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基于移动电话的保密社交网络 HIV 检测转介(CONSORT):一项随机对照试验的方案。

Mobile Phone-Based Confidential Social Network Referrals for HIV Testing (CONSORT): Protocol for a Randomized Controlled Trial.

机构信息

Department of Health Services Policy & Management, University of South Carolina, Columbia, SC, United States.

Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzania.

出版信息

JMIR Res Protoc. 2024 May 30;13:e55068. doi: 10.2196/55068.

Abstract

BACKGROUND

Critical to efforts to end the HIV epidemic is the identification of persons living with HIV who have yet to be diagnosed and engaged in care. Expanded HIV testing outreach efforts need to be both efficient and ambitious, targeting the social networks of persons living with HIV and those at above-average risk of undiagnosed HIV infection. The ubiquity of mobile phones across many high HIV prevalence settings has created opportunities to leverage mobile health (mHealth) technologies to engage social networks for HIV testing outreach, prevention, and treatment.

OBJECTIVE

The purpose of this study is to evaluate the acceptability and efficacy of a novel mHealth intervention, "Confidential Social Network Referrals for HIV Testing (CONSORT)," to nudge at-risk individuals to test for HIV using SMS text messages.

METHODS

We will conduct the CONSORT study in Moshi, Tanzania, the commercial center and administrative capital of the Kilimanjaro Region in northern Tanzania. After qualitative formative work and pilot testing, we will enroll 400 clients presenting for HIV counseling and testing and 200 persons living with HIV and receiving care at HIV care and treatment centers as "inviters" into a randomized controlled trial. Eligible participants will be aged 18 years or older and live, work, or regularly receive care in Moshi. We will randomize inviters into 1 of 2 study arms. All inviters will be asked to complete a survey of their HIV testing and risk behaviors and to think of social network contacts who would benefit from HIV testing. They will then be asked to whom they would prefer to extend an HIV testing invitation in the form of a physical invitation card. Arm 1 participants will also be given the opportunity to extend CONSORT invitations in the form of automated confidential SMS text messages to any of their social network contacts or "invitees." Arm 2 participants will be offered physical invitation cards alone. The primary outcome will be counselor-documented uptake of HIV testing by invitees within 30 days of inviter enrollment. Secondary outcomes will include the acceptability of CONSORT among inviters, the number of new HIV diagnoses, and the HIV risk of invitees who present for testing.

RESULTS

Enrollment in the randomized controlled trial is expected to start in September 2024. The findings will be disseminated to stakeholders and published in peer-reviewed journals.

CONCLUSIONS

If CONSORT is acceptable and effective for increasing the uptake of HIV testing, given the minimal costs of SMS text reminders and the potential for exponential but targeted growth using chain referrals, it may shift current practices for HIV testing programs in the area.

TRIAL REGISTRATION

ClincalTrials.gov NCT05967208; https://clinicaltrials.gov/study/NCT05967208.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55068.

摘要

背景

努力终结艾滋病流行的关键是发现尚未被诊断且尚未接受治疗的艾滋病毒感染者。扩大艾滋病毒检测外展工作需要既有效率又有雄心,针对艾滋病毒感染者和艾滋病毒感染风险高于平均水平的人的社交网络。在许多艾滋病毒高流行地区,手机的普及为利用移动健康(mHealth)技术来扩大社交网络进行艾滋病毒检测外展、预防和治疗提供了机会。

目的

本研究旨在评估一种新的移动健康干预措施“艾滋病毒检测保密社交网络推荐(CONSORT)”的可接受性和效果,通过短信文本消息提示高危个体进行艾滋病毒检测。

方法

我们将在坦桑尼亚莫希市开展 CONSORT 研究,莫希市是坦桑尼亚北部乞力马扎罗地区的商业中心和行政首都。在进行定性形成性工作和试点测试后,我们将招募 400 名前来接受艾滋病毒咨询和检测的客户以及 200 名在艾滋病毒护理和治疗中心接受护理的艾滋病毒感染者作为“邀请者”,进行一项随机对照试验。合格的参与者年龄在 18 岁或以上,居住、工作或定期在莫希接受护理。我们将邀请者随机分为 2 个研究组之一。所有邀请者都将被要求完成一项关于他们的艾滋病毒检测和风险行为的调查,并思考那些可能受益于艾滋病毒检测的社交网络联系人。然后,他们将被要求选择他们愿意以物理邀请卡的形式向谁发出艾滋病毒检测邀请。第 1 组参与者还将有机会通过自动保密短信向他们的任何社交网络联系人或“邀请者”发送 CONSORT 邀请。第 2 组参与者将仅提供物理邀请卡。主要结果将是邀请者登记后 30 天内受邀者接受艾滋病毒检测的咨询师记录。次要结果将包括邀请者对 CONSORT 的可接受性、新的艾滋病毒诊断数量以及接受检测的受邀者的艾滋病毒风险。

结果

预计 2024 年 9 月开始招募参加随机对照试验。研究结果将分发给利益攸关方,并在同行评议期刊上发表。

结论

如果 CONSORT 可以提高艾滋病毒检测的接受率,如果考虑到短信提醒的低费用以及使用连锁推荐实现指数级但有针对性的增长的潜力,那么它可能会改变该地区当前的艾滋病毒检测计划实践。

试验注册

ClincalTrials.gov NCT05967208;https://clinicaltrials.gov/study/NCT05967208。

国际注册报告标识符(IRRID):PRR1-10.2196/55068。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b09e/11176874/c77c7bd7ca8f/resprot_v13i1e55068_fig1.jpg

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