Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II

University of Washington

Status: Not yet enrolling

Conditions: Hypertension; Diabetes; HIV; Malaria Infection; Pregnancy

Treatments: Other: Community health worker rapid testing; Other: Home-based rapid testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06588790

STUDY00019143

Details and patient eligibility

About

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)?

Full description

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.

Enrollment: 2,250 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,250 participants in 3 patient groups

Home-based rapid self-testing

Experimental group

Description:

Participants randomized to the home-based testing arm will be provided with rapid diagnostic tests (RDTs) for priority conditions (malaria, HIV, pregnancy) that can be used on-demand and without prior approval, if/when indicated. In this study arm, testing will be conducted primarily by the participant. Participants will be taught to use applicable RDTs at the baseline visit and a stock of RDTs with instructions for use will be left in the household.

Treatment:

Other: Home-based rapid testing

Community health worker (CHW)-facilitated rapid testing

Experimental group

Description:

Participants who are randomized to the CHW-facilitated rapid testing arm will have access to in-home testing and information through the research team. The research team will include a CHW and/or nurse who has a supply of RDTs and can conduct RDT testing, if/when indicated. This study arm is intended to be similar to local CHW-facilitated healthcare delivery programs, which may vary by country. All testing that is conducted in this arm will be performed by the CHW (or research team).

Treatment:

Other: Community health worker rapid testing

Standard of care

No Intervention group

Description:

Households randomized to the standard of care arm will receive education on indications for testing for priority conditions. Participants will be instructed to seek screening/testing at the local clinic, if/when indicated. This study arm is intended to be similar to local routine health care delivery for those in the household, which may vary by country.