Back to results

An Adaptive Randomized Controlled Trial (ADAP-TIV)

Primary Purpose

Multi Drug Resistant Tuberculosis, HIV Infections

Status

Not yet recruiting

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Adherence support intevention

About this trial

This is an interventional supportive care trial for Multi Drug Resistant Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

King DinuZulu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Other

Arm Label

Enhanced standard of care

Psychosocial support

mHealth

mHealth and Psychosocial support

Arm Description

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.

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)

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.

Combination of Arm 2 and Arm 3.

Outcomes

Primary Outcome Measures

Biological outcome

TB culture conversion

Clinical outcome

Survival

Biological outcome

HIV viral load

Clinical outcome

Retention in care

Biological outcome

TB culture conversion

Secondary Outcome Measures

Full Information

NCT ID

NCT05633056

First Posted

November 21, 2022

Last Updated

November 21, 2022

Sponsor

Columbia University

Collaborators

Centre for the AIDS Programme of Research in South Africa

1. Study Identification

Unique Protocol Identification Number

NCT05633056

Brief Title

An Adaptive Randomized Controlled Trial

Acronym

ADAP-TIV

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2023 (Anticipated)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

Centre for the AIDS Programme of Research in South Africa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multi Drug Resistant Tuberculosis, HIV Infections

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Enhanced standard of care

Arm Type

No Intervention

Arm Description

Arm Title

Psychosocial support

Arm Type

Other

Arm Description

Arm Title

mHealth

Arm Type

Other

Arm Description

Arm Title

mHealth and Psychosocial support

Arm Type

Other

Arm Description

Combination of Arm 2 and Arm 3.

Intervention Type

Behavioral

Intervention Name(s)

Adherence support intevention

Intervention Description

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

Primary Outcome Measure Information:

Title

Biological outcome

Description

TB culture conversion

Time Frame

06 months

Title

Clinical outcome

Description

Survival

Time Frame

12 months

Title

Biological outcome

Description

HIV viral load

Time Frame

12 months

Title

Clinical outcome

Description

Retention in care

Time Frame

12 months

Title

Biological outcome

Description

TB culture conversion

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kogieleum Naidoo, Prof

Phone

+27 31 260 4687

Kogie.Naidoo@caprisa.org

First Name & Middle Initial & Last Name or Official Title & Degree

Max O'Donnell, Prof

mo2130@columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max O'Donnell, Prof

Organizational Affiliation

University of Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

King DinuZulu Hospital

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4001

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25140958

Citation

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.

Results Reference

background

PubMed Identifier

30846058

Citation

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.

Results Reference

background

PubMed Identifier

33010241

Citation

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.

Results Reference

background

PubMed Identifier

31339676

Citation

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.

Results Reference

background

PubMed Identifier

32060065

Citation

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.

Results Reference

background

PubMed Identifier

32803174

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

32444399

Citation

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.

Results Reference

background

PubMed Identifier

26266773

Citation

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.

Results Reference

background

PubMed Identifier

17044205

Citation

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.

Results Reference

background

PubMed Identifier

31534654

Citation

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.

Results Reference

background

PubMed Identifier

22952439

Citation

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.

Results Reference

background

PubMed Identifier

20582324

Citation

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.

Results Reference

background

PubMed Identifier

32703860

Citation

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.

Results Reference

background

PubMed Identifier

17964351

Citation

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.

Results Reference

background

PubMed Identifier

28099825

Citation

Shah NS, Auld SC, Brust JC, Mathema B, Ismail N, Moodley P, Mlisana K, Allana S, Campbell A, Mthiyane T, Morris N, Mpangase P, van der Meulen H, Omar SV, Brown TS, Narechania A, Shaskina E, Kapwata T, Kreiswirth B, Gandhi NR. Transmission of Extensively Drug-Resistant Tuberculosis in South Africa. N Engl J Med. 2017 Jan 19;376(3):243-253. doi: 10.1056/NEJMoa1604544.

