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

NCT06588790 | Not Yet Recruiting

• 1 other identifier: STUDY00019143
• Study Type: interventional
• Target: 2,250
• Locations: 2 countries
• Sites: 2

Brief Summary

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)?

Conditions

Malaria Infection; Pregnancy; HIV; Diabetes; Hypertension

Keywords

Rapid diagnostic testing; Rapid testing; Self-testing; HIV; Malaria; Pregnancy; Home-based testing; community-based testing; Community Health Worker; Blood pressure; Hypertension; Diabetes; RDT

Outcome Measures

Primary Outcomes (1)

• Number of participants who self-report testing for Malaria and HIV

  * Malaria: Participant self-report of testing for malaria (measured as ever tested between baseline and exit). * HIV: Participant self-report of testing for HIV (measured as ever tested after baseline). * Composite: Participant self-report of testing for malaria or HIV (measured as ever tested after baseline).

  Over a period of 6 months.

Secondary Outcomes (4)

• Number of participants who self-report testing for Malaria and HIV when indicated

  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

  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

  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

  Over a period of 6 months.

Study Arms (3)

Home-based rapid self-testing

EXPERIMENTAL

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.

Other: Home-based rapid testing

Community health worker (CHW)-facilitated rapid testing

EXPERIMENTAL

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).

Other: Community health worker rapid testing

Standard of care

NO INTERVENTION

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.

Interventions

Home-based rapid testing OTHER

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.

Home-based rapid self-testing

Community health worker rapid testing OTHER

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.

Community health worker (CHW)-facilitated rapid testing

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Kenya Medical Research Institute: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator
• Human Sciences Research Council: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (3)

Kenya Medical Research Institute

Kisumu, Kenya

Location

Human Sciences Research Council

Durban, South Africa

Location

Center for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Malaria

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Paul Drain, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Lauff

CONTACT

206-520-3820; alauff@uw.edu

Jennifer Morton

CONTACT

jfmorton@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Global Health

Model Details: A three-arm household-randomized controlled implementation trial to assess two community-based intervention strategies for rapid diagnostic screening/testing, as compared to passive standard-of-care clinic-based screening/testing. Enrolled households will be randomized 1:1:1 to either one of two intervention arms, or the standard-of-care arm.

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

KE (1); ZA (1)