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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.

ABSTRACT: BACKGROUND:Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. METHODS:We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. DISCUSSION:3HP-one of the most promising interventions for TB prevention-will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.

SUBMITTER: Kadota JL

PROVIDER: S-EPMC7425004 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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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.

Kadota Jillian L JL Musinguzi Allan A Nabunje Juliet J Welishe Fred F Ssemata Jackie L JL Bishop Opira O Berger Christopher A CA Patel Devika D Sammann Amanda A Katahoire Anne A Nahid Payam P Belknap Robert R Phillips Patrick P J PPJ Namusobya Jennifer J Kamya Moses M Handley Margaret A MA Kiwanuka Noah N Katamba Achilles A Dowdy David D Semitala Fred C FC Cattamanchi Adithya A

Implementation science : IS 20200812 1

<h4>Background</h4>Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain.<h4>Methods</h4>We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune ...[more]

PMID: 32787925

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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:BackgroundA 12-dose, once-weekly regimen of isoniazid and rifapentine (3HP) is effective in preventing tuberculosis (TB) among people living with HIV (PLHIV). We sought to identify potential barriers to and facilitators of acceptance and completion of 3HP treatment from the perspective of people living with HIV (PLHIV) and health workers in a routine HIV care setting in Kampala, Uganda.MethodsWe conducted semi-structured interviews with 25 PLHIV and 10 health workers at an HIV/AIDS clinic in Kampala, Uganda. For both groups, we explored their understanding and interpretations of TB and TB preventive therapy (TPT), and perceptions about social and contextual factors that might influence the willingness of PLHIV to initiate and complete 3HP. We analyzed the data using an inductive thematic approach and aligned the emergent themes to the Behavior Change Wheel framework to identify sources of behavior and targeted behavior change interventions.ResultsFacilitators of acceptance and completion of 3HP treatment among PLHIV were fear of contracting TB, awareness of being at risk of getting TB, willingness to take TPT, trust in health workers, and the perceived benefits of directly observed therapy (DOT) and self-administered therapy (SAT) 3HP delivery strategies. Barriers included inadequate understanding of TPT, fear of potential side effects, concerns about the effectiveness of 3HP, and the perceived challenges of DOT or SAT. Among health workers, perceived facilitators included knowledge that TB is a common cause of mortality for PLHIV, fear of getting TB, and trust in the health workers by PLHIV, the advantages of once-weekly 3HP dosing, and the benefits of DOT and SAT 3HP delivery strategies. Health worker-reported barriers for PLHIV included inadequate understanding of TB and benefits of TPT, TB-associated stigma, potential side effects pill burden, and challenges of DOT and SAT 3HP delivery strategies. Lack of experience in the use of digital technology to monitor patient care was identified as a health worker-specific barrier. Identified intervention functions to address the facilitators or barriers included education, persuasion, environmental restructuring, enablement, and training.ConclusionsUsing a formative qualitative and comprehensive theoretical approach, we identified key barriers, facilitators, and appropriate interventions, including patient education, enhancing trust, and patient-centered treatment support that could be used to optimize the delivery of 3HP to PLHIV in our setting. These interventions are likely generalizable to other clinical interventions in similar populations in sub-Saharan Africa and other TB high-burden settings.

