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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL144406 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Makerere University | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
| University of Colorado, Denver | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial. This hybrid effectiveness-implementation trial will be conducted among people living with HIV infection (PLHIV) enrolled in HIV/AIDS care at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. The overall objective of this study is to identify a patient-centered delivery strategy that will facilitate acceptance and completion of a three-month (12-dose) regimen of weekly rifapentine (RPT) and isoniazid (INH) by PLHIV enrolled in routine HIV/AIDS care in a high HIV/TB burden country. The primary outcome will be acceptance and completion of 3HP. Additional objectives will be to evaluate the implementation and cost-effectiveness of each delivery strategy.
The overall objective of this study is to identify a patient-centered strategy that will facilitate 3HP uptake by PLHIV in the context of routine HIV/AIDS care in a high HIV/TB burden country. The investigators' central hypothesis is that offering PLHIV an informed choice between directly observed therapy (DOT) and self-administered therapy (SAT) delivery strategies that are optimized to overcome key barriers to treatment adherence will result in greater acceptance and completion of 3HP. To test this hypothesis, the investigators will conduct a pragmatic randomized trial of three optimized strategies for delivering 3HP. Eligible participants will be randomized to one of three arms to receive latent tuberculosis infection (LTBI) treatment with once weekly INH and RPT for 12 weeks given by either facilitated DOT, facilitated SAT, or an informed choice between facilitated DOT and facilitated SAT (with the assistance of a decision aid tool).
Primary Objective: To compare the uptake of 3HP under three delivery strategies: 1) Facilitated DOT; 2) Facilitated SAT; and 3) Informed patient choice (using a decision aid) between facilitated DOT and facilitated SAT. The primary outcome will be defined as the proportion of eligible participants who accept treatment and take at least 11 of 12 doses of RPT/INH within 16 weeks of treatment initiation. Study staff will assess medication dosing using clinic records for participants taking 3HP by DOT and using a combination of 99DOTS (Everwell Health Solutions, India) digital medication adherence technology records and pill counts at refill visits for participants taking 3HP by SAT.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facilitated Directly Observed Therapy (DOT) | Experimental | Facilitated DOT arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. |
|
| Facilitated Self-Administered Therapy (SAT) | Experimental | Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streamlined weekly DOT visits | Other | Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Accepted and Completed 3HP | The count of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of rifapentine (RPT)/isoniazid (INH) within 16 weeks of treatment initiation divided by the count of those randomized. | Within 16 weeks of treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Accepted 3HP Treatment | The count of eligible people living with HIV (PLHIV) offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression) divided by the count of those randomized. | Within 16 weeks of treatment initiation |
| Proportion of Participants Who Completed 3HP Treatment |
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Inclusion Criteria:
Exclusion Criteria:
Mixed methods and health economic sub-studies will include a subset of participants enrolled in the trial, as well as clinic administrators and clinicians (clinical officer, doctor, nurse or pharmacist) involved in 3HP delivery at the Mulago ISS clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Adithya Cattamanchi, MD | University of California, San Francisco | Principal Investigator |
| David W Dowdy, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Immune Suppression Syndrome (ISS) Clinic | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26193126 | Background | TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20. | |
