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Objective To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial In the Gambia. Methods Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7,14,21 and 28).The acceptability and ease of use of the multimedia tool were assessed in focus groups. Findings On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P=0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence Interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22,95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the Intervention arm found the multimedia tool dear and easy to understand. Conclusion A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. Objectif Evaluer l'efficacite d'un outil multimedia de consentement eclaire pour les adultes participant a un essai clinique en Gambie. Methodes Les adultes eligibles a la participation a un essai de traitement du paludisme (n=311) ont ete randomises pour le recuell des informations necessaires au consentement eclaire, au moyen d'un outil multimedia (branche d'intervention) ou bien de la procedure standard (branche temoin). Un questionnaire audio informatise a ete utilise pour evaluer la comprehension du consentement eclaire par les participants, immediatement apres l'obtention de ce consentement (jour 0) alnsi que lors des visites de suivi ulterleures (jours 7,14,21 et 28). L'acceptablllte et la facilite d'utillsatlon de cet outil multimedia ont ete evaluees dans des groupes de discussions. Resultats Au jour 0, le score median de comprehension dans la branche d'intervention etalt de 64% contre 40% dans la branche temoin (P=0,042). La difference est restee significative lors de toutes les visites de suivi. Les difficultes de comprehension etaient associees independamment au sexe feminin (rapport des cotes, RC: 0,29; intervalle de confiance de 95%, IC: 0,12-0,70) et au fait de resider dans la province de Jahaly plutot que dans celle de Basse (RC: 0,33; IC de 95%: 0,13-0,82). Aucune association independante significative avec le niveau d'education n'a ete observee. Le risque de voir le score de comprehension d'un participant baisser de moitie par rapport a sa valeur initiale etait plus faible dans la branche d'intervention (ratio de risque 0,22, IC de 95%: 0,16-0,31). Globalement, 70% (42/60) des participants du groupe de discussion de la branche d'intervention ont trouve l'outil multimedia clair et facile a comprendre. Conclusion L'outil multimedia de consentement eclaire a sensiblement ameliore la comprehension et la memorisation des informations sur le consentement par les participants a des recherches ayant un faible niveau d'alphabetisation. Objetivo Evaluar la eficacia de una herramienta multimedia para el consentimiento informado para los adultos que participan en un ensayo clinico en Gambia. Metodos Los adultos elegibles para ser incluidos en un ensayo de los tratamientos de la malaria (n = 311) fueron aleatorizados para recibir la informacion necesaria para el consentimiento informado mediante una herramienta multimedia (brazo de intervencion) o un procedimiento estandar (brazo de control). Se utilizo un cuestionario de audio electronico para evaluar la comprension de los participantes del consentimiento informado. Esto se realizo inmediatamente despues de la obtencion del consentimiento (el dia 0) y en las visitas de seguimiento posteriores (dias 7,14,21 y 28). La aceptacion y facilidad de uso de la herramienta multimedia se evaluo en grupos muestrales. Resultados En el dia 0, la puntuacion de comprension media en el brazo de intervencion fue del 64%, en comparacion con el 40% en el brazo de control (P = 0,042). La diferencia siguio siendo significativa en todas las visitas de seguimiento. La peor comprension se relaciono independientemente con el sexo femenino (cociente de posibilidades, CP: 0,29; 95% intervalo de confianza, IC: 0,12-0,70) y con los residentes en Jahaly en lugar de la provincia de Basse (CP: 0,33 (95% IC: 0,13-0,82). No hubo ninguna asociacion independiente significativa con el nivel educativo. El riesgo de que la puntuacion de comprension de un participante se redujese a la mitad de la puntuacion inicial era menor en el brazo de Intervencion (cociente de riesgos instantaneos 0,22,95% IC: 0,16-0,31). En terminos generales, el 70% (42/60) de los participantes del grupo muestral del brazo de intervencion consideraron que la herramienta multimedia era clara y facil de entender. Conclusion Una herramienta multimedia para el consentimiento informado mejoro considerablemente la comprension y retencion de la informacion consentida por los participantes en la investigacion con bajos niveles de alfabetizacion., Introduction Clinical trial participants in sub-Saharan Africa often have limited understanding of the study information provided during the informed consent process. Low literacy and the difficulty of presenting information in [...]

