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The Information-Motivation-Behavioral Skills (IMB) Model has been used to understand adherence to medications and intentions to uptake pre-exposure prophylaxis (PrEP) to prevent HIV infection. In the current study, the IMB Model was used to understand factors that predict adherence to PrEP among a community-based cohort of 204 Black men who have sex with men (MSM) and transgender women (TGW) using structural equation modeling. PrEP motivation was directly associated with PrEP behavioral skills (β = .320, p = .009), and PrEP behavioral skills were directly associated with PrEP adherence (β = .416, p = .001). PrEP knowledge and PrEP motivation were not associated with PrEP adherence, directly or indirectly. The analysis identified intervenable factors that predicted PrEP adherence. Screening for motivation and behavioral skills could be used to identify where additional support to improve PrEP adherence is needed, or whether to offer alternative PrEP modalities or delivery strategies. RESUMEN: El Modelo de Información-Motivación-Habilidades Conductuales (IMB) ha sido utilizado para comprender la adherencia a los medicamentos y la intención de tomar la profilaxis pre-exposición (PrEP) para prevenir la infección por el VIH. En el estudio actual, se usó el modelo IMB para comprender los factores que predicen la adherencia a la PrEP entre una cohorte reclutada en la comunidad de 204 hombres que tienen sexo con hombres (HSH) y mujeres transgénero (TGW) de raza negra, usando modelos de ecuaciones estructurales. La motivación de adherir a la PrEP se asoció directamente con las habilidades conductuales de la PrEP adherencia (β = 0,320, p = 0,009), y las habilidades conductuales de la PrEP adherencia se asociaron directamente con la adherencia a la PrEP (β = 0,416, p = 0,001). El conocimiento de PrEP y la motivación de adherir a la PrEPno se asociaron con la adherencia a la PrEP, ni directa o indirectamente. El análisis identificó factores intervenibles que predijeron la adherencia a la PrEP. La evaluación de la motivación de adherir a la PrEP y las habilidades conductuales de la PrEP adherencia podría ser usado para identificar situaciones en que se necesita apoyo adicional para mejorar la adherencia a la PrEP, o si se deben ofrecer modalidades alternativas de recibir PrEP o estrategias alternativas para entregar PrEP.

IntroductionUnderstanding patient preferences and the demand for healthcare interventions and technology is critical for health technology assessment (HTA). New health technologies have potential for savings and increased efficiency but even the most cost-effective and efficacious interventions can fail if patient preferences are not properly accounted for. Patient preferences in HTA are primarily limited to representation in appraisal committees; however, more robust methods are available and should be incorporated into the assessment of interventions.MethodsUsing data from three discrete choice experiments (DCEs), we reflect on the importance of patient preferences in the design of healthcare interventions. We draw insights from three studies which investigated preferences relating to HIV self-testing amongst long distance truck drivers in Kenya; differentiated antiretroviral therapy services amongst stable HIV patients in Zimbabwe; and tuberculosis preventive therapy for children in Eswatini.ResultsWe highlight three key findings. First, understanding patient preferences is crucial when designing services, and providers sometimes underestimate behavioural barriers and overestimate the extent to which people are motivated simply by health benefits. Optimism is often driven by evidence showing high acceptability, but when preference structures are incorporated in intervention design, there are important insights into how patients plan to utilize services. Second, trade-offs matter in determining which characteristics are perceived to be most important to patients – a key strength of the DCE methodology. Understanding of these trade-offs can help prioritize which characteristics of interventions to target. Finally, disentangling the effect of different characteristics of service delivery models on preferences is important for rethinking how interventions are delivered. If services are designed to better align with preferences, implementers can ensure new interventions have the desired effect on health and economic outcomes.ConclusionsThese findings highlight the value of behavioural economic approaches for investigating preferences for health interventions and providing insights into the demand for services, which must feed into the HTA analyses. Incorporating DCEs into HTA is inexpensive and provides robust data for improving HTA.