| 23244049 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Facilitated Directly Observed Therapy (DOT) | Facilitated directly observed therapy (DOT) arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2023 | Sep 27, 2023 |
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| NIH |
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| Patient Choice between facilitated DOT and facilitated SAT |
| Experimental |
Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. |
|
| Weekly DOT visit reminders | Other | Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits |
|
| Cost reimbursement DOT | Other | Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) |
|
| 99DOTS | Other | 99DOTS-based digital adherence technology to monitor and promote adherence |
|
| Weekly SAT dosing reminders/check-ins | Other | Weekly SMS or IVR phone call dosing reminder/check-in for side effects |
|
| Cost reimbursement SAT | Other | Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
|
Count of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation divided by the count those who take at least one dose of 3HP. |
| Within 16 weeks of treatment initiation |
| Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | Count of participants for whom treatment is discontinued due to adverse events or intolerance divided by the count of those who initiated 3HP. | Within 16 weeks of treatment initiation |
| Cumulative Incidence of Tuberculosis (TB) | Cumulative 16-month incidence of active TB in each arm | from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 12-month post-treatment follow-up period |
| Cumulative Incidence of TB | Cumulative 28-month incidence of active TB in each arm | from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 24-month post-treatment follow-up period |
| Cost Effectiveness (Patient Perspective) | The incremental patient cost per disability-adjusted life year (DALY) averted. | At the conclusion of the study period, estimated 3 years |
| Cost Effectiveness (Health System Perspective) | The incremental health system cost per disability-adjusted life year (DALY) averted. | At the conclusion of the study period, estimated 3 years |
| Cost Effectiveness (Overall Perspective) | Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted. | At the conclusion of the study period, estimated 3 years |
| Visit Cost Reimbursement - Overall | Proportion reimbursed overall | Through study completion, an average of 16 weeks |
| Visit Cost Reimbursement | Proportion reimbursed on the same day as each 3HP clinic visit | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Time to Complete Clinic Visit - Mean Minutes | Mean number of minutes for each DOT/refill visit | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Time to Complete Clinic Visit - Median Minutes | Median number of minutes for each DOT/refill visit | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Short Messages Service (SMS) or Interactive Voice Response (IVR) Phone Call Reminders Delivered - Clinic Visits | Proportion of SMS or IVR phone call reminders delivered to participants for clinic visits | The day before each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Screening for Active TB | Proportion of participants screened for active TB during DOT or refill visits | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Screening for Side Effects | Proportion of participants screened for side effects during DOT or refill visits. | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks |
| Dosing Confirmation Via 99DOTS (SAT Only) | Proportion of doses confirmed using digital adherence technology. Doses directly observed (i.e., during initial or refill visits) will not be included in the denominator. | On the same day as each scheduled dose throughout study completion, an average of 16 weeks |
| SMS or IVR Phone Call Reminders Delivered - Medication Dosing (SAT Only) | Proportion of SMS or IVR phone call reminders delivered to participants for medication dosing | The day before each scheduled dose throughout study completion, an average of 16 weeks |
| SMS or IVR Phone Calls Delivered - Weekly check-in (SAT Only) | Proportion of weekly SMS or IVR phone call check-ins delivered to participants | On the same day as each scheduled dose throughout study completion, an average of 16 weeks |
| SMS or IVR Phone Call Reminders Delivered - Missed Dose (SAT Only) | Proportion of SMS or IVR phone call reminders delivered to participants following missed doses | 24 hours after missed scheduled dose throughout study completion, an average of 16 weeks |
