The effect of a conditional cash transfer on HIV incidence in young women in rural South Africa (HPTN 068): a phase 3, randomised controlled trial

The effect of a conditional cash transfer on HIV incidence in young women in rural South Africa (HPTN 068): a phase 3, randomised controlled trial
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DOI:
10.1016/s2214-109x(16)30253-4
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发表时间:
2016-12-01
影响因子:
34.3
通讯作者:
Kahn, Kathleen
Kahn, Kathleen
中科院分区:
医学1区
文献类型:
--
作者:
Pettifor, Audrey;MacPhail, Catherine;Kahn, Kathleen

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背景现金转移已被提议作为一种干预措施,以降低撒哈拉以南非洲年轻女性感染艾滋病毒的风险。然而,关于它们在减少艾滋病毒感染方面的作用的证据很少。我们的目的是评估有条件现金转移对南非农村年轻女性艾滋病毒发病率的影响。方法我们在南非姆普马兰加省农村的布什巴克里奇街道进行了一项第三阶段的随机对照试验(HPTN 068)。我们包括13-20岁的女孩,如果她们在学校8-11年级入学,未婚或怀孕,能够阅读,她们和她们的父母或监护人都有开设银行账户所需的文件,并且居住在研究区,并打算一直住到审判结束。年轻妇女(及其父母或监护人)被随机分配(1:1),使用带编号的密封信封,内有随机分配卡,按数字分组随机排序,每月获得现金转移,条件是学校出勤率(=每月上学天数的80%),而不是现金转移。参与者完成了音频计算机辅助自我访谈(ACASI),在检测前艾滋病毒咨询,艾滋病毒和单纯疱疹病毒(HSV)-2检测,以及检测后咨询,然后在12,24和36个月的年度随访中。父母或监护人在基线和每次随访时完成一次计算机辅助个人面谈。使用分层比例风险模型对主要结果--HIV发病率进行意向治疗分析,以比较干预组和对照组。这项研究已在临床试验中注册。在2011年3月5日至2012年12月17日期间,我们招募了10 134名年轻女性,并招募了2537名及其父母或监护人接受现金转移计划(n=1225)或不接受现金转移计划(对照组;n=1223)。在基线时,女孩的年龄中值为15岁(IQR 14-17),672人(27%)报告有过性行为。在研究期间记录了107例HIV感染事件:干预组3048人年59例,对照组2830人年48例。接受现金转移的人和未接受现金转移的人之间的艾滋病毒发病率(1.94%/人-年)和没有接受现金转移的人(1.70%/人-年;风险比1.17,95%可信区间0.80-1.72,p=0.42)没有显著差异。学校出勤率显著降低了感染艾滋病毒的风险,与研究小组无关。让女孩留在学校对于降低她们感染艾滋病毒的风险很重要。
Background Cash transfers have been proposed as an intervention to reduce HIV-infection risk for young women in sub-Saharan Africa. However, scarce evidence is available about their effect on reducing HIV acquisition. We aimed to assess the effect of a conditional cash transfer on HIV incidence among young women in rural South Africa.Methods We did a phase 3, randomised controlled trial (HPTN 068) in the rural Bushbuckridge subdistrict in Mpumalanga province, South Africa. We included girls aged 13-20 years if they were enrolled in school grades 8-11, not married or pregnant, able to read, they and their parent or guardian both had the necessary documentation necessary to open a bank account, and were residing in the study area and intending to remain until trial completion. Young women (and their parents or guardians) were randomly assigned (1:1), by use of numbered sealed envelopes containing a randomisation assignment card which were numerically ordered with block randomisation, to receive a monthly cash transfer conditional on school attendance (>= 80% of school days per month) versus no cash transfer. Participants completed an Audio Computer-Assisted Self-Interview (ACASI), before test HIV counselling, HIV and herpes simplex virus (HSV)-2 testing, and post-test counselling at baseline, then at annual follow-up visits at 12, 24, and 36 months. Parents or guardians completed a Computer-Assisted Personal Interview at baseline and each follow-up visit. A stratified proportional hazards model was used in an intention-to-treat analysis of the primary outcome, HIV incidence, to compare the intervention and control groups. This study is registered at ClinicalTrials. gov (NCT01233531).Findings Between March 5, 2011, and Dec 17, 2012, we recruited 10 134 young women and enrolled 2537 and their parents or guardians to receive a cash transfer programme (n=1225) or not (control group; n=1223). At baseline, the median age of girls was 15 years (IQR 14-17) and 672 (27%) had reported to have ever had sex. 107 incident HIV infections were recorded during the study: 59 cases in 3048 person-years in the intervention group and 48 cases in 2830 person-years in the control group. HIV incidence was not significantly different between those who received a cash transfer (1.94% per person-years) and those who did not (1.70% per person-years; hazard ratio 1.17, 95% CI 0.80-1.72, p=0.42).Interpretation Cash transfers conditional on school attendance did not reduce HIV incidence in young women. School attendance significantly reduced risk of HIV acquisition, irrespective of study group. Keeping girls in school is important to reduce their HIV-infection risk.