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

Adherence, Patient Clinical Trial

— PRAXIS  

Official title:

Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study (PRospective Study of Adherence in M/XDR-TB Implementation Science) Aim 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032730
• Other study ID #: CAP 086 AIM 2
• Status: Completed
• Phase: N/A
• Start date: April 29, 2018
• Est. completion date: December 5, 2022

Study information

• Verified date: February 2023
• Source: Centre for the AIDS Programme of Research in South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).

Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 5, 2022
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance

3. Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin

4. Have capacity for informed consent

5. HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

Exclusion Criteria:

1. Pregnancy

2. Prisoners

3. Discretion of IOR or clinician

Related Conditions & MeSH terms

• Adherence, Patient

Intervention

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.

Locations

Country	Name	City	State
South Africa	King Dinuzulu Hospital	Durban	KwaZulu Natal

Sponsors (2)

Lead Sponsor	Collaborator
Centre for the AIDS Programme of Research in South Africa	Columbia University

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence in M/XDR-TB HIV outcomes	The number of participants that are adherent to their TB and ARV medication as assessed by: the use of wisepill device (electronic pill box). 2 wisepill devices are provided to participants in the intervention arm, one for their ART medication and one for their TB medication (namely Bedaquiline).; By self reporting via 7-day recall and 30-day recall; By self reporting via Visual analogue scale	9-24 months
Primary	Retention in care	Retention in care will be assessed by loss to follow-up.	9-24 months
Primary	TB treatment outcomes	The number of participants with TB treatment outcomes as assessed by death or culture conversion.	9-24 months