Amigas Latinas Motivando el Alma: Participant Perspectives on an In-Person and Online Implementation of an Intervention to Promote Mental Health in Latina Immigrant Women.

Amigas Latinas Motivando el Alma is a community-based intervention designed to increase social support and coping strategies among Latina immigrant women at risk for depression and anxiety. To assess satisfaction and perceived efficacy of the intervention, we conducted interviews with 32 participants that received the intervention in-person and online. Participants across both modalities found the program supportive in maintaining their mental health. They learned stress management techniques and found the support from facilitators and other participants helpful. Those receiving the intervention in-person were able to connect with other participants more easily than those that received it online. Those receiving it online noted distractions at home that made it challenging to fully engage. Community-based interventions that promote coping strategies and social support are a promising strategy for addressing mental health disparities among Latina immigrant women.TRN: NCT03749278, date of registration: November 21, 2018.

Delays to care in infantile epileptic spasms syndrome: Racial and ethnic inequities.

OBJECTIVE: Non-Hispanic (NH) Black children are less likely to receive a standard treatment course for infantile epileptic spasms syndrome (IESS) than White/NH children at pediatric tertiary care epilepsy centers in the United States. However, if inequities exist in time to diagnosis is unknown. Diagnostic delays as little as 1 week can be associated with worse developmental outcomes. METHODS: Diagnostic delays were evaluated in a retrospective cohort of 100 children with new onset IESS between January 2019 and May 2022. RESULTS: Children with Black, Indigenous, and People of Color (BIPOC) caregivers were more likely to experience clinically significant delays in referral from first provider to neurologist, when compared to White/NH children, even after controlling for other demographic and clinical variables (odds ratio = 4.98, confidence interval = 1.24-19.94, p = .023). SIGNIFICANCE: Disproportionate diagnostic delays place BIPOC children at risk of adverse developmental and epilepsy outcomes. Further interventional prospective and qualitative studies are needed to address inequities in care.

Promoting mental health in Latina immigrant women: Results from the Amigas Latinas Motivando el Alma intervention trial.

INTRODUCTION: Latina immigrants are at increased risk of depression and anxiety and limited access to mental health care. This study evaluated the effectiveness of Amigas Latinas Motivando el Alma (ALMA), a community-based intervention to reduce stress and promote mental health among Latina immigrants. METHODS: ALMA was evaluated using a delayed intervention comparison group study design. Latina immigrants (N = 226) were recruited from community organizations in King County, Washington from 2018 to 2021. Although originally developed to be delivered in-person, due to the COVID-19 pandemic the intervention was adapted mid-study to be delivered online. Participants completed surveys to assess changes in depression and anxiety post-intervention and at a two-month follow-up. We estimated generalized estimating equation models to assess differences in outcomes across groups, including stratified models for those receiving the intervention in-person or online. RESULTS: In adjusted models, participants in the intervention group had lower levels of depressive symptoms than the comparison group post-intervention (ß = -1.82, p = 0.01) and at two-month follow-up (ß = -1.52, p = 0.01). Anxiety scores decreased for both groups, and there were no significant differences post-intervention or at follow-up. In stratified models, participants in the online intervention group had lower levels of depressive (ß = -2.50, p = 0.007) and anxiety (ß = -1.86, p = 0.02) symptoms than those in the comparison group, but there were no significant differences among those that received the intervention in-person. CONCLUSIONS: Community-based interventions can be effective in preventing and reducing depressive symptoms among Latina immigrant women, even when delivered online. Further research should evaluate the ALMA intervention among larger more diverse Latina immigrant populations.

Amigas Latinas Motivando el Alma: In-Person and Online Delivery of an Intervention to Promote Mental Health Among Latina Immigrant Women.