Abstract Since 2000, under the Fifth and subsequent Framework Programmes, the European Commission has funded research to spur the development of a malaria vaccine. This funding has contributed to the promotion of an integrated infrastructure consisting of European basic, applied and clinical scientists in academia and small and medium enterprises, together with partners in Africa. Research has added basic understanding of what is required of a malaria vaccine, allowing selected candidates to be prioritized and some to be moved forward into clinical trials. To end the health burden of malaria, and its economic and social impact on development, the international community has now essentially committed itself to the eventual eradication of malaria. Given the current tentative advances towards elimination or eradication of malaria in many endemic areas, malaria vaccines constitute an additional and almost certainly essential component of any strategic plan to interrupt transmission of malaria. However, funding for malaria vaccines has been substantially reduced in the Seventh Framework Programme compared with earlier Framework Programmes, and without further support the gains made by earlier European investment will be lost.

Objective: To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. Setting: We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. Participants: The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. Outcome measure: The primary outcome measure was reliability and validity of the questionnaire. Results: Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. Conclusions: We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. [ABSTRACT FROM AUTHOR]

Malaria transmission is in decline in some parts of Africa, partly due to the scaling up of control measures. If the goal of elimination is to be achieved, additional control measures including an effective and durable vaccine will be required. Studies utilising the prime-boost approach to deliver viral vectors encoding the pre-erythrocytic antigen ME-TRAP (multiple epitope thrombospondin-related adhesion protein) have shown promising safety, immunogenicity and efficacy in sporozoite challenge studies. More recently, a study in Kenyan adults, similar to that reported here, showed substantial efficacy against P. falciparum infection. One hundred and twenty healthy male volunteers, living in a malaria endemic area of Senegal were randomised to receive either the Chimpanzee adenovirus (ChAd63) ME-TRAP as prime vaccination, followed eight weeks later by modified vaccinia Ankara (MVA) also encoding ME-TRAP as booster, or two doses of anti-rabies vaccine as a comparator. Prior to follow-up, antimalarials were administered to clear parasitaemia and then participants were monitored by PCR for malaria infection for eight weeks. The primary endpoint was time-to-infection with P. falciparum malaria, determined by two consecutive positive PCR results. Secondary endpoints included adverse event reporting, measures of cellular and humoral immunogenicity and a meta-analysis of combined vaccine efficacy with the parallel study in Kenyan adults.We show that this pre-erythrocytic malaria vaccine is safe and induces significant immunogenicity, with a peak T-cell response at seven days after boosting of 932 Spot Forming Cells (SFC)/106 Peripheral Blood Mononuclear Cells(PBMC) compared to 57 SFC/ 106 PBMCs in the control group. However, a vaccine efficacy was not observed: 12 of 57 ME-TRAP vaccinees became PCR positive during the intensive monitoring period as compared to 13 of the 58 controls (P = 0.80). This trial confirms that vaccine efficacy against malaria infection in adults may be rapidly assessed using this efficient and cost-effective clinical trial design. Further efficacy evaluation of this vectored candidate vaccine approach in other malaria transmission settings and age-de-escalation into the main target age groups for a malaria vaccine is in progress., Competing Interests: We have the following interests. Adrian V.S. Hill is a named inventor on patent applications and patents on malaria vectored vaccines and immunisation regimes including the following (WO2008/122769, Adenoviral vector encoding malaria antigen; and WO 2008/122811 Novel adenovirus vectors). Egeruan Imoukhuede and Ines Petersen were employees of EVI at the time of the study, which supports the development and testing of malaria vaccines. Nicola Viebig is an employee of EVI and Odile Leroy is executive director of EVI. Authors from ReiThera (formerly Okairos) are employees of and/or shareholders in ReiThera, which is developing vectored vaccines for malaria and other diseases. Alfredo Nicosia was employed by ReiThera (formerly Okairos) at the time of the study. There are no further patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.