Riddler Sharon A, Husnik Marla, Gorbach Pamina M, Levy Lisa, Parikh Urvi, Livant Edward, Pather Arendevi, Makanani Bonus, Muhlanga Felix, Kasaro Margaret, Martinson Francis, Elharrar Vanessa, Balkus Jennifer E
a Division of Infectious Diseases , University of Pittsburgh , Pittsburgh , PA , USA.
b MTN Statistical and Data Management Center , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.
HIV Clin Trials. 2016 Sep;17(5):204-11. doi: 10.1080/15284336.2016.1212561. Epub 2016 Jul 28.
As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort.
Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing.
MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness.
Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.
由于生物医学预防干预措施对血清转化参与者中HIV-1感染自然史的影响尚不清楚，杀微生物剂试验网络（MTN）开展了一项纵向研究（MTN-015），以监测病毒学、免疫学和临床结局，以及在MTN试验期间感染HIV的女性的行为变化。我们描述了MTN血清转化者队列初始参与者组的基本原理、研究设计、实施和入组情况。
MTN-015于2008年启动，是一项正在进行的观察性队列研究，纳入在候选杀微生物剂有效性研究期间感染HIV-1的参与者。近期完成和正在进行的MTN试验中的合格参与者在血清转化后入组，并返回进行定期随访，收集临床和行为数据。储存血液和生殖液等生物样本以供未来检测。
MTN-015最初在非洲的六个地点实施，在HIV预防试验网络方案035（由MTN开展的HPTN 035）中血清转化的139名合格女性中有100名（72%）入组。从HPTN 035血清转化到MTN-015入组的中位时间为18个月。随访情况良好，超过70%的访视完成。实施挑战包括监管审查、问卷翻译和测试以及研究点准备情况。
将HIV血清转化者纳入纵向观察性随访研究对参与者而言是可行且可接受的。本方案收集的数据和样本将用于评估试验性HIV杀微生物剂的安全性，并回答其他有关HIV感染女性的重要公共卫生问题。
