‘I am always crying on the inside’ : a qualitative study on the implications of infertility on women’s lives in urban Gambia

Background: There is an increasing awareness that infertility in Sub-Saharan Africa constitutes a severe social and public health problem. Few of the existing studies on infertility explicitly take into account the differences between women. However, how women experience infertility is formed by their various social positions. This research explores the implications of infertility on women's lives in urban Gambia and aims to provide an in-depth understanding of how this relates to gender and cultural norms as well as different social positions. Methods: Qualitative data were collected through interviews (33), group discussions (13), participatory observations (14) and informal conversations (31). Purposive and snowball sampling techniques were used to identify participants. The data was analysed thematically using NVivo 11. Results: Results showed that there was strong social pressure on urban women in The Gambia to procreate. Unable to conform to their gender role, women with infertility were confronted with financial problems, social stigma, as well as emotional and physical violence in their marriage. All women expressed feelings of trauma, stress and sadness. The intersectional approach used in this study highlighted how different positions influenced women's experiences of infertility. Urban women with a high socio-economic status had a more powerful position within their marriages and the broader community, due to their financial position, professional career and, sometimes, their educational background. In contrast, women from a lower socio-economic background were more likely to be harshly confronted with the social stigma of infertility. Conclusion: The lives of most women with infertility in The Gambia are characterized by social suffering resulting from gender and pro-natal norms, cultural beliefs and moral concerns, cultural practices and limited access to health care. An intersectional approach is an effective tool to inform public health and social policy since it highlights how, in specific situations, certain groups are more vulnerable than others

Stepwise in vitro screening of MMV pathogen box compounds against Plasmodium falciparum to identify potent antimalarial candidates.

Development of resistance to deployed antimalarial drugs is inevitable and needs prompt and continuous discovery of novel candidate drugs. Therefore, the antimalarial activity of 125 compounds from the Medicine for Malaria Ventures (MMV) pathogen box was determined. Combining standard IC50 and normalised growth rate inhibition (GR50) analyses, we found 16 and 22 compounds had higher potencies than CQ respectively. Seven compounds with relatively high potencies (low GR50 and IC50) against P. falciparum 3D7 were further analysed. Three of these were tested on 10 natural P. falciparum isolates from The Gambia using our newly developed parasite survival rate assay (PSRA). According to the IC50, GR50 and PSRA analyses, compound MMV667494 was most potent and highly cytotoxic to parasites. MMV010576 was slow acting but more potent than dihydroartemisinin (DHA) 72 h after exposure. MMV634140 was potent against the laboratory-adapted 3D7 isolate, but 4 out of 10 natural Gambian isolates survived and replicated slowly despite 72 h of exposure to the compound, suggesting potential drug tolerance and risk of resistance development. These results emphasise the usefulness of in vitro testing as a starting point for drug discovery. Improved approaches to data analyses and the use of natural isolates will facilitate the prioritisation of compounds for further clinical development

Understanding adherence to reactive treatment of asymptomatic malaria infections in The Gambia.

The impact of different types of reactive case detection and/or treatment strategies for malaria elimination depends on high coverage and participants' adherence. However, strategies to optimise adherence are limited, particularly for people with asymptomatic or no infections. As part of a cluster-randomized trial to evaluate the effect of reactive treatment in The Gambia, all residents in the compound of a diagnosed clinical malaria patient received dihydro-artemisinin-piperaquine (DP). Using a mixed method approach, we assessed which factors contribute to adherence among the contacts of malaria cases that showed no symptoms. Adherence was defined as the proportion of compound members that (1) returned all medicine bags empty and (2) self-reported (3-day) treatment completion. Among the 273 individuals from 14 compounds who received DP, 227 (83.1%) were available for and willing to participate in the survey; 85.3% (233/273) returned empty medicine bags and 91.6% (208/227) self-reported treatment completion. Although clinical malaria was not considered a major health problem, reported adherence was high. The drivers of adherence were the strong sense of responsibility towards protecting the individual, compound and the village. Adherence can be optimised through a transdisciplinary implementation research process of engaging communities to bridge the gap between research goals and social realities

Reactive, self-administered malaria treatment against asymptomatic malaria infection: results of a cluster randomized controlled trial in The Gambia.