| SMS or IVR Phone Call Missed Appointment Reminders Delivered | Proportion of SMS or IVR phone call reminders delivered to participants following missed appointments | 24 hours after missed scheduled appointment throughout study completion, an average of 16 weeks |
| Follow up (Phone Calls or Home Visits) for Negative Response to Weekly SMS or IVR Phone Call check-in (SAT Only) | Proportion of participants who receive appropriate follow-up (phone call or home visit) for lack of response/negative response to weekly check-in SMS or IVR phone call | 24 hours after negative response throughout study completion, an average of 16 weeks |
| Costs of Preventive Services | Mean total participant costs related to TB preventive care services | Through study completion, an average of 16 weeks |
| Participant Satisfaction | Mean score on participant satisfaction questionnaire | Through study completion, an average of 16 weeks |
| Barriers to 3HP Delivery From the Provider/Clinic Perspective | Thematic interpretation of provider- and clinic-level barriers to care from provider focus group discussions. | At the conclusion of the study period, estimated 3 years |
| Barriers to 3HP Completion From the Patient Perspective | Thematic interpretation of barriers to 3HP completion from patient interviews | Through study completion, an average of 16 weeks |
| Background |
| Dye C, Glaziou P, Floyd K, Raviglione M. Prospects for tuberculosis elimination. Annu Rev Public Health. 2013;34:271-86. doi: 10.1146/annurev-publhealth-031912-114431. Epub 2012 Dec 14. |
| 21079430 | Background | Getahun H, Granich R, Sculier D, Gunneberg C, Blanc L, Nunn P, Raviglione M. Implementation of isoniazid preventive therapy for people living with HIV worldwide: barriers and solutions. AIDS. 2010 Nov;24 Suppl 5:S57-65. doi: 10.1097/01.aids.0000391023.03037.1f. No abstract available. |
| 22154974 | Background | Namuwenge PM, Mukonzo JK, Kiwanuka N, Wanyenze R, Byaruhanga R, Bissell K, Zachariah R. Loss to follow up from isoniazid preventive therapy among adults attending HIV voluntary counseling and testing sites in Uganda. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):84-9. doi: 10.1016/j.trstmh.2011.10.015. Epub 2011 Dec 10. |
| 21732833 | Background | Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011 Jul 7;365(1):11-20. doi: 10.1056/NEJMoa1005136. |
| 22150035 | Background | Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875. |
| 26082504 | Background | Podany AT, Bao Y, Swindells S, Chaisson RE, Andersen JW, Mwelase T, Supparatpinyo K, Mohapi L, Gupta A, Benson CA, Kim P, Fletcher CV; AIDS Clinical Trials Group A5279 Study Team. Efavirenz Pharmacokinetics and Pharmacodynamics in HIV-Infected Persons Receiving Rifapentine and Isoniazid for Tuberculosis Prevention. Clin Infect Dis. 2015 Oct 15;61(8):1322-7. doi: 10.1093/cid/civ464. Epub 2015 Jun 16. |
| 24343893 | Background | Weiner M, Egelund EF, Engle M, Kiser M, Prihoda TJ, Gelfond JA, Mac Kenzie W, Peloquin CA. Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers. J Antimicrob Chemother. 2014 Apr;69(4):1079-85. doi: 10.1093/jac/dkt483. Epub 2013 Dec 15. |
| 30865794 | Background | Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz J, Mwelase N, Jean Juste MA, Lama JR, Valencia J, Omoz-Oarhe A, Supparatpinyo K, Masheto G, Mohapi L, da Silva Escada RO, Mawlana S, Banda P, Severe P, Hakim J, Kanyama C, Langat D, Moran L, Andersen J, Fletcher CV, Nuermberger E, Chaisson RE; BRIEF TB/A5279 Study Team. One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis. N Engl J Med. 2019 Mar 14;380(11):1001-1011. doi: 10.1056/NEJMoa1806808. |
| 29114781 | Background | Belknap R, Holland D, Feng PJ, Millet JP, Cayla JA, Martinson NA, Wright A, Chen MP, Moro RN, Scott NA, Arevalo B, Miro JM, Villarino ME, Weiner M, Borisov AS; TB Trials Consortium iAdhere Study Team. Self-administered Versus Directly Observed Once-Weekly Isoniazid and Rifapentine Treatment of Latent Tuberculosis Infection: A Randomized Trial. Ann Intern Med. 2017 Nov 21;167(10):689-697. doi: 10.7326/M17-1150. Epub 2017 Nov 7. |
| 28946683 | Background | Liu X, Blaschke T, Thomas B, De Geest S, Jiang S, Gao Y, Li X, Buono EW, Buchanan S, Zhang Z, Huan S. Usability of a Medication Event Reminder Monitor System (MERM) by Providers and Patients to Improve Adherence in the Management of Tuberculosis. Int J Environ Res Public Health. 2017 Sep 25;14(10):1115. doi: 10.3390/ijerph14101115. |