Project description:BackgroundExpanding access to shorter regimens for tuberculosis (TB) prevention, such as once-weekly isoniazid and rifapentine taken for 3 months (3HP), is critical for reducing global TB burden among people living with HIV (PLHIV). Our coprimary hypotheses were that high levels of acceptance and completion of 3HP could be achieved with delivery strategies optimized to overcome well-contextualized barriers and that 3HP acceptance and completion would be highest when PLHIV were provided an informed choice between delivery strategies.Methods and findingsIn a pragmatic, single-center, 3-arm, parallel-group randomized trial, PLHIV receiving care at a large urban HIV clinic in Kampala, Uganda, were randomly assigned (1:1:1) to receive 3HP by facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between facilitated DOT and facilitated SAT using a shared decision-making aid. We assessed the primary outcome of acceptance and completion (≥11 of 12 doses of 3HP) within 16 weeks of treatment initiation using proportions with exact binomial confidence intervals (CIs). We compared proportions between arms using Fisher's exact test (two-sided α = 0.025). Trial investigators were blinded to primary and secondary outcomes by study arm. Between July 13, 2020, and July 8, 2022, 1,656 PLHIV underwent randomization, with equal numbers allocated to each study arm. One participant was erroneously enrolled a second time and was excluded in the primary intention-to-treat analysis. Among the remaining 1,655 participants, the proportion who accepted and completed 3HP exceeded the prespecified 80% target in the DOT (0.94; 97.5% CI [0.91, 0.96] p < 0.001), SAT (0.92; 97.5% CI [0.89, 0.94] p < 0.001), and Choice (0.93; 97.5% CI [0.91, 0.96] p < 0.001) arms. There was no difference in acceptance and completion between any 2 arms overall or in prespecified subgroup analyses based on sex, age, time on antiretroviral therapy, and history of prior treatment for TB or TB infection. Only 14 (0.8%) participants experienced an adverse event prompting discontinuation of 3HP. The main limitation of the study is that it was conducted in a single center. Multicenter studies are now needed to confirm the feasibility and generalizability of the facilitated 3HP delivery strategies in other settings.ConclusionsShort-course TB preventive treatment was widely accepted by PLHIV in Uganda, and very high levels of treatment completion were achieved in a programmatic setting with delivery strategies tailored to address known barriers.Trial registrationClinicalTrials.gov NCT03934931.

Project description:BackgroundCommunity violence is a persistent and challenging public health problem. Community violence not only physically affects individuals, but also its effects reverberate to the well-being of families and entire communities. Being exposed to and experiencing violence are adverse community experiences that affect the well-being and health trajectories of both children and adults. In the United States, community violence has historically been addressed through a lens of law enforcement and policing; the impact of this approach on communities has been detrimental and often ignores the strengths and experiences of community members. As such, community-centered approaches to address violence are needed, yet the process to design, implement, and evaluate these approaches is complex. Alternatives to policing responses are increasingly being implemented. However, evidence and implementation guidance for community-level public health approaches remain limited. This study protocol seeks to address community violence through a resilience framework-Adverse Community Experiences and Resilience (ACE|R)-being implemented in a major US city and leveraging a strategy of community organizing to advance community violence prevention.ObjectiveThe objective of this research is to understand the impact of community-level violence prevention interventions. Furthermore, we aim to describe the strategies of implementation and identify barriers to and facilitators of the approach.MethodsThis study uses a hybrid type 1 effectiveness-implementation design. Part 1 of the study will assess the effectiveness of the ACE|R framework plus community organizing by measuring impacts on violence- and health-related outcomes. To do so, we plan to collect quantitative data on homicides, fatal and nonfatal shootings, hospital visits due to nonaccidental injuries, calls for service, and other violence-related data. In Part 2 of the study, to assess the implementation of ACE|R plus community organizing, we will collect process data on community engagement events, deliver community trainings on community leadership and organizing, and conduct focus groups with key partners about violence and violence prevention programs in Milwaukee.ResultsThis project received funding on September 1, 2020. Prospective study data collection began in the fall of 2021 and will continue through the end of 2023. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2024.ConclusionsCommunity violence is a public health problem in need of community-centered solutions. Interventions that center community and leverage community organizing show promise in decreasing violence and increasing the well-being of community members. Methods to identify the impact of community-level interventions continue to evolve. Analysis of outcomes beyond violence-specific outcomes, including norms and community beliefs, may help better inform the short-term and proximal impacts of these community-driven approaches. Furthermore, hybrid implementation-effectiveness trials allow for the inevitable contextualization required to disseminate community interventions where communities drive the adaptations and decision-making.International registered report identifier (irrid)DERR1-10.2196/50444.