To map which tuberculosis care models are best suited for children and adolescents.We conducted a scoping review to assess the impact of decentralized, integrated and family-centred care on child and adolescent tuberculosis-related outcomes, describe approaches for these care models and identify key knowledge gaps. We searched seven literature databases on 5 February 2021 (updated 16 February 2022), searched the references of 18 published reviews and requested data from ongoing studies. We included studies from countries with a high tuberculosis burden that used a care model of interest and reported tuberculosis diagnostic, treatment or prevention outcomes for an age group 20 years old.We identified 28 studies with a comparator group for the impact assessment and added 19 non-comparative studies to a qualitative analysis of care delivery approaches. Approaches included strengthening capacity in primary-level facilities, providing services in communities, screening for tuberculosis in other health services, co-locating tuberculosis and human immunodeficiency virus treatment, offering a choice of treatment location and providing social or economic support. Strengthening both decentralized diagnostic services and community linkages led to one-to-sevenfold increases in case detection across nine studies and improved prevention outcomes. We identified only five comparative studies on integrated or family-centred care, but 11 non-comparative studies reported successful treatment outcomes for at least 71% of children and adolescents.Strengthening decentralized services in facilities and communities can improve tuberculosis outcomes for children and adolescents. Further research is needed to identify optimal integrated and family-centred care approaches.Caractériser les modèles de prise en charge de la tuberculose les mieux adaptés aux enfants et adolescents.Nous avons mené une analyse exploratoire afin d'évaluer l'impact d'une prise en charge décentralisée, intégrée et articulée autour du noyau familial sur les résultats observés chez les enfants et adolescents traités pour une tuberculose, mais aussi de décrire les approches employées pour ces modèles de soins et d'identifier les principales lacunes dans les connaissances à ce sujet. Nous avons effectué des recherches dans sept bases de données dédiées à la littérature le 5 février 2021 (mise à jour le 16 février 2022), examiné les références de 18 revues publiées et demandé des informations issues d'études en cours. Nous avons inclus des études provenant de pays fortement touchés par la tuberculose, qui utilisaient un modèle de prise en charge digne d'intérêt et faisaient mention de résultats de diagnostic, de traitement ou de prévention pour une catégorie d'âge 20 ans.Nous avons identifié 28 études avec un groupe de comparaison pour mesurer l'impact, et nous avons ajouté 19 études non comparatives à une analyse qualitative des approches de prestation de soins. Parmi ces approches figuraient le renforcement des capacités dans les établissements de niveau primaire, la fourniture de services au sein des communautés, le dépistage de la tuberculose dans d'autres services de santé, le regroupement des traitements contre la tuberculose et le virus de l'immunodéficience humaine, la possibilité pour le patient de choisir son lieu de traitement et enfin, la mise à disposition d'une aide sociale ou économique. Développer à la fois les services de diagnostic décentralisés et les réseaux communautaires a permis de multiplier par sept le dépistage des cas dans neuf études, et d'optimiser les résultats de prévention. Nous n'avons trouvé que cinq études comparatives consacrées aux soins intégrés ou articulés autour du noyau familial. En revanche, 11 études non comparatives ont indiqué que le traitement avait été couronné de succès chez au moins 71% des enfants et adolescents.Renforcer les services décentralisés dans les établissements et communautés peut contribuer à améliorer l'état des enfants et adolescents souffrant de tuberculose. D'autres recherches sont nécessaires pour dégager les meilleures approches intégrées et articulées autour du noyau familial.Establecer qué modelos de atención a la tuberculosis son los más adecuados para los niños y adolescentes.Se realizó una revisión exploratoria para evaluar los impactos de la atención descentralizada, integrada y orientada a la familia en los desenlaces relacionados con la tuberculosis en niños y adolescentes, describir los enfoques de estos modelos de atención e identificar las principales deficiencias de conocimiento. Se realizaron búsquedas en siete bases de datos bibliográficas el 5 de febrero de 2021 (actualizadas el 16 de febrero de 2022), se buscaron las referencias de 18 revisiones publicadas y se solicitaron datos de estudios en curso. Se incluyeron estudios de países con una alta carga de tuberculosis que emplearan un modelo de atención de interés e informaran sobre los resultados de diagnóstico, tratamiento o prevención de la tuberculosis en un grupo de edad20 años.Se identificaron 28 estudios con un grupo comparativo para la evaluación del impacto y se añadieron 19 estudios no comparativos a un análisis cualitativo de los enfoques de prestación de atención. Los enfoques incluyeron el fortalecimiento de la capacidad en los centros de nivel primario, la prestación de servicios en las comunidades, la detección de la tuberculosis en otros servicios sanitarios, la ubicación conjunta del tratamiento de la tuberculosis y del virus de la inmunodeficiencia humana, la posibilidad de que el paciente elija el lugar de tratamiento y la prestación de apoyo social o económico. El refuerzo de los servicios de diagnóstico descentralizados y de los vínculos con la comunidad permitió multiplicar de una a siete veces la detección de casos en nueve estudios y mejorar los resultados de la prevención. Solo se identificaron cinco estudios comparativos sobre la atención integrada u orientada a la familia, pero 11 estudios no comparativos informaron de resultados de tratamiento exitosos en al menos el 71% de los niños y adolescentes.El refuerzo de los servicios descentralizados en los centros y las comunidades puede mejorar los desenlaces de la tuberculosis en niños y adolescentes. Es preciso seguir investigando para determinar los enfoques óptimos de atención integrada y orientada a la familia.تحديد أفضل نماذج رعاية السل بالنسبة للأطفال والمراهقين.قمنا بإجراء مراجعة عن كثب لتقييم تأثير الرعاية اللامركزية المتكاملة التي تركز على الأسرة، على النتائج المتعلقة بالسل بالنسبة للأطفال والمراهقين، ووصف الاساليب الخاصة بنماذج الرعاية هذه، وتحديد الفجوات المعرفية الرئيسية. قمنا بالبحث في سبع قواعد بيانات للمنشورات في 5 فبراير/شباط 2021 (تم تحديثها في 16 فبراير/شباط 2022)، والبحث في مراجع لعدد 18 مراجعة منشورة وطلبنا البيانات من الدراسات الجارية. وكذلك قمنا بتضمين دراسات من الدول ذات العبء المرتفع من السل، والتي استخدمت نموذجًا مهمًا للرعاية، وأبلغت عن نتائج تشخيص السل أو علاجه أو الوقاية منه للفئة العمرية الأقل من 20 سنة.قمنا بتحديد 28 دراسة مع مجموعة مقارنة لتقييم التأثير، وأضفنا 19 دراسة غير مقارنة إلى التحليل النوعي لأساليب تقديم الرعاية. تضمنت الأساليب تعزيز القدرات في مرافق المستوى الأولي، وتقديم الخدمات في المجتمعات، والكشف عن مرض السل مع الخدمات الصحية الأخرى، والاشتراك في اكتشاف علاج السل وفيروس نقص المناعة البشرية، وعرض اختيار المريض لمكان العلاج، وتقديم الدعم الاجتماعي أو الاقتصادي. أدى تعزيز كل من خدمات التشخيص اللامركزية والروابط المجتمعية إلى زيادات من واحد إلى سبعة أضعاف في اكتشاف الحالات عبر تسع دراسات، كما أدى لتحسين نتائج الوقاية. قمنا بتحديد خمس دراسات مقارنة فقط حول الرعاية المتكاملة أو التي تركز على الأسرة، لكن 11 دراسة غير مقارنة أفصحت عن نتائج علاجية ناجحة على الأقل لـ %71 من الأطفال والمراهقين.يمكن أن يؤدي تعزيز الخدمات اللامركزية في المرافق والمجتمعات إلى تحسين نتائج مرض السل بالنسبة للأطفال والمراهقين. هناك حاجة لمزيد من الأبحاث لتحديد أساليب الرعاية المثلى المتكاملة والتي تركز على الأسرة.探讨哪种结核病护理模式最适合儿童和青少年。.我们开展了一项范围评审,评估分散式、综合和以家庭为中心的护理对儿童和青少年结核病相关护理效果的影响,介绍适用于此类护理模式的方法并确定关键的知识差距。我们于 2021 年 2 月 5 日从七个文献数据库中搜索了 18 份已出版评审的参考资料(于 2022 年 2 月 16 日进行了更新),并提取了目前正在开展的研究中的数据。我们纳入了存在较高结核病负担国家的研究,采用我们感兴趣的护理模式开展研究,并报告了 20 岁以下人群的结核病诊断、治疗或预防效果。.我们确定了 28 项采用对照组开展的影响评估研究和 19 项未采用对照组开展的研究,对护理方法进行了定性分析。方法包括加强初级护理机构的护理能力、面向社区提供服务、通过其他卫生服务开展结核病筛查、在同一地点协同开展结核病和艾滋病治疗、让患者选择治疗地点以及提供社会或经济支持。九项研究表明,通过加强分散式诊断服务与社区之间的联系,病例检测率提升了一至七倍,并且预防效果也显著提高。我们仅确定了五项综合或以家庭为中心护理方面的对比研究,但是 11 项非对比研究显示儿童和青少年的成功治疗结果至少提高 71%。.加强护理机构和社区内的分散式服务,可提高儿童和青少年的结核病护理效果。需开展进一步研究以确定最佳的综合和以家庭为中心的护理方法。.Определить, какие модели лечения туберкулеза лучше всего подходят для детей и подростков.Для оценки влияния децентрализованного, интегрированного и ориентированного на семью ухода на результаты лечения туберкулеза у детей и подростков, описания подходов к этим моделям ухода и выявления основных пробелов в знаниях была подготовлена концептуальная проработка. 5 февраля 2021 года был проведен поиск в семи базах данных литературы (обновлено 16 февраля 2022 года), просмотрены ссылки на 18 опубликованных обзоров и запрошены данные текущих исследований. Были включены исследования из стран с высоким уровнем заболеваемости туберкулезом, в которых использовалась интересующая модель ухода и сообщалось о результатах диагностики, лечения или профилактики туберкулеза в возрастной группе младше 20 лет.Для оценки воздействия было выделено 28 исследований с группой сравнения и добавлено 19 несравнительных исследований для качественного анализа подходов к оказанию медицинской помощи. В качестве подходов использовались: укрепление потенциала учреждений первичного звена, предоставление услуг в общинах, скрининг на наличие туберкулеза в других медицинских учреждениях, совместное лечение туберкулеза и вируса иммунодефицита человека, предоставление пациенту возможности выбора места лечения и оказание социальной или экономической поддержки. Развитие децентрализованных диагностических служб и укрепление связей с местными общинами привели к увеличению выявления случаев заболевания от одного до семи раз в девяти исследованиях и улучшению результатов профилактики. Было выявлено только пять сравнительных исследований по интегрированному или ориентированному на семью уходу, однако в 11 несравнительных исследованиях сообщалось об успешных результатах лечения не менее 71% детей и подростков.Развитие децентрализованных услуг в учреждениях и общинах может способствовать улучшению результатов лечения туберкулеза у детей и подростков. Для определения оптимальных подходов к интегрированному и ориентированному на семью уходу необходимо проведение дальнейших исследований.

