Cathy J Reback, Raphael J Landovitz, David Benkeser, Ali Jalali, Steven Shoptaw, Michael J Li, Raymond P Mata, Danielle Ryan, Philip J Jeng, Sean M Murphy
{"title":"针对患有药物使用障碍的变性女性和性少数群体男性，采用阶梯式护理方法，利用 PrEP 导航（有或无应急管理）进行随机对照试验的方案：援助服务知识-PrEP（A.S.K.-PrEP）。","authors":"Cathy J Reback, Raphael J Landovitz, David Benkeser, Ali Jalali, Steven Shoptaw, Michael J Li, Raymond P Mata, Danielle Ryan, Philip J Jeng, Sean M Murphy","doi":"10.1186/s13722-024-00482-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.</p><p><strong>Objective: </strong>To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD.</p><p><strong>Methods: </strong>This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone).</p><p><strong>Results: </strong>Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027.</p><p><strong>Discussion: </strong>Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances.</p><p><strong>Trial registration: </strong>This trial has been registered at ClinicalTrials.gov under the number NCT05934877.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"19 1","pages":"79"},"PeriodicalIF":3.7000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549772/pdf/","citationCount":"0","resultStr":"{\"title\":\"Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services Knowledge-PrEP (A.S.K.-PrEP).\",\"authors\":\"Cathy J Reback, Raphael J Landovitz, David Benkeser, Ali Jalali, Steven Shoptaw, Michael J Li, Raymond P Mata, Danielle Ryan, Philip J Jeng, Sean M Murphy\",\"doi\":\"10.1186/s13722-024-00482-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.</p><p><strong>Objective: </strong>To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD.</p><p><strong>Methods: </strong>This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone).</p><p><strong>Results: </strong>Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027.</p><p><strong>Discussion: </strong>Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances.</p><p><strong>Trial registration: </strong>This trial has been registered at ClinicalTrials.gov under the number NCT05934877.</p>\",\"PeriodicalId\":54223,\"journal\":{\"name\":\"Addiction Science & Clinical Practice\",\"volume\":\"19 1\",\"pages\":\"79\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-11-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549772/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Addiction Science & Clinical Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13722-024-00482-6\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SUBSTANCE ABUSE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Addiction Science & Clinical Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13722-024-00482-6","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SUBSTANCE ABUSE","Score":null,"Total":0}
Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services Knowledge-PrEP (A.S.K.-PrEP).
Background: In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration.
Objective: To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD.
Methods: This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone).
Results: Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027.
Discussion: Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances.
Trial registration: This trial has been registered at ClinicalTrials.gov under the number NCT05934877.
期刊介绍：
Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings.
Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use.
Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations.
Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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