Project description:BackgroundClinical guideline recommendations for addressing modifiable risk factors are not routinely implemented into preconception and antenatal care. This review assessed the effectiveness of implementation strategies in improving health professional provision of preconception and antenatal care addressing tobacco smoking, weight management and alcohol consumption.MethodsA systematic review of randomised and non-randomised studies with a parallel comparison group was conducted. Eligible studies used implementation strategy/ies targeted at health professionals to improve at least one element of preconception and/or antenatal care (smoking: ask, advise, assess, assist, arrange; weight/alcohol: assess, advise, refer) compared to usual practice/control or alternative strategies. Eligible studies were identified via CENTRAL, MEDLINE, EMBASE, Maternity and Infant Care, CINAHL and other sources. Random-effects meta-analyses were conducted where appropriate, with other findings summarised using the direction of effect. The certainty of the pooled evidence was assessed using the GRADE approach.ResultsFourteen studies were included in the review. Thirteen were in the antenatal period and 12 tested multiple implementation strategies (median: three). Meta-analyses of RCTs found that implementation strategies compared to usual practice/control probably increase asking (OR: 2.52; 95% CI: 1.13, 5.59; 3 studies; moderate-certainty evidence) and advising (OR: 4.32; 95% CI: 3.06, 6.11; 4 studies; moderate-certainty evidence) about smoking and assessing weight gain (OR: 57.56; 95% CI: 41.78, 79.29; 2 studies; moderate-certainty evidence), and may increase assessing (OR: 2.55; 95% CI: 0.24, 27.06; 2 studies; low-certainty evidence), assisting (OR: 6.34; 95% CI: 1.51, 26.63; 3 studies; low-certainty evidence) and arranging support (OR: 3.55; 95% CI: 0.50, 25.34; 2 studies; low-certainty evidence) for smoking. The true effect of implementation strategies in increasing advice about weight gain (OR: 3.37; 95% CI: 2.34, 4.84; 2 non-randomised studies; very low-certainty evidence) and alcohol consumption (OR: 10.36; 95% CI: 2.37, 41.20; 2 non-randomised studies; very low-certainty evidence) is uncertain due to the quality of evidence to date.ConclusionsReview findings provide some evidence to support the effectiveness of implementation strategies in improving health professional delivery of antenatal care addressing smoking and weight management. Rigorous research is needed to build certainty in the evidence for improving alcohol and weight gain advice, and in preconception care.Trial registrationPROSPERO-CRD42019131691.

Project description:ContextNeuromuscular preventive training programs effectively reduce injury and improve performance in youth athletes. However, program effectiveness is directly linked to program compliance, fidelity, and dosage. Preventive training programs are not widely adopted by youth sport coaches. One way to promote widespread dissemination and compliance is to identify implementation strategies that influence program adoption and maintenance. It is unknown how previously published programs have followed the elements of an implementation framework. The objective of this review was to evaluate how elements of the 7 steps of implementation, developed by Padua et al, have been performed in the evidence of lower extremity preventive training programs.Evidence acquisitionA systematic review of the literature from 1996 through September 2016 was conducted using electronic databases. Investigations that documented implementation of a sport team-based neuromuscular preventive training program in youth athletes and measured lower extremity injury rates were included.Study designClinical review.Level of evidenceLevel 4.ResultsA total of 12 studies met the inclusion criteria and were reviewed. Information regarding the completion of any of the 7 steps within the implementation framework developed by Padua et al was extracted. None of the 12 articles documented completion of all 7 steps. While each study addressed some of the 7 steps, no study addressed maintenance or an exit strategy for youth athletes. Program implementation appears limited in obtaining administrative support, utilizing an interdisciplinary implementation team, and monitoring or promoting fidelity of the intervention.ConclusionDespite strong evidence supporting the effectiveness of preventive training programs in youth athletes, there is a gap between short-term improvements and long-term implementation strategies. Future interventions should include all 7 steps of the implementation framework to promote transparent dissemination of preventive training programs.

Dataset Information

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.

Publications

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.

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