Objective: A few mindfulness-based interventions have been developed for Latina immigrant populations. We describe the feasibility and acceptability of Amigas Latinas Motivando el Alma (ALMA), a culturally grounded intervention developed to prevent and reduce depression and anxiety among Latina immigrants. We also compare participation in the intervention in-person with an online adaptation developed in response to the COVID-19 pandemic. Methods: ALMA was developed through several years of formative research in collaboration with community organizations serving Latino immigrants. The curriculum integrates mindfulness-based approaches with Latino cultural strengths to reduce stress, enhance coping strategies, and increase social support. Latina immigrant women who spoke Spanish were recruited from Latino serving organizations to participate in an intervention trial. The program consisted of eight sessions offered weekly in person to groups of ∼20 Latina immigrants. After the onset of the pandemic, the program was adapted to be delivered online via zoom. Attendance and fidelity were monitored by intervention staff, and a satisfaction survey was given to participants post-intervention. Results: We enrolled 226 Latina immigrant women with an average age of 40 years and an average of 15.0 years living in the United States. The majority of participants were monolingual Spanish speakers (59%) with a high school degree (66%), although almost half were living on less than $2,200 per month (48%). One hundred and seven (47%) attended the program in-person, and 119 (53%) participated online. Program attendance was similar across modalities, with an average of 58% sessions completed among in-person and 60% among online participants. Participant satisfaction and perceived efficacy of the intervention were high in both in-person and online groups. Discussion: Our findings indicate that the ALMA intervention is acceptable and feasible in this population. Future research should assess the efficacy of mindfulness-based interventions in Latina immigrant populations, including both in-person and online modalities. CTR# NCT03749278.

Integrating an early child development intervention into an existing primary healthcare platform in rural Lesotho: a prospective case-control study.

OBJECTIVES: This study evaluated a novel early childhood development (ECD) programme integrated it into the primary healthcare system. SETTING: The intervention was implemented in a rural district of Lesotho from 2017 to 2018. PARTICIPANTS: It targeted primary caregivers during routine postnatal care visits and through village health worker home visits. INTERVENTION: The hybrid care delivery model was adapted from a successful programme in Lima, Peru and focused on parent coaching for knowledge about child development, practicing contingent interaction with the child, parent social support and encouragement. PRIMARY AND SECONDARY OUTCOMES MEASURES: We compared developmental outcomes and caregiving practices in a cohort of 130 caregiver-infant (ages 7-11 months old) dyads who received the ECD intervention, to a control group that did not receive the intervention (n=125) using a case-control study design. Developmental outcomes were evaluated using the Extended Ages and Stages Questionnaire (EASQ), and caregiving practices using two measure sets (ie, UNICEF Multiple Indicator Cluster Survey (MICS), Parent Ladder). Group comparisons were made using multivariable regression analyses, adjusting for caregiver-level, infant-level and household-level demographic characteristics. RESULTS: At completion, children in the intervention group scored meaningfully higher across all EASQ domains, compared with children in the control group: communication (δ=0.21, 95% CI 0.07 to 0.26), social development (δ=0.27, 95% CI 0.11 to 0.8) and motor development (δ=0.33, 95% CI 0.14 to 0.31). Caregivers in the intervention group also reported significantly higher adjusted odds of engaging in positive caregiving practices in four of six MICS domains, compared with caregivers in the control group-including book reading (adjusted OR (AOR): 3.77, 95% CI 1.94 to 7.29) and naming/counting (AOR: 2.05; 95% CI 1.24 to 3.71). CONCLUSIONS: These results suggest that integrating an ECD intervention into a rural primary care platform, such as in the Lesothoan context, may be an effective and efficient way to promote ECD outcomes.

Community Outreach for Navajo People Living with Diabetes: Who Benefits Most?

INTRODUCTION: The Community Outreach and Patient Empowerment (COPE) intervention provides integrated outreach through community health representatives (CHRs) to people living with diabetes in Navajo Nation. The aim of this study was to identify groups for whom the intervention had the greatest effect on glycated hemoglobin A1c (HbA1c). METHODS: We analyzed de-identified data extracted from routine health records dated from December 1, 2010, through August 31, 2014, to compare net change in HbA1c among COPE patients and non-COPE patients. We used linear mixed models to assess whether the intervention was modified by age, sex, preferred language, having a primary care provider, baseline HbA1c, or having a mental health condition. RESULTS: Age, having a primary care provider, and baseline HbA1c significantly modified HbA1c levels. Among patients aged 64 or younger, COPE participation was associated with a net decrease in HbA1c of 0.77%; among patients aged 65 or older, the net decrease was 0.49% (P = .03). COPE participation was associated with a steeper decrease in HbA1c among patients without a primary care physician (net decrease, 0.99%) than among patients with a primary care provider (net decrease, 0.57%) (P = .03). COPE patients with a baseline HbA1c >9% had a net decrease of 0.70%, while those with a baseline HbA1c ≤9% had a net decrease of 0.34% (P = .01). We found no significant differences based on sex, preferred language, or having a mental health condition. CONCLUSION: Findings suggest that the COPE intervention was robust and equitable, benefiting all groups living with diabetes in Navajo Nation, but conferring the greatest benefit on the most vulnerable.

