scholarly journals Effect of a single dose of oral azithromycin on malaria parasitaemia in children: a randomized controlled trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Boubacar Coulibaly ◽  
Ali Sié ◽  
Clarisse Dah ◽  
Mamadou Bountogo ◽  
Mamadou Ouattara ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Childhood Mortality ◽  
Sub Saharan Africa ◽  
Tympanic Temperature ◽  
Malaria Parasitaemia ◽  
Randomized Controlled ◽  
Sub Saharan ◽  
Oral Azithromycin ◽  
Thick Smear

Abstract Background Azithromycin has recently been shown to reduce all-cause childhood mortality in sub-Saharan Africa. One potential mechanism of this effect is via the anti-malarial effect of azithromycin, which may help treat or prevent malaria infection. This study evaluated short- and longer-term effects of azithromycin on malaria outcomes in children. Methods Children aged 8 days to 59 months were randomized in a 1:1 fashion to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Children were evaluated for malaria via thin and thick smear and rapid diagnostic test (for those with tympanic temperature ≥ 37.5 °C) at baseline and 14 days and 6 months after treatment. Malaria outcomes in children receiving azithromycin versus placebo were compared at each follow-up timepoint separately. Results Of 450 children enrolled, 230 were randomized to azithromycin and 220 to placebo. Children were a median of 26 months and 51% were female, and 17% were positive for malaria parasitaemia at baseline. There was no evidence of a difference in malaria parasitaemia at 14 days or 6 months after treatment. In the azithromycin arm, 20% of children were positive for parasitaemia at 14 days compared to 17% in the placebo arm (P = 0.43) and 7.6% vs. 5.6% in the azithromycin compared to placebo arms at 6 months (P = 0.47). Conclusions Azithromycin did not affect malaria outcomes in this study, possibly due to the individually randomized nature of the trial. Trial registration This study is registered at clinicaltrials.gov (NCT03676751; registered 19 September 2018).

scholarly journals A Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Pilot Study of a Mobile Intervention (Preprint)

2018 ◽  
Author(s):  
Gaëlle Sabben ◽  
Victor Akelo ◽  
Victor Mudhune ◽  
Ken Ondeng'e ◽  
Richard Ndivo ◽  
...  
Keyword(s):  
Young People ◽  
Controlled Trial ◽  
Hiv Infections ◽  
Geographic Area ◽  
Sub Saharan Africa ◽  
Hiv Prevention Intervention ◽  
Randomized Controlled ◽  
Sub Saharan ◽  
Lost To Follow Up

BACKGROUND Young people aged under 25 years make up an increasing proportion of the population in emerging economies such as Kenya, where half of new adult HIV infections are among 15- to 24-year olds. Interventions targeting this age group have the potential to avert HIV infections among an increasingly large at-risk population. Interactive communication technologies offer a promising platform for reaching young people in engaging ways. OBJECTIVE Tumaini is a narrative-based smartphone game designed to help young Africans protect themselves from HIV. The objective of this study was to pilot test the game, focusing on the data needed to inform a future randomized controlled efficacy trial, including assessments of study feasibility and safety. METHODS The study took place in Kisumu Town, western Kenya, in spring 2017. The game-based intervention was pilot tested for 16 days with a sample of 60 preadolescents aged 11 to 14 years. Participant recruitment was initiated through schools. Participants were randomly assigned to the control or intervention arms of the study. One parent for each of the intervention arm participants was also recruited (n=30). The intervention arm participants were provided with smartphones on which Tumaini was loaded so that they could play the game at home. Youth completed behavioral surveys at baseline, posttest, and 6-week follow-up. The intervention arm participants provided quantitative feedback on their experience of the game-based intervention at posttest. They and their parents further participated in postintervention focus group discussions. Feasibility-related study metrics were collected on recruitment, enrollment, attrition, safety of participants, and return of phones. RESULTS Recruitment and enrollment of the 60 preadolescents and parents were successfully completed within 18 days. No participants were lost to follow-up: all youth completed all 3 waves of the survey and 27 intervention arm youth and 22 parents and caregivers participated in the focus groups. No safety concerns were reported. All phones were returned after the intervention period; none were damaged or lost. All intervention arm participants initiated gameplay, recording a mean exposure time just under 27 hours. CONCLUSIONS Findings indicate that it is feasible and safe to test a smartphone-based HIV prevention intervention for very young adolescents in urban and peri-urban sub-Saharan Africa by initiating recruitment in schools and temporarily providing youth participants with smartphones on which the game is loaded. A randomized controlled trial powered to assess the efficacy of the game-based intervention is being designed to be carried out in the same geographic area as the pilot, using similar methods. CLINICALTRIAL ClinicalTrials.gov NCT03054051; https://clinicaltrials.gov/ct2/show/NCT03054051 (Archived by WebCite at http://www.webcitation.org/6wjwpX8Bg.) INTERNATIONAL REGISTERED REPOR RR1-10.2196/11209

scholarly journals Effectiveness of preoperative bath using Chloroxylenol antiseptic soap on the incidence of post emergency Cesarean section surgical site infection at Mbarara Regional Referral hospital, Uganda: a Randomized Controlled trial

