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妇女是释放后活跃阿片类药物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口的三倍多，主要是由于他们在入狱前吸毒。研究一直表明，吸毒、犯罪、逮捕和监禁之间存在联系，大多数囚犯在监禁期间或释放后都没有接受戒毒治疗。制定释放后干预措施，可以防止重新活跃的药物使用是重要的，以减少累犯和艾滋病毒的危险行为。为了开始解决这一需求，我们建议研究一种新的药物，丁丙诺啡，结合药物管理（MM）的可行性和可接受性开始在最后2-4周的监禁，并继续在社区中12周。本研究计划的主要目的是检查丁丙诺啡联合MM用于阿片类药物复发和随后感染HIV的高风险女性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、安慰剂对照的试点研究，该研究将检查将丁丙诺啡与MM联合给药至安慰剂+MM的可行性和可接受性，该研究将给予40名有阿片类药物依赖史的女性，这些女性在释放回到社区后四周内。两组在释放后的前8周内每周接受丁丙诺啡或安慰剂加MM，随后是10周和12周的疗程。主要结果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。次要结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。如果这种干预措施是可接受的和可行的，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.