Author(s): Wagman, Jennifer A; Wynn, Adriane; Matsuzaki, Mika; Gnatienko, Natalia; Metsch, Lisa R; Del Rio, Carlos; Feaster, Daniel J; Nance, Robin M; Whitney, Bridget M; Delaney, Joseph AC; Kahana, Shoshana Y; Crane, Heidi M; Chandler, Redonna K; Elliott, Jennifer C; Altice, Frederick; Lucas, Gregory M; Mehta, Shruti H; Hirsch-Moverman, Yael; El-Sadr, Wafaa M; Vu, Quan; Nguyen Thanh, Binh; Springer, Sandra A; Tsui, Judith I; Samet, Jeffrey H | Abstract: ObjectivesIn high-income countries, hazardous alcohol use is associated with reduced receipt of antiretroviral therapy (ART) and viral suppression among people living with HIV (PLHIV) who inject drugs. These associations are less understood in lower middle-income countries (LMIC) and upper middle-income countries.DesignWe examined associations between hazardous alcohol use, ART receipt, and viral suppression among PLHIV who reported current or former injection drug use. Participants were from nine studies in the United States (high-income country), India (LMIC), Russia (upper middle-income country), and Vietnam (LMIC).MethodsHazardous alcohol use was measured via Alcohol Use Disorders Identification Test. Outcomes were HIV viral suppression (viral load of l1000 RNA copies/ml) and self-reported ART receipt. Logistic regression assessed associations between hazardous alcohol use and both outcome variables, controlling for age and sex, among participants with current and former injection drug use.ResultsAmong 2790 participants, 16% were women, mean age was 37.1 ± 9.5 years. Mean Alcohol Use Disorders Identification Test scores were 4.6 ± 8.1 (women) and 6.2 ± 8.3 (men); 42% reported ART receipt; 40% had viral suppression. Hazardous alcohol use was significantly associated with reduced ART receipt in India (adjusted odds ratio = 0.59, 95% confidence interval: 0.45-0.77, P l 0.001); and lower rates of viral suppression in Vietnam (adjusted odds ratio = 0.51, 95% confidence interval: 0.31-0.82, P = 0.006).ConclusionAssociations between hazardous alcohol use, ART receipt, and viral suppression varied across settings and were strongest in LMICs. Addressing hazardous alcohol use holds promise for improving HIV continuum of care outcomes among PLHIV who inject drugs. Specific impact and intervention needs may differ by setting.

