减少美国境内高危HIV感染风险且使用兴奋剂男性中并发药物滥用与HIV风险的研究
在美国，针对高艾滋病风险的兴奋剂使用男性，减少其伴随发生的药物滥用和艾滋病风险。
This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jose Colon-Burgos, DrPH
- 电话号码：(352) 273-9188
- 邮箱：jcolonburgos@phhp.ufl.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- be 18 years of age or older;
- be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;
- report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;
- have HIV-negative serostatus;
- be bilingual (Spanish and English), or Spanish or English monolingual;
- meet CDC criteria for PrEP eligibility.
Exclusion Criteria:
- display diminished capacity to consent (e.g., cognitive impairment); or
- severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;
- if they are HIV positive or living with HIV;
- if they are already taking PrEP; and
- if the participant can't consent to participate in English or Spanish.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Attention-Control condition
Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises. |
Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. |
|
实验性的：Experimental condition
Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of PrEP uptake
大体时间：From enrollment to 6 months
|
Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP. |
From enrollment to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Stimulant use (self-report)
大体时间：Enrollment to 6 months
|
Changes in the severity of participant stimulant use as measured by the Alcohol, Smoking, and Substance Involvement Screen Test (ASSIST) composite scores for cocaine and amphetamine-type stimulants. |
Enrollment to 6 months
|
|
Condomless Anal Sex (CAS)
大体时间：From enrollment to 6 months
|
Changes in the number of CAS partners who are not taking PrEP or virally suppressed. |
From enrollment to 6 months
|
|
Social Network Composition
大体时间：From enrollment to 6 months
|
Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP. |
From enrollment to 6 months
|
合作者和调查者
调查人员
- 首席研究员：Jose Colon-Burgos, DrPH、University of Florida
出版物和有用的链接
一般刊物
- Sauceda JA, Brooks RA, Xavier J, Maiorana A, Georgetti Gomez L, Zamudio-Haas S, Rodriguez-Diaz CE, Cajina A, Myers J. From Theory to Application: A Description of Transnationalism in Culturally-Appropriate HIV Interventions of Outreach, Access, and Retention Among Latino/a Populations. J Immigr Minor Health. 2019 Apr;21(2):332-345. doi: 10.1007/s10903-018-0753-2.
- Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.
- Kelly JA, Amirkhanian YA, Seal DW, Galletly CM, Difranceisco W, Glasman LR, Stevenson LY, Rosado N. Levels and Predictors of Sexual HIV Risk in Social Networks of Men who Have Sex with Men in the Midwest. AIDS Educ Prev. 2010 Dec;22(6):483-95. doi: 10.1521/aeap.2010.22.6.483.
- Reback CJ, Peck JA, Dierst-Davies R, Nuno M, Kamien JB, Amass L. Contingency management among homeless, out-of-treatment men who have sex with men. J Subst Abuse Treat. 2010 Oct;39(3):255-63. doi: 10.1016/j.jsat.2010.06.007. Epub 2010 Jul 29.
- Hojilla JC, Vlahov D, Glidden DV, Amico KR, Mehrotra M, Hance R, Grant RM, Carrico AW. Skating on thin ice: stimulant use and sub-optimal adherence to HIV pre-exposure prophylaxis. J Int AIDS Soc. 2018 Mar;21(3):e25103. doi: 10.1002/jia2.25103.
- Shoptaw S, Reback CJ, Peck JA, Yang X, Rotheram-Fuller E, Larkins S, Veniegas RC, Freese TE, Hucks-Ortiz C. Behavioral treatment approaches for methamphetamine dependence and HIV-related sexual risk behaviors among urban gay and bisexual men. Drug Alcohol Depend. 2005 May 9;78(2):125-34. doi: 10.1016/j.drugalcdep.2004.10.004. Epub 2004 Nov 28.
- Shoptaw S, Klausner JD, Reback CJ, Tierney S, Stansell J, Hare CB, Gibson S, Siever M, King WD, Kao U, Dang J. A public health response to the methamphetamine epidemic: the implementation of contingency management to treat methamphetamine dependence. BMC Public Health. 2006 Aug 18;6:214. doi: 10.1186/1471-2458-6-214.
