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NCT ID: NCT06312514 Not yet recruiting - Clinical trials for HIV Prevention and Care

Lafiya HIV-status Neutral Study - Protocol

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma & discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake.

NCT ID: NCT06282315 Not yet recruiting - Clinical trials for Soil-Transmitted Helminths

Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness

Start date: October 2024
Phase: Phase 4
Study type: Interventional

An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.

NCT ID: NCT06238323 Not yet recruiting - Clinical trials for HIV Prevention and Care

Lafiya HIV Self-testing Study Protocol

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve HIVST among young sexual minority men in Ghana.

NCT ID: NCT06129253 Not yet recruiting - HPV Infection Clinical Trials

Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

HPV
Start date: November 2023
Phase:
Study type: Observational

This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.

NCT ID: NCT06128447 Not yet recruiting - Clinical trials for Soil-Transmitted Helminthiasis (STH)

Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)

Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectiveness, safety, and tolerability of ZP5-9676 compared to placebo for the treatment of STH infections. Approximately 300 participants will be enrolled, randomized at the Baseline visit (Day 1) to one of the following treatments in a 1:1 ratio of active and placebo.

NCT ID: NCT05963568 Not yet recruiting - Stroke Clinical Trials

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)

Start date: May 2024
Phase: Phase 3
Study type: Interventional

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.

NCT ID: NCT04364204 Not yet recruiting - Clinical trials for Neonatal Hypothermia

Hypothermia Prevention in Low Birthweight and Preterm Infants

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Preterm birth complications are the leading cause of neonatal mortality and account for over one million neonatal deaths annually. About 12% of babies are born before 37 weeks of gestation, and are at risk for hypothermia, hypoglycemia, infections, and mortality during the first 28 days of life. Kangaroo Mother Care (KMC) has been shown to reduce hypothermia, neonatal infections and neonatal mortality, while improving weight gain and mother-infant attachment; however, implementation to scale has been slow. The BEMPU® bracelet offers the opportunity to monitor the body temperature of newborns for the early detection of hypothermia and to increase the uptake of KMC. Further research is needed to evaluate the impact of the BEMPU® bracelet on KMC practices and neonatal health outcomes and facilitate its adoption in low-resource settings. The goal of this research is to evaluate its effect on KMC practices and neonatal health outcomes in Ghana. Evidence of a significant impact on outcomes will provide critical evidence to facilitate prompt identification of hypothermia, maximize the benefits of KMC, decrease the risk of neonatal death, and impact the leading cause of neonatal mortality in Ghana and other settings.

NCT ID: NCT04149847 Not yet recruiting - Quality of Life Clinical Trials

Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Inguinal hernia repair may be done by the nylon darn, polypropylene mesh and other methods. Polypropylene mesh is established in the literature as the standard of care for inguinal hernia repair. It is however expensive and not readily available in our community hospitals. Nylon darn repair is widely used in our hospitals. We think that the quality of life following nylon darn repair and polypropylene mesh repair is similar. In order to find out, we are recruiting 79 patients to undergo nylon darn repair for their inguinal hernia and another 79 patients to undergo polypropylene mesh repair for their inguinal hernia repair. We are doing research to compare the quality of life after nylon darn repair of inguinal hernia to polypropylene mesh repair in patients aged 18 years to 80 years who come to St. Luke Hospital for their first-ever inguinal hernia repair.

NCT ID: NCT03704649 Not yet recruiting - Malnutrition Clinical Trials

Evaluating a Participatory Nutrition Education Model on Nutrition Literacy of Adolescent Girls in Rural Ghana.

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Adolescent girls in the Upper Manya Krobo (UMK) district, Ghana are disproportionately burdened by ill-health in relation to their male counterparts. Research also shows that this demographic lacks access to nutrition education and health services. This research aims to assess the feasibility and influence of an intervention that utilizes a participatory video education model on adolescent girls' nutrition knowledge, dietary habits and health behaviour. To address our research objectives, we will conduct a school-based cluster randomized control pilot trial with adolescent girls, 12-16 years of age, who are part of existing girls' clubs in 20 schools of the Upper Manya Krobo district. The intervention group (10 schools) will use a participatory video education model and the control group consists of standard-of-care education received in regular girls' club gatherings. The intervention groups develop a storyboard and produce a short 5-7 minute film on a nutritional issue. These videos can be used by teachers as a means of sharing nutrition information with students and in stimulating discussion around the nutrition topic. Baseline and end line surveys will be conducted to assess nutrition literacy indicators and nutrition behaviour. We will use surveys to assess nutritional knowledge and attitude; food frequency questionnaire to record dietary intakes; and in-depth interviews with participants and school staff to assess challenges and strengths of the nutrition education model being delivered.

NCT ID: NCT02007837 Not yet recruiting - Clinical trials for Pregnancy Induced Hypertension

Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial

4P
Start date: January 2018
Phase: Phase 3
Study type: Interventional

Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.