Background The World Health Organization estimated that 1.12 million children developed tuberculosis (TB) in 2018, and at least 200,000 children died from TB. Implementation of effective child contact management is an important strategy to prevent childhood TB but these practices often are not prioritized or implemented, particularly in low- and middle-income countries. This study aimed to explore attitudes of healthcare providers toward TB prevention and perceived facilitators and challenges to child contact management in Lesotho, a high TB burden country. Qualitative data were collected via group and individual in-depth interviews with 12 healthcare providers at five health facilities in one district and analyzed using a thematic framework. Results Healthcare providers in our study were interested and committed to improve child TB contact management and identified facilitators and challenges to a successful childhood TB prevention program. Facilitators included: provider understanding of the importance of TB prevention and enhanced provider training on child TB contact management, with a particular focus on ruling out TB in children and addressing side effects. Challenges identified by providers were at multiple levels -- structural, clinic, and individual and included: [1] access to care, [2] supply-chain issues, [3] identification and screening of child contacts, and [4] adherence to isoniazid preventive therapy. Conclusions Given the significant burden of TB morbidity and mortality in young children and the recent requirement by the WHO to report IPT initiation in child contacts, prioritization of child TB contact management is imperative and should include enhanced provider training on childhood TB and mentorship as well as strategies to eliminate challenges. Strategies that enable more efficient child TB contact management delivery include creating standardized tools that facilitate the implementation, tracking, and monitoring of child TB contact management coupled with guidance and mentorship from the district health management team. To tackle access to care challenges, we propose delivering intensive community health education, conducting community screening more efficiently using standardized tools, and facilitating access to services in the community.

While oral pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention, consistent use is necessary to achieve its intended impact. We compared effectiveness of enhanced PrEP (enPrEP) adherence support to standard of care (sPrEP) among Black MSM and TGW attending a community clinic in Harlem, NY. EnPrEP included peer navigation, in-person/online support groups, and SMS messages. Self-reported adherence over previous 30 days, collected in quarterly interviews, was defined as ≥ 57%. Crude and adjusted analyses examined factors associated with adherence. A total of 204 participants were enrolled and randomized; 35% were lost to follow-up. PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69). Multivariable regression analysis found that lower adherence was associated with low education and depressive symptoms. We found that an enhanced adherence intervention did not improve PrEP adherence. Findings point to the need for innovative methods to improve PrEP adherence among Black MSM and TGW. Clinical Trial Registration NCT02167386, June 19, 2014

Background Child tuberculosis (TB) contact management is recommended for preventing TB in children but its implementation is suboptimal in high TB/HIV-burden settings. The PREVENT Study was a mixed-methods, clustered-randomized implementation study that evaluated the effectiveness and acceptability of a community-based intervention (CBI) to improve child TB contact management in Lesotho, a high TB burden country. Methods Ten health facilities were randomized to CBI or standard of care (SOC). CBI holistically addressed the complex provider-, patient-, and caregiver-related barriers to prevention of childhood TB. Routine TB program data were abstracted from TB registers and cards for all adult TB patients aged >18 years registered during the study period, and their child contacts. Primary outcome was yield (number) of child contacts identified and screened per adult TB patient. Generalized linear mixed models tested for differences between study arms. CBI acceptability was assessed via semi-structured in-depth interviews with a purposively selected sample of 20 healthcare providers and 28 caregivers. Qualitative data were used to explain and confirm quantitative results. We used thematic analysis to analyze the data. Results From 01/2017-06/2018, 973 adult TB patients were recorded, 490 at CBI and 483 at SOC health facilities; 64% male, 68% HIV-positive. At CBI and SOC health facilities, 216 and 164 child contacts were identified, respectively (p = 0.16). Screening proportions (94% vs. 62%, p = 0.13) were similar; contact yield per TB case (0.40 vs. 0.20, p = 0.08) was higher at CBI than SOC health facilities, respectively. CBI was acceptable to caregivers and healthcare providers. Conclusion Identification and screening for TB child contacts were similar across study arms but yield was marginally higher at CBI compared with SOC health facilities. CBI scale-up may enhance the ability to reach and engage child TB contacts, contributing to efforts to improve TB prevention among children.

BACKGROUND: Shorter-duration regimens for preventing drug-susceptible tuberculosis (TB) have been shown to be safe and efficacious in children, and may improve acceptability, adherence, and treatment completion. While these regimens have been used in children in low TB burden countries, they are not yet widely used in high TB burden countries. SETTING: Five health facilities in one district in Lesotho, a high TB burden country. OBJECTIVE: Assess the preventive treatment preferences of care givers of child TB contacts. DESIGN: Qualitative data were collected using in-depth interviews with 12 care givers whose children completed preventive treatment, and analyzed using grounded theory. FINDINGS: Care givers were interested in being involved in the children’s treatment decisions. Pill burden, treatment duration and related frequency of dosing were identified as important factors that influenced preventive treatment preferences among care givers. CONCLUSION: Understanding care giver preferences and involving them in treatment decisions may facilitate efforts to implement successful preventive treatment for TB among children in high TB burden countries.

The HPTN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT) study evaluated daily and non-daily dosing schedules for oral pre-exposure prophylaxis (PrEP) to prevent HIV. A qualitative sub-study including focus groups and in-depth interviews was conducted among men who have sex with men participating in New York City to understand their experience with PrEP and study dosing schedules. The 37 sub-study participants were 68% black, 11% white, and 8% Asian; 27% were of Hispanic/Latino ethnicity. Mean age was 34 years. Themes resulting from qualitative analysis include: PrEP is a significant advance for HIV prevention; non-daily dosing of PrEP is congruent with HIV risk; and pervasive stigma connected to HIV and risk behavior is a barrier to PrEP adherence, especially for non-daily dosing schedules. The findings underscore how PrEP intersects with other HIV prevention practices and highlight the need to understand and address multidimensional stigma related to PrEP use.

Setting Limited data exist on the prevalence and correlates, including stigma, of mental health conditions, including depressive symptoms and alcohol use, among patients co-infected with tuberculosis (TB) and the human immunodeficiency virus (HIV) in sub-Saharan Africa, despite their negative impact on health outcomes. Objective To assess the prevalence and correlates of depressive symptoms and hazardous/harmful alcohol use among TB-HIV patients in the Start TB patients on ART and Retain on Treatment (START) study. Design START, a mixed-methods cluster-randomized trial, evaluated a combination intervention package vs. standard of care (SOC) to improve treatment outcomes in TB-HIV co-infected patients in Lesotho. Moderate/severe depressive symptoms and hazardous/harmful alcohol use were measured using baseline questionnaire data collected from April 2013 to March 2015. Demographic, psychosocial, and TB- and HIV-related knowledge and attitudes, including stigma, were assessed for association with both conditions using generalized linear mixed models. Results Among 371 participants, 29.8% reported moderate/severe depressive symptoms, and 24.7% reported hazardous/harmful alcohol use; 7% reported both. Depressive symptoms were significantly associated with less education, more difficulty understanding written medical information, non-disclosure of TB, greater TB stigma, and the SOC study arm. Hazardous/harmful alcohol use was significantly associated with male sex, as well as greater TB and external HIV stigma. Conclusion Prevalence of depressive symptoms and hazardous/harmful alcohol use were high, suggesting a need for routine screening for, and treatment of, mental health disorders in TB-HIV patients.