Community-based outreach associated with increased health utilization among Navajo individuals living with diabetes: a matched cohort study.

BACKGROUND: Navajo community members face high rates of diabetes mellitus and other chronic diseases. The Navajo Community Health Representative Outreach Program collaborated with healthcare providers and academic partners to implement structured and coordinated outreach to patients living with diabetes. The intervention, called Community Outreach and Patient Empowerment or COPE, provides home-based health coaching and community-clinic linkages to promote self-management and engagement in healthcare services among patients living with diabetes. The purpose of this study was to evaluate how outreach by Navajo Community Health Representatives ("COPE Program") affected utilization of health care services among patients living with diabetes. METHODS: De-identified data from 2010 to 2014 were abstracted from electronic health records at participating health facilities. In this observational cohort study, 173 cases were matched to 2880 controls. Healthcare utilization was measured as the number of times per quarter services were accessed by the patient. Changes in utilization over 4 years were modeled using a difference-in-differences approach, comparing the trajectory of COPE patients' utilization before versus after enrollment with that of the control group. The model was estimated using generalized linear mixed models for count outcomes, controlling for clustering at the patient level and the service unit level. RESULTS: COPE enrollees showed a 2.5% per patient per quarter (pppq) greater increase in total utilization (p = 0.001) of healthcare services than non-COPE enrollees; a 3.2% greater increase in primary care visits (p = 0.024); a 6.3% greater increase in utilization of counseling and behavioral health services (p = 0.013); and a 9.0% greater increase in pharmacy visits (p <  0.001). We found no statistically significant differences in utilization trends of inpatient, emergency room, specialty outpatient, dental, laboratory, radiology, or community encounter services among COPE participants versus control. CONCLUSIONS: A structured intervention consisting of Community Health Representative outreach and coordination with clinic-based providers was associated with a modest increase in health care utilization, including primary care and counseling services, among Navajo patients living with diabetes. Community health workers may provide an important linkage to enable patients to access and engage in clinic-based health care. TRIAL REGISTRATION: NCT03326206, registered 10/31/2017, retrospectively registered.

Community-clinic linkages: qualitative provider perspectives on partnering with community health representatives in Navajo Nation.

OBJECTIVE: To understand providers' opinions about the Community Outreach and Patient Empowerment (COPE) Project designed to strengthen Navajo Community Health Representative (CHR) outreach to individuals living with diabetes. DESIGN: This was a qualitative study nested within a larger evaluation of a programme intervention. SETTING: The study took place in Navajo Nation and evaluated a programme initiative designed to strengthen collaboration between CHRs and clinic-based healthcare providers and provide structured outreach to individuals living with diabetes in Navajo Nation. The CHR Programme is a formal community health worker programme that exists in most tribal healthcare systems across the USA. PARTICIPANTS: Healthcare providers involved in the programme took part in one-on-one interviews. ANALYSIS: We used thematic analysis for this study. A team of three study staff used open-coding to create a codebook. Coded material were summarised and patterns were identified and tied into a narrative using concept mapping. The study design and instrument construction were guided by a Community Health Advisory Panel. RESULTS: A total of 13 interviews were completed. Providers acknowledged CHRs as an asset to the clinical team and were enthusiastic about the COPE coaching materials, mentioning they provided a consistent message to CHRs and the community. Providers that led COPE trainings with CHRs valued the face-to-face time and opportunity to build relationships. Providers (n=4) supported CHRs' access to electronic health record to record patient visits and streamline referrals. Among their requests were having designated personnel to manage referrals with CHRs and a formal system to record modules CHRs have completed. CONCLUSION: Providers participating in COPE activities valued the work of CHRs and endorsed further strengthening relationships and communication with CHRs. Healthcare programmes should consider systems changes to integrate community health workers into clinic-based teams. TRIAL REGISTRATION NUMBER: NCT03326206; Results.

Qualitative evaluation of a community health representative program on patient experiences in Navajo Nation.

