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NCT ID: NCT06257927 Completed - Adolescent Behavior Clinical Trials

Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

This study aims to contribute to the evidence base related to effective interventions for families in low-resource settings who are experiencing conflict and difficulties in relationships that affect child and caregiver well being alike. Results of this study will (a) inform whether a family therapy approach is feasible and promising in communities in and surrounding Kisumu, Kenya and (b) inform how family wellbeing and mental health can be integrated within the sexual reproductive health service points through culturally-valid ways in this context. Main Objective: To pilot test the implementation of a family therapy intervention (Tuko Pamoja) in collaboration with two sexual and reproductive healthcare settings in Kisumu, Kenya. Specific Objective: To pilot test the Tuko Pamoja family therapy intervention to assess feasibility, acceptability, and preliminary effectiveness.

NCT ID: NCT06132373 Completed - Clinical trials for Mental Disorder of Infancy, Childhood, or Adolescence (Diagnosis)

Assessing Implementation of Delivering Community-based, Peer-led Interventions for Mental Health Problems Among Youth in Eldoret, Kenya

Husisha
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

Introduction: Mental health disorders are a leading cause of disability among youth globally, and this has been worsened by the COVID-19 pandemic. In low and middle-income countries like Kenya and in rural Indiana, there is an enormous treatment gap for youth mental disorders due to limited mental health care resources. Goals: The purpose of this project is to examine the implementation of community-based, peer-led management of mental health care screening, and treatment for adolescents in Eldoret, Kenya using the REAIM framework. Methods: We shall conduct a one-week training to peer-mentors on screening for common mental health problems using the SDQ, PHQ-9, GAD-7, and YTP and treating adolescents who screen positive using a 5 session Problem Solving Treatment (PST), an evidence-based treatment for common youth mental health problems. We will then select five of the peers to deliver the intervention under the supervision of the study team at the largest community-based youth drop-in center, Family Health Options Kenya (FHOK), in Eldoret, where the peers already provide mentorship to adolescents. We will use the REAIM Framework to assess the reach, effectiveness, adoption, implementation, and maintenance of this intervention.

NCT ID: NCT05882682 Completed - Iron-deficiency Clinical Trials

Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya

KenyaMPS
Start date: October 20, 2022
Phase:
Study type: Observational [Patient Registry]

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study will be 1) to assess the nutritional adequacy of Kenyan households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study will simulate a market study, the investigators conducted a product launch, determined market potential based on sales, evaluated marketing strategy to increase market share, and modeled the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a throughout evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

NCT ID: NCT05746065 Completed - HIV Infections Clinical Trials

A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women

INSIGHT
Start date: August 1, 2022
Phase:
Study type: Observational

INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance. There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.

NCT ID: NCT05634265 Completed - Depression Clinical Trials

Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study

Start date: January 31, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.

NCT ID: NCT05560256 Completed - Type 1 Diabetes Clinical Trials

Developing a Diabetes Mobile Health Application for and With Kenyan Adolescents

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

With over 6 billion mobile phone subscribers and 75% of the world having access to a device, global health communities increasingly recognize the potential for using these devices to improve access to health care and health outcomes-especially in sub-Saharan Africa (SSA), where device ownership has grown dramatically. Less attention, however, has been given to developing the research capacity to allow these countries' public health researchers to collaborate with software developers and the users of mobile health applications (henceforth apps) to develop their own interventions. If mobile health apps are to be adopted, effective, and scalable, they must be designed by and with these individuals, the people most knowledgeable about the issues affecting technology use and disease management in their countries. Human-centered design (HCD), or design thinking, is a promising design strategy that prioritizes the needs of the intended population. It has also been successfully used to develop innovative and locally relevant health interventions that improve health outcomes. The purpose of this R21 proposal is to introduce Kenyan public health researchers and software developers to the HCD process and then collaboratively develop and evaluate an mobile health app that targets a growing epidemic among middle-to-late adolescents (13-18 yrs.) in Kenya-Type 1 Diabetes (T1D). To achieve this goal, we will pursue these specific aims: (1) train Kenyan health practitioners and software developers in HCD; (2) use HCD to build a prototype mHealth intervention for adolescents in Kenya with T1D; and (3) assess the prototype's usability, accessibility, and feasibility in using it to increase adolescents' knowledge of T1D and management of the disease. Our long-term goals include: (1) building research capacity by establishing a research network between health researchers at The Kenyan Diabetes Management and Information Center (DMI-a non-profit organization that works with adolescents with T1D) and mobile software developers at Lake Hub (an innovation space) so they can design future mobile health apps; (2) developing a commercially available app that Kenyan adolescents can use to manage T1D and stay healthy; and (3) evaluating the HCD process as it applies to developing mobile health interventions that improve health outcomes.