- Folkman S. The case for positive emotions in the stress process. Anxiety Stress Coping. 2008 Jan;21(1):3-14. doi: 10.1080/10615800701740457.
- Ostrow DG, Plankey MW, Cox C, Li X, Shoptaw S, Jacobson LP, Stall RC. Specific sex drug combinations contribute to the majority of recent HIV seroconversions among MSM in the MACS. J Acquir Immune Defic Syndr. 2009 Jul 1;51(3):349-55. doi: 10.1097/QAI.0b013e3181a24b20.
- Koblin BA, Husnik MJ, Colfax G, Huang Y, Madison M, Mayer K, Barresi PJ, Coates TJ, Chesney MA, Buchbinder S. Risk factors for HIV infection among men who have sex with men. AIDS. 2006 Mar 21;20(5):731-9. doi: 10.1097/01.aids.0000216374.61442.55.
- Bernal G, Bonilla J, Bellido C. Ecological validity and cultural sensitivity for outcome research: issues for the cultural adaptation and development of psychosocial treatments with Hispanics. J Abnorm Child Psychol. 1995 Feb;23(1):67-82. doi: 10.1007/BF01447045.
- Finlayson TJ, Le B, Smith A, Bowles K, Cribbin M, Miles I, Oster AM, Martin T, Edwards A, Dinenno E; Centers for Disease Control and Prevention (CDC). HIV risk, prevention, and testing behaviors among men who have sex with men--National HIV Behavioral Surveillance System, 21 U.S. cities, United States, 2008. MMWR Surveill Summ. 2011 Oct 28;60(14):1-34.
- Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, New Jersey: Lawrence Earlbaum Associates; 1988.
- Molenberghs G, Verbeke G. Models for Discrete Longituidnal Data. New York: Springer- Verlag; 2005.
- Saldaña J. The Coding Manual for Qualitative Researchers. 3rd ed. Los Angeles, CA: SAGE; 2016.
- Creswell JW. Qualitative Inquiry and Research Design: Choosing among Five Approaches. 3ed ed. Thousand Oaks,California: SAGE Publications; 2013.
- Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Clinical Practice Guideline.; 2018. https://www.cdc.gov/std/tg2015/tg-2015-.
- Mccarty C, Lubbers MJ, Vacca R, Molina JL. Conducting Personal Network Research: A Practical Guide. New York, N.Y.: The Guilford Press; 2019. www.guilford.com.
- 27855594
- Padilla M, Colon-Burgos JF, Varas-Diaz N, Matiz-Reyes A, Parker CM. Tourism Labor, Embodied Suffering, and the Deportation Regime in the Dominican Republic. Med Anthropol Q. 2018 Dec;32(4):498-519. doi: 10.1111/maq.12447. Epub 2018 May 8.
- Colon Burgos JF, Padilla M, Nunez A, Varas-Diaz N, Matiz-Reyes A. An ethnographic study of 'touristic escapism' and health vulnerability among Dominican male tourism workers. Glob Public Health. 2019 Nov;14(11):1578-1588. doi: 10.1080/17441692.2019.1651370. Epub 2019 Aug 9.
- Carrico AW, Zepf R, Meanley S, Batchelder A, Stall R. Critical Review: When the Party is Over: A Systematic Review of Behavioral Interventions for Substance-Using Men Who Have Sex with Men. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):299-306. doi: 10.1097/QAI.0000000000001102.
- Carrico AW, Neilands TB, Dilworth SE, Evans JL, Gomicronmez W, Jain JP, Gandhi M, Shoptaw S, Horvath KJ, Coffin L, Discepola MV, Andrews R, Woods WJ, Feaster DJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine. J Int AIDS Soc. 2019 Dec;22(12):e25436. doi: 10.1002/jia2.25436.
- Bernal G, Saez-Santiago E. Culturally Centered Psychosocial Interventions. Focus (Am Psychiatr Publ). 2024 Oct;22(4):508-514. doi: 10.1176/appi.focus.24022022. Epub 2024 Oct 15.
- Akresh IR, Do DP, Frank R. Segmented assimilation, neighborhood disadvantage, and Hispanic immigrant health. Soc Sci Med. 2016 Jan;149:114-21. doi: 10.1016/j.socscimed.2015.12.013. Epub 2015 Dec 13.
