Dana Ruth, Sullivan Stephen, MacGowan Robin J, Chavez Pollyanna R, Wall Kristin M, Sanchez Travis H, Stephenson Rob, Hightow-Weidman Lisa, Johnson Jeffrey A, Smith Amanda, Sharma Akshay, Jones Jeb, Hannah Marissa, Trigg Monica, Luo Wei, Caldwell Joanna, Sullivan Patrick Sean
Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.
School of Nursing, University of Michigan, Ann Arbor, MI, United States.
JMIR Res Protoc. 2023 Jan 6;12:e43414. doi: 10.2196/43414.
Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services.
This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care.
Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed.
During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM.
This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services.
ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.
男同性恋者、双性恋者以及其他与男性发生性关系的男性（MSM），尤其是黑人或非裔美国MSM（BMSM）以及西班牙裔或拉丁裔MSM（HLMSM），在美国仍然受到艾滋病毒流行的不成比例的影响。以往的艾滋病毒自我检测项目取得了很高的检测率，尽管这些研究主要招募的是白人、非西班牙裔MSM。移动健康工具可以支持艾滋病毒的预防、检测和治疗。本方案详细介绍了一项实施研究，该研究将免费艾滋病毒自我检测（HIVST）邮寄纳入一项随机对照试验，旨在评估一款手机应用程序在提高艾滋病毒预防和其他社会服务利用率方面的益处。
本研究是一项比较有效性试验，旨在采用创新的招募和检测推广策略，有效覆盖顺性别BMSM和HLMSM。我们评估了使用一款移动应用程序来增加获得护理的机会。
研究开发始于个人和小组咨询，从3个核心群体收集反馈意见：艾滋病毒护理从业者和研究人员、来自研究州的艾滋病毒服务组织领导人，以及居住在研究州的BMSM和HLMSM。在完成形成性定性工作后，根据在黑人和西班牙裔MSM中观察到的新艾滋病毒诊断率最高的地区，从11个州招募参与者，通过社交网站和智能手机应用程序进行招募。在核实资格后，参与者同意并被随机分配到干预组（可使用Know@Home移动应用程序）或对照组（转介到网络资源）。我们为所有参与者提供HIVST。已计划评估一款手机应用程序在支持与检测后预防服务建立联系方面的功效，这些服务包括性传播感染检测、暴露前预防启动、抗逆转录病毒治疗，以及获取避孕套和兼容润滑剂。关于这些结果的数据来自多个来源，包括HIVST报告调查、4个月的随访调查、对参与者返回的干血斑卡的实验室分析，以及从州卫生部门监测系统获得的数据。在可能的情况下，进行了相关的亚组分析。
在形成性开发阶段，进行了9次咨询：6次深入的个人讨论和3次小组咨询。从2020年2月到2021年2月，我们在一项随机对照试验中从11个州招募了2093名MSM，其中1149名BMSM和944名HLMSM。
本研究的设计和实施旨在评估招募策略对覆盖BMSM和HMSM的有效性，以及一款移动应用程序在与艾滋病毒预防或治疗服务建立联系方面的有效性。还获得了数据，以便分析与研究招募、艾滋病毒检测利用率、识别先前未诊断的艾滋病毒、性传播感染检测和治疗，以及与艾滋病毒预防或治疗服务建立联系相关的成本和成本效益。
ClinicalTrials.gov（NCT04219878）；https://clinicaltrials.gov/ct2/show/NCT04219878。
国际注册报告识别码（IRRID）：DERR1-10.2196/43414。