Results Reference

background

PubMed Identifier

24244364

Citation

Adane AA, Alene KA, Koye DN, Zeleke BM. Non-adherence to anti-tuberculosis treatment and determinant factors among patients with tuberculosis in northwest Ethiopia. PLoS One. 2013 Nov 11;8(11):e78791. doi: 10.1371/journal.pone.0078791. eCollection 2013.

Results Reference

background

PubMed Identifier

23634333

Citation

Kulkarni P, Akarte S, Mankeshwar R, Bhawalkar J, Banerjee A, Kulkarni A. Non-adherence of new pulmonary tuberculosis patients to anti-tuberculosis treatment. Ann Med Health Sci Res. 2013 Jan;3(1):67-74. doi: 10.4103/2141-9248.109507.

Results Reference

background

PubMed Identifier

17084757

Citation

Gandhi NR, Moll A, Sturm AW, Pawinski R, Govender T, Lalloo U, Zeller K, Andrews J, Friedland G. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet. 2006 Nov 4;368(9547):1575-80. doi: 10.1016/S0140-6736(06)69573-1.

Results Reference

background

PubMed Identifier

21367734

Citation

Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011 Mar 15;52(6):793-800. doi: 10.1093/cid/ciq243.

Results Reference

background

PubMed Identifier

25941041

Citation

Senthilingam M, Pietersen E, McNerney R, Te Riele J, Sedres P, Wilson R, Dheda K. Lifestyle, attitudes and needs of uncured XDR-TB patients living in the communities of South Africa: a qualitative study. Trop Med Int Health. 2015 Sep;20(9):1155-1161. doi: 10.1111/tmi.12532. Epub 2015 May 18.

Results Reference

background

PubMed Identifier

25035943

Citation

Daftary A, Padayatchi N, O'Donnell M. Preferential adherence to antiretroviral therapy over tuberculosis treatment: a qualitative study of drug-resistant TB/HIV co-infected patients in South Africa. Glob Public Health. 2014;9(9):1107-16. doi: 10.1080/17441692.2014.934266. Epub 2014 Jul 18.

Results Reference

background

PubMed Identifier

22530855

Citation

Daftary A, Padayatchi N. Social constraints to TB/HIV healthcare: accounts from coinfected patients in South Africa. AIDS Care. 2012;24(12):1480-6. doi: 10.1080/09540121.2012.672719. Epub 2012 Apr 24.

Results Reference

background

PubMed Identifier

24633717

Citation

Mansoor LE, Karim QA, Werner L, Madlala B, Ngcobo N, Cornman DH, Amico KR, Fisher J, Fisher WA, Macqueen KM, Karim SS. Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial. AIDS Behav. 2014 May;18(5):841-8. doi: 10.1007/s10461-014-0752-9.

Results Reference

background

PubMed Identifier

21947835

Citation

O'Laughlin KN, Wyatt MA, Kaaya S, Bangsberg DR, Ware NC. How treatment partners help: social analysis of an African adherence support intervention. AIDS Behav. 2012 Jul;16(5):1308-15. doi: 10.1007/s10461-011-0038-4.

Results Reference

background

PubMed Identifier

20202298

Citation

Brust JC, Gandhi NR, Carrara H, Osburn G, Padayatchi N. High treatment failure and default rates for patients with multidrug-resistant tuberculosis in KwaZulu-Natal, South Africa, 2000-2003. Int J Tuberc Lung Dis. 2010 Apr;14(4):413-9.

Results Reference

background

PubMed Identifier

29961879

Citation

Nelson KN, Shah NS, Mathema B, Ismail N, Brust JCM, Brown TS, Auld SC, Omar SV, Morris N, Campbell A, Allana S, Moodley P, Mlisana K, Gandhi NR. Spatial Patterns of Extensively Drug-Resistant Tuberculosis Transmission in KwaZulu-Natal, South Africa. J Infect Dis. 2018 Nov 5;218(12):1964-1973. doi: 10.1093/infdis/jiy394. Erratum In: J Infect Dis. 2019 Jan 9;219(3):509.

