Randomized controlled trial of interventions to improve follow-up for latent tuberculosis infection after release from jail. Behavioral interventions for the control of tuberculosis among adolescents. Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa. Does routine home visiting improve the return rate and outcome of DOTS patients who delay treatment? A clinical trial of a financial incentive to go to the tuberculosis clinic for isoniazid after release from jail. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Randomised controlled trial of self-supervised and directly observed treatment of tuberculosis. Intervention to improve psychological functioning for newly diagnosed patients with cancer. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste.
Adherence to treatment of persons with latent tuberculosis infection after release from jail has been poor.
                A randomized controlled trial was conducted at the San Francisco City and County Jail, San Francisco, Calif. Subjects undergoing therapy for latent tuberculosis infection who spoke either English or Spanish were randomly allocated to receive education every 2 weeks while in jail; an incentive if they went to the San Francisco County Tuberculosis Clinic within 1 month of release; or usual care. The main outcome measures were completion of a visit to the tuberculosis clinic within 1 month of release and completion of therapy.
                Of 558 inmates enrolled, 325 were released before completion of therapy. Subjects in either intervention group were significantly more likely to complete a first visit than were control subjects (education group, 37%; incentive group, 37%; and controls, 24%) (adjusted odds ratio based on pooled results for the education and incentive groups, 1.85; 95% confidence interval, 1.04-3.28; P =.02). Those in the education group were twice as likely to complete therapy compared with controls (adjusted odds ratio, 2.2; 95% confidence interval, 1.04-4.72; P =.04). Of those who went to the tuberculosis clinic after release, subjects in the education group were more likely to complete therapy (education group, 65% [24/37]; incentive group, 33% [14/42]; and control group, 48% [12/25]; P =.02).
                Education or the promise of an incentive improved initial follow-up. Education was superior to an incentive for the completion of therapy. Fairly modest strategies provided in jail can improve adherence. Further links between jail health services and community care should be explored. Activation of latent tuberculosis infection into tuberculosis disease (TB), the primary killer among infectious diseases worldwide, can be prevented with six months of anti-TB medication. A large percentage of adolescents started on medication, however, fail to complete their treatment. The authors developed and tested the effects of innovative educational strategies on infected adolescents at two health centers serving ethnically diverse populations.
                The authors used a randomized experimental four-group design to assess the independent and combined effects of peer counseling and a participant-parent contingency contract intervention.
                A total of 794 adolescents were recruited into the study, for a 79% participation rate. The overall rate of treatment completion was 79.8%. Self-efficacy for medication-taking behavior at post-test correlated strongly with completion of care (R = 0.367, p = 0.002). Participants randomized to the peer counseling groups demonstrated significantly greater improvements in self-efficacy and mastery than the usual care control group. Based on the study results, continuing education seminars and workshops were implemented for TB control staff at the two health clinics and for all TB Control Division staff at the Los Angeles County Health Department. Educational materials and a training manual for enhancing completion of treatment of latent TB infection through tailored educational approaches were developed and disseminated to the clinics.
                Health education and incentives are helpful adjuncts to the completion of treatment for latent tuberculosis infection in adolescents. To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%.
                A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment.
                The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation.
                This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required. Over a period of 6 months the effect of home visits on compliance with directly observed therapy, short course (DOTS), was studied on 480 new smear-positive tuberculosis patients who had delayed collecting their drugs on one occasion. Patients registered at 15 tuberculosis treatment centres in Baghdad, Iraq, were randomized to an intervention group (receiving home visits from trained personnel) or a control group. Home visits were highly effective in improving the return to treatment of patients who were late for treatment (231/240, 96.3%). The intervention group showed a higher treatment success rate (94.2% versus 76.7%), lower default rate (0.8% versus 10.0%) and higher smear conversion rate after the end of treatment (92.9% versus 75.0%) than controls. Home visiting by trained personnel significantly improves patient compliance with DOTS. Screening for active tuberculosis (TB) and providing isoniazid (INH) preventive therapy in jails are important control measures. In San Francisco, however, historical data showed that 62% of inmates were released before completing preventive therapy, and of those only 3% attended the TB Clinic for follow-up.
                A randomized clinical trial to compare a $5 cash incentive plus standardized TB education with standardized TB education alone in encouraging released inmates to make a first visit to the clinic.
                Of 79 persons enrolled in the trial, 77.2% were released before INH completion. Rates of first visit were not significantly different for those receiving +5 plus standardized education (25.8%) versus standardized education alone (23.3%), but were higher than rates seen in historical data for inmates not receiving standardized education. Age was an important predictor of completion of a first visit (odds ratio 1.09, 95% confidence interval 1.02-1.16, P = 0.017). Other variables predicting adherence included intent to adhere, more previous time in jail, stable housing, and being partnered versus alone, although these were not statistically significant.
