Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial.
Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial.
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DOI：
10.1136/bmjopen-2020-039972
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发表时间：
2020-12-02
期刊：
影响因子：
2.9
通讯作者：
John-Stewart G
中科院分区：
文献类型：
--
作者：
Njuguna IN;Beima-Sofie K;Mburu CW;Mugo C;Neary J;Itindi J;Onyango A;Richardson BA;Rubin Means A;Sharma M;Weiner BJ;Wagner AD;Oyiengo L;Wamalwa D;John-Stewart G
成功地将青少年过渡到成人艾滋病毒护理对优化结果至关重要。披露艾滋病毒状况是过渡的先决条件，但在撒哈拉以南非洲仍然不够理想。很少有干预措施同时解决了信息披露和过渡问题。结合信息披露和过渡工具的青少年过渡一揽子计划（ATP）可以支持过渡并改善结果。在这项混合1型有效性-实施聚类随机对照试验中，肯尼亚10家艾滋病毒诊所将被随机分配实施ATP，并与10家接受标准治疗的诊所进行比较，这些诊所估计有≥100名10 - 24岁的青少年和年轻人感染艾滋病毒（ALWHIV）。ATP包括协助披露和转换的提供者工具。干预诊所的医疗服务提供者将接受ATP使用的培训，并在研究的最初6个月内通过持续的质量改进周期来适应它，并持续实施1年。主要结果是15-24岁ALWHIV患者的过渡准备情况，使用22项准备情况评分每月评估6次。次要结果包括干预期（第18个月）结束时ALWHIV病毒的保留率和病毒抑制率、实施结果（可接受性、可行性、保真度、覆盖率和渗透率）和规划成本对有效性结果的补充。主要分析将是治疗意图，使用混合效应线性回归模型比较控制和干预地点随时间的过渡准备得分（总体和按领域（艾滋病毒素养，自我管理，沟通，支持）），调整多重测试，考虑临床和重复评估的聚类。我们将用双侧α=0.05来估计系数和95% ci。这项研究得到了华盛顿大学机构审查委员会和肯雅塔国家医院伦理与研究委员会的批准。研究结果将与参与机构、县和国家决策者共享。NCT03574129;Pre-results。
Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes. In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ≥100 adolescents and young adults age 10–24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1 year. The primary outcome is transition readiness among ALWHIV ages 15–24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided α=0.05. The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers. NCT03574129; Pre-results.
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影响因子：
3.2
作者：
Hsieh, HF;Shannon, SE
通讯作者：
Shannon, SE
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
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通讯作者：
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作者：
Ferrand, Rashida A.;Bandason, Tsitsi;Corbett, Elizabeth L.
通讯作者：
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影响因子：
3.7
作者：
Gaitho D;Kumar M;Wamalwa D;Wambua GN;Nduati R
通讯作者：
Nduati R
影响因子：
2.8
作者：
Maturo, Donna;Powell, Alexis;Friedman, Lawrence B.
通讯作者：
Friedman, Lawrence B.