Results Reference

background

PubMed Identifier

31659018

Citation

Brown TS, Challagundla L, Baugh EH, Omar SV, Mustaev A, Auld SC, Shah NS, Kreiswirth BN, Brust JCM, Nelson KN, Narechania A, Kurepina N, Mlisana K, Bonneau R, Eldholm V, Ismail N, Kolokotronis SO, Robinson DA, Gandhi NR, Mathema B. Pre-detection history of extensively drug-resistant tuberculosis in KwaZulu-Natal, South Africa. Proc Natl Acad Sci U S A. 2019 Nov 12;116(46):23284-23291. doi: 10.1073/pnas.1906636116. Epub 2019 Oct 28.

Results Reference

background

PubMed Identifier

26162364

Citation

Isaakidis P, Casas EC, Das M, Tseretopoulou X, Ntzani EE, Ford N. Treatment outcomes for HIV and MDR-TB co-infected adults and children: systematic review and meta-analysis. Int J Tuberc Lung Dis. 2015 Aug;19(8):969-78. doi: 10.5588/ijtld.15.0123.

Results Reference

background

PubMed Identifier

32021483

Citation

Singh A, Prasad R, Balasubramanian V, Gupta N. Drug-Resistant Tuberculosis and HIV Infection: Current Perspectives. HIV AIDS (Auckl). 2020 Jan 13;12:9-31. doi: 10.2147/HIV.S193059. eCollection 2020.

Results Reference

background

PubMed Identifier

24195548

Citation

Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

Results Reference

background

PubMed Identifier

29746295

Citation

Vitoria M, Hill A, Ford N, Doherty M, Clayden P, Venter F, Ripin D, Flexner C, Domanico PL. The transition to dolutegravir and other new antiretrovirals in low-income and middle-income countries: what are the issues? AIDS. 2018 Jul 31;32(12):1551-1561. doi: 10.1097/QAD.0000000000001845.

Results Reference

background

PubMed Identifier

30001994

Citation

Schnippel K, Ndjeka N, Maartens G, Meintjes G, Master I, Ismail N, Hughes J, Ferreira H, Padanilam X, Romero R, Te Riele J, Conradie F. Effect of bedaquiline on mortality in South African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir Med. 2018 Sep;6(9):699-706. doi: 10.1016/S2213-2600(18)30235-2. Epub 2018 Jul 11.

Results Reference

background

PubMed Identifier

31082860

Citation

Meireles MV, Pascom ARP, Duarte EC, McFarland W. Comparative effectiveness of first-line antiretroviral therapy: results from a large real-world cohort after the implementation of dolutegravir. AIDS. 2019 Aug 1;33(10):1663-1668. doi: 10.1097/QAD.0000000000002254.

Results Reference

background

PubMed Identifier

29625569

Citation

Howell EM, Kigozi NG, Heunis JC. Community-based directly observed treatment for TB patients to improve HIV services: a cross-sectional study in a South African province. BMC Health Serv Res. 2018 Apr 7;18(1):255. doi: 10.1186/s12913-018-3074-1.

Results Reference

background

PubMed Identifier

11915001

Citation

Mannheimer S, Friedland G, Matts J, Child C, Chesney M. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin Infect Dis. 2002 Apr 15;34(8):1115-21. doi: 10.1086/339074. Epub 2002 Mar 11.

Results Reference

background

PubMed Identifier

29969463

Citation

Alipanah N, Jarlsberg L, Miller C, Linh NN, Falzon D, Jaramillo E, Nahid P. Adherence interventions and outcomes of tuberculosis treatment: A systematic review and meta-analysis of trials and observational studies. PLoS Med. 2018 Jul 3;15(7):e1002595. doi: 10.1371/journal.pmed.1002595. eCollection 2018 Jul.

Results Reference

background

PubMed Identifier

29218008

Citation

Iacob SA, Iacob DG, Jugulete G. Improving the Adherence to Antiretroviral Therapy, a Difficult but Essential Task for a Successful HIV Treatment-Clinical Points of View and Practical Considerations. Front Pharmacol. 2017 Nov 23;8:831. doi: 10.3389/fphar.2017.00831. eCollection 2017.