Background Effective, evidence-based interventions to prevent childhood tuberculosis (TB) in high TB/HIV-burden, resource-limited settings are urgently needed. There is limited implementation of evidence-based contact management strategies, including isoniazid preventive therapy (IPT), for child contacts of TB cases in Lesotho. Methods/design This mixed-methods implementation science study utilizes a two-arm cluster-randomized trial design with randomization at the health facility level. The study aims to evaluate the effectiveness and acceptability of a combination community-based intervention (CBI) versus standard of care (SOC) for the management of child TB contacts. The study includes three phases: (I) exploratory phase; (II) intervention implementation and testing phase; (III) post-intervention explanatory phase. Healthcare provider interviews to inform intervention refinement (phase I) were completed in December 2015. In phase II, 10 health facilities were randomized to deliver the CBI or SOC, with stratification by facility type (i.e., hospital vs. health center). CBI holistically addresses the complex provider-related, patient-related, and caregiver-related barriers to prevention of childhood TB through nurse training and mentorship; health education for caregivers and patients by village health workers; adherence support using text messaging and village health workers; and multidisciplinary team meetings, where programmatic data are reviewed and challenges and solutions are discussed. SOC sites follow country guidelines for child TB contact management. Routine TB program data will be abstracted for all adult TB cases newly registered during the study period and their child contacts from TB registers and cards. The anticipated sample size is 1080 child contacts. Primary outcomes are yield (number) of child contacts, including children

ObjectiveIsoniazid preventive therapy initiation and completion rates are suboptimal among children. Shorter tuberculosis (TB) preventive treatment (TPT) regimens have demonstrated safety and efficacy in children and may improve adherence but are not widely used in high TB burden countries. Understanding preferences regarding TPT regimens’ characteristics and service delivery models is key to designing services to improve TPT initiation and completion rates. We examined paediatric TPT preferences in Eswatini, a high TB burden country.DesignWe conducted a sequential mixed-methods study utilising qualitative methods to inform the design of a discrete choice experiment (DCE) among HIV-positive children, caregivers and healthcare providers (HCP). Drug regimen and service delivery characteristics included pill size and formulation, dosing frequency, medication taste, treatment duration and visit frequency, visit cost, clinic wait time, and clinic operating hours. An unlabelled, binary choice design was used; data were analysed using fixed and mixed effects logistic regression models, with stratified models for children, caregivers and HCP.SettingThe study was conducted in 20 healthcare facilities providing TB/HIV care in Manzini, Eswatini, from November 2018 to December 2019.ParticipantsNinety-one stakeholders completed in-depth interviews to inform the DCE design; 150 children 10–14 years, 150 caregivers and 150 HCP completed the DCE.ResultsDespite some heterogeneity, the results were fairly consistent among participants, with palatability of medications viewed as the most important TPT attribute; fewer and smaller pills were also preferred. Additionally, shorter waiting times and cost of visit were found to be significant drivers of choices.ConclusionPalatable medication, smaller/fewer pills, low visit costs and shorter clinic wait times are important factors when designing TPT services for children and should be considered as new paediatric TPT regimens in Eswatini are rolled out. More research is needed to determine the extent to which preferences drive TPT initiation, adherence and completion rates.

Awareness of Pre-exposure prophylaxis (PrEP) was assessed among a cohort of substance-using black men who have sex with men and transgender women (MSM/TGW) participating in the STAR Study, which recruited black MSM/TGW in New York City for HIV testing and linked HIV-infected individuals into care from July 2012 to April 2015. Sociodemographic, psychosocial, known HIV risk factors, and PrEP awareness were assessed among participants. Multivariable logistic regression was conducted to assess factors associated with PrEP awareness. Of 1673 participants, median age was 43 years and 25% were under age 30. Most participants (85.8%) reported having insufficient income for basic necessities at least occasionally, 54.8% were homeless, and 71.3% were unemployed. Awareness of PrEP was reported among 18.2% of participants. PrEP awareness was associated with younger age (adjusted odds ratio [aOR] 0.87, per 5 years), gay identity (aOR 2.46), higher education (aOR 1.70), more frequent past HIV testing (aOR 3.18), less HIV stigma (aOR 0.61), less hazardous/harmful alcohol use (aOR 0.61), and more sexual partners (aOR 1.04, per additional partner in past 30 days). In this substance-using black MSM/TGW cohort with high rates of poverty and homelessness, PrEP awareness was low. This study demonstrates the need for targeted dissemination of PrEP information to key populations to increase awareness and ultimately improve uptake and utilization of PrEP.

Background Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. Design Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6–9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete. Discussion The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.

Disclosure of HIV-positive status has important implications for patient outcomes and preventing HIV transmission, but has been understudied in TB-HIV patients. We assessed disclosure patterns and correlates of non-disclosure among adult TB-HIV patients initiating ART enrolled in the START Study, a mixed-methods cluster-randomized trial conducted in Lesotho, which evaluated a combination intervention package (CIP) versus standard of care. Interviewer-administered questionnaire data were analyzed to describe patterns of disclosure. Patient-related factors were assessed for association with non-disclosure to anyone other than a health-care provider and primary partners using generalized linear mixed models. Among 371 participants, 95% had disclosed their HIV diagnosis to someone other than a health-care provider, most commonly a spouse/primary partner (76%). Age, TB knowledge, not planning to disclose TB status, greater perceived TB stigma, and CIP were associated with non-disclosure in unadjusted models (p .1). In adjusted models, all point estimates were similar and greater TB knowledge (adjusted odds ratio [aOR] 0.59, 95% confidence interval [CI] 0.39-0.90) and CIP (aOR 0.20, 95% CI 0.05-0.79) remained statistically significant. Among 220 participants with a primary partner, 76% had disclosed to that partner. Significant correlates of partner non-disclosure (p .1) in unadjusted analyses included being female, married/cohabitating, electricity at home, not knowing if partner was HIV-positive, and TB knowledge. Adjusted point estimates were largely similar, and being married/cohabitating (aOR 0.03, 95% CI 0.01-0.12), having electricity at home (aOR 0.38, 95% CI 0.17-0.85) and greater TB knowledge (aOR 0.76, 95% CI 0.59-0.98) remained significant. In conclusion, although nearly all participants reported disclosing their HIV status to someone other than a health-care provider at ART initiation, nearly a quarter of participants with a primary partner had not disclosed to their partner. Additional efforts to support HIV disclosure (e.g., counseling) may be needed for TB-HIV patients, particularly for women and those unaware of their partners' status.

