Retention and Viral Suppression Among Adolescents Newly Initiating Antiretroviral Therapy in Adult HIV Care in Lima, Peru: A Retrospective Cohort Study.

PURPOSE: Published data on outcomes among adolescents newly initiating antiretroviral treatment in the Latin American context are sparse. We estimated the frequency of sustained retention with viral load suppression (i.e., successful transition) and identified predictors of successful transition into adult care among youth (aged 14-21 years) with recently acquired HIV in Lima, Peru. METHODS: A retrospective cohort study was conducted among 184 adolescents and young adults who initiated antiretroviral therapy in an adult public sector HIV clinic between June 2014 and June 2019. Sustained retention (no loss-to-follow-up or death) with viral suppression was calculated for the first 12 and 24 months following treatment initiation. We conducted regression analyses to assess factors associated with successful transition to adult HIV care, including gender, age, occupation, nationality, pregnancy, same-sex sexual behavior, presence of treatment supporter, number of living parents, and social risk factors that may adversely influence health (e.g., lack of social support, economic deprivation). RESULTS: Patients were predominantly male (n = 167, 90.8%). Median age was 19 years (interquartile range: 18-21). Frequency of sustained retention with viral load suppression was 42.4% (78/184) and 35.3% (30/85) at 12 and 24 months following treatment initiation. In multivariable analyses, working and/or studying was inversely associated with successful transition into adult care at 12 months; number of known living parents (relative risk: 2.20; 95% confidence interval: 1.12, 4.34) and absence of social risk factors (relative risk: 1.68; 95% confidence interval: 0.91, 3.11) were positively associated with successful transition at 24 months. DISCUSSION: Sustained retention in HIV care was uncommon. Parental support and interventions targeting social risk factors may contribute to successful transition into adult HIV care in this group.

Global Learning for Health Equity: A Survey of Five Global Learning Sites in the United States.

Global learning is the practice of adopting and adapting global ideas to local challenges. To advance the field of global learning, we performed a case study of five communities that had implemented global health models to advance health equity in a U.S. setting. Surveys were developed using a Consolidated Framework for Implementation Research (CFIR) framework, and each site completed surveys to characterize their global learning experience with respect to community context, the learning and implementation process, implementation science considerations, and health equity. The immense diversity of sites and their experiences underscored the heterogenous nature of global learning. Nonetheless, all cases highlighted core themes of addressing social determinants of health through strong community engagement. Cross-sector participation and implementation science evaluation were strategies applied by many but not all sites. We advocate for continued global learning that advances health equity and fosters equitable partnerships with mutual benefits to origination and destination sites.

Teacher and Caregiver Perspectives on Water Is K'é: An Early Child Education Program to Promote Healthy Beverages among Navajo Children.

The Water is K'é program was developed to increase water consumption and decrease consumption of sugar-sweetened beverages for young children and caregivers. The pilot program was successfully delivered by three Family and Child Education (FACE) programs on the Navajo Nation using a culturally centered curriculum between 2020 to 2022. The purpose of this research was to understand teacher and caregiver perspectives of program feasibility, acceptability, impact, and other factors influencing beverage behaviors due to the pilot program. Nine caregivers and teachers were interviewed between June 2022 and December 2022, and a study team of four, including three who self-identified as Navajo, analyzed the data using inductive thematic analysis and consensus building to agree on codes. Five themes emerged, including feasibility, acceptability, impact, suggestions for future use of the program, and external factors that influenced water consumption. The analysis showed stakeholders' strong approval for continuing the program based on impact and acceptability, and identified factors that promote the program and barriers that can be addressed to make the program sustainable. Overall, the Water is K'é program and staff overcame many challenges during the COVID-19 pandemic to support healthy behavior change that had a rippled influence among children, caregivers, teachers, and many others.

Impact of a Fruit and Vegetable Prescription Program on Health Outcomes and Behaviors in Young Navajo Children.

BACKGROUND: Rates of childhood obesity are higher in American Indian and Alaska Native populations, and food insecurity plays a major role in diet-related disparities. To address this need, local healthcare providers and a local nonprofit launched the Navajo Fruit and Vegetable Prescription (FVRx) Program in 2015. Children up to 6 y of age and their caregivers are enrolled in the 6-mo program by healthcare providers. Families attend monthly health coaching sessions where they receive vouchers redeemable for fruits, vegetables, and healthy traditional foods at retailers participating in the FVRx program. OBJECTIVES: We assessed the impact of a fruit and vegetable prescription program on the health outcomes and behaviors of participating children. METHODS: Caregivers completed voluntary surveys to assess food security, fruit and vegetable consumption, hours of sleep, and minutes of physical activity; healthcare providers also measured children's body mass index [BMI (kg/m2)] z score at initiation and completion of the program. We calculated changes in health behaviors, BMI, and food security at the end of the program, compared with baseline values. RESULTS: A total of 243 Navajo children enrolled in Navajo FVRx between May 2015 and September 2018. Fruit and vegetable consumption significantly increased from 5.2 to 6.8 servings per day between initiation and program completion (P < 0.001). The proportion of participant households reporting food insecurity significantly decreased from 82% to 65% (P < 0.001). Among children classified as overweight or obese at baseline, 38% achieved a healthy BMI z score at program completion (P < 0.001). Sixty-five percent of children were retained in the program. CONCLUSIONS: The Navajo FVRx program improves fruit and vegetable consumption among young children. Children who are obese or overweight may benefit most from the program.

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.

Implementation of the Navajo fruit and vegetable prescription programme to improve access to healthy foods in a rural food desert.

OBJECTIVE: To utilise a community-based participatory approach in the design and implementation of an intervention targeting diet-related health problems on Navajo Nation. DESIGN: A dual strategy approach of community needs/assets assessment and engagement of cross-sectorial partners in programme design with systematic cyclical feedback for programme modifications. SETTING: Navajo Nation, USA. PARTICIPANTS: Navajo families with individuals meeting criteria for programme enrolment. Participant enrolment increased with iterative cycles. RESULTS: The Navajo Fruit and Vegetable Prescription (FVRx) Programme. CONCLUSIONS: A broad, community-driven and culturally relevant programme design has resulted in a programme able to maintain core programmatic principles, while also allowing for flexible adaptation to changing needs.

The complexities of selling fruits and vegetables in remote Navajo Nation retail outlets: perspectives from owners and managers of small stores.

OBJECTIVE: Navajo Nation residents experience extreme rates of poverty, food insecurity and diet-related diseases. While many residents travel far to shop at grocery stores, there are small stores closer to home that could provide more healthy options, like fruits and vegetables (F&V). Little is known from the perspective of store owners and managers regarding the barriers and facilitators to offering F&V; the present study contributes to filling that gap. DESIGN: Data were collected through structured interviews from a sampling frame of all store owners or managers in the setting (n 29). SETTING: Small stores in Navajo Nation, New Mexico, USA. Navajo Nation is predominantly rural and the largest federally recognized Native American tribe in the USA. PARTICIPANTS: Sixteen managers and six owners at twenty-two stores. RESULTS: When asked about the types of foods that were most commonly purchased at their stores, most participants reported snacks and drinks (82 and 68 %, respectively). Many participants reported they would like to offer more fresh F&V. However, barriers included varying perceived customer demand, limited F&V choices from distributors and (for some managers) limited authority over product selection. CONCLUSIONS: Findings contribute to the discussion on engaging store owners and managers in providing quality, healthy foods close to home in low-income, rural regions.

Integrating community health representatives with health care systems: clinical outcomes among individuals with diabetes in Navajo Nation.

BACKGROUND: We studied the impact of Community Outreach and Patient Empowerment (COPE) intervention to support Community Health Representatives (CHR) on the clinical outcomes of patients living with diabetes in the Navajo Nation extending into the States of Arizona, Utah, and New Mexico. The COPE intervention integrated CHRs into healthcare teams by providing a structured approach to referrals and home visits. METHODS: We abstracted routine clinical data from the Indian Health Service's information system on individuals with diabetes mellitus seen at participating clinical sites from 2010 to 2014. We matched 173 COPE participants to 2880 patients with similar demographic and clinical characteristics who had not participated in COPE. We compared the changes in clinical outcomes between the two groups using linear mixed models. RESULTS: Over the four years of the study, COPE patients had greater improvements in glycosylated hemoglobin (- 0.56%) than non-COPE participants (+ 0.07%) for a difference in differences of 0.63% (95% confidence interval (CI): 0.50, 0.76). Low-density lipoprotein fell more steeply in the COPE group (- 10.58 mg/dl) compared to the non-COPE group (- 3.18 mg/dl) for a difference in differences of 7.40 mg/dl (95%CI: 2.00, 12.80). Systolic blood pressure increased slightly more among COPE (2.06 mmHg) than non-COPE patients (0.61 mmHg). We noted no significant change for body mass index in either group. CONCLUSION: Structured outreach by Community Health Representatives as part of an integrated care team was associated with improved glycemic and lipid levels in the target Navajo population. TRIAL REGISTRATION: Trial registration: NCT03326206. Registered 31 October 2017 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT03326206.

Healthy Stores Initiative Associated with Produce Purchasing on Navajo Nation.

BACKGROUND: American Indians and Alaska Natives experience diet-related health disparities compared with non-Hispanic whites. Navajo Nation's colonial history and remote setting present unique challenges for healthy food access. OBJECTIVE: This study aims to understand the impact of the Healthy Navajo Stores Initiative (HNSI) on fruit and vegetable purchasing on Navajo Nation. METHODS: We conducted a cross-sectional survey of 692 customers shopping at 28 convenience stores, trading posts, and grocery stores on Navajo Nation. Individual- and household-level sociodemographic data and food purchasing behaviors were collected. Descriptive and bivariate analyses for customers' individual- and household-level characteristics were conducted using chi-squared tests. The impact of individual-, household-, and store-level factors on fruit and vegetable purchasing was assessed using multiple logistic regression modeling. RESULTS: Store participation in the HNSI was significantly associated with customers' purchase of produce. Customers experienced 150% higher odds of purchasing produce if they shopped in participating stores, compared with nonparticipating stores (P < 0.001). Store type was strongly associated with customers' purchase of fruits or vegetables. Customers shopping at a grocery store had 520% higher odds of purchasing produce than did customers shopping at convenience stores (P < 0.001). Customers shopping at trading posts had 120% higher odds of purchasing fruits or vegetables than did customers shopping at convenience stores (P = 0.001). CONCLUSIONS: Our findings reveal increased produce purchasing at stores participating in the HNSI. Customers were significantly more likely to purchase fruits or vegetables in stores enrolled in a healthy store intervention than in nonenrolled stores, after controlling for quantity of produce stocked and store type. Customers shopping in grocery stores and trading posts were significantly more likely to purchase produce than customers shopping in convenience stores. These findings have implications for food access in rural tribal communities.

CASITA: a controlled pilot study of community-based family coaching to stimulate early child development in Lima, Peru.

OBJECTIVE: To determine whether the 3-month, community-based early stimulation coaching and social support intervention 'CASITA', delivered by community health workers, could improve early child development and caregiver-child interaction in a resource-limited district in Lima, Peru. DESIGN: A controlled two-arm proof-of-concept study. SETTING: Six neighbourhood health posts in Carabayllo, a mixed rural/urban district in Lima. Sessions were held in homes and community centres. PARTICIPANTS: Children aged 6-24 months who screened positive for risk of neurodevelopmental delay (using validated developmental delay tool) and poverty (using progress out of poverty tool) were enrolled with their caregivers. Dyads with children born >21 days early were excluded. INTERVENTION: 12-week parenting/support intervention plus nutritional support (n=41) or nutrition alone (n=19). OUTCOME MEASURES: Development and home environment differences and mean changes from baseline to 3 months postintervention were evaluated using age-adjusted z-scores on the Extended Ages and Stages Questionnaire (EASQ) and the Home Observation Measurement of the Environment (HOME) scores, respectively. RESULTS: Development in CASITA improved significantly in all EASQ domains, whereas the control group's z-scores did not improve significantly in any domain. The mean adjusted difference (MAD) in change in EASQ age-adjusted z-scores between the two study arms was 1.39 (95% CI 0.55 to 2.22); Cohen's d effect size of 0.87 (95% CI 0.23 to 1.50). Likewise, intervention significantly improved global HOME scores versus control group (MAD change of 6.33 (95% CI 2.12 to 10.55); Cohen's d of 0.85 (95% CI 0.28 to 1.41)). CONCLUSIONS: An evidence-based early intervention delivered weekly during 3 months by a community health worker significantly improved children's communication, motor and personal/social development in this proof-of-concept study.

Multidrug-resistant tuberculosis treatment failure detection depends on monitoring interval and microbiological method.

Debate persists about monitoring method (culture or smear) and interval (monthly or less frequently) during treatment for multidrug-resistant tuberculosis (MDR-TB). We analysed existing data and estimated the effect of monitoring strategies on timing of failure detection.We identified studies reporting microbiological response to MDR-TB treatment and solicited individual patient data from authors. Frailty survival models were used to estimate pooled relative risk of failure detection in the last 12 months of treatment; hazard of failure using monthly culture was the reference.Data were obtained for 5410 patients across 12 observational studies. During the last 12 months of treatment, failure detection occurred in a median of 3 months by monthly culture; failure detection was delayed by 2, 7, and 9 months relying on bimonthly culture, monthly smear and bimonthly smear, respectively. Risk (95% CI) of failure detection delay resulting from monthly smear relative to culture is 0.38 (0.34-0.42) for all patients and 0.33 (0.25-0.42) for HIV-co-infected patients.Failure detection is delayed by reducing the sensitivity and frequency of the monitoring method. Monthly monitoring of sputum cultures from patients receiving MDR-TB treatment is recommended. Expanded laboratory capacity is needed for high-quality culture, and for smear microscopy and rapid molecular tests.

Aggressive Regimens Reduce Risk of Recurrence After Successful Treatment of MDR-TB.

BACKGROUND: We sought to determine whether treatment with a "long aggressive regimen" was associated with lower rates of relapse among patients successfully treated for pulmonary multidrug-resistant tuberculosis (MDR-TB) in Tomsk, Russia. METHODS: We conducted a retrospective cohort study of adult patients that initiated MDR-TB treatment with individualized regimens between September 2000 and November 2004, and were successfully treated. Patients were classified as having received "aggressive regimens" if their intensive phase consisted of at least 5 likely effective drugs (including a second-line injectable and a fluoroquinolone) used for at least 6 months post culture conversion, and their continuation phase included at least 4 likely effective drugs. Patients that were treated with aggressive regimens for a minimum duration of 18 months post culture conversion were classified as having received "long aggressive regimens." We used recurrence as a proxy for relapse because genotyping was not performed. After treatment, patients were classified as having disease recurrence if cultures grew MDR-TB or they re-initiated MDR-TB therapy. Data were analyzed using Cox proportional hazard regression. RESULTS: Of 408 successfully treated patients, 399 (97.5%) with at least 1 follow-up visit were included. Median duration of follow-up was 42.4 months (interquartile range: 20.5-59.5), and there were 27 recurrence episodes. In a multivariable complete case analysis (n = 371 [92.9%]) adjusting for potential confounders, long aggressive regimens were associated with a lower rate of recurrence (adjusted hazard ratio: 0.22, 95% confidence interval, .05-.92). CONCLUSIONS: Long aggressive regimens for MDR-TB treatment are associated with lower risk of disease recurrence.

Impact of HIV on mortality among patients treated for tuberculosis in Lima, Peru: a prospective cohort study.

BACKGROUND: Human immunodeficiency virus (HIV)-associated tuberculosis deaths have decreased worldwide over the past decade. We sought to evaluate the effect of HIV status on tuberculosis mortality among patients undergoing treatment for tuberculosis in Lima, Peru, a low HIV prevalence setting. METHODS: We conducted a prospective cohort study of patients treated for tuberculosis between 2005 and 2008 in two adjacent health regions in Lima, Peru (Lima Ciudad and Lima Este). We constructed a multivariate Cox proportional hazards model to evaluate the effect of HIV status on mortality during tuberculosis treatment. RESULTS: Of 1701 participants treated for tuberculosis, 136 (8.0%) died during tuberculosis treatment. HIV-positive patients constituted 11.0% of the cohort and contributed to 34.6% of all deaths. HIV-positive patients were significantly more likely to die (25.1 vs. 5.9%, P < 0.001) and less likely to be cured (28.3 vs. 39.4%, P = 0.003). On multivariate analysis, positive HIV status (hazard ratio [HR] = 6.06; 95% confidence interval [CI], 3.96-9.27), unemployment (HR = 2.24; 95% CI, 1.55-3.25), and sputum acid-fast bacilli smear positivity (HR = 1.91; 95% CI, 1.10-3.31) were significantly associated with a higher hazard of death. CONCLUSIONS: We demonstrate that positive HIV status was a strong predictor of mortality among patients treated for tuberculosis in the early years after Peru started providing free antiretroviral therapy. As HIV diagnosis and antiretroviral therapy provision are more widely implemented for tuberculosis patients in Peru, future operational research should document the changing profile of HIV-associated tuberculosis mortality.

Understanding HIV Risk Behavior among Tuberculosis Patients with Alcohol Use Disorders in Tomsk, Russian Federation.

Russian Federation's (RF) HIV epidemic is the fastest growing of any country. This study explores factors associated with high HIV risk behavior in tuberculosis (TB) patients with alcohol use disorders in Tomsk, RF. This analysis was nested within the Integrated Management of Physician-delivered Alcohol Care for TB Patients (IMPACT, trial number NCT00675961) randomized controlled study of integrating alcohol treatment into TB treatment in Tomsk. Demographics, HIV risk behavior (defined as participant report of high-risk intravenous drug use and/or multiple sexual partners with inconsistent condom use in the last six months), clinical data, alcohol use, depression and psychosocial factors were collected from 196 participants (161 male and 35 female) at baseline. Forty-six participants (23.5%) endorsed HIV risk behavior at baseline. Incarceration history(Odds Ratio (OR)3.93, 95% confidence interval (CI) 1.95, 7.95), age under 41 (OR:2.97, CI:1.46, 6.04), drug addiction(OR: 3.60 CI:1.10, 11.77), history of a sexually transmitted disease(STD)(OR 2.00 CI:1.02, 3.90), low social capital (OR:2.81 CI:0.99, 8.03) and heavier alcohol use (OR:2.56 CI: 1.02, 6.46) were significantly more likely to be associated with HIV risk behavior at baseline. In adjusted analysis, age under 41(OR: 4.93, CI: 2.10, 11.58), incarceration history(OR: 3.56 CI:1.55, 8.17) and STD history (OR: 3.48, CI: 1.5, 8.10) continued to be significantly associated with HIV risk behavior. Understanding HIV transmission dynamics in Russia remains an urgent priority to inform strategies to address the epidemic. Larger studies addressing sex differences in risks and barriers to protective behavior are needed.

Surgery as an Adjunctive Treatment for Multidrug-Resistant Tuberculosis: An Individual Patient Data Metaanalysis.

BACKGROUND: Medical treatment for multidrug-resistant (MDR)-tuberculosis is complex, toxic, and associated with poor outcomes. Surgical lung resection may be used as an adjunct to medical therapy, with the intent of reducing bacterial burden and improving cure rates. We conducted an individual patient data metaanalysis to evaluate the effectiveness of surgery as adjunctive therapy for MDR-tuberculosis. METHODS: Individual patient data, was obtained from the authors of 26 cohort studies, identified from 3 systematic reviews of MDR-tuberculosis treatment. Data included the clinical characteristics and medical and surgical therapy of each patient. Primary analyses compared treatment success (cure and completion) to a combined outcome of failure, relapse, or death. The effects of all forms of resection surgery, pneumonectomy, and partial lung resection were evaluated. RESULTS: A total of 4238 patients from 18 surgical studies and 2193 patients from 8 nonsurgical studies were included. Pulmonary resection surgery was performed on 478 patients. Partial lung resection surgery was associated with improved treatment success (adjusted odds ratio [aOR], 3.0; 95% confidence interval [CI], 1.5-5.9; I(2)R, 11.8%), but pneumonectomy was not (aOR, 1.1; 95% CI, .6-2.3; I(2)R, 13.2%). Treatment success was more likely when surgery was performed after culture conversion than before conversion (aOR, 2.6; 95% CI, 0.9-7.1; I(2)R, 0.2%). CONCLUSIONS: Partial lung resection, but not pneumonectomy, was associated with improved treatment success among patients with MDR-tuberculosis. Although improved outcomes may reflect patient selection, partial lung resection surgery after culture conversion may improve treatment outcomes in patients who receive optimal medical therapy.

Validation of 2 Spanish-Language Scales to Assess HIV-Related Stigma in Communities.