Results Reference

background

PubMed Identifier

21375681

Citation

van den Boogaard J, Boeree MJ, Kibiki GS, Aarnoutse RE. The complexity of the adherence-response relationship in tuberculosis treatment: why are we still in the dark and how can we get out? Trop Med Int Health. 2011 Jun;16(6):693-8. doi: 10.1111/j.1365-3156.2011.02755.x. Epub 2011 Mar 6.

Results Reference

background

PubMed Identifier

26970149

Citation

O'Donnell MR, Daftary A, Frick M, Hirsch-Moverman Y, Amico KR, Senthilingam M, Wolf A, Metcalfe JZ, Isaakidis P, Davis JL, Zelnick JR, Brust JC, Naidu N, Garretson M, Bangsberg DR, Padayatchi N, Friedland G. Re-inventing adherence: toward a patient-centered model of care for drug-resistant tuberculosis and HIV. Int J Tuberc Lung Dis. 2016 Apr;20(4):430-4. doi: 10.5588/ijtld.15.0360.

Results Reference

background

PubMed Identifier

31513073

Citation

Stephens F, Gandhi NR, Brust JCM, Mlisana K, Moodley P, Allana S, Campbell A, Shah S. Treatment Adherence Among Persons Receiving Concurrent Multidrug-Resistant Tuberculosis and HIV Treatment in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):124-130. doi: 10.1097/QAI.0000000000002120.

Results Reference

background

PubMed Identifier

24872138

Citation

O'Donnell MR, Wolf A, Werner L, Horsburgh CR, Padayatchi N. Adherence in the treatment of patients with extensively drug-resistant tuberculosis and HIV in South Africa: a prospective cohort study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):22-9. doi: 10.1097/QAI.0000000000000221.

Results Reference

background

PubMed Identifier

33740409

Citation

Daftary A, Mondal S, Zelnick J, Friedland G, Seepamore B, Boodhram R, Amico KR, Padayatchi N, O'Donnell MR. Dynamic needs and challenges of people with drug-resistant tuberculosis and HIV in South Africa: a qualitative study. Lancet Glob Health. 2021 Apr;9(4):e479-e488. doi: 10.1016/S2214-109X(20)30548-9.

Results Reference

background

PubMed Identifier

30309972

Citation

Law S, Daftary A, O'Donnell M, Padayatchi N, Calzavara L, Menzies D. Interventions to improve retention-in-care and treatment adherence among patients with drug-resistant tuberculosis: a systematic review. Eur Respir J. 2019 Jan 10;53(1):1801030. doi: 10.1183/13993003.01030-2018. Print 2019 Jan.

Results Reference

background

PubMed Identifier

29642874

Citation

Bionghi N, Daftary A, Maharaj B, Msibi Z, Amico KR, Friedland G, Orrell C, Padayatchi N, O'Donnell MR. Pilot evaluation of a second-generation electronic pill box for adherence to Bedaquiline and antiretroviral therapy in drug-resistant TB/HIV co-infected patients in KwaZulu-Natal, South Africa. BMC Infect Dis. 2018 Apr 11;18(1):171. doi: 10.1186/s12879-018-3080-2.

Results Reference

background

PubMed Identifier

31137959

Citation

MacCarthy S, Mendoza-Graf A, Saya U, Samba C, Birungi J, Okoboi S, Linnemayr S. Lessons learned from a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda. AIDS Care. 2020 May;32(5):616-622. doi: 10.1080/09540121.2019.1622630. Epub 2019 May 28.

