Giguere Rebecca, Lentz Cody, Kajura-Manyindo Clare, Kutner Bryan A, Dolezal Curtis, Buthelezi Mbongeleni, Lukas Irene, Nampiira Susan, Rushwaya Chenai, Sitima Edith, Katz Ariana, van der Straten Ariane, Balán Iván C
HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, New York, NY, USA.
South African Medical Research Council, Chatsworth Clinical Trials Unit, Durban, South Africa.
AIDS Care. 2020 Jan-Dec;32(sup1):19-28. doi: 10.1080/09540121.2020.1823312. Epub 2020 Oct 6.
Biomedical HIV prevention trials increasingly include evidence-based adherence counseling to encourage product use. To retain effectiveness, interventions must contain key components. Monitoring counseling fidelity ensures inclusion of components but is challenging in multinational contexts with different languages and scarce local supervision. The MTN-025/HOPE Study, a Phase 3b open-label trial to assess continued safety of and adherence to the dapivirine vaginal ring for HIV prevention, was the largest such trial to integrate fidelity monitoring using audio recordings of counseling sessions. We describe the monitoring process, along with counselor and participants' perceptions of it, which were collected via quantitative online survey (counselors only = 42) and in-depth interviews with a subset of counselors ( = 22) and participants ( = 10). Sessions were conducted in five languages across 14 study sites in four countries. In total, 1238 sessions (23% of submitted sessions) were randomly selected and rated. Assessment of interrater reliability was essential to address drift in ratings. Counselors were apprehensive about being monitored, but appreciated clear guidance and found ratings very helpful (mean = 6.64 out of 7). Some participants perceived sessions as time-consuming; others found monitoring improved counseling quality. Fidelity monitoring of counseling sessions in mult-isite biomedical HIV studies is feasible and supportive for counselors.
生物医学艾滋病毒预防试验越来越多地纳入循证依从性咨询,以鼓励使用相关产品。为保持有效性,干预措施必须包含关键要素。监测咨询的保真度可确保关键要素的纳入,但在语言各异且当地监督匮乏的跨国背景下颇具挑战。MTN - 025/HOPE研究是一项3b期开放标签试验,旨在评估达匹韦林阴道环用于艾滋病毒预防的持续安全性和依从性,是此类将咨询环节录音用于保真度监测的最大规模试验。我们描述了监测过程,以及通过定量在线调查(仅针对42名咨询师)和对一部分咨询师(22名)及参与者(10名)进行深入访谈所收集到的咨询师和参与者对此的看法。咨询环节在四个国家的14个研究地点以五种语言进行。总共随机抽取并评估了1238个环节(占提交环节的23%)。评估评分者间的可靠性对于解决评分偏差至关重要。咨询师对被监测感到担忧,但认可明确的指导,并认为评分非常有帮助(平均评分为7分制中的6.64分)。一些参与者认为咨询环节耗时;另一些人则发现监测提高了咨询质量。在多地点生物医学艾滋病毒研究中对咨询环节进行保真度监测对咨询师而言是可行且有帮助的。