A stigma reduction intervention at time of entry into antenatal care to improve PMTCT services in Tanzania

在进入产前保健时进行减少耻辱干预，以改善坦桑尼亚的预防母婴传播服务

• 批准号: 10002389
• 负责人: Blandina Theophil Mmbaga
• 金额: $ 7.94万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10002389
• 关键词: AIDS prevention; Address; Adherence; Appointment; Attitude; Behavior; Biological Markers; Caring; Clinic; Clinical; Cluster randomized trial; Cognitive; Cognitive Therapy; Collaborations; Counseling; Data; Development; Disclosure; Discrimination; Emotional; Empathy; Enrollment; Evaluation; Feeling; Future; Goals; HIV; HIV Seronegativity; HIV-1; Health; Human immunodeficiency virus test; Individual; Intervention; Intervention Studies; Interview; Life; Logistics; Maintenance; Measurement; Measures; Mental Depression; Methodology; Misinformation; Mother-to-child HIV transmission; National Institute of Mental Health; Newly Diagnosed; Outcome; Participant; Pregnancy; Pregnant Women; Prejudice; Prevention; Prevention Guidelines; Prevention Research; Probability; Procedures; Protocols documentation; Qualitative Methods; Quality of life; Randomized; Readiness; Records; Reporting; Research Design; Research Infrastructure; Research Methodology; Risk; Schedule; Services; Sexual Partners; Shame; Social Alienation; Social Environment; Statistical Data Interpretation; Stigmatization; Tanzania; Testing; Thinking; Time; Vertical Disease Transmission; Visit; Woman; Women' s Group; Work; antenatal; antiretroviral therapy; base; cognitive interview; emotional distress; experience; flexibility; follow-up; improved; novel; pregnant; programs; quality assurance; social stigma; standard of care; success; theories; transmission process; unborn child

PROJECT SUMMARY Antenatal care (ANC) provides a unique and important entry point to address HIV stigma. Stigma-based counseling during the first ANC visit can promote readiness to initiate and sustain treatment among those who are HIV infected, and can address stigmatizing attitudes and behaviors among those who are HIV uninfected. With this application, we are proposing to develop and pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to ANC in Tanzania. The intervention will include: 1) a video and brief counseling that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for women who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement. The primary intervention outcome is early engagement in PMTCT care among women who are HIV infected. We will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of women, including women who are already established on ART and women who are HIV uninfected. The intervention content is based on principles of cognitive-behavioral therapy (addressing automatic negative thoughts about the self, future and the world) to address and mitigate multiple forms of HIV stigma (internalized, anticipated and enacted). The study has three aims: 1) to develop Maisha to address stigma during ANC, 2) to establish the methodological protocol for the evaluation of Maisha in a clinical setting, and 3) to pilot test Maisha to determine feasibility and acceptability in a PMTCT care setting and explore potential for impact on early PMTCT care engagement, HIV disclosure, and stigma. For Aims 1 & 2, we will use multiple qualitative methods with a variety of stakeholders and clinical observations, as well as cognitive interviews to refine our stigma measures. For Aim 3, we will conduct a pilot RCT of the intervention, enrolling all women who attend a first ANC appointment at two clinics in the Moshi district. Maisha will be compared to the standard of HIV counseling without the focus on stigma. In addition to a baseline assessment, all women who are identified as HIV-infected (n=25 intervention, 25 control) and a subset of women who are identified as HIV-uninfected (n=50 intervention, 50 control) will get a 3-month assessment. Measures will include health outcomes (care engagement, adherence, depression) and stigma outcomes including HIV disclosure. Quality assurance data will be collected and the feasibility and acceptability of the intervention and RCT will be described. Statistical analysis will examine differences between conditions in health outcomes and stigma measures, stratified by HIV status. Results will be used to generate parameter estimates and potential ranges of values to estimate power for a future R01 proposal, which will be a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker.

项目概要 产前护理 (ANC) 为解决艾滋病毒耻辱问题提供了独特且重要的切入点。基于耻辱的 第一次 ANC 就诊期间的咨询可以促进患者做好开始和维持治疗的准备 艾滋病毒感染者，并可以解决未感染艾滋病毒者中的污名化态度和行为。 通过此应用程序，我们建议开发并试点测试一种名为 Maisha 的简短、可扩展的干预措施 （斯瓦希里语表示终身），旨在解决坦桑尼亚非国大妇女所面临的艾滋病毒耻辱问题。干预将 包括：1) 在 ANC 访视开始时（在艾滋病毒感染之前）解决艾滋病毒耻辱问题的视频和简短咨询 检测），以及 2）以视频为基础，为感染艾滋病毒的女性提供两次基于耻辱的咨询课程 提供情感支持、促进接受、消除耻辱并加强护理参与度的内容。 主要干预结果是感染艾滋病毒的妇女尽早参与预防母婴传播护理。 我们还将研究所有妇女群体中艾滋病毒耻辱的结果（已制定的、预期的、内化的）， 包括已经接受抗逆转录病毒治疗的女性和未感染艾滋病毒的女性。干预 内容基于认知行为疗法的原则（解决关于 自我、未来和世界），以解决和减轻多种形式的艾滋病毒耻辱感（内在的、预期的 并颁布）。该研究有三个目标：1) 开发 Maisha 以解决 ANC 期间的耻辱问题，2) 建立 在临床环境中评估 Maisha 的方法方案，以及 3) 对 Maisha 进行试点测试 确定 PMTCT 护理环境的可行性和可接受性，并探索对早期影响的潜力 PMTCT 护理参与、艾滋病毒披露和耻辱。对于目标 1 和 2，我们将使用多个定性 与各种利益相关者和临床观察以及认知访谈的方法，以完善我们的 污名化措施。对于目标 3，我们将开展一项干预措施试点随机对照试验，招募所有参加培训的女性 莫希区两家诊所的首次 ANC 预约。麦莎将与艾滋病毒标准进行比较 不关注耻辱的咨询。除了基线评估外，所有被确定为 HIV 感染者（n = 25 名干预组，25 名对照者）和一部分被确定为 HIV 未感染者的女性（n = 50 干预，50个对照）将得到为期3个月的评估。措施将包括健康结果（护理 参与、依从性、抑郁）和耻辱结果，包括艾滋病毒披露。质量保证数据 将收集并描述干预和随机对照试验的可行性和可接受性。统计 分析将检查健康结果条件和耻辱测量之间的差异，按分层 艾滋病毒状况。结果将用于生成参数估计值和要估计的潜在值范围 为未来的 R01 提案提供动力，这将是 PMTCT 环境中的完全整群随机试验，并有扩展 使用生物标记物进行后续和增强的依从性测量。