                Standardized education may be important in improving follow-up after release. Further work on the role of a financial incentive in this population is needed. A prison in northern Taiwan.
                To compare safety and the completion rate of the 4-month daily rifampicin regimen (4R) vs. the standard 6-month daily isoniazid regimen (6H) for latent tuberculosis infection (LTBI) in prison inmates.
                This was an open-label randomised trial among human immunodeficiency virus negative male inmates. Inmates without active tuberculosis (TB) who tested positive for both the tuberculin skin test and QuantiFERON®-TB Gold In-Tube were eligible, but those with baseline glutamic pyruvic transaminase (GPT) levels ≥ 120 U/l, bilirubin levels ≥ 2.4 U/l or a platelet count < 150 k/mm(3) were excluded. The primary endpoint was any adverse event that resulted in discontinuation of LTBI treatment.
                Participants (n = 373; 14% hepatitis B surface antigen positive, 21% anti-hepatitis C virus [HCV] positive) were randomised (stratified by hepatitis B virus, HCV status and 2-year prison term) to receive either 4R or 6H under directly observed treatment. The 4R group (n = 190) was less likely to experience an adverse event leading to discontinuation of treatment (2% vs. 12%, P < 0.001 for all adverse events; 0% vs. 8%, P < 0.001 for hepatotoxicity), and more likely to complete LTBI treatment (86% vs. 78%, P = 0.041), compared with the 6H group (n = 183).
                4R is safer and has a higher completion rate than 6H as treatment for LTBI among male prison inmates. Tuberculosis is a major public-health problem in South Africa, made worse by poor adherence to and frequent interruption of treatment. Direct observation (DO) of tuberculosis patients taking their drugs is supposed to improve treatment completion and outcome. We compared DO with self-supervision, in which patients on the same drug regimen are not observed taking their pills, to assess the effect of each on the success of tuberculosis treatment.
                We undertook an unblinded randomised controlled trial in two communities with large tuberculosis caseloads. The trial included 216 adults who started pulmonary tuberculosis treatment for the first time, or who had a second course of treatment (retreatment patients). No changes to existing treatment delivery were made other than randomisation. Analysis was by intention to treat. Individual patient data from the two communities were combined.
                Treatment for tuberculosis was more successful among self-supervised patients (60% of patients) than among those on DO (54% of patients, difference between groups 6% [90% CI -5.1 to 17.0]). Retreatment patients had significantly more successful treatment outcomes if self-supervised (74% of patients) than on DO (42% of patients, difference between groups 32% [11%-52%]).
                At high rates of treatment interruption, self-supervision achieved equivalent outcomes to clinic DO at lower cost. Self-supervision achieved better outcomes for retreatment patients. Supportive patient-carer relations, rather than the authoritarian surveillance implicit in DO, may improve treatment outcomes and help to control tuberculosis. To test the effects of a computer-based nursing intervention designed to provide patients and family caregivers with concrete, objective information on symptom management; provide education about disease and treatment; coordinate medical resources; and provide emotional support and counseling.
                Two-site, randomized clinical trial.
                A large, urban, midwestern, tertiary-cancer center and a community-based cancer center in a medium-sized midwestern city.
                109 patients newly diagnosed with breast, colon, or lung cancer who were receiving chemotherapy; 54 received standard care, and 55 participated in the intervention group.
                Outcome data were collected via structured telephone interviews at three time points: baseline, midway through the intervention, and one month postintervention. The intervention consisting of nine visits, five in person and four by telephone, was conducted over 18 weeks by advanced practice oncology nurses.
                Psychosocial functioning, anxiety, and depression.
                Patients who received the intervention had significantly less depression between baseline and the midway point, as well as less anxiety and greater improvement in the role-emotional and mental health subscales of the Medical Outcomes Study 36 Short Form.
                Cancer-care nursing interventions can decrease psychosocial morbidity and improve quality of life for newly diagnosed patients with cancer undergoing treatment. Additional research is needed to understand who benefited most from the intervention.
                This nurse-directed intervention resulted in improved mental health for patients; however, physical subscales were not changed. Further work is needed to determine why depression and mental health were affected yet physical health and symptoms did not differ between groups. Results support the important role of nurses in addressing mental health issues in patients and families experiencing cancer. To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis.
                Parallel group randomised controlled trial.
                Three primary care clinics in Dili, Timor-Leste.
                270 adults aged >or=18 with previously untreated newly diagnosed pulmonary tuberculosis.
                Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes.
                Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3).
                Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required.
                Clinical Trials NCT0019256.
Educational or counselling interventions may improve completion of treatment for latent tuberculosis. As would be expected, the magnitude of the benefit is likely to depend on the nature of the intervention, and the reasons for low completion rates in the specific setting.