Relapse prevention to reduce HIV among women prisoners

描述（由申请人提供）：监禁前有阿片类药物依赖史的女性是释放后阿片类药物活跃使用和艾滋病毒风险行为复发的高风险群体。囚犯的艾滋病毒感染率是一般人群的三倍多，这主要是由于他们在入狱前吸毒。研究一致表明，毒品使用、犯罪、逮捕和监禁之间存在联系，而且大多数囚犯在监禁期间或释放后都没有接受药物治疗。开发释放后干预措施，防止再次积极使用药物，对于减少再犯和艾滋病毒风险行为非常重要。为了开始解决这一需求，我们建议研究一种新型药物丁丙诺啡的可行性和可接受性，并结合在监禁的最后2-4周开始并在社区持续12周的药物管理（MM）。本研究计划的主要目的是研究丁丙诺啡联合MM用于阿片类药物复发和随后感染艾滋病毒的高风险妇女的可接受性和可行性。我们建议最初实施积极干预（丁丙诺啡和MM）， 10名参与者离开监狱，作为预试点研究的一部分。所有参与者将在监狱中开始积极干预，并在释放后继续干预12周，并在释放后24周完成随访。接下来，我们将进行一项小型随机、双盲安慰剂对照试验研究，对40名有阿片类药物依赖史的妇女进行丁丙诺啡联合MM或安慰剂加MM的可行性和可接受性，这些妇女在释放后四周内返回社区。两组在释放后的前8周内每周服用丁丙诺啡或安慰剂加MM，随后是10周和12周的疗程。主要的结局变量是这种干预的可接受性和可行性。另一个主要结果是比较两组在释放后12周和24周的艾滋病毒相关风险变量，包括阿片类药物使用和性风险。次要后果包括使用其他非法药物或酒精，以及在释放后从事其他犯罪行为。如果这种干预既可接受又可行，这将为更大规模的有效性试验提供试点数据，以调查在释放回社区的阿片类药物依赖囚犯中预防艾滋病毒的干预措施。

DESCRIPTION (provided by applicant): Women with histories of opioid dependence prior to incarceration are a group at high risk for relapse to active opioid use and HIV-risk behaviors after release. Prisoners have HIV rates more than three times the general population largely due to their drug use prior to incarceration. Research has consistently demonstrated the link between drug use, crime, arrest, and incarceration and most inmates do not receive drug treatment during incarceration or after release. Development of post-release interventions that can prevent relapse to active drug use are important to reduce recidivism and HIV risk behaviors. To begin to address this need, we propose examining the feasibility and acceptability of a novel medication, buprenorphine, combined with Medication Management (MM) initiated during the last 2-4 weeks of incarceration and continued for 12 weeks in the community. The primary aims of this research plan are to examine the acceptability and feasibility of using buprenorphine combined with MM for women at high risk for opioid relapse and subsequent HIV infection. We proposed to initially implement the active intervention (buprenophine and MM) with 10 participants leaving prison as part of a pre-pilot study. All participants would be started on the active intervention in prison and continued with the intervention for 12 weeks after release and complete a follow-up at 24 weeks post-release. Next we would conduct a small randomized, double- blind placebo-controlled pilot study that would examine the feasibility and acceptability of administering buprenorphine combined with MM to placebo plus MM to 40 women with histories of opioid dependence who are within four weeks of release back to the community. Both groups would receive weekly buprenorphine or placebo plus MM during the first 8 weeks after release, followed by 10 and 12 week sessions. The primary outcome variable would be the acceptability and feasibility of this intervention. Another primary outcome would compare the two groups on HIV-related risk variables including opioid use and sexual risk at 12 and 24 weeks post-release. Secondary outcomes include use of other illicit drugs or alcohol, as well as engaging in other criminal behavior after release. If this intervention is both acceptable and feasible, this would provide pilot data for a larger efficacy trial to investigate interventions for HIV-prevention among opioid-dependent prisoners released back to the community.