Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
Department of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, WA, United States.
JMIR Public Health Surveill. 2023 Apr 19;9:e44961. doi: 10.2196/44961.
Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs).
ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services.
This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively.
During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023.
ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South.
Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44961.
长效注射用卡替拉韦（CAB-LA）用于暴露前预防（PrEP）已被随机对照试验证明有效。进一步的研究对于评估其在真实环境中的有效性和确定有效的实施方法至关重要，特别是在年轻的性和性别少数群体（SGM）中。
ImPrEP CAB Brasil 是一项实施研究，旨在为将 CAB-LA 纳入巴西 6 个城市现有的公共卫生口服 PrEP 服务中提供关键证据，评估移动健康（mHealth）教育和决策支持工具、数字注射预约提醒，以及整合 CAB-LA 到现有服务中面临的促进因素和障碍。
这种 2 型混合实施效果研究包括形成性工作、定性评估和临床步骤 1 到 4。对于形成性工作，我们将使用参与式设计方法在每个地点开发初始 CAB-LA 实施包和流程映射，以促进最佳的客户流程。有兴趣接受 PrEP（初治）的年龄在 18 至 30 岁的 SGM 将被邀请参加第 1 步。测试 HIV 阴性的个体将接受 mHealth 干预和标准护理（SOC）咨询或 SOC 用于 PrEP 选择（口服或 CAB-LA）。有兴趣接受 CAB-LA 的参与者将被邀请参加第 2 步，而那些 HIV 病毒载量无法检测到的参与者将在当天接受 CAB-LA 注射，并随机接受数字预约提醒或 SOC。在第 1 个月和之后每 2 个月（25 个月随访）安排临床预约和 CAB-LA 注射。如果参与者决定改用口服 PrEP 或停止使用 CAB-LA，他们将被邀请参加第 3 步的 1 年随访，如果在研究期间被诊断出 HIV，他们将被邀请参加第 4 步的随访。感兴趣的结果包括 PrEP 的可接受性、选择、效果、实施和可行性。CAB-LA 队列（n=1200）的 HIV 发病率将与公共卫生系统中类似的口服 PrEP 队列进行比较。mHealth 和数字干预的效果将分别使用中断时间序列分析和逻辑混合模型进行评估。
在 2022 年第三和第四季度，我们获得了监管批准；编程数据录入和管理系统；培训了站点；并进行了社区咨询和形成性工作。计划于 2023 年第二季度开始研究招募。
ImPrEP CAB Brasil 是第一项评估拉丁美洲 CAB-LA PrEP 实施情况的研究，拉丁美洲是 PrEP 推广最需要的地区之一。这项研究对于设计实施和扩大可行、公平、具有成本效益、可持续和全面的 PrEP 方案的计划策略将是至关重要的。它还将有助于最大限度地发挥公共卫生方法的影响，以降低巴西和其他南方国家性少数群体的 HIV 发病率。
Clinicaltrials.gov NCT05515770；https://clinicaltrials.gov/ct2/show/NCT05515770。
国际注册报告标识符（IRRID）：PRR1-10.2196/44961。
