Hovell Melbourne F, Schmitz Katharine E, Blumberg Elaine J, Hill Linda, Sipan Carol, Friedman Lawrence
The Center for Behavioral Epidemiology and Community Health, Graduate School of Public Heath, San Diego State University, San Diego, CA, United States.
Department of Family and Preventive Medicine, University of California, San Diego, CA, United States.
Contemp Clin Trials Commun. 2018 Aug 16;12:129-136. doi: 10.1016/j.conctc.2018.08.002. eCollection 2018 Dec.
Effort is required to meet the Healthy People 2020 goal of tuberculosis (TB) disease reduction to 1 new case per 100,000 in the United States (US) and reduce burden among those disparately affected. Preventing new cases by reducing conversion from latent TB infection (LTBI) to infectious disease is one approach to reducing disease burden. This paper describes the outcome of a trial designed to determine if LTBI-positive youth prescribed daily Isoniazid with peer counseling would achieve higher adherence than attention control participants. The paper also compares adherence to a previous trial. 263 students age 15.9 years (SD = 1.2), 51.7% female, 96.2% Latino, 43.7% foreign-born were randomly assigned to condition. Adherence was measured by self-report validated by metabolite analysis. Outcome analyses used number of pills taken and proportion of youth consuming 80% of medication. There was no significant difference by condition for either analysis. Thirty-seven percent of adherence participants completed treatment versus 40% of controls. Without a usual-care control group we were unable to determine whether conditions were equally effective or ineffective. The study's inability to pay for treatment resulted in the intervention being tested in the context of compromised access to care. Still to be determined is whether same-age peers can influence adherence among Latino adolescents.
ClinicalTrials.gov Identifier NCT00233168.
要实现《健康人民2020》的目标,即把美国的结核病(TB)发病率降至每10万人1例新发病例,并减轻受影响差异较大人群的负担,需要付出努力。通过减少潜伏性结核感染(LTBI)向传染病的转化来预防新发病例是减轻疾病负担的一种方法。本文描述了一项试验的结果,该试验旨在确定接受每日异烟肼治疗并接受同伴咨询的LTBI阳性青少年是否比接受注意力控制的参与者有更高的依从性。本文还将依从性与之前的一项试验进行了比较。263名年龄为15.9岁(标准差=1.2)的学生,51.7%为女性,96.2%为拉丁裔,43.7%为外国出生,被随机分配到不同条件组。依从性通过经代谢物分析验证的自我报告来衡量。结果分析采用服药片数和服用80%药物的青少年比例。两种分析在不同条件组之间均无显著差异。37%的依从性参与者完成了治疗,而对照组为40%。由于没有常规护理对照组,我们无法确定不同条件组是否同样有效或无效。该研究无力支付治疗费用,导致干预措施是在获得医疗服务受限的情况下进行测试的。同年龄的同伴是否能影响拉丁裔青少年的依从性仍有待确定。
ClinicalTrials.gov标识符NCT00233168。