| 25057539 | Background | Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/ |
| 9032835 | Background | Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997 Mar;44(5):681-92. doi: 10.1016/s0277-9536(96)00221-3. |
| 18418028 | Background | Joosten EA, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CP, de Jong CA. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77(4):219-26. doi: 10.1159/000126073. Epub 2008 Apr 16. |
| 28402085 | Background | Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. |
| 16005784 | Background | Epstein RM, Franks P, Fiscella K, Shields CG, Meldrum SC, Kravitz RL, Duberstein PR. Measuring patient-centered communication in patient-physician consultations: theoretical and practical issues. Soc Sci Med. 2005 Oct;61(7):1516-28. doi: 10.1016/j.socscimed.2005.02.001. Epub 2005 Apr 15. |
| 24736389 | Background | Durand MA, Carpenter L, Dolan H, Bravo P, Mann M, Bunn F, Elwyn G. Do interventions designed to support shared decision-making reduce health inequalities? A systematic review and meta-analysis. PLoS One. 2014 Apr 15;9(4):e94670. doi: 10.1371/journal.pone.0094670. eCollection 2014. |
| 10487995 | Background | O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. doi: 10.1136/bmj.319.7212.731. |
| 25883405 | Background | Marseille E, Larson B, Kazi DS, Kahn JG, Rosen S. Thresholds for the cost-effectiveness of interventions: alternative approaches. Bull World Health Organ. 2015 Feb 1;93(2):118-24. doi: 10.2471/BLT.14.138206. Epub 2014 Dec 15. |
| 20519452 | Background | Oxlade O, Schwartzman K, Benedetti A, Pai M, Heymann J, Menzies D. Developing a tuberculosis transmission model that accounts for changes in population health. Med Decis Making. 2011 Jan-Feb;31(1):53-68. doi: 10.1177/0272989X10369001. Epub 2010 Jun 2. |
| 21762236 | Background | Dowdy DW, Rodriguez RM, Hare CB, Kaplan B. Cost-effectiveness of targeted human immunodeficiency virus screening in an urban emergency department. Acad Emerg Med. 2011 Jul;18(7):745-53. doi: 10.1111/j.1553-2712.2011.01110.x. |
| 21492926 | Background | Samandari T, Agizew TB, Nyirenda S, Tedla Z, Sibanda T, Shang N, Mosimaneotsile B, Motsamai OI, Bozeman L, Davis MK, Talbot EA, Moeti TL, Moffat HJ, Kilmarx PH, Castro KG, Wells CD. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 May 7;377(9777):1588-98. doi: 10.1016/S0140-6736(11)60204-3. Epub 2011 Apr 12. |
| 25189546 | Background | Dowdy DW, Houben R, Cohen T, Pai M, Cobelens F, Vassall A, Menzies NA, Gomez GB, Langley I, Squire SB, White R; TB MAC meeting participants. Impact and cost-effectiveness of current and future tuberculosis diagnostics: the contribution of modelling. Int J Tuberc Lung Dis. 2014 Sep;18(9):1012-8. doi: 10.5588/ijtld.13.0851. |
| 23185139 | Background | Menzies NA, Cohen T, Lin HH, Murray M, Salomon JA. Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation. PLoS Med. 2012;9(11):e1001347. doi: 10.1371/journal.pmed.1001347. Epub 2012 Nov 20. |
| 22745362 | Background | Sandelowski M, Leeman J. Writing usable qualitative health research findings. Qual Health Res. 2012 Oct;22(10):1404-13. doi: 10.1177/1049732312450368. Epub 2012 Jun 28. |
| 18288640 | Background | Sandelowski MJ. Justifying qualitative research. Res Nurs Health. 2008 Jun;31(3):193-5. doi: 10.1002/nur.20272. No abstract available. |
| 18677415 | Background | Voils CI, Sandelowski M, Barroso J, Hasselblad V. Making Sense of Qualitative and Quantitative Findings in Mixed Research Synthesis Studies. Field methods. 2008;20(1):3-25. doi: 10.1177/1525822X07307463. |
| 15987728 | Background | Spiegelman D, Hertzmark E. Easy SAS calculations for risk or prevalence ratios and differences. Am J Epidemiol. 2005 Aug 1;162(3):199-200. doi: 10.1093/aje/kwi188. Epub 2005 Jun 29. No abstract available. |
| 39582503 | Derived | Kadota JL, Musinguzi A, Aschmann HE, Akello L, Welishe F, Nakimuli J, Berger CA, Kiwanuka N, Phillips PPJ, Katamba A, Dowdy DW, Cattamanchi A, Semitala FC. Adverse Events Reported During Weekly Isoniazid-Rifapentine (3HP) Tuberculosis Preventive Treatment Among People With Human Immunodeficiency Virus in Uganda. Open Forum Infect Dis. 2024 Nov 14;11(11):ofae667. doi: 10.1093/ofid/ofae667. eCollection 2024 Nov. |