Supplemental Digital Content is Available in the Text., Background: HPTN 067 assessed the feasibility of daily and non-daily dosing of open-label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)-based pre-exposure prophylaxis (PrEP). Methods: Factors associated with sex-related PrEP adherence were assessed among men who have sex with men (MSM) randomized to one of 3 PrEP dosing arms in HPTN 067 in New York City. Sex-related PrEP adherence was defined per protocol as at least 1 PrEP tablet taken within 4 days pre-sex and at least 1 additional PrEP tablet taken within 24 hours post-sex, assessed via electronic drug monitoring and weekly interviews. Demographic data and behavioral measures were evaluated for association with sex-related PrEP adherence. Logistic regression for clustered data was used to estimate the unadjusted and adjusted odds ratios. Results: Of 176 randomized MSM participants, 59% were Black, 10% White, 25% Hispanic, and 6% other; median age was 31 years. In the multivariable analyses, higher sex-related PrEP adherence was significantly associated with daily dosing arm, older age, employment, and higher PrEP adherence behavioral skills. Lower sex-related PrEP adherence was significantly associated with identifying as Black or Hispanic (compared with White), opiate use, and reporting “I forgot” as an adherence barrier. Conclusions: This analysis identified populations of MSM who might benefit from additional support to optimize PrEP adherence, including those who are younger, unemployed, or opiate users. MSM with lower PrEP behavioral skills may benefit from targeted interventions. Further study is needed to assess racial and ethnic disparities in PrEP adherence, which may reflect broader social and economic inequalities not captured in this study.

Background : Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective : The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP) to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho. Design : Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center). The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW) for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months). Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete. Discussion : The START Study evaluates a CIP targeting barriers to early ART implementation among TB/HIV patients. If the CIP is found effective and acceptable, this study has the potential to inform care for TB/HIV patients in high-burden, resource-limited countries in sub-Saharan Africa. Keywords : TB/HIV integration; implementation science; cost-effectiveness; acceptability; TB treatment success (Published: 27 June 2017) Citation: Glob Health Action 2016, 9 : 31543 - http://dx.doi.org/10.3402/gha.v9.31543 Supplementary material: To access the supplementary material for this article, please see Supplementary files under ‘Article Tools’

Background Hepatotoxicity, an adverse effect of isoniazid preventative therapy (IPT), is exacerbated by alcohol consumption. Although the WHO recommends IPT for people living with HIV (PLHIV), it is contraindicated in regular alcohol users. The objective of this study was to identify the prevalence and determinants of alcohol use among PLHIV initiating IPT in Ethiopia. Methods Baseline data (July 2013-May 2015) from 316 participants in the Enhance Initiation and Retention in IPT Care for HIV (ENRICH) study were used to assess the prevalence of alcohol use. Multinomial logistic regression was used to identify determinants of non-hazardous and hazardous alcohol use, compared to no alcohol use. Results Overall, 41.8% of participants reported alcohol use, of which 45.5% reported hazardous use. Compared to non-alcohol users, hazardous users were younger (adjusted odds ratio [AOR]: 1.06; 95% confidence interval [95% CI]: 1.02, 1.11), more likely to be male (AOR: 6.40; 95% CI: 3.17, 12.93), Orthodox (AOR: 3.96; 95% CI: 1.74, 9.00), have larger support networks (AOR: 3.82; 95% CI: 1.61, 9.06), and report greater amount (AOR: 14.80; 95% CI: 5.76, 38.02) and frequency (AOR: 5.91; 95% CI: 2.75, 12.67) of khat use. Conclusions Alcohol use was prevalent in this population, and current WHO guidelines would exclude a substantial proportion of the population from receiving IPT. PLHIV in this region would benefit from routine screening for alcohol and khat use, and from substance use education and counseling while receiving IPT until it can be determined whether alcohol users can safely receive IPT.

Current guidelines suggest that HIV-infected patients should receive chemoprophylaxis against Pneumocystis jirovecii pneumonia (PJP) if they have a cluster determinant 4 (CD4) count 3or oropharyngeal candidiasis. Persons with CD4 percentage (CD4%) below 14% should also be considered for prophylaxis. Discordance between CD4 count and CD4% occurs in 16% to 25% of HIV-infected patients. Provider compliance with current PJP prophylaxis guidelines when such discordance is present was assessed. Electronic medical records of 429 HIV-infected individuals who had CD4 count and CD4% measured at our clinic were reviewed. CD4 count and percentage discordance was seen in 57 (13%) of 429. Patients with CD4 count >200 but CD4% 14 (29% versus 86%; odds ratio = 0.064, 95% confidence interval: 0.0168-0.2436; P < .0001). We emphasize monitoring both the absolute CD4 count and percentage to appropriately guide PJP primary and secondary prophylaxis.