Results Reference

background

PubMed Identifier

28630651

Citation

Haberer JE, Sabin L, Amico KR, Orrell C, Galarraga O, Tsai AC, Vreeman RC, Wilson I, Sam-Agudu NA, Blaschke TF, Vrijens B, Mellins CA, Remien RH, Weiser SD, Lowenthal E, Stirratt MJ, Sow PS, Thomas B, Ford N, Mills E, Lester R, Nachega JB, Bwana BM, Ssewamala F, Mbuagbaw L, Munderi P, Geng E, Bangsberg DR. Improving antiretroviral therapy adherence in resource-limited settings at scale: a discussion of interventions and recommendations. J Int AIDS Soc. 2017 Mar 22;20(1):21371. doi: 10.7448/IAS.20.1.21371. eCollection 2017.

Results Reference

background

PubMed Identifier

26959190

Citation

Shaw S, Amico KR. Antiretroviral Therapy Adherence Enhancing Interventions for Adolescents and Young Adults 13-24 Years of Age: A Review of the Evidence Base. J Acquir Immune Defic Syndr. 2016 Aug 1;72(4):387-99. doi: 10.1097/QAI.0000000000000977.

Results Reference

background

PubMed Identifier

29290888

Citation

Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017 Nov 21;11:119-132. doi: 10.2174/1874613601711010119. eCollection 2017.

Results Reference

background

PubMed Identifier

29650504

Citation

Chiang N, Guo M, Amico KR, Atkins L, Lester RT. Interactive Two-Way mHealth Interventions for Improving Medication Adherence: An Evaluation Using The Behaviour Change Wheel Framework. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e87. doi: 10.2196/mhealth.9187.

Results Reference

background

PubMed Identifier

31140445

Citation

Haldane V, Koh JJK, Srivastava A, Teo KWQ, Tan YG, Cheng RX, Yap YC, Ong PS, Van Dam RM, Foo JM, Muller-Riemenschneider F, Koh GC, Foong PS, Perel P, Legido-Quigley H. User Preferences and Persona Design for an mHealth Intervention to Support Adherence to Cardiovascular Disease Medication in Singapore: A Multi-Method Study. JMIR Mhealth Uhealth. 2019 May 28;7(5):e10465. doi: 10.2196/10465.

Results Reference

background

PubMed Identifier

29386174

Citation

Brewer LC, Jenkins S, Lackore K, Johnson J, Jones C, Cooper LA, Radecki Breitkopf C, Hayes SN, Patten C. mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study. JMIR Res Protoc. 2018 Jan 31;7(1):e31. doi: 10.2196/resprot.8842.

Results Reference

background

PubMed Identifier

31653588

Citation

Zhuang Q, Chen F, Wang T. Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies. Prim Care Diabetes. 2020 Aug;14(4):356-363. doi: 10.1016/j.pcd.2019.09.007. Epub 2019 Oct 23.

Results Reference

background

PubMed Identifier

30081390

Citation

Menon V, Selvakumar N, Kattimani S, Andrade C. Therapeutic effects of mobile-based text message reminders for medication adherence in bipolar I disorder: Are they maintained after intervention cessation? J Psychiatr Res. 2018 Sep;104:163-168. doi: 10.1016/j.jpsychires.2018.07.013. Epub 2018 Jul 26.

Results Reference

background

PubMed Identifier

29857410

Citation

Xiao Q, Wang J, Chiang V, Choi T, Wang Y, Sun L, Wu Y. Effectiveness of mHealth Interventions for Asthma Self-Management: A Systematic Review and Meta-Analysis. Stud Health Technol Inform. 2018;250:144-145.

Results Reference

background

PubMed Identifier

29787686

Citation

Schindler-Ruwisch JM, Roess A, Robert RC, Napolitano MA, Chiang S. Social Support for Breastfeeding in the Era of mHealth: A Content Analysis. J Hum Lact. 2018 Aug;34(3):543-555. doi: 10.1177/0890334418773302. Epub 2018 May 22.

Results Reference

background

PubMed Identifier

29581940

Citation

Zelnick JR, Seepamore B, Daftary A, Amico KR, Bhengu X, Friedland G, Padayatchi N, Naidoo K, O'Donnell MR. Training social workers to enhance patient-centered care for drug-resistant TB-HIV in South Africa. Public Health Action. 2018 Mar 21;8(1):25-27. doi: 10.5588/pha.17.0114.

