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NCT ID: NCT06363695 Recruiting - Parenting Clinical Trials

Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya

Start date: March 14, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are: - Will SafeCare Kenya improve child and parent outcomes? - Is virtual delivery as effective as in-person delivery of SafeCare Kenya? - Is SafeCare Kenya feasible to deliver by community health volunteers? Mothers will: - Complete study assessments at three timepoints: baseline, 6 months and 18 months - Mothers in the SafeCare Kenya group will receive the program from their community health volunteer Researchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life.

NCT ID: NCT06362837 Not yet recruiting - Stunting Clinical Trials

Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services

REACTS-IN
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.

NCT ID: NCT06356636 Recruiting - Clinical trials for Health Knowledge, Attitudes, Practice

Impact of the Financial Inclusion Improves Sanitation and Health

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

The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are: 1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups? 2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model? 3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated? The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene. Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits.

NCT ID: NCT06286462 Recruiting - Cervical Cancer Clinical Trials

Evaluation of the Cancer Tracking System (CATSystem)

CATSystem
Start date: February 5, 2024
Phase: N/A
Study type: Interventional

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

NCT ID: NCT06285110 Recruiting - Hiv Clinical Trials

HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

DTG-Resist
Start date: June 13, 2022
Phase:
Study type: Observational

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

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: NCT06281119 Not yet recruiting - Clinical trials for Human Papillomavirus Infection

Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years

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

Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.

NCT ID: NCT06266780 Recruiting - Clinical trials for Postpartum Family Planning

Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals. Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale.

NCT ID: NCT06263582 Not yet recruiting - Cervix Cancer Clinical Trials

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya

Start date: June 2024
Phase: Phase 1
Study type: Interventional

This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.

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.