一项采用新型行为干预措施“坚守誓言”降低赞比亚未感染艾滋病毒夫妇外部伴侣感染艾滋病毒风险的整群随机试验:研究方案和基线数据。
A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, "Strengthening Our Vows": Study protocol and baseline data.
作者信息
Sharkey Tyronza, Wall Kristin M, Parker Rachel, Tichacek Amanda, Pappas-DeLuca Katina A, Kilembe William, Inambao Mubiana, Malama Kalonde, Hoagland Alexandra, Peeling Rosanna, Allen Susan
机构信息
Rwanda Zambia HIV Research Group, Department of Pathology & Laboratory Medicine, School of Medicine and Hubert Department of Global Health, Rollins School of Public Health, Laney Graduate School, Emory University, Atlanta, GA, 30322, USA.
London School of Hygiene and Tropical Medicine, UK.
出版信息
Contemp Clin Trials Commun. 2021 Sep 23;24:100850. doi: 10.1016/j.conctc.2021.100850. eCollection 2021 Dec.
BACKGROUND
Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples' Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of residual new infections in couples. These infections are attributed to concurrent sexual partners, a key driver of the HIV epidemic in Zambia.
METHODS/DESIGN: Ten Zambian government clinics in two of the largest cities were randomized in matched pairs to a Strengthening Our Vows (SOV) intervention or a Good Health Package (GHP) comparison arm. SOV addressed preventing HIV infection from concurrent partners and protecting spouses after exposures outside the relationship. GHP focused on handwashing; water chlorination; household deworming; and screening for hypertension, diabetes and schistosomiasis. CNC were referred from CVCT services in government clinics. Follow-up includes post-intervention questionnaires and outcome assessments through 60 months. Longitudinal outcomes of interest include self-report and laboratory markers of condomless sex with outside partners and reported sexual agreements. We present baseline characteristics and factors associated with study arm and reported risk using descriptive statistics.
RESULTS
The mean age of men was 32 and 26 for women. On average, couples cohabited for 6 years and had 2 children. Baseline analyses demonstrated some failures of randomization by study arm which will be considered in future primary analyses of longitudinal data. An HIV/STI risk factor composite was not different in the two study arms. Almost one-quarter of couples had an HIV risk factor at baseline.
DISCUSSION
In preparation for future biomedical and behavioral interventions in sub-Saharan Africa, it is critical to understand and decrease HIV risk within CNC.
背景
在撒哈拉以南非洲广泛流行艾滋病病毒的地区,异性恋伴侣是新增艾滋病病毒感染的主要群体。在伴侣自愿咨询检测(CVCT)之后,同居关系中艾滋病病毒检测结果均为阴性的异性恋伴侣(CNC)约占伴侣中新增感染病例的47%。这些感染归因于性伴关系外的性伴侣,这是赞比亚艾滋病病毒流行的一个关键驱动因素。
方法/设计:赞比亚两个最大城市的10家政府诊所被随机配对分为两组,一组接受强化誓言(SOV)干预,另一组接受健康套餐(GHP)对照。SOV旨在预防来自性伴关系外性伴侣感染艾滋病病毒,并在关系外暴露后保护配偶。GHP侧重于洗手、水氯化处理、家庭驱虫以及高血压、糖尿病和血吸虫病筛查。CNC由政府诊所的CVCT服务机构转介而来。随访包括干预后问卷调查以及长达60个月的结果评估。感兴趣的纵向结果包括与关系外性伴侣无保护性行为的自我报告和实验室指标以及报告的性协议。我们使用描述性统计方法呈现基线特征以及与研究组相关的因素和报告的风险。
结果
男性的平均年龄为32岁,女性为26岁。平均而言,伴侣同居6年,育有2个孩子。基线分析表明按研究组进行的随机分组存在一些失败情况,这将在未来纵向数据的主要分析中予以考虑。两个研究组的艾滋病病毒/性传播感染风险因素综合情况并无差异。近四分之一的伴侣在基线时有艾滋病病毒风险因素。
讨论
为撒哈拉以南非洲未来的生物医学和行为干预做准备时,了解并降低CNC中的艾滋病病毒风险至关重要。