健康选择：坦桑尼亚针对围产期 HIV 阳性合并抑郁的女性开展团体心理治疗的群组随机对照试验的研究方案及基线特征
Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania.
机构信息
Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Ave., Boston, MA, 02115, USA.
Management and Development for Health, Plot #802 Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.
出版信息
BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.
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.
背景
接受预防母婴传播艾滋病毒（PMTCT）服务的围产期妇女患抑郁症的风险增加；然而，坦桑尼亚获得心理健康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，该研究评估了由基层社区卫生工作者（CBHW）为艾滋病毒阳性和抑郁的围产期妇女提供的心理社会支持小组干预措施，该研究在达累斯萨拉姆进行。
方法
采用整群随机对照试验（RCT）比较：1）心理社会支持小组干预；2）改善心理健康护理标准。该研究在提供 PMTCT 服务的生殖和儿童保健（RCH）中心进行。通过比较干预组和对照组的社会人口学特征以及主要和次要结局，介绍了基线特征。该试验在 clinicaltrials.gov（NCT02039973）注册。
结果
在纳入的 742 名妇女中，干预组和对照组的基线特征相当，尽管对照组中有更多的妇女完成了中学教育（25.2%对 18.2%）。总体而言，研究结果表明，该人群高度脆弱，超过 45%的人存在粮食不安全问题，17%的人在过去 6 个月中报告了亲密伴侣暴力。
结论
整群 RCT 的基线特征在干预组和对照组之间相当。该试验将研究心理社会支持小组干预对接受 PMTCT 服务的艾滋病毒阳性妇女中抑郁的治疗效果。在这个弱势群体中，减少抑郁的负担对改善与艾滋病毒相关的结果具有短期意义，并可能对儿童的生长发育产生潜在的长期影响。
试验注册
该试验在 clinicaltrials.gov 注册（NCT02039973）。于 2014 年 1 月 20 日回顾性注册。
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