Results Reference

background

PubMed Identifier

32127099

Citation

Rabkin M, Howard AA, Ehrenkranz P, Fernandez LG, Preko P, Singh V, Tomlinson HL, El-Sadr WM. Leveraging differentiated HIV service delivery to expand tuberculosis preventive treatment: a call to action. Int J Tuberc Lung Dis. 2020 Feb 1;24(2):165-169. doi: 10.5588/ijtld.19.0595.

Results Reference

background

PubMed Identifier

33136818

Citation

Ehrenkranz P, Grimsrud A, Holmes CB, Preko P, Rabkin M. Expanding the Vision for Differentiated Service Delivery: A Call for More Inclusive and Truly Patient-Centered Care for People Living With HIV. J Acquir Immune Defic Syndr. 2021 Feb 1;86(2):147-152. doi: 10.1097/QAI.0000000000002549.

Results Reference

background

PubMed Identifier

30394947

Citation

Ehrenkranz P, Grimsrud A, Rabkin M. Differentiated service delivery: navigating the path to scale. Curr Opin HIV AIDS. 2019 Jan;14(1):60-65. doi: 10.1097/COH.0000000000000509.

Results Reference

background

PubMed Identifier

31230342

Citation

Roy M, Bolton Moore C, Sikazwe I, Holmes CB. A Review of Differentiated Service Delivery for HIV Treatment: Effectiveness, Mechanisms, Targeting, and Scale. Curr HIV/AIDS Rep. 2019 Aug;16(4):324-334. doi: 10.1007/s11904-019-00454-5.

Results Reference

background

Citation

E. G. Stigma: notes on the management of spoiled identity. USA: Simons & Schuster, Inc.; 1963

Results Reference

background

PubMed Identifier

26855471

Citation

Pescosolido BA, Martin JK. The Stigma Complex. Annu Rev Sociol. 2015 Aug;41:87-116. doi: 10.1146/annurev-soc-071312-145702. Epub 2015 May 4.

Results Reference

background

PubMed Identifier

12753813

Citation

Parker R, Aggleton P. HIV and AIDS-related stigma and discrimination: a conceptual framework and implications for action. Soc Sci Med. 2003 Jul;57(1):13-24. doi: 10.1016/s0277-9536(02)00304-0.

Results Reference

background

PubMed Identifier

24242268

Citation

Stangl AL, Lloyd JK, Brady LM, Holland CE, Baral S. A systematic review of interventions to reduce HIV-related stigma and discrimination from 2002 to 2013: how far have we come? J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18734. doi: 10.7448/IAS.16.3.18734.

Results Reference

background

PubMed Identifier

27930610

Citation

Hirsch-Moverman Y, Daftary A, Yuengling KA, Saito S, Ntoane M, Frederix K, Maama LB, Howard AA. Using mHealth for HIV/TB Treatment Support in Lesotho: Enhancing Patient-Provider Communication in the START Study. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S37-S43. doi: 10.1097/QAI.0000000000001202.

Results Reference

background

PubMed Identifier

12546115

Citation

Edginton ME, Sekatane CS, Goldstein SJ. Patients' beliefs: do they affect tuberculosis control? A study in a rural district of South Africa. Int J Tuberc Lung Dis. 2002 Dec;6(12):1075-82.

Results Reference

background

PubMed Identifier

22444460

Citation

Daftary A. HIV and tuberculosis: the construction and management of double stigma. Soc Sci Med. 2012 May;74(10):1512-9. doi: 10.1016/j.socscimed.2012.01.027. Epub 2012 Mar 7.

Results Reference

background

PubMed Identifier

17130069

Citation

Nyblade LC. Measuring HIV stigma: existing knowledge and gaps. Psychol Health Med. 2006 Aug;11(3):335-45. doi: 10.1080/13548500600595178.

