Efficacy Trial for a Smartphone Game to Prevent HIV among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19 (Preprint)

2021 ◽  
Author(s):  
Victor Mudhune ◽  
Gaelle Sabben ◽  
Ken Ondenge ◽  
Calvin Mbeda ◽  
Robert H. Lyles ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Unprotected Sex ◽  
Sub Saharan Africa ◽  
Local Health Authority ◽  
Successful Implementation ◽  
Biological Testing ◽  
Ongoing Research ◽  
Randomized Controlled ◽  
Study Participants

BACKGROUND Adolescent girls contribute about a quarter of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation, and retention of the study participants in ongoing research. OBJECTIVE The objective of our protocol is to: (1) determine if Tumaini delays sexual debut and increases condom use at first sex, and (2) determine whether it influences behavioral mediators of early and unprotected sex. METHODS Participants were recruited from Kisumu County, in Western Kenya. This study is a two-arm, individual-randomized controlled trial that enrolled 1,004 adolescents aged between 12 and 15 years. The intervention arm participants are playing Tumaini, while the control arm are provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and HSV-2; participants will have annual gameplay sessions in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines. RESULTS Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. Enrolled participant sample was 50.1% female (n=499) and had a mean age of 14.0 years (SD=0.6 years). CONCLUSIONS This ongoing research demonstrates that with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adherence to IRB and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform. CLINICALTRIAL ClinicalTrials.gov (NCT04437667).

scholarly journals Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial

10.2196/21636 ◽  
2021 ◽  
Vol 23 (1) ◽  
pp. e21636
Author(s):  
Jie Li ◽  
Peishan Ning ◽  
Peixia Cheng ◽  
David C Schwebel ◽  
Yang Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Demographic Characteristics ◽  
Parenting Education ◽  
Control Group ◽  
Child Injury ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Study Participants

Background Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies. Objective We explored factors associated with attrition of study participants in an mHealth randomized controlled trial (RCT) evaluating an intervention to reduce unintentional child injury risk in China. Methods The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6–year-old children (Bao Hu San). The intervention group received unintentional child injury and parenting education, whereas only parenting education was implemented in the control group. The trial included 2920 study participants in Changsha, China, and lasted 6 months. Data on participant engagement (using the app) were collected electronically throughout the 6-month period. Associations between participant attrition and demographic characteristics, and between attrition and intervention engagement were tested and quantified separately for the intervention and control groups using the adjusted odds ratio (aOR) based on generalized linear mixed models. Results In total, 2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group. The 6-month attrition rate differed significantly between the two groups (P<.001), at 28.9% (437/1510) in the intervention group and 35.7% (503/1410) in the control group. For the intervention group, the only significant predictor of attrition risk was participants who learned fewer knowledge segments (aOR 2.69, 95% CI 1.19-6.09). For the control group, significant predictors of attrition risk were lower monthly login frequency (aOR 1.48, 95% CI 1.00-2.18), learning fewer knowledge segments (aOR 1.70, 95% CI 1.02-2.81), and shorter learning durations during app engagement (aOR 2.39, 95% CI 1.11-5.15). Demographic characteristics were unrelated to attrition. Conclusions Engagement in the app intervention was associated with participant attrition. Researchers and practitioners should consider how to best engage participants in app-based interventions to reduce attrition. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

scholarly journals Assessing the impact of the addition of pyriproxyfen on the durability of permethrin-treated bed nets in Burkina Faso: a compound-randomized controlled trial