BACKGROUND: Community Health Representatives (CHRs) overcome health disparities in Native communities by delivering home care, health education, and community health promotion. The Navajo CHR Program partners with the non-profit Community Outreach and Patient Empowerment (COPE), to provide home-based outreach to Navajo clients living with diabetes. COPE has created an intervention (COPE intervention) focusing on multiple levels of improved care including trainings for CHRs on Motivational Interviewing and providing CHRs with culturally-appropriate education materials. The objective of this research is to understand the participant perspective of the CHR-COPE collaborative outreach through exploring patient-reported outcomes (PROs) of clients who consent to receiving the COPE intervention (COPE clients) using a qualitative methods evaluation. METHODS: Seven COPE clients were selected to participate in semi-structured interviews one year after finishing COPE to explore their perspective and experiences. Qualitative interviews were recorded, transcribed, and coded to identify themes. RESULTS: Clients revealed that health education delivered by CHRs facilitated lifestyle changes by helping them understand key health indicators and setting achievable goals through the use of accessible material and encouragement. Clients felt comfortable with CHRs who respected traditional practices and made regular visits. Clients also appreciated when CHRs educated their family members, who in turn were better able to support the client in their health management. Finally, CHRs who implemented the COPE intervention helped patients who were unable to regularly see a primary care doctor for critical care and support in their disease management. CONCLUSION: The COPE-CHR collaboration facilitated trusting client-CHR relationships and allowed clients to better understand their diagnoses. Further investment in materials that respect traditional practices and aim to educate clients' families may foster these relationships and improve health outcomes. TRIAL REGISTRATION: clinicaltrials.gov: NCT03326206. Registered 9/26/2017 (retrospectively registered).

Correction to: Glycemic control and healthcare utilization following pregnancy among women with pre-existing diabetes in Navajo Nation.

In the original publication of this article [1] an author's name needs to be revised from Katrina Nelson to Adrianne Katrina Nelson.

Emotional Experiences of Mothers Living With HIV and the Quest for Emotional Recovery: A Qualitative Study in Lima, Peru.

Little evidence exists about the emotional experiences of mothers with HIV, and a better understanding is essential to support their emotional health and treatment adherence. We describe the emotional experiences of eight mothers who initiated antiretroviral therapy during pregnancy or within a few years of childbirth in Lima, Peru. An interpretive phenomenological approach was used, and the following themes emerged: (a) emotions involved in diagnosis and disclosure, (b) the meaning of motherhood with HIV, (c) the mothers' roles in seeking and maintaining relationships with partners and families, and (d) mechanisms for resilience and emotional recovery. Participants experienced sadness and denial after diagnosis, which gave way to emotional recovery. Participant abilities to find refuge in caring for children and coordinating support from loved ones proved to be essential. Participants recognized that intense emotions motivated them to seek creative solutions and cited personal growth as an important outcome.

Dynamics of Treatment Supporters and Patients Starting HIV Therapy in Lima, Peru.

As per the National HIV Program in Peru, the designation of a patient-elected treatment supporter is a requisite for starting antiretroviral therapy (ART). These individuals are expected to aid the patient in medical and social support. This qualitative study examines the interaction between treatment supporters and people living with HIV/AIDS (PLWHA) to elucidate key dynamics contributing to care. Twenty individual interviews with treatment supporters were analyzed alongside 5 group interviews: 2 groups of treatment supporters, 2 groups of PLWHA, and 1 group of community health workers. Findings characterized formal means of treatment support and informal emotional and instrumental support. Gradual transfer of treatment responsibilities from supporters to PLWHA was found to foster a sense of self-efficacy among PLWHA, and when paired with open communication and committed emotional support, created an ideal reciprocal relationship. However, lack of HIV-related knowledge among treatment supporters was detrimental. More training and systemic support for treatment supporters may optimize their role as informed participants in the care of PLWHA.

Training Toward a Movement: Career Development Insights From the First 7 Years of a Global Health Equity Residency.

BACKGROUND: The Doris and Howard Hiatt Residency in Global Health Equity and Internal Medicine at Brigham and Women's Hospital provides global health training during residency, but little is known about its effect on participants' selection of a global health career. OBJECTIVE: We assessed the perceptions of residency graduates from the first 7 classes to better understand the outcomes of this education program, and the challenges faced by participants. METHODS: We interviewed 27 of 31 physicians (87%) who graduated from the program between 2003 and 2013 using a convergent mixed-methods design and a structured interview tool that included both open-ended and forced-choice questions. We independently coded and analyzed qualitative data using a case study design, and then wove together the qualitative and quantitative data at the interpretation phase using a parallel convergent mixed-methods design. RESULTS: Entering a career focused on social justice was cited as the most common motivator for selecting to train in global health. Most respondents (83%, 20 of 24) reported they were able to achieve this goal despite structural barriers, such as lower salaries compared with peers, a lack of mentors in the field, poorly structured and undersupported career pathways at their institutions, and unique work-life challenges. CONCLUSIONS: A majority of graduates from 1 dedicated residency program in global health and internal medicine reported they were able to continue to engage in global health activities after graduation and, despite identified challenges, reported that they planned long-term careers in global health.

Identifying risk factors for 30-day readmission events among American Indian patients with diabetes in the Four Corners region of the southwest from 2009 to 2016.

OBJECTIVE: The objective of this study was to identify risk factors for 30-day readmission events for American Indian patients with diabetes in the southwest. RESEARCH DESIGN AND METHODS: Data from patients with diabetes admitted to Gallup Indian Medical Center between 2009 and 2016 were analyzed using logistic regression analyses. RESULTS: Of 2,660 patients, 394 (14.8%) patients had at least one readmission within 30 days of discharge. Older age (OR (95% CI) = 1.26, (1.17, 1.36)), longer length of stay (OR (95% CI) = 1.01, (1.0001, 1.0342)), and a history of substance use disorder (OR (95% CI) = 1.80, (1.25, 2.60)) were risk factors for 30-day readmission. An American Indian language preference was protective against readmission. CONCLUSIONS: Readmission events are complex and may reflect broad and interwoven disparities in community systems. Future research should work to support community-defined interventions to address both in hospital and external factors that impact risk factors for readmission.

Glycemic control and healthcare utilization following pregnancy among women with pre-existing diabetes in Navajo Nation.

BACKGROUND: Native American communities experience greater burden of diabetes than the general population, including high rates of Type 2 diabetes among women of childbearing age. Diabetes in pregnancy is associated with risks to both the mother and offspring, and glycemic control surrounding the pregnancy period is of vital importance. METHODS: A retrospective chart review was conducted at a major Navajo Area Indian Health Service (IHS) hospital, tracking women with pre-existing diabetes who became pregnant between 2010 and 2012. Logistic regression was performed to find patient-level predictors of our desired primary outcome-having hemoglobin A1c (HbA1c) consistently < 8% within 2 years after pregnancy. Descriptive statistics were generated for other outcomes, including glycemic control and seeking timely IHS care. RESULTS: One hundred twenty-two pregnancies and 114 individuals were identified in the dataset. Baseline HbA1c was the only covariate which predicted our primary outcome (OR = 1.821, 95% CI = 1.184-2.801). Examining glycemic control among pregnancies with complete HbA1c data (n = 59), 59% were controlled before, 85% during, and 34% after pregnancy. While nearly all women received care in the immediate postpartum period, only 49% of women visited a primary care provider and 71% had HbA1c testing in the 2 years after pregnancy. CONCLUSIONS: This is the first analysis of outcomes among women with diabetes in pregnancy in Navajo Nation, the largest reservation and tribal health system in the United States. Our findings demonstrate the positive impact of specialized prenatal care in achieving glycemic control during pregnancy, while highlighting the challenges in maintaining glycemic control and continuity of healthcare after pregnancy.

Primary care and survival among American Indian patients with diabetes in the Southwest United States: Evaluation of a cohort study at Gallup Indian Medical Center, 2009-2016.

OBJECTIVES: To evaluate the role of primary care healthcare delivery on survival for American Indian patients with diabetes in the southwest United States. METHODS: Data from patients with diabetes admitted to Gallup Indian Medical Center between 2009 and 2016 were analyzed using a log-rank test and Cox Proportional Hazards analyses. RESULTS: Of the 2661 patients included in analysis, 286 patients died during the study period. Having visited a primary care provider in the year prior to first admission of the study period was protective against all-cause mortality in unadjusted analysis (HR (95% CI)=0.47 (0.31, 0.73)), and after adjustment. The log-rank test indicated there is a significant difference in overall survival by primary care engagement history prior to admission (p<0.001). The median survival time for patients who had seen a primary care provider was 2322days versus 2158days for those who had not seen a primary care provider. CONCLUSIONS: Compared with those who did not see a primary care provider in the year prior to admission, having seen a primary care provider was associated with improved survival after admission.

Strengthening the role of Community Health Representatives in the Navajo Nation.