Results Reference

background

PubMed Identifier

31282997

Citation

Gao J, Su PF, Hu F, Cheung SH. Adaptive treatment allocation for comparative clinical studies with recurrent events data. Biometrics. 2020 Mar;76(1):183-196. doi: 10.1111/biom.13117. Epub 2019 Sep 12.

Results Reference

background

PubMed Identifier

25527071

Citation

Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.

Results Reference

background

PubMed Identifier

25178110

Citation

Lassi ZS, Kumar R, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential interventions: implementation strategies and proposed packages of care. Reprod Health. 2014;11 Suppl 1(Suppl 1):S5. doi: 10.1186/1742-4755-11-S1-S5. Epub 2014 Aug 21.

Results Reference

background

PubMed Identifier

16025549

Citation

Cheung YK, Inoue LY, Wathen JK, Thall PF. Continuous Bayesian adaptive randomization based on event times with covariates. Stat Med. 2006 Jan 15;25(1):55-70. doi: 10.1002/sim.2247.

Results Reference

background

PubMed Identifier

11890331

Citation

Cheung YK, Thall PF. Monitoring the rates of composite events with censored data in phase II clinical trials. Biometrics. 2002 Mar;58(1):89-97. doi: 10.1111/j.0006-341x.2002.00089.x.

Results Reference

background

PubMed Identifier

28726479

Citation

Miller WR, Moyers TB. Motivational interviewing and the clinical science of Carl Rogers. J Consult Clin Psychol. 2017 Aug;85(8):757-766. doi: 10.1037/ccp0000179.

Results Reference

background

PubMed Identifier

30212394

Citation

Yuengling KA, Padayatchi N, Wolf A, Mathema B, Brown T, Horsburgh CR, O'Donnell MR. Effect of Antiretroviral Therapy on Treatment Outcomes in a Prospective Study of Extensively Drug-Resistant Tuberculosis (XDR-TB) HIV Coinfection Treatment in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):474-480. doi: 10.1097/QAI.0000000000001833.

Results Reference

background

PubMed Identifier

17600975

Citation

Visser M, Mundell J, de Villiers A, Sikkema K, Jeffery B. Development of structured support groups for HIV-positive women in South Africa. SAHARA J. 2005 Nov;2(3):333-43. doi: 10.1080/17290376.2005.9724858.

Results Reference

background

Citation

Lennon-Dearing R. The Benefits of Women-Only HIV Support Groups. Journal of HIV/AIDS & Social Services. 2008;7(1):27-45

Results Reference

background

Citation

THOMPSON WR. ON THE LIKELIHOOD THAT ONE UNKNOWN PROBABILITY EXCEEDS ANOTHER IN VIEW OF THE EVIDENCE OF TWO SAMPLES. Biometrika. 1933;25(3-4):285-94.

Results Reference

background

Citation

Moller V, Erstad I. Stigma asociated with tuberculosis in a time of HIV/AIDS: narratives from the Eastern Cape, South Africa. South African Review of Sociology. 2007;38(2):103-19.

Results Reference

background

PubMed Identifier

25320836

Citation

Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK247420/

Results Reference

background

Citation

NIAID Research Agenda Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis. NIAID. 2007.

Results Reference

background

PubMed Identifier

33053186

Citation

Zelnick JR, Daftary A, Hwang C, Labar AS, Boodhram R, Maharaj B, Wolf AK, Mondal S, Amico KR, Orrell C, Seepamore B, Friedland G, Padayatchi N, O'Donnell MR. Electronic Dose Monitoring Identifies a High-Risk Subpopulation in the Treatment of Drug-resistant Tuberculosis and Human Immunodeficiency Virus. Clin Infect Dis. 2021 Oct 5;73(7):e1901-e1910. doi: 10.1093/cid/ciaa1557.

Results Reference

result

Links:

URL

https://www.who.int/teams/global-tuberculosis-programme/the-end-tb-strategy

Description

WHO World Health Organization. The end of TB strategy.2015

Learn more about this trial

An Adaptive Randomized Controlled Trial

We'll reach out to this number within 24 hrs