BACKGROUND: Selectively targeting and treating malaria-infected individuals may further decrease parasite carriage in low-burden settings. Using a trans-disciplinary approach, a reactive treatment strategy to reduce Plasmodium falciparum prevalence in participating communities was co-developed and tested. METHODS: This is a 2-arm, open-label, cluster-randomized trial involving villages in Central Gambia during the 2017 and 2018 malaria transmission season. Villages were randomized in a 1:1 ratio using a minimizing algorithm. In the intervention arm, trained village health workers delivered a full course of pre-packed dihydroartemisinin-piperaquine to all residents of compounds where clinical cases were reported while in the control arm, compound residents were screened for infection at the time of the index case reporting. All index cases were treated following national guidelines. The primary endpoint was malaria prevalence, determined by molecular methods, at the end of the intervention period. RESULTS: The trial was carried out in 50 villages: 34 in 2017 and 16 additional villages in 2018. At the end of the 2018 transmission season, malaria prevalence was 0.8% (16/1924, range 0-4%) and 1.1% (20/1814, range 0-17%) in the intervention and control arms, respectively. The odds of malaria infection were 29% lower in the intervention than in the control arm after adjustment for age (OR 0.71, 95% CI 0.27-1.84, p = 0.48). Adherence to treatment was high, with 98% (964/979) of those treated completing the 3-day treatment. Over the course of the study, only 37 villages, 20 in the intervention and 17 in the control arm, reported at least one clinical case. The distribution of clinical cases by month in both transmission seasons was similar and the odds of new clinical malaria cases during the trial period did not vary between arms (OR 1.04, 95% CI 0.57-1.91, p = 0.893). All adverse events were classified as mild to moderate and resolved completely. CONCLUSION: The systematic and timely administration of an anti-malarial treatment to residents of compounds with confirmed malaria cases did not significantly decrease malaria prevalence and incidence in communities where malaria prevalence was already low. Treatment coverage and adherence was very high. Results were strongly influenced by the lower-than-expected malaria prevalence, and by no clinical cases in villages with asymptomatic malaria-infected individuals. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov, NCT02878200. Registered 25 August 2016. https://clinicaltrials.gov/ct2/show/NCT02878200

The Community Lab of Ideas for Health: Community-Based Transdisciplinary Solutions in a Malaria Elimination Trial in The Gambia

Background: Community participation in global health interventions may improve outcomes and solve complex health issues. Although numerous community participatory approaches have been developed and introduced, there has been little focus on "how" and "who" to involve in the implementation of community-based clinical trials where unequal distribution of power between implementers and communities pre-exists. Addressing how to achieve community-based solutions in a malaria elimination trial in The Gambia, we developed the Community Lab of Ideas for Health (CLIH): a participatory approach that enabled communities to shape trial implementation. Methods: As part of transdisciplinary research, we conducted qualitative research with in-depth interviews, discussions, and observations in 17 villages in the North Bank Region of The Gambia between March 2016 and December 2017. We designed an iterative research process involving ethnography, stakeholder-analysis, participatory-discussions, and qualitative monitoring and evaluation, whereby each step guided the next. We drew upon ethnographic results and stakeholder-analysis to identify key-informants who became participants in study design and implementation. The participatory-discussions provided a co-creative space for sharing community-centric ideas to tackle trial implementation challenges. The proposed strategies for trial implementation were continuously refined and improved through our monitoring and evaluation. Results: The CLIH incorporated communities' insights, to co-create tailored trial implementation strategies including: village health workers prescribing and distributing antimalarial treatments; "compounds" as community-accepted treatment units; medicine distribution following compound micro-politics; and appropriate modes of health message delivery. Throughout the iterative research process, the researchers and communities set the common goal, namely to curtail the medical poverty trap by reducing malaria transmission and the burden thereof. This innovative collaborative process built trust among stakeholders and fully engaged researchers and communities in co-creation and co-implementation of the trial. Discussion: The CLIH approach succeeded in touching the local realities by incorporating a spectrum of perspectives from community-members and discerning project-derived knowledge from local-knowledge. This process allowed us to co-develop locally-oriented solutions and ultimately to co-establish an intervention structure that community-members were ready and willing to use, which resulted in high uptake of the intervention (92% adherence to treatment). Successfully, the CLIH contributed in bridging research and implementation

