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| ID | Type | Description | Link |
|---|---|---|---|
| CAP262 | Other Identifier | University of KwaZulu Natal-Biomedical Research Ethics Committee | |
| 1R01AI167795 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centre for the AIDS Programme of Research in South Africa | NETWORK |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced standard of care | No Intervention |
| |
| Psychosocial support | Other |
|
|
| mHealth | Other |
A Wisepill device is an RT2000 cellular-enabled electronic pill boxes using 2G/3G cellular network.
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence support intevention | Behavioral | Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biological outcome | TB culture conversion | 06 months |
| Clinical outcome | Survival | 12 months |
| Biological outcome | HIV viral load | 12 months |
| Clinical outcome | Retention in care | 12 months |
| Biological outcome | TB culture conversion | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kogieleum Naidoo | Contact | +27 31 260 4687 | Kogie.Naidoo@caprisa.org | |
| Max O'Donnell, MD, MPH | Contact | mo2130@columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Max O'Donnell, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King DinuZulu Hospital | Recruiting | Durban | KwaZulu-Natal | 4001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25140958 | Background | 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. | |
| 30846058 | Background | 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. |
| Label | URL |
|---|---|
| WHO World Health Organization. The end of TB strategy.2015 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: Informed Consent Form-English | Apr 8, 2022 | Nov 21, 2022 | Prot_ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: English version | Apr 8, 2022 | Nov 21, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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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.
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|
| mHealth and Psychosocial support | Other | Combination of Arm 2 and Arm 3. |
|
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| 27930610 | Background | 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. |
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| 22444460 | Background | 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. |
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| 31282997 | Background | 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. |
| 25527071 | Background | 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. |
| 25178110 | Background | 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. |
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| 28726479 | Background | 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. |
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| Background | 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. |
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| 33053186 | Result | 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. |
| 38037105 | Derived | Ross J, Perumal R, Wolf A, Zulu M, Guzman K, Seepamore B, Reis K, Nyilana H, Hlathi S, Narasimmulu R, Cheung YKK, Amico KR, Friedland G, Daftary A, Zelnick JR, Naidoo K, O'Donnell MR. Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa (ADAP-TIV): study protocol for an adaptive randomized controlled trial. Trials. 2023 Dec 1;24(1):776. doi: 10.1186/s13063-023-07520-9. |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |