Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Home-based rapid testing, Community health worker rapid testing.
- Кому может быть актуально
- Состояния в реестре: Malaria Infection, Pregnancy, HIV, Diabetes. Базовые параметры: от 6 мес. · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Kenya, ЮАР, Zambia
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Our primary goal is to determine if on-demand, home-based rapid testing, or rapid testing done by a community health worker (CHW) results in people testing for diseases more frequently and getting care more quickly. These two testing approaches will be compared to how individuals would normally test if they were concerned about certain diseases. The main questions the study aims to answer are: * Do either of the testing approaches result in more people testing themselves for certain diseases when needed? * Does self-testing at home or testing done by a community health worker increase the number of individuals receiving test results and getting care/treatment more quickly? * Does at-home screening for high blood pressure and diabetes result in lower blood pressure and hemoglobin A1c levels (an indicator for diabetes)?
Подробное описание
Our long-term objective is to evaluate the best use case scenarios and implementation of community-based rapid testing to enhance testing adoption and case detection, accelerate linkage to care and treatment, and improve overall health outcomes. In this study, our primary objective is to determine if on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing may improve testing adoption and access to care for select infectious diseases and non-communicable diseases in Kenya, Zambia, and South Africa. This will be completed by conducting a randomized controlled trial to evaluate two testing strategies using RDTs, as compared to the standard of care.
The specific aims of this study are the following:
* Aim #1 (Primary) - To evaluate whether on-demand, home-based rapid diagnostic testing or community health worker (CHW)-facilitated rapid diagnostic testing improve testing adoption per event (or indication) for malaria or HIV in Kenya, Zambia, and South Africa. * Aim #2 - To evaluate whether on-demand, home-based rapid testing or community health worker (CHW)-facilitated rapid testing improves the percentage of people or households receiving a test result, improving access to care, or accelerating time to diagnosis/treatment for malaria or HIV in Kenya, Zambia, and South Africa. * Aim #3 - To evaluate whether household screening for hypertension and diabetes with appropriate referral for confirmatory testing and treatment may decrease the median blood pressure (hypertension) or hemoglobin A1c level (diabetes) during a 6-month observational period in Kenya, Zambia, and South Africa.
Вмешательства
- Другое Home-based rapid testing
Participants will be provided with rapid diagnostic tests for HIV, pregnancy and malaria (in Kenya and Zambia only) for on-demand, at-home self testing if/when indicated. - Другое Community health worker rapid testing
Participants will have access to rapid testing through a community health worker who will conduct rapid testing in the home or at a community-based location when indicated.
Первичные конечные точки
- Number of participants who self-report testing for Malaria and HIV [Срок оценки: Over a period of 6 months.]
Вторичные конечные точки (4)
- Number of participants who self-report testing for Malaria and HIV when indicated [Срок оценки: Over a period of 6 months.]
- Time from testing to treatment initiation or linkage to care among participants who tested positive for malaria or HIV [Срок оценки: Over a period of 6 months]
- Prevalence and incidence of positive malaria test results among participants asymptomatic and symptomatic for malaria among study populations in Zambia and Kenya [Срок оценки: Over a period of 6 months.]
- Diagnostic accuracy of a research use only malaria test for asymptomatic or symptomatic infection, as compared to rt-PCR testing from dried blood spots [Срок оценки: Over a period of 6 months.]
Критерии участия
Критерии включения
- Resides in the household and has spent ≥1 night at the house in the prior four weeks
- Plans to reside in the house for duration of the study
- Willing and able to provide informed consent, assent, or parental consent (where needed)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Kenya · 1 центр
- Kenya Medical Research Institute — Kisumu
ЮАР · 1 центр
- Human Sciences Research Council — Durban
Zambia · 1 центр
- Center for Infectious Disease Research in Zambia — Lusaka
Идентификаторы
NCT: NCT06588790 · STUDY00019143