Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial

BACKGROUND: People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes. METHODS: A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention. RESULTS: Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference -0.03 (95% CI -0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%. CONCLUSIONS: Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required. TRIAL REGISTRATION NUMBER: ISRCTN05815615

High Rates of Uncontrolled Blood Pressure in Malawian Adults Living with HIV and Hypertension.

BackgroundHypertension is among the most commonly diagnosed non-communicable diseases in Africa, and studies have demonstrated a high prevalence of hypertension among individuals with HIV. Despite high prevalence, there has been limited attention on the clinical outcomes of hypertension treatment in this population.ObjectiveWe sought to characterize rates of and factors associated with blood pressure control over one year among individuals on antiretroviral therapy (ART) and antihypertensive medications.MethodsWe performed a prospective observational cohort study at an HIV clinic in Malawi. We defined uncontrolled hypertension as a systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg at two or more follow-up visits during the year, while controlled hypertension was defined as <140 mm Hg systolic and <90 mm Hg diastolic at all visits, or at all but one visit. We calculated an antihypertensive non-adherence score based on self-report of missed doses at each visit (higher score = worse adherence) and used rank sum and chi-square tests to compare sociodemographic and clinical factors (including adherence) associated with blood pressure control over the year.ResultsAt study entry, 158 participants (23.5%) were on antihypertensive medication; participants had a median age of 51.0 years, were 66.5% female, and had a median of 6.9 years on ART. 19.0% (n = 30) achieved blood pressure control over the year of follow-up. Self-reported non-adherence to hypertension medications was the only factor significantly associated with uncontrolled blood pressure. The average non-adherence score for those with controlled blood pressure was 0.22, and for those with uncontrolled blood pressure was 0.61 (p = 0.009).ConclusionsAdults living with HIV and hypertension in our cohort had low rates of blood pressure control over one year associated with self-reported non-adherence to antihypertensive medications. Given the high prevalence and incidence of hypertension, interventions to improve blood pressure control are needed to prevent associated long-term cardio- and cerebrovascular morbidity and mortality