BACKGROUND: Strengthening Community Health Worker systems has been recognized to improve access to chronic disease prevention and management efforts in low-resource communities. The Community Outreach and Patient Empowerment (COPE) Program is a Native non-profit organization with formal partnerships with both the Navajo Nation Community Health Representative (CHR) Program and the clinical facilities serving the Navajo Nation. COPE works to better integrate CHRs into the local health care system through training, strengthening care coordination, and a standardized culturally appropriate suite of health promotion materials for CHRs to deliver to high-risk individuals in their homes. METHODS: The objective of this mixed methods, cross sectional evaluation of a longitudinal cohort study was to explore how the COPE Program has effected CHR teams over the past 6 years. COPE staff surveyed CHRs in concurrent years (2014 and 2015) about their perceptions of and experience working with COPE, including potential effects COPE may have had on communication among patients, CHRs, and hospital-based providers. COPE staff also conducted focus groups with all eight Navajo Nation CHR teams. RESULTS: CHRs and other stakeholders who viewed our results agree that COPE has improved clinic-community linkages, primarily through strengthened collaborations between Public Health Nurses and CHRs, and access to the Electronic Health Records. CHRs perceived that COPE's programmatic support has strengthened their validity and reputation with providers and clients, and has enhanced their ability to positively effect health outcomes among their clients. CHRs report an improved ability to deliver health coaching to their clients. Survey results show that 80. 2% of CHRs feel strongly positive that COPE trainings are useful, while 44.6% of CHRs felt that communication and teamwork had improved because of COPE. CONCLUSIONS: These findings suggest that CHRs have experienced positive benefits from COPE through training. COPE may provide a useful programmatic model on how best to support other Community Health Workers through strengthening clinic-community linkages, standardizing competencies and training support, and structuring home-based interventions for high-risk individuals.

Cultural elements underlying the community health representative - client relationship on Navajo Nation.

BACKGROUND: Navajo Nation Community Health Representatives (CHR) are trained community health workers (CHWs) who provide crucial services for patients and families. The success of the CHRs' interventions depends on the interactions between the CHRs and their clients. This research investigates the culturally specific factors that build and sustain the CHR-client interaction. METHODS: In-depth interviews were conducted with 16 CHRs on Navajo Nation. Interviews were transcribed and coded according to relevant themes. Code summaries were organized into a narrative using grounded theory techniques. RESULTS: The analysis revealed four findings critical to the development of a CHR-client relationship. Trust is essential to this relationship and provides a basis for providing quality services to the client. The ability to build and maintain trust is defined by tradition and culture. CHRs must be respectful of the diverse traditional and social practices. Lastly, the passing of clients brings together the CHR, the client's family, and the community. CONCLUSION: Understanding the cultural elements of the CHR-client relationship will inform the work of community partners, clinical providers, and other indigenous communities working to strengthen CHR programs and obtain positive health outcomes among marginalized communities.

From HIV diagnosis to initiation of treatment: Social transformation among people starting antiretroviral therapy in Peru.

Social support is a key, yet elusive resource for HIV patients living in poverty in Lima, Peru. Despite a greater need for health services and encouragement from others, economic restraints, stigma, and trouble negotiating a fractured health system act as hurdles to accessing support. In this study, 33 people with HIV and 15 of their treatment supporters were interviewed upon initiation of antiretroviral therapy in order to understand changes in social support during this critical time, and how these changes affected their well-being. Everyone's social network underwent dramatic transformation, while some were rejected upon disclosure by people they knew, many successfully trimmed their social circles to a few trusted parties. Treatment supporters were most frequently the first to whom they disclosed their HIV status, and most backed the person with HIV, although sometimes out of obligation. HIV peers became a vital new source of strength. Ultimately, people with HIV who successfully reorganized their social network drew personal strength and self-worth from new and old relationships in their lives.

Training and fidelity monitoring of alcohol treatment interventions integrated into routine tuberculosis care in Tomsk, Russia: the IMPACT Effectiveness Trial.

IMPACT (Integrated Management of Physician-Delivered Alcohol Care for Tuberculosis patients) is a randomized, controlled effectiveness trial based in Tomsk, Russia, that assesses the effect of oral naltrexone and brief behavioral counseling on tuberculosis outcomes and alcohol use in 200 patients. Tuberculosis physicians without addiction experience delivered interventions as part of routine care over a 6-month period, focusing on alcohol intake reduction to support successful tuberculosis treatment. We describe design, training, and fidelity monitoring using a Russian and American team of physicians, bilingual coders, and supervisors. Culturally appropriate adaptations, limitations, and implications for future trials are discussed. The clinical trial identification number is NCT00675961. Funding came from the National Institutes of Health and National Institute on Drug Abuse.