We report the psychometric properties of 2 Spanish-language scales designed to measure (1) opinions about HIV in the community and particularly among health care workers and (2) observed acts of stigma toward people living with HIV/AIDS (PLWHA) by health care workers. The Opinions about HIV Scale included 3 components (policy, avoidance, and empathy) and 9 items, while an adapted version of the HIV/AIDS Stigma Instrument-Nurse, designed to capture acts of stigma, included 2 components (discrimination related to clinical care and refusal to share or exchange food/gifts). Scales demonstrated good reliability and construct validity. Relative to community health workers, treatment supporters were more likely to have stigmatizing opinions related to avoidance and empathy. We offer 2 Spanish-language scales that could be used to identify populations with high levels of stigmatizing opinions and behaviors toward PLWHA. Formal training of health care workers, especially treatment supporters, may raise awareness and reduce stigma toward HIV.

Improving outcomes for multidrug-resistant tuberculosis: aggressive regimens prevent treatment failure and death.

BACKGROUND: Evidence is sparse regarding the optimal construction of regimens to treat multidrug-resistant (MDR) tuberculosis disease due to strains of Mycobacterium tuberculosis resistant to at least both isoniazid and rifampin. Given the low potency of many second-line antituberculous drugs, we hypothesized that an aggressive regimen of at least 5 likely effective drugs during the intensive phase, including a fluoroquinolone and a parenteral agent, would be associated with a reduced risk of death or treatment failure. METHODS: We conducted a retrospective cohort study of patients initiating MDR tuberculosis treatment between 2000 and 2004 in Tomsk, Russian Federation. We used a multivariate Cox proportional hazards model to assess whether monthly exposure to an aggressive regimen was associated with the risk of death or treatment failure. RESULTS: Six hundred fourteen individuals with confirmed MDR tuberculosis were eligible for analysis. On multivariable analysis that adjusted for extensively drug-resistant (XDR) tuberculosis-MDR tuberculosis isolates resistant to fluoroquinolones and parenteral agents-we found that monthly exposure to an aggressive regimen was significantly associated with a lower risk of death or treatment failure (hazard ratio, 0.52 [95% confidence interval, .29-.94]; P = .030). CONCLUSIONS: Receipt of an aggressive treatment regimen was a robust predictor of decreased risk of death or failure during MDR tuberculosis treatment. These findings further support the use of this regimen definition as the benchmark for the standard of care of MDR tuberculosis patients and should be used as the basis for evaluating novel therapies.

Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial.

BACKGROUND: Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). SETTING: 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. RESULTS: 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). CONCLUSIONS: The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. TRIAL REGISTRATION: ClinicalTrials.gov NCT01201941.

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.

Aggressive regimens for multidrug-resistant tuberculosis decrease all-cause mortality.

RATIONALE: A better understanding of the composition of optimal treatment regimens for multidrug-resistant tuberculosis (MDR-TB) is essential for expanding universal access to effective treatment and for developing new therapies for MDR-TB. Analysis of observational data may inform the definition of an optimized regimen. OBJECTIVES: This study assessed the impact of an aggressive regimen-one containing at least five likely effective drugs, including a fluoroquinolone and injectable-on treatment outcomes in a large MDR-TB patient cohort. METHODS: This was a retrospective cohort study of patients treated in a national outpatient program in Peru between 1999 and 2002. We examined the association between receiving an aggressive regimen and the rate of death. MEASUREMENTS AND MAIN RESULTS: In total, 669 patients were treated with individualized regimens for laboratory-confirmed MDR-TB. Isolates were resistant to a mean of 5.4 (SD 1.7) drugs. Cure or completion was achieved in 66.1% (442) of patients; death occurred in 20.8% (139). Patients who received an aggressive regimen were less likely to die (crude hazard ratio [HR]: 0.62; 95% CI: 0.44,0.89), compared to those who did not receive such a regimen. This association held in analyses adjusted for comorbidities and indicators of severity (adjusted HR: 0.63; 95% CI: 0.43,0.93). CONCLUSIONS: The aggressive regimen is a robust predictor of MDR-TB treatment outcome. TB policy makers and program directors should consider this standard as they design and implement regimens for patients with drug-resistant disease. Furthermore, the aggressive regimen should be considered the standard background regimen when designing randomized trials of treatment for drug-resistant TB.