Comparing different support methods for treating drug-resistant tuberculosis and HIV in South Africa
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
This study is testing four different ways to help adults with drug-resistant tuberculosis and HIV stick to their treatment plans to see which method works best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (Durban, KwaZulu-Natal) |
| Trial ID | NCT05633056 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, adaptive, randomized controlled trial designed to evaluate the effectiveness of four different intervention arms aimed at improving treatment adherence in adults with multi-drug resistant tuberculosis (MDR-TB) and HIV. Participants will be randomized into one of the four arms, which include enhanced standard care, psychosocial support, mHealth with electronic dose monitoring, and a combination of mHealth and psychosocial support. The study will utilize a Bayesian adaptive design, allowing for adjustments based on ongoing assessments of treatment support needs. Participants will be followed for six months during the intervention and monitored telephonically until the end of treatment, with a primary outcome assessed at 12 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who are confirmed to have multi-drug resistant tuberculosis and are also HIV positive, initiating treatment with a Bedaquiline-containing regimen.
Not a fit: Patients who are pregnant, incarcerated, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment adherence and outcomes for patients with MDR-TB and HIV.
How similar studies have performed: Other studies have shown success with similar approaches in improving treatment adherence for HIV and tuberculosis, indicating a promising avenue for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Culture or molecular test positive for MTB 2. Molecular test positive for HIV or a documented HIV positive history 3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB, 4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ 5. 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, 6. Capacity for informed consent in either isiZulu or English Exclusion Criteria: 1. Pregnancy 2. Prisoners 3. Discretion of IOR or clinician
Where this trial is running
Durban, KwaZulu-Natal
- King DinuZulu Hospital — Durban, KwaZulu-Natal, South Africa (Recruiting)
Study contacts
- Principal investigator: Max O'Donnell, Prof — University of Columbia
- Study coordinator: Kogieleum Naidoo, Prof
- Email: Kogie.Naidoo@caprisa.org
- Phone: +27 31 260 4687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.