2020 ◽  
Author(s):  
Henry Lukabwe ◽  
Rogers Kajabwangu ◽  
Dale Mugisha ◽  
Horace Kizito ◽  
Baraka Munyanderu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Surgical Site Infections ◽  
Referral Hospital ◽  
Sub Saharan Africa ◽  
Regional Referral Hospital ◽  
Randomized Controlled ◽  
Emergency Cesarean ◽  
Sub Saharan

Abstract Introduction: Surgical Site Infections (SSIs) are infections that occur at or near the surgical incision within 30 days of the surgery. SSIs are the commonest form of hospital acquired infections in sub Saharan Africa with estimates between 15%-45%. Cesarean section (CS) is the single most important risk factor for postpartum infections, carrying a 5 to 20-fold increase in the risk of developing sepsis, with an even higher risk when the operation is an emergency. In sub Saharan Africa, the leading cause of maternal mortality is puerperal sepsis. There is a need for simple interventions that can reduce this burden of SSI in the limited resource settings. Therefore, the purpose of this study was to measure the effectiveness of chloroxylenol in reducing the incidence of post Cesarean section surgical site infections at Mbarara Regional Referral Hospital (MRRH).Methods: We conducted a single blinded randomized controlled trial at MRRH maternity ward in which women due for CS were randomized into either control or intervention arms. The intervention was a complete body bath with chloroxylenol antiseptic soap before the operation, while the control arm study participants received a standard pre-operative preparation procedures according to the existing ward protocol. All participants were followed up for 30 days and assessed using a standard SSI screening tool. Results: Ninety-six women were randomized, and 48 were assigned to either arm. The overall incidence of SSI was 30.21%. The incidence of SSI was significantly lower in the intervention compared to the control arm, at 6.25% in the intervention arm versus 54.17% in the control arm (p value<0.001). Chloroxylenol bath was protective of SSI with a 90% risk reduction for SSI (95% confidence interval of 67% – 97%). Conclusion: A preoperative bath with chloroxylenol for pregnant mothers is associated with a significantly lower risk of post Cesarean section surgical site infections. Health facilities with a high burden of post SSI should consider adding this simple and effective intervention to the existing infection prevention measures. Clinical Trials.gov registration (NCT03544710).

Short-term Effects of Calcium and Vitamin D Supplementation in Postmenopausal Hypertensive Patients in sub-Saharan Africa: A Double Blinded Randomized Controlled Trial

2021 ◽  
Vol 1 (3) ◽  
pp. 59-64
Author(s):  
Chris Nadège Nganou-Gnindjio ◽  
Vicky Jocelyne Ama Moor ◽  
Constant Anatole Pieme ◽  
Guy Sadeu Wafeu ◽  
Ingrid Ngandjeu Kamtchoum ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Sub Saharan Africa ◽  
Short Term ◽  
Hypertensive Patients ◽  
Randomized Controlled ◽  
Sub Saharan ◽  
Double Blinded

scholarly journals Effectiveness of preoperative bath using Chloroxylenol antiseptic soap on the incidence of post emergency Cesarean section surgical site infection at Mbarara Regional Referral hospital, Uganda: a Randomized Controlled trial

2020 ◽  
Author(s):  
Henry Lukabwe ◽  
Rodgers Kajabwangu ◽  
Dale Mugisha ◽  
Horace Mayengo ◽  
Baraka Munyanderu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Surgical Site Infections ◽  
Sub Saharan Africa ◽  
P Value ◽  
Prevention Measures ◽  
Randomized Controlled ◽  
Emergency Cesarean ◽  
Sub Saharan

Abstract Introduction: Surgical Site Infections (SSIs) are infections that occur at or near the surgical incision within 30 days of the surgery. SSIs are the commonest form of hospital acquired infections in sub Saharan Africa with estimates between 15%-45%. Cesarean delivery is the single most important risk factor for postpartum infections, carrying a 5 to 20-fold increase in the risk of developing sepsis, with an even higher risk when the operation is an emergency. In sub Saharan Africa, the leading cause of maternal mortality is puerperal sepsis. There is a need for simple interventions that can reduce this burden of SSI in the limited resource settings. Therefore, the purpose of this study was to measure the effectiveness of chloroxylenol in reducing the incidence of post Cesarean section surgical site infections at Mbarara Regional Referral Hospital.Methods: We conducted a single blinded randomized controlled trial at MRRH maternity ward in which women due for CS were randomized into either control or intervention arms. The intervention was a complete body bath with chloroxylenol antiseptic soap before the operation, while the control arm study participants received a standard pre-operative preparation procedures according to the existing ward protocol. All participants were followed up for 30 days and assessed using a standard SSI screening tool.Results: Ninety-six women were randomized, and 48 were assigned to either arm. The overall incidence of SSI was 30.21%. The incidence of SSI was significantly lower in the intervention compared to the control arm, at 6.25% in the intervention arm versus 54.17% in the control arm (p value<0.001). Chloroxylenol bath was protective of SSI with a 90% risk reduction for SSI (95% confidence interval of 67% – 97%).Conclusion: A preoperative bath with chloroxylenol for pregnant mothers is associated with a significantly lower risk of post Cesarean section surgical site infections. Health facilities with a high burden of post SSI should consider adding this simple and effective intervention to the existing infection prevention measures. Clinical Trials.gov registration (NCT03544710)