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Kobié H. Toé ◽  
Frank Mechan ◽  
Julie-Anne A. Tangena ◽  
Marion Morris ◽  
Joanna Solino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Burkina Faso ◽  
Pyrethroid Resistance ◽  
Controlled Trial ◽  
Sub Saharan Africa ◽  
World Health ◽  
Target Range ◽  
Bed Nets ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Long-lasting insecticidal nets (LLINs) treated with pyrethroids are the foundation of malaria control in sub-Saharan Africa. Rising pyrethroid resistance in vectors, however, has driven the development of alternative net formulations. Here the durability of polyethylene nets with a novel combination of a pyrethroid, permethrin, and the insect juvenile hormone mimic, pyriproxyfen (PPF), compared to a standard permethrin LLIN, was assessed in rural Burkina Faso. Methods A compound-randomized controlled trial was completed in two villages. In one village 326 of the PPF-permethrin nets (Olyset Duo) and 327 standard LLINs (Olyset) were distributed to assess bioefficacy. In a second village, 170 PPF-permethrin nets and 376 LLINs were distributed to assess survivorship. Nets were followed at 6-monthly intervals for 3 years. Bioefficacy was assessed by exposing permethrin-susceptible and resistant Anopheles gambiae sensu lato mosquito strains to standard World Health Organization (WHO) cone and tunnel tests with impacts on fertility measured in the resistant strain. Insecticide content was measured using high-performance liquid chromatography. LLIN survivorship was recorded with a questionnaire and assessed by comparing the physical integrity using the proportionate hole index (pHI). Results The PPF-permethrin net met WHO bioefficacy criteria (≥ 80% mortality or ≥ 95% knockdown) for the first 18 months, compared to 6 months for the standard LLIN. Mean mosquito mortality for PPF-permethrin nets, across all time points, was 8.6% (CI 2.6–14.6%) higher than the standard LLIN. Fertility rates were reduced after PPF-permethrin net exposure at 1-month post distribution, but not later. Permethrin content of both types of nets remained within the target range of 20 g/kg ± 25% for 242/248 nets tested. The pyriproxyfen content of PPF-permethrin nets declined by 54%, from 10.4 g/kg (CI 10.2–10.6) to 4.7 g/kg (CI 3.5–6.0, p < 0.001) over 36 months. Net survivorship was poor, with only 13% of PPF-permethrin nets and 12% of LLINs still present in the original household after 36 months. There was no difference in the fabric integrity or survivorship between the two net types. Conclusion The PPF-permethrin net, Olyset Duo, met or exceeded the performance of the WHO-recommended standard LLIN (Olyset) in the current study but both net types failed the 3-year WHO bioefficacy criteria.

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 Retraction Note: Successful implementation of an enhanced recovery after surgery (ERAS) protocol reduces nausea and vomiting after infratentorial craniotomy for tumour resection: a randomized controlled trial

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dan Lu ◽  
Yuan Wang ◽  
Tianzhi Zhao ◽  
Bolin Liu ◽  
Lin Ye ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Tumour Resection ◽  
Successful Implementation ◽  
Randomized Controlled ◽  
Retraction Notice ◽  
Eras Protocol

This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1186/s12883-020-02027-1.

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 An education session on sickle cell disease with teachers in Lagos, Nigeria: evaluation of a randomized controlled trial

2018 ◽  
Vol 5 (3) ◽  
pp. 115-124
Author(s):  
Bolanle Ola ◽  
Ayoola Olajide ◽  
Segun Olajide ◽  
Iain R. Williamson ◽  
Simon M. Dyson
Keyword(s):  
Randomized Controlled Trial ◽  
Sickle Cell Disease ◽  
Young People ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sub Saharan Africa ◽  
Cell Disease ◽  
Education Session ◽  
Randomized Controlled

Sickle cell disease is a major public health issue in sub-Saharan Africa, with Nigeria having the largest absolute numbers of young people living with sickle cell disease. Research in the Global North suggests that young people with sickle cell disease are not well supported at school, whilst research in the Global South focuses on attitudes to the identification of genetic carriers to prevent births of children with sickle cell disease, rather than support of those with the sickle cell disease condition itself. Between 2015 and 2017 a randomized controlled trial based on one hour education session for school teachers, based on information contained in a guide to school policy on sickle cell disease, was conducted with 402 young people with sickle cell disease across 314 schools in Lagos State, Nigeria. Young people with sickle cell disease in both intervention group and control groups showed significant decreases in the number of days of school absence and in self-reported indicators of lack of support, and significant increases in self-reported indicators of school support. The results suggest a breakdown of the randomization, probably because the young people with sickle cell disease all reacted positively to researchers taking an interest in their welfare in a context where they would usually be heavily stigmatized and would be inclined to hide their sickle cell disease status from others at school. In conclusion, conditions conducive to conducting successful research on sickle cell disease in this context - increased self-esteem in young people with sickle cell disease, reduction in within-school stigmatizing attitudes, and commitment by policy makers to improve the situation of young people in schools – are the very factors that would improve the experiences of young people living with sickle cell disease at school in Lagos, Nigeria. The fact that positive changes did occur warrants further research on this topic.

scholarly journals Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

10.2196/15314 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e15314
Author(s):  
Sujha Subramanian ◽  
Patrick Edwards ◽  
Sarah T Roberts ◽  
Maurice Musheke ◽  
Michael Mbizvo
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Adolescent Girls ◽  
Young Women ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Depth Interviews

Background Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. Objective The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. Methods We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. Results Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. Conclusions This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. Trial Registration ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953 International Registered Report Identifier (IRRID) PRR1-10.2196/15314

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