RESUMO
Strong local abortion research capacity is missing in many African countries. We report on the Strengthening Abortion Research Capacity in sub-Saharan Africa (STARS) program, an ongoing initiative to strengthen local capacity for abortion research in Mali, West Africa. We highlight the background, context, and methodology of the initiative as well as its achievements, challenges, and emerging lessons. Within a short time, STARS has initiated some key studies on abortion in Mali and created a much-needed platform for nurturing the country's next generation of abortion researchers, institutionalizing abortion research, increasing the quantity and quality of locally generated evidence on abortion, and facilitating evidence-informed abortion policy and programmatic action. The program's learning-by-doing approach has boosted the skills of individual researchers while also enhancing institution-based abortion and sexual and reproductive health and rights (SRHR) research expertise in Mali. Although STARS' capacity to deliver its mandate over time is evident, ultimate results will depend on the sustained commitment of funders to the program in the full realization that capacity building requires long-term investment and support for it to fully bear fruits.
Assuntos
Aborto Induzido , Gravidez , Feminino , Humanos , Mali , Reprodução , Direitos Sexuais e Reprodutivos , Saúde Reprodutiva , Fortalecimento InstitucionalRESUMO
A qualitative study assessed the effects of the COVID-19 epidemic on Malian sexual and reproductive health services. Sexual and reproductive health (SRHR) providers in 25 purposively selected public health facilities in urban Bamako, rural Kita (western Mali) and Koutiala (southeast Mali) were interviewed. Disruptions within SRH supply, staffing, the prioritization of SRHR services, and patients' ability to seek, obtain and pay for services were reported across urban and rural settings at all levels of public health care, and by all cadres of SRHR providers. Most facilities in the study areas sustained some SRHR services at the height of the COVID-19 epidemic through innovative outreach and phone-based consultations. This study offers critical lessons for SRHR service provision during future waves of the pandemic or during periods of comparable emergency.
Assuntos
COVID-19 , Serviços de Saúde Reprodutiva , Humanos , Pandemias , COVID-19/epidemiologia , Mali/epidemiologia , Saúde ReprodutivaRESUMO
BACKGROUND: Mass drug administration (MDA) of azithromycin (AZI) has been shown to reduce under-5 mortality in some but not all sub-Saharan African settings. A large-scale cluster-randomized trial conducted in Malawi, Niger, and Tanzania suggested that the effect differs by country, may be stronger in infants, and may be concentrated within the first 3 months after treatment. Another study found no effect when azithromycin was given concomitantly with seasonal malaria chemoprevention (SMC). Given the observed heterogeneity and possible effect modification by other co-interventions, further trials are needed to determine the efficacy in additional settings and to determine the most effective treatment regimen. METHODS: LAKANA stands for Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin. The LAKANA trial is designed to address the mortality and health impacts of 4 or 2 annual rounds of azithromycin MDA delivered to 1-11-month-old (29-364 days) infants, in a high-mortality and malaria holoendemic Malian setting where there is a national SMC program. Participating villages (clusters) are randomly allocated in a ratio of 3:2:4 to three groups: placebo (control):4-dose AZI:2-dose AZI. The primary outcome measured is mortality. Antimicrobial resistance (AMR) will be monitored closely before, during, and after the intervention and both among those receiving and those not receiving MDA with the study drugs. Other outcomes, from a subset of villages, comprise efficacy outcomes related to morbidity, growth and nutritional status, outcomes related to the mechanism of azithromycin activity through measures of malaria parasitemia and inflammation, safety outcomes (AMR, adverse and serious adverse events), and outcomes related to the implementation of the intervention documenting feasibility, acceptability, and economic aspects. The enrolment commenced in October 2020 and is planned to be completed by the end of 2022. The expected date of study completion is December 2024. DISCUSSION: If LAKANA provides evidence in support of a positive mortality benefit resulting from azithromycin MDA, it will significantly contribute to the options for successfully promoting child survival in Mali, and elsewhere in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov NCT04424511. Registered on 11 June 2020.
