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NCT ID: NCT06237374 Active, not recruiting - Vaccine Hesitancy Clinical Trials

Supporting CHWs as Vaccine Educators: Impact of a Digital Training and Chatbot Intervention on Vaccination in Kenya

Start date: January 16, 2024
Phase: N/A
Study type: Interventional

This study seeks to understand how to support community health workers (CHWs) to improve routine vaccination rates in high-need areas by testing a two-part intervention. The first part of the intervention is a digital training provided to CHWs, which includes videos and job aids on vaccine education to support patient communication. The second part of the intervention is a patient-facing chatbot that CHWs can share with their patients. The chatbot is designed to answer patient questions about routine immunization. The intervention will be implemented in two sub-counties in Migori County Kenya (Awendo and Nyatike) that Lwala Community Health Alliance has identified as high need with respect to vaccine education. We hypothesize that the intervention will increase knowledge about routine immunization among CHWs and patients, increase vaccine acceptance, intent-to-vaccinate, and vaccination rates among patients in the treatment group.

NCT ID: NCT06165315 Active, not recruiting - Child Development Clinical Trials

Evaluation of a Group-based Parenting Intervention for Early Childhood Development

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.

NCT ID: NCT05992376 Active, not recruiting - Clinical trials for Vegetable Consumption

Vegetables for All Evaluation Kenya

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

Global Alliance for Improved Nutrition (GAIN)'s "Vegetables for All" program in Kenya seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different vegetables by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change. The evaluation will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.

NCT ID: NCT05845619 Active, not recruiting - HIV Infections Clinical Trials

Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.

NCT ID: NCT05817422 Active, not recruiting - Clinical trials for Marburg Virus Disease

Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

Start date: October 19, 2023
Phase: Phase 2
Study type: Interventional

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

NCT ID: NCT05796934 Active, not recruiting - Child Development Clinical Trials

Evaluation of the Moments That Matter Program in Kenya

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

This cluster-randomized trial aims to evaluate the impact of the Moments That Matter® (MTM) Program on early child development and caregiving outcomes in two selected counties in western Kenya.

NCT ID: NCT05666778 Active, not recruiting - Bacterial Vaginosis Clinical Trials

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

POWWERHealth
Start date: February 13, 2023
Phase: Phase 2
Study type: Interventional

HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.

NCT ID: NCT05656352 Active, not recruiting - Clinical trials for Pregnancy, High Risk

Validation of a Non-invasive Hemoglobin Measurement Device in Pregnancy and Postpartum in Kenya, Pakistan, and Zambia

Start date: September 22, 2022
Phase:
Study type: Observational

Accurate, precise, and comparable hemoglobin measurements is of great importance, both for clinical value in diagnosing anemia and ensuring pregnant women receive appropriate treatment. The Masimo Total Hemoglobin SpHb® is a continuous and non-invasive handheld device with an optical sensor placed on the finger that measures hemoglobin levels using pulse oximetry. The objective of this study is evaluate the compatibility of hemoglobin measurements between SpHb and the gold standard laboratory-based assessment (complete blood count assessed via five-part autoanalyzer) throughout the course of pregnancy and at six weeks postpartum.

NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05549726 Active, not recruiting - HIV Clinical Trials

SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Start date: January 2, 2023
Phase: Phase 4
Study type: Interventional

The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study is to determine if adding the option of CAB-LA as a prevention choice using a person-centered dynamic choice HIV (human immunodeficiency virus) prevention model, with option to switch products over time, compared to the standard of care: 1) increases prevention coverage ; 2) reduces HIV incident infection; and 3) increases prevention coverage during periods of self-assessed risk of HIV infection, in three settings in rural Uganda and Kenya. In addition, this study will describe implementation of a person-centered model for dynamic choice HIV prevention including CAB-LA, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluation framework among persons randomized to the intervention arm.