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。马拉维有一个成功的方案，在常规产前检查的基础上预防艾滋病毒母婴传播。然而，23%接受艾滋病毒产前护理的妇女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。艾滋病毒感染者患抑郁症的几率是一般人群的两到三倍，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、记忆力、解决问题的能力和动力下降，会对医疗保健的参与和对药物的依从性产生不利影响。马拉维成功的产前检测方案为其男性伴侣参与艾滋病毒检测提供了机会。男性比女性更不可能进行艾滋病毒检测并了解自己的状况。在马拉维，45%以上处于稳定关系中的艾滋病毒阳性妇女有一个艾滋病毒阴性的伴侣。如果不进行干预，艾滋病毒阴性伴侣每年感染艾滋病毒的几率高达12%。支持妇女以最佳方式坚持艾滋病毒药物治疗，以确保其病毒得到良好控制，可将传播风险降至零。艾滋病毒自我检测，即个人收集自己的样本，进行检测并解释其结果，增加了检测的覆盖率和频率。在包括马拉维在内的艾滋病毒高流行环境中，伴侣提供的自我检测包（妇女向其男性伴侣分发检测包）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感染艾滋病毒和抑郁症的孕妇进行干预的可行性和可接受性，以减少抑郁症和优化艾滋病毒护理的参与，并增加对其男性伴侣的艾滋病毒检测，预防和护理的吸收。这将通过开展形成性工作来实现，利用定性方法调整干预措施，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，男性伴侣可以通过短信收到如何使用艾滋病毒自检试剂盒的指导。我们将制定信息，提供有关艾滋病毒感染者或艾滋病毒预防战略的关键信息。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名怀孕中期的艾滋病毒阳性妇女，随机分配她们接受干预或增强的常规护理。“TENDAI Together”干预措施将包括六期抑郁症治疗和参与艾滋病毒护理，由受过培训和监督的艾滋病毒诊断助理提供，这是对抗抑郁药的评估。参与试验的女性还将获得一套自我检测试剂盒，分发给她们的男性伴侣。有关如何使用自检试剂盒的说明以及有关艾滋病毒感染者或艾滋病毒阳性伴侣的关键信息，以解决检测后的担忧，将通过短信发送。我们将在基线和6个月随访时收集评估措施。这将包括确定更大规模试验可行性的结果，例如招募并保留在研究中的合格参与者的比例。我们将通过参加的会议数量和对接受干预的妇女的退出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，如女性及其男性伴侣的艾滋病毒和抑郁症结果，以及分娩后2个月婴儿的临床结果。将采用经过当地验证的基于证据的措施作为心理准入标准和结果数据。

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.