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Multi Drug Resistant TuberculosisADAP-TIVNCT05633056

An Adaptive Randomized Controlled Trial

A study testing Adherence support intevention in people with Multi Drug Resistant Tuberculosis and HIV Infections, run by Columbia University at 1 site in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Adherence support intevention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteSouth Africa
Study dates
7 Mar 2023to Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Prisoners
  • Discretion of IOR or clinician

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kogieleum Naidoo contact

+27 31 260 4687

Kogie.Naidoo@caprisa.org

Max O'Donnell, MD, MPH contact

mo2130@columbia.edu

South Africa1 site, 1 recruiting

  • King DinuZulu Hospital

    Durban, KwaZulu-Natal, 4001

    Kogieleum Naidoo, +27 31 260 4684, Kogie.Naidoo@caprisa.org

    Max O'Donnell, MD, MPH, mo2130@columbia.edu

    Recruiting

Other trials in South Africa

About this study

Official title: 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 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.

Read the detailed description

This study will follow a 4-arm Bayesian, adaptive trial design. As patients are enrolled, they will be randomized into one of the four arms.

The study will be carried out within a common structure to allow for efficient enrollment and analysis. The overall structure is a 4-arm adaptive platform of mHealth and psychosocial adherence support interventions informed by a differentiated service delivery (DSD) approach.

Aim 1 is an adaptive study of mHealth and psychosocial adherence support interventions using a Bayesian adaptive design to allow comparison of elements of the intervention separately and in combination. Aim 1 participants will be randomized into one of 4 arms and followed monthly through the 6 months of intervention, then through the end of treatment telephonically, with an additional in-person visit to establish the primary outcome. Primary outcome is a combined clinical/biological outcome at 12 months described below. Hypothesis 1a utilizes all participants while 1b utilizes only those in the mHealth intervention arms (3+4) since granular EDM-measured adherence is required.

Being tested
Adherence support intevention
Medical subject headings
Tuberculosis, Multidrug-Resistant, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adherence support inteventionBehavioural

    Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.

Study groups in NCT05633056
Study groupRoleWhat they receive
Enhanced standard of careNo intervention* 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.
Psychosocial supportOther* 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)
Receives: Behavioral: Adherence support intevention
mHealthOther* 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.
Receives: Behavioral: Adherence support intevention
mHealth and Psychosocial supportOtherCombination of Arm 2 and Arm 3.
Receives: Behavioral: Adherence support intevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biological outcome

    TB culture conversion

    Measured: 06 months

  2. Clinical outcome

    Survival

    Measured: 12 months

  3. Biological outcome

    HIV viral load

    Measured: 12 months

  4. Clinical outcome

    Retention in care

    Measured: 12 months

  5. Biological outcome

    TB culture conversion

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start7 Mar 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
An adaptive, randomized controlled trial comparing the effectiveness of 4 adherence support intervention arms. 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.
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633056
Sponsor's protocol ID
AAAT8513
Other IDs
CAP262, 1R01AI167795
Acronym
ADAP-TIV
Status last verified
May 2026
First submitted
21 Nov 2022
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diacon AH, Pym A, Grobusch MP, de los Rios JM, Gotuzzo E, Vasilyeva I, Leimane V, Andries K, Bakare N, De Marez T, Haxaire-Theeuwes M, Lounis N, Meyvisch P, De Paepe E, van Heeswijk RP, Dannemann B; TMC207-C208 Study Group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014 Aug 21;371(8):723-32. doi: 10.1056/NEJMoa1313865.

    PubMed 25140958

  • O'Donnell MR, Padayatchi N, Daftary A, Orrell C, Dooley KE, Rivet Amico K, Friedland G. Antiretroviral switching and bedaquiline treatment of drug-resistant tuberculosis HIV co-infection. Lancet HIV. 2019 Mar;6(3):e201-e204. doi: 10.1016/S2352-3018(19)30035-9.

    PubMed 30846058

  • Calmy A, Tovar Sanchez T, Kouanfack C, Mpoudi-Etame M, Leroy S, Perrineau S, Lantche Wandji M, Tetsa Tata D, Omgba Bassega P, Abong Bwenda T, Varloteaux M, Tongo M, Mpoudi-Ngole E, Montoyo A, Mercier N, LeMoing V, Peeters M, Reynes J, Delaporte E; New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-Income Countries (NAMSAL) ANRS 12313 Study Group. Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon. Lancet HIV. 2020 Oct;7(10):e677-e687. doi: 10.1016/S2352-3018(20)30238-1.

    PubMed 33010241

  • NAMSAL ANRS 12313 Study Group; Kouanfack C, Mpoudi-Etame M, Omgba Bassega P, Eymard-Duvernay S, Leroy S, Boyer S, Peeters M, Calmy A, Delaporte E. Dolutegravir-Based or Low-Dose Efavirenz-Based Regimen for the Treatment of HIV-1. N Engl J Med. 2019 Aug 29;381(9):816-826. doi: 10.1056/NEJMoa1904340. Epub 2019 Jul 24.

