Havens Jennifer R, Leukefeld Carl G, Oser Carrie B, Staton-Tindall Michele, Knudsen Hannah K, Mooney Jennifer, Duvall Jamieson L, Clarke Jennifer G, Frisman Linda, Surratt Hilary L, Inciardi James A
Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 333 Waller Avenue, Suite 480, Lexington, KY 40504, USA; Department of Behavioral Science, University of Kentucky, Lexington, KY, USA.
J Exp Criminol. 2009 Sep 1;5(3):245-272. doi: 10.1007/s11292-009-9081-9.
The purpose of this study was to examine the implementation, adherence and protocol fidelity for the Reducing Risky Relationships for HIV (RRR-HIV) study. The RRR-HIV study is a phase III trial of a randomized intervention to reduce human immunodeficiency virus (HIV) risk behaviors among incarcerated women in four US states: Connecticut, Delaware, Kentucky and Rhode Island. The intervention consists of five interventionist-led prison-based group sessions and a sixth individual community-based session. Data on adherence, implementation, acceptability and fidelity of the intervention were obtained from forms completed after the five prison-based sessions by both the interventionist and participant. Data from the sixth session were collected by the interventionist. Of the 363 women recruited to date, 173 (47.6%) have been randomly allocated to the experimental RRR intervention, of which implementation measures were available for 162 (93.6%). Almost three-quarters of women attended all five sessions, each of which lasted a median of 90 minutes, indicating successful implementation of the protocol across multiple study sites. Interventionists and participants alike reported that all of the topics for each session were discussed, suggesting adherence to the protocol. In addition, protocol interventionists indicated that more than 95% of the women were engaged/involved, interested, and understood the materials presented, indicating high levels of acceptability among the participants and fidelity to the intervention protocols. The majority of participants also answered all of the post-test questions correctly, which is another strong indicator of the fidelity to the intervention. Results suggest that the RRR-HIV study has been successfully implemented across multiple study sites. Adherence to the protocol, as well as protocol fidelity and acceptability, were also strong, which is essential to establish prior to examining outcome data.
本研究的目的是检验降低HIV风险关系（RRR-HIV）研究的实施情况、依从性和方案保真度。RRR-HIV研究是一项三期试验，采用随机干预措施，以降低美国四个州（康涅狄格州、特拉华州、肯塔基州和罗德岛州）被监禁女性中的人类免疫缺陷病毒（HIV）风险行为。干预措施包括由干预者主导的五次监狱内小组会议和第六次基于社区的个人会议。干预的依从性、实施情况、可接受性和保真度数据来自干预者和参与者在五次监狱内会议后填写的表格。第六次会议的数据由干预者收集。在迄今为止招募的363名女性中，173名（47.6%）被随机分配到RRR实验性干预组，其中162名（93.6%）有实施措施数据。近四分之三的女性参加了所有五次会议，每次会议的时长中位数为90分钟，这表明该方案在多个研究地点成功实施。干预者和参与者均报告称，每次会议的所有主题都进行了讨论，这表明对方案的依从性良好。此外，方案干预者指出，超过95%的女性参与其中、感兴趣并理解了所展示的材料，这表明参与者的接受程度很高，并且对干预方案的保真度很高。大多数参与者也正确回答了所有测试后问题，这是干预保真度的另一个有力指标。结果表明，RRR-HIV研究已在多个研究地点成功实施。对方案的依从性以及方案保真度和可接受性也很强，这在检查结果数据之前至关重要。