| 39446746 | Derived | Musinguzi A, Kasidi JR, Kadota JL, Welishe F, Nakitende A, Akello L, Nakimuli J, Kunihira LT, Opira B, Baik Y, Patel D, Sammann A, Berger CA, Aschmann HE, Nahid P, Belknap R, Kamya MR, Handley MA, Phillips PPJ, Kiwanuka N, Katamba A, Dowdy DW, Cattamanchi A, Semitala FC, Katahoire AR. Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial. PLOS Glob Public Health. 2024 Oct 24;4(10):e0003347. doi: 10.1371/journal.pgph.0003347. eCollection 2024. |
| 38377166 | Derived | Semitala FC, Kadota JL, Musinguzi A, Welishe F, Nakitende A, Akello L, Kunihira Tinka L, Nakimuli J, Ritar Kasidi J, Bishop O, Nakasendwa S, Baik Y, Patel D, Sammann A, Nahid P, Belknap R, Kamya MR, Handley MA, Phillips PP, Katahoire A, Berger CA, Kiwanuka N, Katamba A, Dowdy DW, Cattamanchi A. Comparison of 3 optimized delivery strategies for completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV in Uganda: A single-center randomized trial. PLoS Med. 2024 Feb 20;21(2):e1004356. doi: 10.1371/journal.pmed.1004356. eCollection 2024 Feb. |
| 34914696 | Derived | Semitala FC, Kadota JL, Musinguzi A, Nabunje J, Welishe F, Nakitende A, Akello L, Bishop O, Patel D, Sammann A, Nahid P, Belknap R, Kamya MR, Handley MA, Phillips PPJ, Katahoire A, Berger CA, Kiwanuka N, Katamba A, Dowdy DW, Cattamanchi A. Completion of isoniazid-rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness-implementation randomized trial. PLoS Med. 2021 Dec 16;18(12):e1003875. doi: 10.1371/journal.pmed.1003875. eCollection 2021 Dec. |
| 32787925 | Derived | Kadota JL, Musinguzi A, Nabunje J, Welishe F, Ssemata JL, Bishop O, Berger CA, Patel D, Sammann A, Katahoire A, Nahid P, Belknap R, Phillips PPJ, Namusobya J, Kamya M, Handley MA, Kiwanuka N, Katamba A, Dowdy D, Semitala FC, Cattamanchi A. Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda. Implement Sci. 2020 Aug 12;15(1):65. doi: 10.1186/s13012-020-01025-8. |
| FG001 | Facilitated Self-Administered Therapy (SAT) | Facilitated self-administered therapy (SAT) participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| FG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
1 participant in the DOT arm was excluded as a duplicate enrollment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Facilitated Directly Observed Therapy (DOT) | Facilitated DOT arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) |
| BG001 | Facilitated Self-Administered Therapy (SAT) | Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| BG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Prior Tuberculosis | Count of Participants | Participants |
| ||||||||||||||||
| Time on Antiretroviral therapy (ART) | Median | Inter-Quartile Range | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Accepted and Completed 3HP | The count of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of rifapentine (RPT)/isoniazid (INH) within 16 weeks of treatment initiation divided by the count of those randomized. | 1,656 people were eligible and randomized. One participant was erroneously re-randomized (facilitated DOT arm) after an initial enrollment; data from their second randomization was excluded. 1,655 were included in the primary outcome analysis. | Posted | Number | proportion of participants | No | Within 16 weeks of treatment initiation |
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|
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Accepted 3HP Treatment | The count of eligible people living with HIV (PLHIV) offered 3HP who accept to initiate treatment (by age, gender, CD4 stratum, viral load suppression) divided by the count of those randomized. | 1,656 people were eligible and randomized. One participant was erroneously re-randomized (facilitated DOT arm) after an initial enrollment; data from their second randomization was excluded. 1,655 were included in this secondary outcome analysis. | Posted | Number | proportion of participants | No | Within 16 weeks of treatment initiation |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Completed 3HP Treatment | Count of participants who take at least 11 of 12 doses within 16 weeks of treatment initiation divided by the count those who take at least one dose of 3HP. | Those analyzed included the number of participants who took at least one dose of 3HP. | Posted | Number | proportion of participants | No | Within 16 weeks of treatment initiation |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of People Who Discontinued 3HP Treatment Due to Adverse Events/Intolerance | Count of participants for whom treatment is discontinued due to adverse events or intolerance divided by the count of those who initiated 3HP. | Those analyzed included the number of participants who took at least one dose of 3HP. | Posted | Number | proportion of participants | No | Within 16 weeks of treatment initiation |
