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Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study

NCT04032730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2023-02-08

No results posted yet for this study

Summary

The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

Conditions

  • Adherence, Patient

Interventions

DEVICE

Wisepill device

Participants will receive a Wisepill device for TB and ART medications. Participants will receive an exit counselling session prior to being discharged. Participants will select the content of a text message to be sent when missing a dose as measured by Wisepill non-opening during medication dose-window. Participants will receive a post-discharge phone call by study staff for the purpose of identifying any early challenges or obstacles. All participants may receive a titrated Wisepill intervention (TWI) consisting of a text message, phone call, and/or study home visit triggered by medication non-adherence as detected by Wisepill non-opening. All participants will receive a monthly counselling intervention (MCI). Adherence support groups (ASG) will be conducted on a monthly basis.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Centre for the AIDS Programme of Research in South Africa

    lead NETWORK

Principal Investigators

  • Nesri Padayatchi · Deputy Director

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-29
Primary Completion
2021-09-28
Completion
2022-12-05

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032730 on ClinicalTrials.gov