Task Shifting for Initiation and Monitoring of Antiretroviral Therapy for HIV-Infected Adults in Uganda: The SHARE Trial.

BACKGROUND: With countries moving toward the World Health Organization's "Treat All" recommendation, there is a need to initiate more HIV-infected persons into antiretroviral therapy (ART). In resource-limited settings, task shifting is 1 approach that can address clinician shortages. SETTING: Uganda. METHODS: We conducted a randomized controlled trial to test if nurse-initiated and monitored ART (NIMART) is noninferior to clinician-initiated and monitored ART in HIV-infected adults in Uganda. Study participants were HIV-infected, ART-naive, and clinically stable adults. The primary outcome was a composite end point of any of the following: all-cause mortality, virological failure, toxicity, and loss to follow-up at 12 months post-ART initiation. RESULTS: Over half of the study cohort (1,760) was women (54.9%). The mean age was 35.1 years (SD 9.51). Five hundred thirty-three (31.6%) participants experienced the composite end point. At 12 months post-ART initiation, nurse-initiated and monitored ART was noninferior to clinician-initiated and monitored ART. The intention-to-treat site-adjusted risk differences for the composite end point were -4.1 [97.5% confidence interval (CI): = -9.8 to 0.2] with complete case analysis and -3.4 (97.5% CI: = -9.1 to 2.5) with multiple imputation analysis. Per-protocol site-adjusted risk differences were -3.6 (97.5% CI: = -10.5 to 0.6) for complete case analysis and -3.1 (-8.8 to 2.8) for multiple imputation analysis. This difference was within hypothesized margins (6%) for noninferiority. CONCLUSIONS: Nurses were noninferior to clinicians for initiation and monitoring of ART. Task shifting to trained nurses is a viable means to increase access to ART. Future studies should evaluate NIMART for other groups (e.g., children, adolescents, and unstable patients).

Implementation and evaluation of a Project ECHO telementoring program for the Namibian HIV workforce.

BACKGROUND: The Namibian Ministry of Health and Social Services (MoHSS) piloted the first HIV Project ECHO (Extension for Community Health Outcomes) in Africa at 10 clinical sites between 2015 and 2016. Goals of Project ECHO implementation included strengthening clinical capacity, improving professional satisfaction, and reducing isolation while addressing HIV service challenges during decentralization of antiretroviral therapy. METHODS: MoHSS conducted a mixed-methods evaluation to assess the pilot. Methods included pre/post program assessments of healthcare worker knowledge, self-efficacy, and professional satisfaction; assessment of continuing professional development (CPD) credit acquisition; and focus group discussions and in-depth interviews. Analysis compared the differences between pre/post scores descriptively. Qualitative transcripts were analyzed to extract themes and representative quotes. RESULTS: Knowledge of clinical HIV improved 17.8% overall (95% confidence interval 12.2-23.5%) and 22.3% (95% confidence interval 13.2-31.5%) for nurses. Professional satisfaction increased 30 percentage points. Most participants experienced reduced professional isolation (66%) and improved CPD credit access (57%). Qualitative findings reinforced quantitative results. Following the pilot, the Namibia MoHSS Project ECHO expanded to over 40 clinical sites by May 2019 serving more than 140 000 people living with HIV. CONCLUSIONS: Similar to other Project ECHO evaluation results in the United States of America, Namibia's Project ECHO led to the development of ongoing virtual communities of practice. The evaluation demonstrated the ability of the Namibia HIV Project ECHO to improve healthcare worker knowledge and satisfaction and decrease professional isolation.

Impact of regulatory labeling for troglitazone and rosiglitazone on hepatic enzyme monitoring compliance: findings from the state of Ohio medicaid program.

PURPOSE: Troglitazone, the first drug of the thiazolidinediones class for type II diabetes, was first marketed in March 1997 and was removed from the U.S. market 36 months later after 90 cases of liver failure were reported despite multiple warnings containing liver enzyme monitoring recommendations. Rosiglitazone has been available since June 1999 and is still on the market. The purpose of this study was to evaluate the impact of labeled hepatic enzyme monitoring for troglitazone and rosiglitazone. METHODS: Drug cohorts were assembled, using population-based fee-for-service Medicaid claims, for patients between 18 and 65 years of age who had received at least one troglitazone (n = 7226) or rosiglitazone (n = 1480) prescription between 1 April, 1997, and 21 March, 2000. The outcome of interest was the percentage of patients, based on their first treatment episode, who had baseline and post-baseline liver enzyme testing. RESULTS: Overall baseline testing was under 9% before regulatory actions, increased to 14% after the first two 'Dear Doctor' letters issued by the FDA in October and December 1997, and peaked to about 26% afterwards. Coincident with the marketing of rosiglitazone and the fourth 'Dear Doctor' letter issued in June 1999, baseline testing dropped to 18%. Baseline testing increased 2.5-fold (race-sex-age adjusted) after regulatory action. Achieving 50% post-baseline testing took approximately 6 months for both drugs. CONCLUSION: Regulatory actions had only modest effects on the incidence of liver monitoring. More effective and timely communication strategies, health provider prescribing interventions and modification of health provider behaviors to enhance compliance with recommended risk management measures need to be identified, evaluated and implemented.