RecruitingNot Applicable

An Adaptive Randomized Controlled Trial

South Africa360 participantsStarted 2023-03-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Pregnancy
✕. Prisoners
✕. Discretion of IOR or clinician

What they're measuring

Biological outcome

Timeframe: 06 months

Clinical outcome

Timeframe: 12 months

Biological outcome

Timeframe: 12 months

Clinical outcome

Timeframe: 12 months

Biological outcome

Timeframe: 12 months

Trial details

NCT IDNCT05633056

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Kogieleum Naidoo, Prof

+27 31 260 4687 Kogie.Naidoo@caprisa.org

View on ClinicalTrials.gov More Multi Drug Resistant Tuberculosis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Pregnancy
✕. Prisoners
✕. Discretion of IOR or clinician