NCT ID: NCT05498727 Completed - COVID-19 Clinical Trials

Evaluation of the Integration of Ag-RDTs for COVID-19 in MNCH, HIV and TB Services in Cameroon and Kenya

Start date: May 2, 2022
Phase:
Study type: Observational [Patient Registry]

In many national Coronavirus Disease 2019 (COVID-19) response plans, including in Kenya and Cameroon, antigen detection tests are being used to improve access for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. Targeting the populations most at risk for COVID-19 disease, including pregnant women, people living with HIV, and patients with tuberculosis (TB), and those who are the most vulnerable to transmission to other populations, can reduce the negative impact of the SARS-CoV-2 pandemic. Catalyzing COVID-19 Action (CCA) aims to strengthen detection by screening and diagnosing cases of SARS-CoV-2 in MNCH clinics, HIV clinics, and TB clinics and enhancing the management of COVID-positive cases. The main goal of the CCA project is to reduce deaths and severe illnesses caused by COVID-19 through early access to reliable diagnosis and effective treatment through innovative models of care. Both countries will conduct a pre- and post-implementation evaluation to compare screening, testing, care, and treatment of patients undergoing COVID-19 screening, testing, and treatment before and after the integration of facilities taking part in the CCA project.

NCT ID: NCT05458557 Completed - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Antigen Rapid Diagnostic Tests for Community Identification of Severe Acute Respiratory Syndrome Coronavirus 2

Start date: June 20, 2022
Phase:
Study type: Observational

Background: Background: Testing with antigen-detecting rapid diagnostic tests (Ag-RDTs), including in asymptomatic individuals, has the potential to promptly identify more Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections and consequently decrease spread of coronavirus-19 disease at the community level. In addition, rapid test results are important for immediate clinical management and isolation of patients with SARS-CoV-2 infection, and for contact tracing and quarantining of contacts. Data on SARS-CoV-2 infection rates, the acceptability of Ag-RDT, and the cost of conducting widespread testing in these communities are limited in Africa. Study Aim and Objectives: To generate evidence evaluating the use of Ag-RDTs for community identification of SARS-CoV-2 infections within large gathering venues such as work places, schools, places of worship, and markets. The primary objective is to determine the SARS-CoV-2 case detection rate through a mass testing approach in large gatherings. Secondary objectives include determining the proportion of asymptomatic and symptomatic infections detected, acceptance of mass SARS-CoV-2 Ag-RDT testing, the prevalence of circulating variants, and the cost of implementing this community testing strategy. Study Design: The investigators propose a serial cross-sectional study design targeting approximately 15,000 persons, who will be offered testing in up to 50 different high attendance venues of Kiambu County that will be identified as possible points of community-based transmission. The study will follow an opt-in consent approach, with those accepting to participate providing additional information to the trained research assistant and/or health worker. Outcome: Evidence will be generated to provide recommendations to the Kenya Ministry of Health, and more broadly to inform the field on the use of Ag-RDTs for large scale community screening by identifying best practices and stratifying risk areas for community transmission based on rates of infections detected within various settings.

NCT ID: NCT05435209 Completed - HPV Infection Clinical Trials

Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents

Start date: May 25, 2022
Phase: Phase 4
Study type: Interventional

The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection. Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection. Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.

NCT ID: NCT05409274 Completed - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Phase:
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population