Pilot of an Intervention for Malawian Pregnant Women with HIV to Improve Depression, Viral Suppression and Engagement of Partners in HIV Self-Testing

艾滋病毒感染仍然是全球最大的杀手之一。马拉维在常规产前检测的基础上制定了预防艾滋病毒母婴传播的成功方案。然而，接受艾滋病毒产前护理的妇女中，23%的人在一年内失去了护理。抑郁症是艾滋病毒治疗药物依从性差和脱离艾滋病毒护理的一个重要原因。艾滋病毒携带者的抑郁程度是普通人群的两到三倍，在南部非洲的孕妇和产后妇女中很常见。抑郁症的症状，如注意力下降、记忆力下降、解决问题的能力和动力下降，对参与医疗保健和坚持服药有不利影响。马拉维成功的产前检测方案提供了让其男性伴侣参与艾滋病毒检测的机会。男性比女性更不可能检测艾滋病毒并了解自己的状况。在马拉维，在稳定的关系中，超过45%的艾滋病毒阳性妇女有艾滋病毒阴性的伴侣。在没有干预的情况下，艾滋病毒阴性的伴侣每年感染艾滋病毒的比例高达12%。支持妇女坚持最佳的艾滋病毒药物治疗，以确保她们的病毒得到很好的控制，将传播风险降低到零。艾滋病毒自我检测，即个人收集自己的样本，进行检测并解释结果，增加了检测的覆盖面和频率。在包括马拉维在内的艾滋病毒高流行地区，伴侣提供的自我检测试剂盒，即妇女向其男性伴侣分发检测结果，正在成为常规的产前政策和做法。拟议研究的目的是最终确定和测试对患有艾滋病毒和抑郁症的孕妇进行干预的可行性和可接受性，以减少抑郁和优化艾滋病毒护理的参与，并增加对艾滋病毒检测、预防和对其男性伴侣的护理的接受。这将通过开展形成性工作来实现，使用定性的方法来调整干预措施以治疗抑郁症，并优化马拉维产前情况下对艾滋病毒药物的依从性。对于艾滋病毒阳性孕妇的男性伴侣，我们将开发一个基于手机的短信平台，男性伴侣将能够通过短信收到如何使用艾滋病毒自检试剂盒的说明。我们将制定信息，提供有关艾滋病毒携带者或艾滋病毒预防策略的关键信息。这项研究将在马拉维布兰太尔的一家产前诊所进行。我们将招募40名艾滋病毒阳性妇女在她们怀孕的第二个三个月，并随机让她们接受干预或加强常规护理。“Tendai Together”干预将包括六个疗程的抑郁症治疗和参与艾滋病毒护理，由一名训练有素并受到监督的艾滋病毒诊断助理提供，这是一种抗抑郁药物的评估。被招募参加试验的女性还将获得一份自我测试试剂盒，分发给她们的男性伴侣。关于如何使用自检试剂盒和有关艾滋病毒携带者或艾滋病毒阳性伴侣的关键信息以解决检测后担忧的说明将通过短信发送。我们将在基线和6个月的随访时收集评估措施。这将包括确定更大规模试验的可行性的结果，例如招募并保留在研究中的合格参与者的比例。我们将通过参加会议的次数和与接受干预的妇女的离职访谈来评估干预的可接受性。我们还将确定收集临床结果测量的可行性，如妇女及其男性伴侣的艾滋病毒和抑郁结果，以及婴儿出生后2个月的临床结果。心理进入标准和结果数据将使用当地经过验证的循证措施。

HIV infection remains one of the biggest killers globally. Malawi has a successful programme for prevention of mother to child transmission of HIV based on routine antenatal testing. However, 23% of women attending HIV antenatal care are lost to care at one year. Depression is an important cause of poor adherence to medication for the treatment of HIV and disengagement from HIV care. Depression is two to three times higher in people living with HIV than in the general population, and common in pregnant and post-natal women in Southern Africa. Symptoms of depression such as reduced concentration, memory, problem-solving ability and motivation, adversely affect engagement with health care and adherence to medication. Malawi's successful programme of antenatal testing presents an opportunity to engage their male partners in HIV testing. Men are less likely than women to test for HIV and know their status. In Malawi over 45% of HIV-positive women in stable relationships have an HIV-negative partner. Without intervention, HIV-negative partners acquire HIV at up to 12% per year. Supporting women to adhere optimally to their HIV medication to ensure their virus is well controlled reduces the risk of transmission to zero. HIV self-testing, whereby an individual collects their own sample, conducts the test and interprets their result increases coverage and frequency of testing. Partner-delivered self-test kits, where woman distribute a test to their male partner, is becoming routine antenatal policy and practice in high HIV prevalence settings including Malawi. The aim of the proposed research is to finalise and test the feasibility and acceptability of an intervention for pregnant women living with HIV and depression, to reduce depression and optimise engagement in HIV care, and to increase uptake of HIV testing, prevention and care for their male partners. This will be achieved through conducting formative work using qualitative methods to adapt an intervention to treat depression and optimise adherence to HIV medication for the Malawian antenatal context. For the male partners of HIV positive pregnant women, we will develop a mobile phone based SMS platform where the male partner will be able to receive instructions on how to use an HIV self-test kit via SMS. We will develop messages providing key information on living with HIV, or HIV prevention strategies The study will take place in an antenatal clinic in Blantyre, Malawi. We will recruit 40 HIV positive women in the 2nd trimester of their pregnancy and randomise them to receive the intervention or enhanced usual care. The 'TENDAI Together' intervention will consist of six sessions of therapy for depression and engagement in HIV care delivered by a trained and supervised HIV Diagnostic Assistant, an assessment for an antidepressant. The women recruited to the trial will also be given a self-test kit to distribute to their male partners. Instructions on how to use the self-test kit and key information on living with HIV or with an HIV positive partner to address post-test worries will be sent via SMS.We will collect assessment measures at baseline and at 6 month follow up. This will include outcomes to determine the feasibility of a larger trial, such as the proportion of eligible participants recruited and then retained in the study. We will assess the acceptability of the intervention by the number of sessions attended and exit interviews with the women who received the intervention. We will also determine feasibility of collecting clinical outcome measures such as HIV and depression outcomes for the women and her male partner, and clinical outcomes for the infant 2 months post-delivery. Locally validated, evidence-based measures will be used for the psychological entry criteria and outcome data.