    PubMed 31339676

  • Nimmo C, Millard J, Brien K, Moodley S, van Dorp L, Lutchminarain K, Wolf A, Grant AD, Balloux F, Pym AS, Padayatchi N, O'Donnell M. Bedaquiline resistance in drug-resistant tuberculosis HIV co-infected patients. Eur Respir J. 2020 Jun 4;55(6):1902383. doi: 10.1183/13993003.02383-2019. Print 2020 Jun.

    PubMed 32060065

  • Nimmo C, Millard J, van Dorp L, Brien K, Moodley S, Wolf A, Grant AD, Padayatchi N, Pym AS, Balloux F, O'Donnell M. Population-level emergence of bedaquiline and clofazimine resistance-associated variants among patients with drug-resistant tuberculosis in southern Africa: a phenotypic and phylogenetic analysis. Lancet Microbe. 2020 Aug;1(4):e165-e174. doi: 10.1016/S2666-5247(20)30031-8.

    PubMed 32803174

  • WHO. World Health Organization. Global tuberculosis report 2020. 2020.

  • Saunders MJ, Evans CA. COVID-19, tuberculosis and poverty: preventing a perfect storm. Eur Respir J. 2020 Jul 9;56(1):2001348. doi: 10.1183/13993003.01348-2020. Print 2020 Jul.

    PubMed 32444399

  • Gupta RK, Lucas SB, Fielding KL, Lawn SD. Prevalence of tuberculosis in post-mortem studies of HIV-infected adults and children in resource-limited settings: a systematic review and meta-analysis. AIDS. 2015 Sep 24;29(15):1987-2002. doi: 10.1097/QAD.0000000000000802.

    PubMed 26266773

  • Zellweger JP, Heinzer R, Touray M, Vidondo B, Altpeter E. Intra-observer and overall agreement in the radiological assessment of tuberculosis. Int J Tuberc Lung Dis. 2006 Oct;10(10):1123-6.

    PubMed 17044205

  • Mabhula A, Singh V. Drug-resistance in Mycobacterium tuberculosis: where we stand. Medchemcomm. 2019 Jun 11;10(8):1342-1360. doi: 10.1039/c9md00057g. eCollection 2019 Aug 1.

    PubMed 31534654

  • Ahuja SD, Ashkin D, Avendano M, Banerjee R, Bauer M, Bayona JN, Becerra MC, Benedetti A, Burgos M, Centis R, Chan ED, Chiang CY, Cox H, D'Ambrosio L, DeRiemer K, Dung NH, Enarson D, Falzon D, Flanagan K, Flood J, Garcia-Garcia ML, Gandhi N, Granich RM, Hollm-Delgado MG, Holtz TH, Iseman MD, Jarlsberg LG, Keshavjee S, Kim HR, Koh WJ, Lancaster J, Lange C, de Lange WC, Leimane V, Leung CC, Li J, Menzies D, Migliori GB, Mishustin SP, Mitnick CD, Narita M, O'Riordan P, Pai M, Palmero D, Park SK, Pasvol G, Pena J, Perez-Guzman C, Quelapio MI, Ponce-de-Leon A, Riekstina V, Robert J, Royce S, Schaaf HS, Seung KJ, Shah L, Shim TS, Shin SS, Shiraishi Y, Sifuentes-Osornio J, Sotgiu G, Strand MJ, Tabarsi P, Tupasi TE, van Altena R, Van der Walt M, Van der Werf TS, Vargas MH, Viiklepp P, Westenhouse J, Yew WW, Yim JJ; Collaborative Group for Meta-Analysis of Individual Patient Data in MDR-TB. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patients. PLoS Med. 2012;9(8):e1001300. doi: 10.1371/journal.pmed.1001300. Epub 2012 Aug 28.

    PubMed 22952439

  • Cohen T, Murray M, Wallengren K, Alvarez GG, Samuel EY, Wilson D. The prevalence and drug sensitivity of tuberculosis among patients dying in hospital in KwaZulu-Natal, South Africa: a postmortem study. PLoS Med. 2010 Jun 22;7(6):e1000296. doi: 10.1371/journal.pmed.1000296.

    PubMed 20582324

  • Abdool Karim Q, Abdool Karim SS. COVID-19 affects HIV and tuberculosis care. Science. 2020 Jul 24;369(6502):366-368. doi: 10.1126/science.abd1072. No abstract available.

    PubMed 32703860

  • Basu S, Andrews JR, Poolman EM, Gandhi NR, Shah NS, Moll A, Moodley P, Galvani AP, Friedland GH. Prevention of nosocomial transmission of extensively drug-resistant tuberculosis in rural South African district hospitals: an epidemiological modelling study. Lancet. 2007 Oct 27;370(9597):1500-7. doi: 10.1016/S0140-6736(07)61636-5.

    PubMed 17964351

Questions about this trial

What is this clinical trial studying?

A study testing Adherence support intevention in people with Multi Drug Resistant Tuberculosis and HIV Infections, run by Columbia University at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kogieleum Naidoo (+27 31 260 4687, Kogie.Naidoo@caprisa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological outcome (time frame: 06 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05633056, which also lists 84 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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