Mansoor Leila E, Abdool Karim Quarraisha, Mngadi Kathryn T, Dlamini Sarah, Montague Carl, Nkomonde Nelisiwe, Mvandaba Nomzamo, Baxter Cheryl, Gengiah Tanuja N, Samsunder Natasha, Dawood Halima, Grobler Anneke, Frohlich Janet A, Abdool Karim Salim S
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.
Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial demonstrated a 39% reduction in HIV infection, with a 54% HIV reduction in women who used tenofovir gel consistently. A confirmatory trial is expected to report results in early 2015. In the interim, we have a unique window of opportunity to prepare for and devise effective strategies for the future policy and programmatic scale-up of tenofovir gel provision. One approach is to integrate tenofovir gel provision into family planning (FP) services. The CAPRISA 008 implementation trial provides an opportunity to provide post-trial access to tenofovir gel while generating empiric evidence to assess whether integrating tenofovir gel provision into routine FP services can achieve similar levels of adherence as the CAPRISA 004 trial.
METHODS/DESIGN: This is a two-arm, open-label, randomized controlled non-inferiority trial. A maximum of 700 sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral prevention study will be enrolled from an urban and rural site in KwaZulu-Natal, South Africa. The anticipated study duration is 30 months, with active accrual requiring approximately 12 months (following which an open cohort will be maintained) and follow-up continuing for approximately 18 months. At each of the two sites, eligible participants will be randomly assigned to receive tenofovir gel through either FP services (intervention arm) or through the CAPRISA research clinics (control arm). As part of the study intervention, a quality improvement approach will be used to assist the FP services to expand their current services to include tenofovir gel provision.
This protocol aims to address an important implementation question on whether FP services are able to effectively incorporate tenofovir gel provision for this at-risk group of women in South Africa. Provision of tenofovir gel to the women from the CAPRISA 004 trial meets the ethical obligation for post-trial access, and helps identify a potential avenue for future scale-up of microbicides within the public health system of South Africa.
This trial was registered with the South Africa Department of Health (reference: DOH-27-0812-4129) and ClinicalTrials.gov (reference: NCT01691768) on 05 July 2012.
南非艾滋病研究项目中心（CAPRISA）004试验表明，使用替诺福韦凝胶的女性艾滋病毒感染率降低了39%，持续使用替诺福韦凝胶的女性艾滋病毒感染率降低了54%。一项验证性试验预计将于2015年初公布结果。在此期间，我们有一个独特的机会窗口来为替诺福韦凝胶供应的未来政策和项目扩大做准备并制定有效的策略。一种方法是将替诺福韦凝胶供应纳入计划生育（FP）服务。CAPRISA 008实施试验提供了一个机会，在试验后提供替诺福韦凝胶的同时，生成实证证据，以评估将替诺福韦凝胶供应纳入常规FP服务是否能达到与CAPRISA 004试验相似的依从水平。
方法/设计：这是一项双臂、开放标签、随机对照非劣效性试验。最多700名年龄在18岁及以上、性活跃、未感染艾滋病毒且此前参加过抗逆转录病毒预防研究的女性将从南非夸祖鲁-纳塔尔省的一个城市和农村地点招募。预计研究持续时间为30个月，积极招募约需12个月（之后将维持一个开放队列），随访持续约18个月。在两个地点的每一个，符合条件的参与者将被随机分配通过FP服务（干预组）或通过CAPRISA研究诊所（对照组）接受替诺福韦凝胶。作为研究干预的一部分，将采用质量改进方法来协助FP服务扩大其现有服务，以包括提供替诺福韦凝胶。
本方案旨在解决一个重要的实施问题，即FP服务是否能够有效地为南非这一高危女性群体提供替诺福韦凝胶。向CAPRISA 004试验中的女性提供替诺福韦凝胶符合试验后获取的伦理义务，并有助于确定南非公共卫生系统内未来扩大杀微生物剂规模的潜在途径。
本试验于2012年7月5日在南非卫生部注册（参考编号：DOH-27-0812-4129），并在ClinicalTrials.gov注册（参考编号：NCT01691768）。
