Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial.
Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial.
复制标题
DOI：
10.1371/journal.pone.0281472
复制
发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
在撒哈拉以南非洲（SSA），男性在接受抗逆转录病毒治疗时的死亡率是女性的两倍，这主要是由于艾滋病毒诊断较晚和保留率低。在这里，我们建议进行一项单独的随机对照试验（RCT），以调查三个月的家庭为基础的ART（hbART）的影响，对病毒抑制的男性谁没有从事护理。一项程序性、个体随机、非盲、非劣效性对照试验设计（ClinicalTrials.org NCT 04858243）。通过病历审查，我们将识别出年龄≥ 15岁、目前未接受抗逆转录病毒治疗的“未参与”男性艾滋病毒感染者，包括（1）艾滋病毒检测呈阳性且7天内未开始抗逆转录病毒治疗的男性;（2）已开始抗逆转录病毒治疗但有立即违约风险的男性;以及（3）未接受抗逆转录病毒治疗的男性。1计算机区组随机分配到hbART或基于设施的ART（fbART）组，我们将从马拉维中部和南部的10-15个高负担卫生设施招募男性。hbART干预将包括3个月内由经认证的男性研究护士ART提供者进行的3次家访。在fbART组中，将在男性参与者家中或参与者喜欢的附近地点为男性参与者提供咨询，然后陪同他们前往当地卫生设施和设施导航。主要结果是在ART开始后6个月病毒抑制的男性比例。假设两组的主要结局实现率分别为24.0%和33.6%，则每组350名男性将提供80%的把握度来检测所述差异。确定有效的抗逆转录病毒治疗策略，方便和获得的男子在撒哈拉以南非洲是一个优先事项，在艾滋病毒的世界。由于各种障碍，男子可能不会（重新）参加以设施为基础的护理。之前的两项试验研究了hbART对一般人群病毒抑制的影响，而本试验侧重于男性。此外，该试验涉及更长的hbART持续时间，即，与两周相比，三个月使男性有更多的时间来克服最初对服用ART的心理否认。
Men experience twice the mortality of women while on ART in sub-Saharan Africa (SSA) largely due to late HIV diagnosis and poor retention. Here we propose to conduct an individually randomized control trial (RCT) to investigate the impact of three-month home-based ART (hbART) on viral suppression among men who were not engaged in care. A programmatic, individually randomized non-blinded, non-inferiority-controlled trial design (ClinicalTrials.org NCT04858243). Through medical chart reviews we will identify “non-engaged” men living with HIV, ≥15years of age who are not currently engaged in ART care, including (1) men who have tested HIV-positive and have not initiated ART within 7 days; (2) men who have initiated ART but are at risk of immediate default; and (3) men who have defaulted from ART. With 1:1 computer block randomization to either hbART or facility-based ART (fbART) arms, we will recruit men from 10–15 high-burden health facilities in central and southern Malawi. The hbART intervention will consist of 3 home-visits in a 3-month period by a certified male study nurse ART provider. In the fbART arm, male participants will be offered counselling at male participant’s home, or a nearby location that is preferred by participants, followed with an escort to the local health facility and facility navigation. The primary outcome is the proportion of men who are virally suppressed at 6-months after ART initiation. Assuming primary outcome achievement of 24.0% and 33.6% in the two arms, 350 men per arm will provide 80% power to detect the stated difference. Identifying effective ART strategies that are convenient and accessible for men in SSA is a priority in the HIV world. Men may not (re-)engage in facility-based care due to a myriad of barriers. Two previous trials investigated the impact of hbART on viral suppression in the general population whereas this trial focuses on men. Additionally, this trial involves a longer duration of hbART i.e., three months compared to two weeks allowing men more time to overcome the initial psychological denial of taking ART.
登录
查看更多内容
影响因子：
3.8
作者：
Druyts, Eric;Dybul, Mark;Mills, Edward J.
通讯作者：
Mills, Edward J.
影响因子：
15.8
作者：
Amstutz A;Lejone TI;Khesa L;Kopo M;Kao M;Muhairwe J;Bresser M;Räber F;Klimkait T;Battegay M;Glass TR;Labhardt ND
通讯作者：
Labhardt ND
影响因子：
2.5
作者：
Choko AT;Fielding K;Stallard N;Maheswaran H;Lepine A;Desmond N;Kumwenda MK;Corbett EL
通讯作者：
Corbett EL
影响因子：
3.7
作者：
Bell J;Sharma S;Malone S;Levy M;Reast J;Ciecieląg J;Gogolina S;Ansons T;Fourie S;Braz R;Little K;Hasen N
通讯作者：
Hasen N
影响因子：
4.5
作者：
Larsson, Elin C.;Thorson, Anna;Ekstrom, Anna Mia
通讯作者：
Ekstrom, Anna Mia