Assuntos
Azitromicina , Administração Massiva de Medicamentos , Humanos , Lactente , Antibacterianos/efeitos adversos , Azitromicina/efeitos adversos , Mortalidade Infantil , Malária/prevenção & controle , Mali/epidemiologia , Administração Massiva de Medicamentos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: The Large-scale Assessment of the Key health-promoting Activities of two New mass drug administration regimens with Azithromycin (LAKANA) trial in Mali aims to evaluate the efficacy and safety of azithromycin (AZI) mass drug administration (MDA) to 1-11-month-old infants as well as the impact of the intervention on antimicrobial resistance (AMR) and mechanisms of action of azithromycin. To improve the transparency and quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS/DESIGN: LAKANA is a cluster randomized trial that aims to address the mortality and health impacts of biannual and quarterly AZI MDA. AZI is given to 1-11-month-old infants in a high-mortality setting where a seasonal malaria chemoprevention (SMC) program is in place. The participating villages are randomly assigned to placebo (control), two-dose AZI (biannual azithromycin-MDA), and four-dose AZI (quarterly azithromycin-MDA) in a 3:4:2 ratio. The primary outcome of the study is mortality among the intention-to-treat population of 1-11-month-old infants. We will evaluate relative risk reduction between the study arms using a mixed-effects Poisson model with random intercepts for villages, using log link function with person-years as an offset variable. We will model outcomes related to secondary objectives of the study using generalized linear models with considerations on clustering. CONCLUSION: The SAP written prior to data collection completion will help avoid reporting bias and data-driven analysis for the primary and secondary aims of the trial. If there are deviations from the analysis methods described here, they will be described and justified in the publications of the trial results. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04424511 . Registered on 11 June 2020.
Assuntos
Azitromicina , Malária , Humanos , Lactente , Antibacterianos/efeitos adversos , Quimioprevenção , Malária/tratamento farmacológico , Malária/prevenção & controle , Malária/epidemiologia , Mali , Administração Massiva de Medicamentos , Método Duplo-CegoRESUMO
OBJECTIVE: To estimate the degree of SARS-CoV-2 transmission among healthcare workers (HCWs) and general population in Kita region of Mali. DESIGN: Routine surveillance in 12 health facilities, HCWs serosurvey in five health facilities and community serosurvey in 16 villages in or near Kita town, Mali. SETTING: Kita region, western Mali; local health centres around the central (regional) referral health centre. PARTICIPANTS: Patients in routine surveillance, HCWs in local health centres and community members of all ages in populations associated with study health centres. MAIN OUTCOME MEASURES: Seropositivity of ELISA test detecting SARS-CoV-2-specific total antibodies and real-time RT-PCR confirmed SARS-CoV-2 infection. RESULTS: From 2392 routine surveillance samples, 68 (2.8%, 95% CI: 2.2% to 3.6%) tested positive for SARS-CoV-2 by RT-PCR. The monthly positivity rate was 0% in June-August 2020 and gradually increased to 6% by December 2020 and 6.2% by January 2021, then declined to 5.5%, 3.3%, 3.6% and 0.8% in February, March, April and May 2021, respectively. From 397 serum samples collected from 113 HCWs, 175 (44.1%, 95% CI: 39.1% to 49.1%) were positive for SARS-CoV-2 antibodies. The monthly seroprevalence was around 10% from September to November 2020 and increased to over 40% from December 2020 to May 2021. For community serosurvey in December 2020, overall seroprevalence of SARS-CoV-2 antibodies was 27.7%. The highest age-stratified seroprevalence was observed in participants aged 60-69 years (45.5%, 95% CI: 32.3% to 58.6%). The lowest was in children aged 0-9 years (14.0%, 95% CI: 7.4% to 20.6%). CONCLUSIONS: SARS-CoV-2 in rural Mali is much more widespread than assumed by national testing data and particularly in the older population and frontline HCWs. The observation is contrary to the widely expressed view, based on limited data, that COVID-19 infection rates were lower in 2020-2021 in West Africa than in other settings.