BACKGROUND: Nondaily dosing of oral preexposure prophylaxis (PrEP) may provide equivalent coverage of sex events compared with daily dosing. METHODS: At-risk men and transgender women who have sex with men were randomly assigned to 1 of 3 dosing regimens: 1 tablet daily, 1 tablet twice weekly with a postsex dose (time-driven), or 1 tablet before and after sex (event-driven), and were followed for coverage of sex events with pre- and postsex dosing measured by weekly self-report, drug concentrations, and electronic drug monitoring. RESULTS: From July 2012 to May 2014, 357 participants were randomized. In Bangkok, the coverage of sex events was 85% for the daily arm compared with 84% for the time-driven arm (P = .79) and 74% for the event-driven arm (P = .02). In Harlem, coverage was 66%, 47% (P = .01), and 52% (P = .01) for these groups. In Bangkok, PrEP medication concentrations in blood were consistent with use of ≥2 tablets per week in >95% of visits when sex was reported in the prior week, while in Harlem, such medication concentrations occurred in 48.5% in the daily arm, 30.9% in the time-driven arm, and 16.7% in the event-driven arm (P < .0001). Creatinine elevations were more common in the daily arm (P = .050), although they were not dose limiting. CONCLUSIONS: Daily dosing recommendations increased coverage and protective drug concentrations in the Harlem cohort, while daily and nondaily regimens led to comparably favorable outcomes in Bangkok, where participants had higher levels of education and employment. CLINICAL TRIALS REGISTRATION: NCT01327651.

OBJECTIVES To assess latent tuberculous infection (LTBI) treatment completion rates in a large prospective US/Canada multisite cohort and identify associated risk factors. METHODS This prospective cohort study assessed factors associated with LTBI treatment completion through interviews with persons who initiated treatment at 12 sites. Interviews were conducted at treatment initiation and completion/cessation. Participants received usual care according to each clinic's procedure. Multivariable models were constructed based on stepwise assessment of potential predictors and interactions. RESULTS Of 1515 participants initiating LTBI treatment, 1323 had information available on treatment completion; 617 (46.6%) completed treatment. Baseline predictors of completion included male sex, foreign birth, not thinking it would be a problem to take anti-tuberculosis medication, and having health insurance. Participants in stable housing who received monthly appointment reminders were more likely to complete treatment than those without stable housing or without monthly reminders. End-of-treatment predictors of non-completion included severe symptoms and the inconvenience of clinic/pharmacy schedules, barriers to care and changes of residence. Common reasons for treatment non-completion were patient concerns about tolerability/toxicity, appointment conflicts, low prioritization of TB, and forgetfulness. CONCLUSIONS Less than half of treatment initiators completed treatment in our multisite study. Addressing tangible issues such as not having health insurance, toxicity concerns, and clinic accessibility could help to improve treatment completion rates.

Non-Hispanic blacks represent 13 % of the U.S.-born population but account for 37 % of tuberculosis (TB) cases reported in U.S.-born persons. Few studies have explored whether this disparity is associated with differences in TB-related knowledge and attitudes. Interviews were conducted with U.S.-born, non-Hispanic blacks and whites diagnosed with TB from August 2009 to December 2010 in cities and states that accounted for 27 % of all TB cases diagnosed in these racial groups in the U.S. during that time period. Of 477 participants, 368 (77 %) were non-Hispanic black and 109 (23 %) were non-Hispanic white. Blacks had significantly less knowledge and more misconceptions about TB transmission and latent TB infection than whites. Most TB patients in both groups recalled being given TB information; having received such information was strongly correlated with TB knowledge. Providing information to U.S.-born TB patients significantly increased their knowledge and understanding of TB. More focused efforts are needed to provide TB information to U.S.-born black TB patients.

Setting Twelve health facilities in Berea District, Lesotho, that participated in the Start TB Patients on ART and Retain on Treatment (START) Study, a mixed-methods cluster-randomized trial evaluating a combination intervention package to improve early initiation of antiretroviral therapy (ART) and anti-tuberculosis treatment success among patients with tuberculosis (TB) and human immunodeficiency virus (HIV). Objective To assess TB and HIV diagnostic practices among TB-HIV patients. Design A standardized survey assessed services at each facility at baseline. Routine clinical data were abstracted for all newly registered adult TB-HIV patients during the study period. Descriptive statistics were used to assess TB diagnostic practices, timing of the HIV diagnosis, and ART status at TB treatment initiation. Results Between April 2013 and March 2015, 1233 TB-HIV patients were enrolled. Among 1215 patients with available data, 87.2% had pulmonary TB, of which 34.8% were bacteriologically confirmed, 40.9% tested negative and 24.3% were not tested. Among 1138 patients with available data, 53.3% had an existing HIV diagnosis, of whom 39.3% were ART-naive. Conclusions The majority of pulmonary TB patients were clinically diagnosed, and many were unaware of their HIV status or were ART-naive despite known status. The Test and Treat Strategy holds promise to prevent TB and reduce TB-related mortality among people living with HIV; however, enhanced TB diagnostic capacity and improved HIV case detection are urgently needed.

Introduction Black men who have sex with men and transgender women are at high risk for HIV infection, but are more likely to be unaware of their infection or not in care for diagnosed HIV compared to other races. Respondent driven sampling has been advanced as a method to reach stigmatized and hidden populations for HIV testing. We compared strategies to recruit black, substance‐using men who have sex with men and transgender women to identify newly diagnosed HIV infection, or those previously diagnosed but not in care. Methods The STAR (Seek, Test, and Retain) study (ClinicalTrials.gov NCT01790360) used several recruitment strategies to identify black, substance‐using men who have sex with men and transgender women with undiagnosed HIV infection or with previously diagnosed HIV infection but who were not in HIV care. Respondent‐driven sampling, community‐based recruitment and online advertising were used to recruit participants. Incentivized peer referral was integrated into all recruitment strategies. Participants completed interviewer‐administered questionnaires and HIV testing. Demographic and HIV risk‐related characteristics and recruitment strategy were summarized and stratified by HIV status. Associations were tested using Pearson's chi‐squared, Fisher's exact, and Wilcoxon rank sum tests. Factors associated with HIV‐positive diagnosis at p

Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide. Considering the World Health Organization recommendation to implement child contact management (CCM) for TB, we conducted a mixed-methods systematic review to summarize CCM implementation, challenges, predictors, and recommendations. We searched the electronic databases of PubMed/MEDLINE, Scopus, and Web of Science for studies published between 1996–2017 that reported CCM data from high TB-burden countries. Protocol details for this systematic review were registered on PROSPERO: International prospective register of systematic reviews (#CRD42016038105). We formulated a search strategy to identify all available studies, published in English that specifically targeted a) population: child contacts (