A Cohort Study on the Duration of Plasmodium falciparum Infections During the Dry Season in The Gambia.

BACKGROUND: In areas where Plasmodium falciparum malaria is seasonal, a dry season reservoir of blood-stage infection is essential for initiating transmission during the following wet season. METHODS: In The Gambia, a cohort of 42 individuals with quantitative polymerase chain reaction-positive P falciparum infections at the end of the transmission season (December) were followed monthly until the end of the dry season (May) to evaluate infection persistence. The influence of human host and parasitological factors was investigated. RESULTS: A large proportion of individuals infected at the end of the wet season had detectable infections until the end of the dry season (40.0%; 16 of 40). At the start of the dry season, the majority of these persistent infections (82%) had parasite densities >10 p/µL compared to only 5.9% of short-lived infections. Persistent infections (59%) were also more likely to be multiclonal than short-lived infections (5.9%) and were associated with individuals having higher levels of P falciparum-specific antibodies (P = .02). CONCLUSIONS: Asymptomatic persistent infections were multiclonal with higher parasite densities at the beginning of the dry season. Screening and treating asymptomatic infections during the dry season may reduce the human reservoir of malaria responsible for initiating transmission in the wet season

From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia.

BACKGROUND: The World Health Organization (WHO) recommends consideration of mass drug administration (MDA) for malaria control in low-endemic settings approaching elimination. However, MDA remains a controversial strategy, as multiple individual, social, and operational factors have shown to affect its acceptability at local levels. This is further complicated by inconsistent definitions of key indicators derived from individual and community involvement-coverage, adherence, and compliance-that cast doubts about the actual and potential epidemiological impact of MDA on disease control and elimination. This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia. METHODS: This social science study used a mixed-methods approach. Qualitative data were collected in intervention and control villages through ethnographic methods, including in-depth interviews (IDIs), focus group discussions (FGDs), and participant observation conducted with trial participants and decliners, community leaders, and field staff. A cross-sectional survey was conducted in the intervention villages after the first year of MDA. Both strands of the study explored malaria knowledge and opinions, social dynamics influencing decision-making, as well as perceived risks, burdens, and benefits associated with this MDA. RESULTS: 157 IDIs and 11 FGDs were conducted, and 864 respondents were included in the survey. Barriers and enabling factors to involvement were differentially influential at the various stages of the MDA. Issues of social influence, concerns regarding secondary effects of the medication, costs associated with malaria, and acceptability of the implementing organization, among other factors, differently affected the decision-making processes throughout the trial. Rather than a linear trajectory, involvement in this MDA trial was subjected to multiple revaluations from enrolment and consent to medicine intake and adherence to treatment. CONCLUSIONS: This study went beyond the individual factors often associated with coverage and adherence, and found that nuanced social dynamics greatly influence the decision-making process at all phases of the trial. These issues need to be consider for MDA implementation strategies and inform discussions about more accurate ways of reporting on critical effectiveness indicators

‘Some anti-malarials are too strong for your body, they will harm you.’ Socio-cultural factors influencing pregnant women’s adherence to anti-malarial treatment in rural Gambia

