High Completion Rate for 12 Weekly Doses of Isoniazid and Rifapentine as Treatment for Latent Mycobacterium tuberculosis Infection in the Federal Bureau of Prisons.

CONTEXT: Correctional facilities provide unique opportunities to diagnose and treat persons with latent tuberculosis infection (LTBI). Studies have shown that 12 weekly doses of isoniazid and rifapentine (INH-RPT) to treat LTBI resulted in high completion rates with good tolerability. OBJECTIVE: To evaluate completion rates and clinical signs or reported symptoms associated with discontinuation of 12 weekly doses of INH-RPT for LTBI treatment. SETTING/PARTICIPANTS: During July 2012 to February 2015, 7 Federal Bureau of Prisons facilities participated in an assessment of 12 weekly doses of INH-RPT for LTBI treatment among 463 inmates. MAIN OUTCOME MEASURES: Fisher exact test was used to assess the associations between patient sociodemographic characteristics and clinical signs or symptoms with discontinuation of treatment. RESULTS: Of 463 inmates treated with INH-RPT, 424 (92%) completed treatment. Reasons for discontinuation of treatment for 39 (8%) inmates included the following: 17 (44%) signs/symptoms, 9 (23%) transfer or release, 8 (21%) treatment refusal, and 5 (13%) provider error. A total of 229 (49.5%) inmates reported experiencing at least 1 sign or symptom during treatment; most frequently reported were fatigue (16%), nausea (13%), and abdominal pain (7%). Among these 229 inmates, signs/symptoms significantly associated with discontinuation of treatment included abdominal pain (P < .001), appetite loss (P = .02), fever/chills (P = .01), nausea (P = .03), sore muscles (P = .002), and elevation of liver transaminases 5× upper limits of normal or greater (P = .03). CONCLUSIONS: The LTBI completion rates were high for the INH-RPT regimen, with few inmates discontinuing because of signs or symptoms related to treatment. This regimen also has practical advantages to aid in treatment completion in the correctional setting and can be considered a viable alternative to standard LTBI regimens.

Using the exploration, preparation, implementation, sustainment (EPIS) framework to assess the cooperative re-engagement controlled trial (CoRECT).

Background: "Data to Care" (D2C) is a strategy which relies on a combination of public health surveillance data supplemented by clinic data to support continuity of HIV care. The Cooperative Re-Engagement Controlled Trial (CoRECT) was a CDC-sponsored randomized controlled trial of a D2C model, which provided an opportunity to examine the process of implementing an intervention for people with HIV (PWH) who are out-of-care across three public health department jurisdictions. Using the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, we aimed to retrospectively describe the implementation process for each site to provide insights and guidance to inform future D2C activities implemented by public health agencies and their clinical and community partners. Methods: After completion of CoRECT, the three (Connecticut, Massachusetts, Philadelphia) trial sites reviewed study protocols and held iterative discussions to describe and compare their processes regarding case identification, interactions with partnering clinics and patients, and sustainability. The EPIS framework provided a structure for comparing key organizational and operational practices and was applied to the entire implementation process. Results: The trial sites varied in their implementation processes and the specific elements of the intervention. Factors including prior D2C experience, data management and analytic infrastructure, staff capacity, and relationships with clinic partners informed intervention development and implementation. Additionally, this review identified key lessons learned including to: (1) explore new supplemental sources for public health surveillance data; (2) work with stakeholders representing core functions/components in the early stages of the intervention design process; (3) build flexibility into all components of the follow-up activities; and (4) integrate data sharing, project management, and follow-up activities within existing DPH organizational structure. Conclusion: The CoRECT study provides a general blueprint and lessons learned for implementing a D2C intervention for re-engagement in HIV care. Interventions should be tailored to local operational and structural factors, and responsive to evolving clinical and public health practices.