BACKGROUND Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam. METHODS A cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973). RESULTS Among 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months. CONCLUSIONS Baseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development. TRIAL REGISTRATION The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

中文翻译：

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健康选择：坦桑尼亚围产期感染艾滋病毒和抑郁症妇女群体心理治疗的集群随机对照试验的研究方案和基线特征。

背景 获得预防艾滋病毒母婴传播 (PMTCT) 服务的围产期妇女患抑郁症的风险增加；然而，在坦桑尼亚，获得精神卫生专业人员提供的服务的机会有限。本文介绍了一项研究的方案和基线特征，该研究评估了一项由非专业社区卫生工作者 (CBHW) 为达累斯萨拉姆感染艾滋病毒和抑郁症的围产期妇女提供的心理社会支持小组干预。方法 集群随机对照试验 (RCT) 进行了比较：1) 社会心理支持小组干预；2）提高精神卫生保健水平。该研究在提供 PMTCT 服务的生殖和儿童健康 (RCH) 中心实施。通过比较干预组和对照组试验的社会人口学特征以及主要和次要结果来呈现基线特征。该试验在clinicaltrials.gov (NCT02039973) 下注册。结果 在纳入的 742 名女性中，干预组和对照组的基线特征具有可比性，尽管对照组中完成中学教育的女性更多（25.2% 对 18.2%）。总体而言，调查结果表明，人口高度脆弱，在过去 6 个月内，超过 45% 的人表现出粮食不安全，17% 的人报告亲密伴侣暴力。结论 集群 RCT 的基线特征对于干预组和对照组具有可比性。该试验将检查心理社会支持小组干预治疗艾滋病毒感染者获得 PMTCT 服务的抑郁症的有效性。减轻这一弱势人群的抑郁负担在短期内对改善 HIV 相关结果和对儿童生长和发育的潜在长期影响具有影响。试验注册 该试验在clinicaltrials.gov (NCT02039973) 下注册。于2014年1月20日追溯登记。