| |||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Tuberculosis (TB) | Cumulative 16-month incidence of active TB in each arm | Not Posted | from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 12-month post-treatment follow-up period | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of TB | Cumulative 28-month incidence of active TB in each arm | Not Posted | from date of 3HP treatment completion (11/12 doses) or once reached 16 weeks (regardless of number of doses taken) until time of active TB diagnosis or treatment initiation, death, loss to follow-up or end of the 24-month post-treatment follow-up period | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness (Patient Perspective) | The incremental patient cost per disability-adjusted life year (DALY) averted. | Not Posted | At the conclusion of the study period, estimated 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness (Health System Perspective) | The incremental health system cost per disability-adjusted life year (DALY) averted. | Not Posted | At the conclusion of the study period, estimated 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness (Overall Perspective) | Incremental cost of each delivery strategy per disability adjusted life year (DALY) averted. | Not Posted | At the conclusion of the study period, estimated 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Visit Cost Reimbursement - Overall | Proportion reimbursed overall | Not Posted | Through study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Visit Cost Reimbursement | Proportion reimbursed on the same day as each 3HP clinic visit | Not Posted | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Complete Clinic Visit - Mean Minutes | Mean number of minutes for each DOT/refill visit | Not Posted | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Complete Clinic Visit - Median Minutes | Median number of minutes for each DOT/refill visit | Not Posted | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Short Messages Service (SMS) or Interactive Voice Response (IVR) Phone Call Reminders Delivered - Clinic Visits | Proportion of SMS or IVR phone call reminders delivered to participants for clinic visits | Not Posted | The day before each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Screening for Active TB | Proportion of participants screened for active TB during DOT or refill visits | Not Posted | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Screening for Side Effects | Proportion of participants screened for side effects during DOT or refill visits. | Not Posted | On the same day as each 3HP clinic visit throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Dosing Confirmation Via 99DOTS (SAT Only) | Proportion of doses confirmed using digital adherence technology. Doses directly observed (i.e., during initial or refill visits) will not be included in the denominator. | Not Posted | On the same day as each scheduled dose throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | SMS or IVR Phone Call Reminders Delivered - Medication Dosing (SAT Only) | Proportion of SMS or IVR phone call reminders delivered to participants for medication dosing | Not Posted | The day before each scheduled dose throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | SMS or IVR Phone Calls Delivered - Weekly check-in (SAT Only) | Proportion of weekly SMS or IVR phone call check-ins delivered to participants | Not Posted | On the same day as each scheduled dose throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | SMS or IVR Phone Call Reminders Delivered - Missed Dose (SAT Only) | Proportion of SMS or IVR phone call reminders delivered to participants following missed doses | Not Posted | 24 hours after missed scheduled dose throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | SMS or IVR Phone Call Missed Appointment Reminders Delivered | Proportion of SMS or IVR phone call reminders delivered to participants following missed appointments | Not Posted | 24 hours after missed scheduled appointment throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Follow up (Phone Calls or Home