Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Culture or molecular test positive for MTB

• Molecular test positive for HIV or a documented HIV positive history

• Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,

• Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ

• On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,

• Capacity for informed consent in either isiZulu or English

Locations
Other Locations
South Africa
King DinuZulu Hospital
RECRUITING
Durban
Contact Information
Primary
Kogieleum Naidoo, Prof
Kogie.Naidoo@caprisa.org
+27 31 260 4687
Backup
Max O'Donnell, Prof
mo2130@columbia.edu
Time Frame
Start Date: 2023-03-07
Estimated Completion Date: 2029-04
Participants
Target number of participants: 360
Treatments
No_intervention: Enhanced standard of care
* Care from trained and supported physicians, nurses, and social workers who have received repeated trainings from study staff on medical and behavioral aspects of DR-TB HIV care, which will be documented in terms of date, attendance, and content~* All participants who receive care as inpatients will receive an orientation to DR-TB treatment in form of a group session designed to impart key behavioral information and health knowledge about the disease, treatment, and skills to obtain optimal outcome.~* Discharge counselling session will be conducted prior to discharge.~* Study participants will complete study assessments at baseline (enrollment) and monthly for the first six months.
Other: Psychosocial support
* In addition to Arm 1~* Participants will participate in individual counseling aligned with their monthly clinic visit.~* Individual counseling will use motivational interviewing (MI) techniques, based on the 4-part engaging, focusing, evoking and planning approach for each participant.~* Home visits will be conducted (if warranted/consented for by the participant) by the same trained counselors known to patients.~* Adherence support groups will be facilitated by counselors trained in group facilitation methods; group curriculum will include 6 sessions (monthly, gender specific, structured adherence support groups) that focus on practical topics.~* Discharge planning (if inpatient)~* Community treatment planning (if outpatient)
Other: mHealth
* In addition to Arm 1~* Participants will receive x 2 portable Wisepill devices. (x1 for MDR-TB treatment and x1 for ART).~A Wisepill device is an RT2000 cellular-enabled electronic pill boxes using 2G/3G cellular network.~* Participants will select a text message reminder from a guided menu of choices and receive a weekly text message encouraging adherence.~* Participants will receive a study call to support regular adherence. Participants will be assessed weekly. Less than 85% observed/expected doses will be considered at risk for non-adherence and the intervention will be increased.
Other: mHealth and Psychosocial support
Combination of Arm 2 and Arm 3.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Centre for the AIDS Programme of Research in South Africa
Leads: Columbia University

This content was sourced from clinicaltrials.gov