- Garcia M, Harris AL. PrEP awareness and decision-making for Latino MSM in San Antonio, Texas. PLoS One. 2017 Sep 27;12(9):e0184014. doi: 10.1371/journal.pone.0184014. eCollection 2017.
- Brooks RA, Nieto O, Landrian A, Fehrenbacher A, Cabral A. Experiences of Pre-Exposure Prophylaxis (PrEP)-Related Stigma among Black MSM PrEP Users in Los Angeles. J Urban Health. 2020 Oct;97(5):679-691. doi: 10.1007/s11524-019-00371-3.
- Castro FG, Marsiglia FF, Kulis S, Kellison JG. Lifetime segmented assimilation trajectories and health outcomes in Latino and other community residents. Am J Public Health. 2010 Apr;100(4):669-76. doi: 10.2105/AJPH.2009.167999. Epub 2010 Feb 18.
- Centers for Disease Control and Prevention. Estimated HIV Incidence and Prevalence in the United States, 2010-2016. Vol 24. Atlanta, Georgia; 2019. http://www.cdc.gov/hiv/library/reports/hivsurveillance. html.http://www.cdc.gov/hiv/library/reports/hivsurveillance. htmlhttp://wwwn.cdc.gov/dcs/ContactUs/Form.
- Brooks RA, Nieto O, Landrian A, Donohoe TJ. Persistent stigmatizing and negative perceptions of pre-exposure prophylaxis (PrEP) users: implications for PrEP adoption among Latino men who have sex with men. AIDS Care. 2019 Apr;31(4):427-435. doi: 10.1080/09540121.2018.1499864. Epub 2018 Jul 18.
- Rhodes SD, McCoy TP, Vissman AT, DiClemente RJ, Duck S, Hergenrather KC, Foley KL, Alonzo J, Bloom FR, Eng E. A randomized controlled trial of a culturally congruent intervention to increase condom use and HIV testing among heterosexually active immigrant Latino men. AIDS Behav. 2011 Nov;15(8):1764-75. doi: 10.1007/s10461-011-9903-4.
- Perez A, Santamaria EK, Operario D. A Systematic Review of Behavioral Interventions to Reduce Condomless Sex and Increase HIV Testing for Latino MSM. J Immigr Minor Health. 2018 Oct;20(5):1261-1276. doi: 10.1007/s10903-017-0682-5.
- Rhodes SD, McCoy TP, Hergenrather KC, Vissman AT, Wolfson M, Alonzo J, Bloom FR, Alegria-Ortega J, Eng E. Prevalence estimates of health risk behaviors of immigrant latino men who have sex with men. J Rural Health. 2012 Jan;28(1):73-83. doi: 10.1111/j.1748-0361.2011.00373.x. Epub 2011 Mar 31.
- Fernandez MI, Jacobs RJ, Warren JC, Sanchez J, Bowen GS. Drug use and Hispanic men who have sex with men in South Florida: implications for intervention development. AIDS Educ Prev. 2009 Oct;21(5 Suppl):45-60. doi: 10.1521/aeap.2009.21.5_supp.45.
- Fernandez MI, Bowen GS, Varga LM, Collazo JB, Hernandez N, Perrino T, Rehbein A. High rates of club drug use and risky sexual practices among Hispanic men who have sex with men in Miami, Florida. Subst Use Misuse. 2005;40(9-10):1347-62. doi: 10.1081/JA-200066904.
- Egan JE, Frye V, Kurtz SP, Latkin C, Chen M, Tobin K, Yang C, Koblin BA. Migration, neighborhoods, and networks: approaches to understanding how urban environmental conditions affect syndemic adverse health outcomes among gay, bisexual and other men who have sex with men. AIDS Behav. 2011 Apr;15 Suppl 1(Suppl 1):S35-50. doi: 10.1007/s10461-011-9902-5.
- NDEWS. Methamphetamine Highlights.; 2018. https://ndews.umd.edu/sentinelsites/ sentinel-sites-reports-and-community-contacts.