Visits) for Negative Response to Weekly SMS or IVR Phone Call check-in (SAT Only) | Proportion of participants who receive appropriate follow-up (phone call or home visit) for lack of response/negative response to weekly check-in SMS or IVR phone call | Not Posted | 24 hours after negative response throughout study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Costs of Preventive Services | Mean total participant costs related to TB preventive care services | Not Posted | Through study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Participant Satisfaction | Mean score on participant satisfaction questionnaire | Not Posted | Through study completion, an average of 16 weeks | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Barriers to 3HP Delivery From the Provider/Clinic Perspective | Thematic interpretation of provider- and clinic-level barriers to care from provider focus group discussions. | Not Posted | At the conclusion of the study period, estimated 3 years | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Barriers to 3HP Completion From the Patient Perspective | Thematic interpretation of barriers to 3HP completion from patient interviews | Not Posted | Through study completion, an average of 16 weeks | Participants |
Adverse events were collected weekly over the course of 3HP treatment duration (up to 16 weeks after treatment initiation)
Adverse Events (AE) pre-specified to be reported according to participant randomization; AEs were not reported with respect to the specific intervention received by the participant in the "Patient Choice Between Facilitated DOT and Facilitated SAT" Arm, only the randomization group.
Facilitated DOT: weekly in-person by pharmacy technician using standard checklist. Facilitated SAT: dose 2-5 & 7-11: two-way interactive voice response phone calls; dose 6 & 12: in-person using standard checklist
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Facilitated Directly Observed Therapy (DOT) | Facilitated DOT arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) | 1 | 551 | 3 | 551 | 83 | 551 |
| EG001 | Facilitated Self-Administered Therapy (SAT) | Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) | 0 | 552 | 7 | 552 | 86 | 552 |
| EG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) | 0 | 552 | 4 | 552 | 76 | 552 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalized pruritus/skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hearing impairment | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
| ||
| 3HP-related hypersensitivity | General disorders | Systematic Assessment |
| ||
| Flu-like syndrome | General disorders | Systematic Assessment |
| ||
| Toxic Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Venous thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
| ||
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Adithya Cattamanchi | University of California Irvine | 415-206-5489 | adithya.cattamanchi@uci.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2022 | Sep 27, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2021 | Sep 27, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D055985 | Latent Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
| D015658 | HIV 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Facilitated Self-Administered Therapy (SAT) | Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| OG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
|
|
| OG001 |
| Facilitated Self-Administered Therapy (SAT) |
Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| OG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
|
|
| OG001 |
| Facilitated Self-Administered Therapy (SAT) |
Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment. 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
| OG002 | Patient Choice Between Facilitated DOT and Facilitated SAT | Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded. Streamlined weekly DOT visits: Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects Weekly DOT visit reminders: Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits Cost reimbursement DOT: Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12) 99DOTS: 99DOTS-based digital adherence technology to monitor and promote adherence Weekly SAT dosing reminders/check-ins: Weekly SMS or IVR phone call dosing reminder/check-in for side effects Cost reimbursement SAT: Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12) |
|
|