Clinical trial NCT04032730: Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Lead sponsor: Centre for the AIDS Programme of Research in South Africa
Sponsor class: NETWORK
Collaborators: name: Columbia University
First posted: 2019-07-25
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Adherence in M/XDR-TB HIV outcomes
timeFrame: 9-24 months
measure: Retention in care
timeFrame: 9-24 months
measure: TB treatment outcomes
timeFrame: 9-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: King Dinuzulu Hospital
state: KwaZulu Natal
Study officials:
affiliation: Deputy Director
name: Nesri Padayatchi
role: PRINCIPAL_INVESTIGATOR
References: