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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a two-way text-message (SMS) system called the Maternally Administered Malnutrition Monitoring System with Infant and Young Child Feeding (MAMMS-IYCF) education. This program aims to help caregivers in Kenya monitor the nutritional status of HIV-exposed children aged 6 to 24 months at home, with the goal of reducing malnutrition, hospitalizations, severe malnutrition cases, and deaths. The study also investigates the cost-effectiveness of the intervention and how it influences caregiver behavior, feeding practices, trust in healthcare, and care-seeking intentions. Caregivers and their children are randomly assigned to either the MAMMS-IYCF group or a standard of care (SOC) group for 180 days. Those in the MAMMS-IYCF group receive weekly two-way SMS messages with education on age-appropriate feeding and reminders to measure their child’s mid-upper arm circumference (MUAC) using provided tapes. Caregivers send back the color result via SMS and can ask health questions. If a child shows signs of wasting, caregivers are prompted to visit the clinic for confirmation and possible treatment. The SOC group receives one-way SMS reminders for clinic visits, and their children’s MUAC is measured during routine visits with follow-up care provided as needed. Participants attend study visits at enrollment, day 90, and day 180 for clinical exams, anthropometric measurements, and surveys about child health and caregiver knowledge. Caregivers in the intervention group complete an acceptability questionnaire at the end, and focus groups and interviews are conducted to assess experiences with the SMS system. The study measures outcomes like incidence and duration of wasting, recovery time, and hospitalizations over the 180-day follow-up period.
Actively Recruiting
Healthy Volunteer
Researchers are investigating ways to improve the use of antenatal clinics (ANC) in Western Kenya by linking digital health data from community and facility sources. This study focuses on a health system strengthening approach called C-it DU-it, which combines digital data linkage ('C-it') with community team activities ('DU-it') to help identify issues and develop local solutions. The research includes a cluster-randomized controlled trial in Homa Bay County to compare the new intervention with an enhanced standard of care and aims to understand how well the approach works and what is needed for it to be scaled up across other counties. The study involves a two-arm design where one group receives the C-it DU-it intervention, combining data linkage with training community Work Improvement Teams to use the data for improving ANC uptake. The control group receives the C-it standard of care, which includes digital data linkage without the community data use component. The intervention is evaluated over time to see its effects on increasing ANC contacts and integrating digital platforms at community and facility levels. Participants are pregnant women or those within six weeks postpartum living in the study area who consent to take part. Researchers will monitor antenatal clinic attendance, socioeconomic impacts, and costs to women and their families over a 14-month period. The study also includes economic evaluations and qualitative assessments to measure cost-effectiveness, equity, and the feasibility of expanding the intervention to other regions. Data will be collected through digital platforms and community team activities to track progress and outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are conducting a randomized controlled trial in Kisumu and Siaya, Kenya, to compare perinatal outcomes among pregnant women receiving three different approaches to testing and managing sexually transmitted infections (STIs) during antenatal care. The study will enroll 3,132 pregnant women and evaluate outcomes such as pregnancy loss, stillbirth, preterm birth, low birth weight, small for gestational age, and neonatal death. This trial aims to inform policy decisions by including a representative sample of antenatal clients regardless of age, HIV status, or gestational age at enrollment. Participants will be randomly assigned to one of three groups: standard care with syndromic management only, universal STI testing using Xpert4 assays for chlamydia, gonorrhea, and trichomonas, or STI testing only among women without symptoms. Women with detected STIs or symptoms will receive immediate treatment, expedited partner therapy according to national guidelines, and tests of cure. Enrollment occurs during routine antenatal visits, with follow-up continuing through nine months postpartum. During the study, participants will complete demographic, behavioral, and clinical assessments, including sexual history and pregnancy history. Study nurses will collect vaginal swabs for testing when applicable, and participants will receive counseling on STI testing benefits. Researchers will monitor health outcomes up to six weeks postpartum, focusing on perinatal results and safety. The trial includes ongoing data monitoring to ensure unbiased outcome assessment.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating whether nutritional supplements made from milk proteins lactoferrin and lysozyme, alone or combined, can reduce repeated diarrhea episodes and improve nutritional recovery in children aged 6 to 24 months hospitalized with diarrhea and malnutrition in Western Kenya. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address the high risk of illness and death faced by these children despite current diarrhea treatments like oral rehydration solution. The study will enroll 600 children with moderate or severe wasting (MUAC <12.5 cm) to test if these supplements can improve gut health and prevent new disease during a 6-month follow-up period. Participants will be randomly assigned to receive either lactoferrin, lysozyme, a combination of both, or a placebo for 16 weeks. Caregivers will be instructed to mix the supplements daily with their child's porridge or other complementary foods. The study includes bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. This design allows monitoring of the supplements' effects and adherence over 6 months. Throughout the study, information on the child's health history will be collected along with stool, blood, and possibly urine samples to evaluate enteric infections, enteric function, and hemoglobin levels. The main outcomes measured are the incidence of moderate-to-severe diarrhea and the time to nutritional recovery over 6 months. Safety and acceptability will be assessed, and caregivers' adherence to the supplements will be monitored. The results aim to inform new strategies to reduce mortality and complications in malnourished children recovering from diarrhea.