scholarly journals Assessing the efficacy of two dual-active ingredients long-lasting insecticidal nets for the control of malaria transmitted by pyrethroid-resistant vectors in Benin: study protocol for a three-arm, single-blinded, parallel, cluster-randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Manfred Accrombessi ◽  
Jackie Cook ◽  
Corine Ngufor ◽  
Arthur Sovi ◽  
Edouard Dangbenon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Malaria Control ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Infection Prevalence ◽  
Randomized Controlled ◽  
Sub Saharan ◽  
Cluster Randomized ◽  
Long Lasting Insecticidal Nets

Abstract Background Long-lasting insecticidal nets (LLINs) are currently the primary method of malaria control in sub-Saharan Africa and have contributed to a significant reduction in malaria burden over the past 15 years. However, this progress is threatened by the wide-scale selection of insecticide-resistant malaria vectors. It is, therefore, important to accelerate the generation of evidence for new classes of LLINs. Methods This protocol presents a three-arm superiority, single-blinded, cluster randomized controlled trial to evaluate the impact of 2 novel dual-active ingredient LLINs on epidemiological and entomological outcomes in Benin, a malaria-endemic area with highly pyrethroid-resistant vector populations. The study arms consist of (i) Royal Guard® LLIN, a net combining a pyrethroid (alpha-cypermethrin) plus an insect growth regulator (pyriproxyfen), which in the adult female is known to disrupt reproduction and egg fertility; (ii) Interceptor G2® LLIN, a net incorporating two adulticides (alpha-cypermethrin and chlorfenapyr) with different modes of action; and (iii) the control arm, Interceptor® LLIN, a pyrethroid (alpha-cypermethrin) only LLIN. In all arms, one net for every 2 people will be distributed to each household. Sixty clusters were identified and randomised 1:1:1 to each study arm. The primary outcome is malaria case incidence measured over 24 months through active case detection in a cohort of 25 children aged 6 months to 10 years, randomly selected from each cluster. Secondary outcomes include 1) malaria infection prevalence (all ages) and prevalence of moderate to severe anaemia in children under 5 years old, measured at 6 and 18 months post-intervention; 2) entomological indices measured every 3 months using human landing catches over 24 months. Insecticide resistance intensity will also be monitored over the study period. Discussion This study is the second cluster randomised controlled trial to evaluate the efficacy of these next-generation LLINs to control malaria transmitted by insecticide-resistant mosquitoes. The results of this study will form part of the WHO evidence-based review to support potential public health recommendations of these nets and shape malaria control strategies of sub-Saharan Africa for the next decade. Trial registration ClinicalTrials.gov, NCT03931473, registered on 30 April 2019.

scholarly journals The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Herry Mapesi ◽  
Ravi Gupta ◽  
Herieth Ismael Wilson ◽  
Blaise Lukau ◽  
Alain Amstutz ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Arterial Hypertension ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Link Type ◽  
Sub Saharan

Abstract Background Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of African descent living in sub-Saharan Africa. Methods In this open-label, three-arm, parallel randomized controlled trial conducted at two rural hospitals in Lesotho and Tanzania, we compare the efficacy and cost-effectiveness of three antihypertensive treatment strategies among participants aged ≥ 18 years. The study includes patients with untreated uncomplicated arterial hypertension diagnosed by a standardized office blood pressure ≥ 140/90 mmHg. The trial encompasses a superiority comparison between a triple low-dose antihypertensive drug combination versus the current standard of care (monotherapy followed by dual treatment), as well as a non-inferiority comparison for a dual drug combination versus standard of care with optional dose titration after 4 and 8 weeks for participants not reaching the target blood pressure. The sample size is 1268 participants with parallel allocation and a randomization ratio of 2:1:2 for the dual, triple and control arms, respectively. The primary endpoint is the proportion of participants reaching a target blood pressure at 12 weeks of ≤ 130/80 mmHg and ≤ 140/90 mmHg among those aged < 65 years and ≥ 65 years, respectively. Clinical manifestations of end-organ damage and cost-effectiveness at 6 months are secondary endpoints. Discussion This trial will help to identify the most effective and cost-effective treatment strategies for uncomplicated arterial hypertension among people of African descent living in rural sub-Saharan Africa and inform future clinical guidelines on antihypertensive management in the region. Trial registration Clinicaltrials.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

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