- Oldenburg CE, Jain S, Mayer KH, Mimiaga MJ. Post-exposure prophylaxis use and recurrent exposure to HIV among men who have sex with men who use crystal methamphetamine. Drug Alcohol Depend. 2015 Jan 1;146:75-80. doi: 10.1016/j.drugalcdep.2014.11.010. Epub 2014 Nov 26.
- Plankey MW, Ostrow DG, Stall R, Cox C, Li X, Peck JA, Jacobson LP. The relationship between methamphetamine and popper use and risk of HIV seroconversion in the multicenter AIDS cohort study. J Acquir Immune Defic Syndr. 2007 May 1;45(1):85-92. doi: 10.1097/QAI.0b013e3180417c99.
- Portes A, Zhou M. The New Second Generation : Segmented Assimilation and its Variants. Ann Am Acad Pol Soc Sci. 1993;530:74-96.
- Folkman S, Moskowitz JT. Positive affect and the other side of coping. Am Psychol. 2000 Jun;55(6):647-54. doi: 10.1037//0003-066x.55.6.647.
- Carrico AW, Gomicronmez W, Jain J, Shoptaw S, Discepola MV, Olem D, Lagana-Jackson J, Andrews R, Neilands TB, Dilworth SE, Evans JL, Woods WJ, Moskowitz JT. Randomized controlled trial of a positive affect intervention for methamphetamine users. Drug Alcohol Depend. 2018 Nov 1;192:8-15. doi: 10.1016/j.drugalcdep.2018.07.029. Epub 2018 Sep 5.
- Sanchez M, Dillon FR, Concha M, De La Rosa M. The Impact of Religious Coping on the Acculturative Stress and Alcohol Use of Recent Latino Immigrants. J Relig Health. 2015 Dec;54(6):1986-2004. doi: 10.1007/s10943-014-9883-6.
- Colon-Burgos J, Padilla MB, Buttram M, Varas N. Examining the syndemic of drug use and HIV among Latino MSM that work in the tourism sector of South Beach. In: American Public Health Association; 2019.
- Hojilla JC, Vlahov D, Crouch PC, Dawson-Rose C, Freeborn K, Carrico A. HIV Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex with Men in a Community-Based Sexual Health Clinic. AIDS Behav. 2018 Apr;22(4):1096-1099. doi: 10.1007/s10461-017-2009-x.
- Lewis NM, Wilson K. HIV risk behaviours among immigrant and ethnic minority gay and bisexual men in North America and Europe: A systematic review. Soc Sci Med. 2017 Apr;179:115-128. doi: 10.1016/j.socscimed.2017.02.033. Epub 2017 Feb 24.
- Hojilla JC, Satre DD, Glidden DV, McMahan VM, Gandhi M, Defechereux P, Guanira JV, Mehrotra M, Grant RM, Carrico AW. Brief Report: Cocaine Use and Pre-exposure Prophylaxis: Adherence, Care Engagement, and Kidney Function. J Acquir Immune Defic Syndr. 2019 May 1;81(1):78-82. doi: 10.1097/QAI.0000000000001972.
- CDC. Diagnoses of HIV Infection in the United States and Dependent Areas, 2018 (Preliminary) HIV Surveillance Supplemental Report 2 Vol. 30. Atlanta, Georgia; 2019. http://www.cdc.gov/hiv/library/reports/hivsurveillance. html.http://www.cdc.gov/hiv/library/reports/hivsurveillance. htmlhttp://wwwn.cdc.gov/dcs/ContactUs/Form.
- Rhodes SD, Alonzo J, Mann L, Freeman A, Sun CJ, Garcia M, Painter TM. Enhancement of a Locally Developed HIV Prevention Intervention for Hispanic/Latino MSM: A Partnership of Community-Based Organizations, a University, and the Centers for Disease Control and Prevention. AIDS Educ Prev. 2015 Aug;27(4):312-32. doi: 10.1521/aeap.2015.27.4.312.
- U.S. Department of Health & Human Services. What is 'Ending the HIV Epidemic: A Plan for America'? | HIV.gov. https://www.hiv.gov/federal-response/ending-the-hivepidemic/ overview.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB202501242
- 5R00DA053158-05 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified datasets from the study will be shared.
IPD 共享时间框架
12 months after completion of the study
IPD 共享访问标准
Data will be accessible via UF data repository
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.