of evidence about the science of research capacity strengthening. The tools could be used by institutions seeking to understand their strengths and to address gaps in research capacity. Research capacity gaps that were common to several institutions could be a ‘smart’ investment for governments and health research funders

Seasonal malaria chemoprevention in an area of extended seasonal transmission in Ashanti, Ghana: an individually randomised clinical trial.

OBJECTIVE: To investigate the effectiveness of seasonal malaria chemoprevention (SMC) and community case management with long-acting artemisinin-based combination therapies (ACTs) for the control of malaria in areas of extended seasonal malaria transmission. METHOD: Individually randomised, placebo-controlled trial in the Ashanti Region of Ghana. A total of 2400 children aged 3-59 months received either: (i) a short-acting ACT for case management of malaria (artemether-lumefantrine, AL) plus placebo SMC, or (ii) a long-acting ACT (dihydroartemisinin-piperaquine, DP) for case management plus placebo SMC or (iii) AL for case management plus active SMC with sulphadoxine-pyrimethamine and amodiaquine. SMC or placebo was delivered on five occasions during the rainy season. Malaria cases were managed by community health workers, who used rapid diagnostic tests to confirm infection prior to treatment. RESULTS: The incidence of malaria was lower in children given SMC during the rainy season. Compared to those given placebo SMC and AL for case management, the adjusted hazard ratio (aHR) was 0.62 (95% CI: 0.41, 0.93), P = 0.020 by intention to treat and 0.53 (95% CI: 0.29, 0.95), P = 0.033 among children given five SMC courses. There were no major differences between groups given different ACTs for case management (aHR DP vs. AL 1.18 (95% CI 0.83, 1.67), P = 0.356). CONCLUSION: SMC may have an important public health impact in areas with a longer transmission season, but further optimisation of SMC schedules is needed to maximise its impact in such settings