Dataset Information

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study.

ABSTRACT: Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.Methods: A prospective open-label 2-year observational postmarketing study was conducted introducing 3HP for the first time in Canada in Iqaluit followed by a program rollout in Qikiqtarjuaq, Nunavut.Results: A total of 247 people were offered 3HP, 102 in the Iqaluit postmarketing study and 145 in the Qikiqtarjuaq program roll out. Although statistical significance was not reached, more people who started treatment completed treatment in the 3HP group (Iqaluit, 60/73 (82.2%) and Qikiqtarjuaq, 89/115 (77.4%)) than in the historical control 9INHgroup (306/420 = 72.9%) (p = 0.2). Most of the adverse events in 3HP treated patients were associated with mild discomfort but no disruption of normal daily activity. Not drinking alcohol was associated with increased 3HP completion (OR 13.33, 95% CI, 2.27-78.20) as was not taking concomitant medications (OR 7.19, 95% CI, 1.47-35.30).Conclusions: The present study supports the feasibility and safety profile of 3HP for the treatment of LTBI in Nunavut.

SUBMITTER: Alvarez GG

PROVIDER: S-EPMC7241515 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study.

Alvarez G G GG Van Dyk D D Mallick R R Lesperance S S Demaio P P Finn S S Potvin S Edmunds SE Patterson M M Pease C C Amaratunga K K Hui C C Cameron D W DW Mulpuru S S Aaron S D SD Momoli F F Zwerling A A

International journal of circumpolar health 20201201 1

Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.Methods: A prospective open-label 2-year observational postmarketing study was conducted introducing 3HP for the first time in Canada in Iqaluit followed by a program rollout in Qikiqtarjuaq, Nunavut.Results: A total of 247 people were of ...[more]

PMID: 32379538

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Project description:Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We used thematic analysis (inductive and deductive) to align the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as needed enabled acceptance of patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, prior TPT experience with daily isoniazid, and few 3HP-related serious adverse events enabled adoption, whereas initial concerns about 3HP safety among HCPs, and COVID-19 treatment disruptions delayed 3HP adoption. Refresher training and collaboration among HCPs enabled implementation whereas limited diagnostic facilities for adverse events at the clinic hindered implementation. SAT was modified post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up. Trial registration: ClinicalTrials.gov (NCT03934931); Registered 2nd May 2019; https://clinicaltrials.gov/study/NCT03934931?id = NCT03934931&rank = 1.

Project description:BackgroundScaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid-rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization's (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa.Methods and findingsThe 3HP Options Trial is a pragmatic, parallel type 3 effectiveness-implementation randomized trial comparing 3 optimized strategies for delivering 3HP-facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid-to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (≥11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes.Conclusions3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion.Trial registrationClinicalTrials.gov NCT03934931.

Project description:BackgroundInuit in Canada have the highest reported tuberculosis (TB) incidence rate in Canada, even higher than other Canadian Indigenous groups. The aim of this study was to increase TB awareness among Inuit youth and their communities by equipping those who can best reach this population with a community based, youth focused, education initiative built on interventions adapted from a previous TB awareness study.MethodsThe Taima TB Youth Education Initiative was a field test case study of a knowledge translation (KT) strategy aimed at community members who provide health education in these communities. In the first stage of this study, interventions from a larger TB awareness campaign were adapted to focus on youth living in remote Inuit communities. During the second stage of the study, investigators field tested the initiative in two isolated Inuit communities. It was then applied by local implementation teams in two other communities. Evaluation criteria included feasibility, acceptability, knowledge uptake and health behavior change.ResultsImplementation of the adapted KT interventions resulted in participation of a total of 41 youth (19 females, 22 males) with an average age of 16 years (range 12-21 years) in four different communities in Nunavut. Community celebration events were attended by 271 community members where TB messaging were presented and discussed. All of the health care workers and community members surveyed reported that the adapted interventions were acceptable and a useful way of learning to some extent. Knowledge uptake measures indicated an average TB knowledge score of 64 out of 100. Local partners in all four communities indicated that they would use the Taima TB Youth Education Initiative again to raise awareness about TB among youth in their communities.ConclusionsThe TB awareness interventions adapted for the Taima TB Youth Education Initiative were acceptable to the Inuit communities involved in the study. They resulted in uptake of knowledge among participants. Implementation by local implementation teams was feasible as evidenced by the participation and attendance of youth and community members in all communities. The ability to implement the interventions by local implementation teams indicates there is potential to scale up in other remote communities in the arctic setting.

Dataset Information

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study.

Publications

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study.

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