Drug resistance was extensive and care was complex; nevertheless, high rates of treatment completion were achieved albeit at considerable cost., To describe factors associated with multidrug-resistant (MDR), including extensively-drug-resistant (XDR), tuberculosis (TB) in the United States, we abstracted inpatient, laboratory, and public health clinic records of a sample of MDR TB patients reported to the Centers for Disease Control and Prevention from California, New York City, and Texas during 2005–2007. At initial diagnosis, MDR TB was detected in 94% of 130 MDR TB patients and XDR TB in 80% of 5 XDR TB patients. Mutually exclusive resistance was 4% XDR, 17% pre-XDR, 24% total first-line resistance, 43% isoniazid/rifampin/rifabutin-plus-other resistance, and 13% isoniazid/rifampin/rifabutin-only resistance. Nearly three-quarters of patients were hospitalized, 78% completed treatment, and 9% died during treatment. Direct costs, mostly covered by the public sector, averaged $134,000 per MDR TB and $430,000 per XDR TB patient; in comparison, estimated cost per non-MDR TB patient is $17,000. Drug resistance was extensive, care was complex, treatment completion rates were high, and treatment was expensive.

IFN-γ release assays (IGRAs) are alternatives to tuberculin skin testing (TST) for diagnosis of latent tuberculosis infection. Limited data suggest IGRAs may not perform well for serial testing of healthcare workers (HCWs).Determine the performance characteristics of IGRAs versus TST for serial testing of HCWs.A longitudinal study involving 2,563 HCWs undergoing occupational tuberculosis screening at four healthcare institutions in the United States, where the average tuberculosis case rate ranged from 4 to 9 per 100,000 persons. QuantiFERON-TB Gold In-Tube (QFT-GIT), T-SPOT.TB (T-SPOT), and TST were performed at baseline and every 6 months for 18 months between February 2008 and March 2011.A total of 2,418 HCWs completed baseline testing, which was positive for 125 (5.2%) by TST, 118 (4.9%) by QFT-GIT, and 144 (6.0%) by T-SPOT. A baseline positive TST with negative IGRAs was associated with bacillus Calmette-Guérin (BCG) vaccination (odds ratio: 25.1 [95% confidence interval: 15.5, 40.5] vs. no BCG). Proportions of participants with test conversion during the study period were 138 of 2,263 (6.1%) for QFT-GIT, 177 of 2,137 (8.3%) for T-SPOT, and 21 of 2,293 (0.9%) for TST (P0.001 for QFT-GIT vs. TST and for T-SPOT vs. TST; P = 0.005 for QFT-GIT vs. T-SPOT). Of the QFT-GIT and T-SPOT converters, 81 of 106 (76.4%) and 91 of 118 (77.1%), respectively, were negative when retested 6 months later. There was negative/positive discordance for 15 of 170 (8.8%) participants by QFT-GIT and for 19 of 151 (12.6%) by T-SPOT when blood was drawn 2 weeks later.Most conversions among HCWs in low TB incidence settings appear to be false positives, and these occurred six to nine times more frequently with IGRAs than TST; repeat testing of apparent converters is warranted.

Summary Objectives To determine the rate of and risk factors for discontinuation of isoniazid due to adverse effects during the treatment of latent tuberculosis infection in a large, multi-site study. Methods The Tuberculosis Epidemiologic Studies Consortium (TBESC) conducted a prospective study from March 2007–September 2008 among adults initiating isoniazid for treatment of LTBI at 12 sites in the US and Canada. The relative risk for isoniazid discontinuation due to adverse effects was determined using negative binomial regression. Adjusted models were constructed using forward stepwise regression. Results Of 1306 persons initiating isoniazid, 617 (47.2%, 95% CI 44.5–50.0%) completed treatment and 196 (15.0%, 95% CI 13.1–17.1%) discontinued due to adverse effects. In multivariable analysis, female sex (RR 1.67, 95% CI 1.32–2.10, p p = 0.003) were independently associated with isoniazid discontinuation due to adverse effects. Conclusions The rate of discontinuation of isoniazid due to adverse effects was substantially higher than reported earlier. Women were at increased risk of discontinuing isoniazid due to adverse effects; close monitoring of women for adverse effects may be warranted. Current alcohol use was also associated with isoniazid discontinuation; counseling patients to abstain from alcohol could decrease discontinuation due to adverse effects.

AN ESTIMATED 9–14 million persons in the United States have latent tuberculous infection (LTBI) and are at risk for progression to active TB disease.1 Diagnosis and successful treatment of LTBI is a cornerstone of the US strategy to eliminate TB.2 An estimated 300 000 individuals are treated annually for LTBI in the United States;3 however, LTBI treatment completion rates fall well below established targets, ranging from 30% to 60% for a standard 9-month isoniazid regimen.4 Several US studies have evaluated interventions for improving adherence to LTBI treatment, including use of supervised therapy, financial incentives, counseling, peer education and case management.5 However, few studies have rigorously evaluated LTBI interventions through randomized controlled trials (RCTs),5 and most have focused on specific populations, such as jail/prison inmates,6 drug users,7–9 homeless persons10,11 and immigrants/refugees from TB-endemic countries,12 rather than the mix of populations eligible for LTBI treatment. Peer workers are widely used to promote changes in health behavior and are thought to play a unique role in health care, in part due to shared ethnicity, sex, illness experience, sexual orientation, risk behaviors and/or socio-economic characteristics with the target population.13–15 Peer collaboration is recognized as a potentially powerful tool to influence the complex interaction of factors known to influence adherence.16,17 With TB rates greatly exceeding national averages and the concomitant human immunodeficiency virus epidemic, the Harlem community in New York is vulnerable to TB.18 For many community members, tuberculin skin testing and the determination of LTBI status is frequently required to access homeless shelters, substance use programs and community-based organizations. The objective of this RCT was to assess the effectiveness of a peer-based intervention on adherence and completion of LTBI treatment in a general US clinic population.