Background Despite declining prevalence of malaria in The Gambia, non-adherence to anti-malarial treatment still remains a challenge to control efforts. There is limited evidence on the socio-cultural factors that influence adherence to anti-malarial treatment in pregnancy. This study explored perceptions of malaria in pregnancy and their influence on adherence to anti-malarial treatment in a rural area of The Gambia. Methods An exploratory ethnographic study was conducted ancillary to a cluster-randomized trial on scheduled screening and treatment of malaria in pregnancy at village level in the Upper River Region of The Gambia from June to August 2014. Qualitative data were collected through interviewing and participant observation. Analysis was concurrent to data collection and carried out using NVivo 10. Results Although women had good bio-medical knowledge of malaria in pregnancy, adherence to anti-malarial treatment was generally perceived to be low. Pregnant women were perceived to discontinue the provided anti-malarial treatment after one or 2 days mainly due to non-recognition of symptoms, perceived ineffectiveness of the anti-malarial treatment, the perceived risks of medication and advice received from mothers-in-law. Conclusion Improving women’s knowledge of malaria in pregnancy is not sufficient to assure adherence to anti-malarial treatment. Addressing structural barriers such as unclear health workers’ messages about medication dosage, illness recognition, side effects of the medication and the integration of relatives, especially the mothers-in-law, in community-based programmes are additionally required

Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial

Background: Systematic treatment of all individuals living in the same compound of a clinical malaria case may clear asymptomatic infections and possibly reduce malaria transmission, where this is focal. High and sustained coverage is extremely important and requires active community engagement. This study explores a communitybased approach to treating malaria case contacts. Methods/design: This is a cluster-randomized trial to determine whether, in low-transmission areas, treating individuals living in the same compound of a clinical malaria case with dihydroartemisinin-piperaquine can reduce parasite carriage and thus residual malaria transmission. Treatment will be administered through the local health system with the approach of encouraging community participation designed and monitored through formative research. The trial goal is to show that this approach can reduce in intervention villages the prevalence of Plasmodium falciparum infection toward the end of the malaria transmission season. Discussion: Adherence and cooperation of the local communities are critical for the success of mass treatment campaigns aimed at reducing malaria transmission. By exploring community perceptions of the changing trends in malaria burden, existing health systems, and reaction to self-administered treatment, this study will develop and adapt a model for community engagement toward malaria elimination that is cost-effective and fits within the existing health system. Trial registration: Clinical trials.gov, NCT02878200. Registered on 25 August 2016

Fear and rumours regarding placental biopsies in a malaria-in-pregnancy trial in Benin.

BACKGROUND: A multi-country, community-based trial on scheduled screening and treatment for malaria in pregnancy was conducted in Benin, The Gambia and Burkina Faso. Despite standardized procedures and outcomes, the study became subject to rumours and accusations of placenta being sold for mystical and financial gain by trial staff, leading to drop-out rates of 30% and the consequent halting of placental biopsy sampling in Benin. This paper explores the role of socio-cultural beliefs related to placenta and identified additional factors contributing these rumours. METHODS: A qualitative comparative emergent-theory design was used to assess social factors related to trial implementation and uptake in the three countries. Data from participant observation, informal conversations, group discussions and interviews were triangulated and analysed with NVivo Qualitative Analysis software. RESULTS: Despite similar sociocultural beliefs about the sacred nature of the placenta in all three study countries, these beliefs did not affect participation rates in Burkina Faso and The Gambia and placenta-related rumours only emerged in Benin. Therefore, the presence of beliefs is not a sufficient condition to have generated placenta-selling fears. The rumours in Benin reflected the confluence of placenta-related beliefs and factors related to the implementation of the trial (including a catalysing adverse event and miscommunication during the informed consent procedure). Furthermore, distinct socio-political factors contributed to the emergence of rumours, including the historical distrust in governmental organizations and the tense relationship between some of the actors involved in the trial. CONCLUSION: Transdisciplinary social science research designs should accompany the implementation of the trial. The integration of multiple stakeholders' knowledge and involvement is required to define and solve upcoming barriers