跳至主要内容
临床试验/NCT05542914
NCT05542914终止不适用

Integration of Electronic SBI(RT) Into an HIV Testing Program to Reduce Substance Use and HIV Risk Behavior Among MSM in Argentina

Florida State University2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
196
试验地点
2
主要终点
Mean overall acceptability rating of e-SBI from the TFA questionnaire

研究概览

简要总结

Men who have sex with men (MSM) are disproportionally affected by HIV and substance abuse in the U.S., Europe, and Latin America. However, as in the general population, identifying and engaging MSM with problematic substance use (PSU) into treatment is a significant challenge, which results in the great majority of MSM with PSU never receiving treatment. The proposed study seeks to develop and pilot an electronic-Screening, Brief Intervention, Referral to Treatment (e-SBI-RT)program tailored for MSM awaiting their HIV test at Nexo Asociacion Civil, our community partners in Buenos Aires. The tablet-based e-SBI will integrate substance use and sexual risk behavior screeners and individually tailored Motivational Interviewing (MI) as the BI. We will also adapt and pilot the implementation of the Young Men's Health Project (from YMHP to MHP) a four-session MI-based intervention that effectively reduced substance use and condomless anal intercourse among substance using MSM. The Specific Aims of this R34 study are to: 1) develop the e-SBI intervention for MSM in an HIV testing context to reduce substance use and HIV risk behavior (Primary); 2) assess the feasibility and acceptability of integrating e-SBI into the HIV testing process at Nexo; and 3) assess the feasibility and acceptability of implementing adapted YMHP at Nexo. In Stage 1 (Development) we will develop e-SBI, adapt YMHP into MHP, train MHP counselors, and pilot e-SBI with 50 MSM coming to Nexo for HIV testing. In Stage 2 (RCT Pilot), we will randomize 200 MSM coming to Nexo for HIV testing at a 3:1 ratio (eSBI: Screening Assessments Only-SA) to assess the feasibility and acceptability of e-SBI among MSM coming to Nexo for HIV testing and establish and pilot the RCT process for a future trial. As a secondary aim, we will assess uptake, acceptability, and feasibility of delivering MHP to participants with low or moderate risk substance use and subsequent referrals to substance abuse treatment among participants with high-risk substance use or dependence. Lastly, we will explore preliminary findings on substance use and sexual risk reduction outcomes.

详细描述

This proposed study consists of two stages. Stage 1: Development will consist of developing e-SBI, the adaptation of YMHP into MHP, training counselors to deliver MHP, and piloting e-SBI with 50 MSM coming to Nexo for HIV testing. During the Stage 2: RCT Pilot, we will randomize 200 MSM coming to Nexo for HIV testing at a 3:1 ratio (eSBI: Screening Assessments Only-SA) to assess the feasibility and acceptability of e-SBI among MSM coming to Nexo for HIV testing and establish and pilot the RCT process for a future trial. As a secondary aim, we will assess uptake, acceptability, and feasibility of delivering MHP to participants with moderate risk substance use and subsequent referrals to SATx among participants with high-risk substance use or dependence. Lastly, we will explore preliminary findings on substance use and sexual risk reduction outcomes.

3.3.4. Stage 1: Development. 3.3.4.1. Development of e-SBI. Development of e-SBI app will be guided by the User Centered Rapid Application Development process (UCRAD). UCRAD merges the streamlined, iterative Rapid Application Development (RAD) approach with the User Centered Design approach (UC) which engages intended users throughout the app development process. This integrated approach aims to develop successful apps with good functionality, simple features, and a usable interface. As such, intended users are given access to prototypes of the app, allowing them to provide feedback before the next iteration of the app. UCRAD uses a three-phase process, as follows: Pre-design and interface prototyping, System architecture and coding, Deployment.

3.3.4.1.A Pre-design and interface prototyping. To accomplish this phase of UCRAD will obtain feedback from the Community Advisory Board regarding the study screening instruments (see below) and preliminary plans for the e-SBI content. After incorporating their feedback, we will conduct two focus groups (FGs) with MSM (N=16) recruited from Nexo testing clients who are 18+ years of age. They will complete a substance use screener consisting of the Illicit drug use question on the NIDA-modified ASSIST brief screen and the AUDIT-C (a 3-item alcohol use screen). Those who indicate using illicit drugs at least monthly and/or receive a score ≥4 on the AUDIT C will be eligible to participate. After completing informed consent, they will each complete paper and pencil versions of the screening instruments planned for inclusion in e-SBI. The 90-minute audio-recorded FGs will: 1) explore participants' reaction to the screeners and their impact on risk perception and motivation to reduce PSU and risk behavior; 2) evoke content for the BI component to develop menus of options for reasons to change and potential approaches to reduce problem substance use (PSU) and sexual risk behavior from which e-SBI users can choose. Within 48 hours of completing the FG, we will initiate a rapid analysis of this data using a qualitative matrix onto which participants responses and recommendations will be entered to quickly organize and summarize FG findings. These findings will be used to build the prototype of the e-SBI.

3.3.4.1.B System architecture and coding. This Phase 2 iterative app development process will be conducted with waves of 6 MSM also recruited from Nexo testing clients, with the same inclusion criteria as in the FGs. They will be recruited during two-week intervals to maintain a steady pace of feedback and revisions. Participants will complete the intervention on the tablet. Then, they will complete a 7-item self-report acceptability assessment. Afterwards, participants will be debriefed during an audio-recorded interview to explore four main areas: 1) their responses to the acceptability assessment; 2) overall reactions to e-SBI; 3) emotional reactions as e-SBI progressed, including heightened risk awareness, concern, or motivation to reduce substance use and sexual risk behavior; and 4) recommendations for improving the ability of the e-SBI to engage MSM who high-risk drugs and/or alcohol use into treatment. Interview data will undergo the same matrix-based, rapid analysis process used for the FG to quickly inform the next revision of the intervention. This process will be repeated with waves of 6 participants until mean scores on each acceptability question are ≥4.0 (≤2.0 on annoying), which we expect within 3-4 cycles. Development of the e-SBI will be guided by Choice Theory which has been used extensively to inform goal choice interventions, including MI interventions to reduce substance use among MSM. Rather than pre-set outcome expectations (ie., abstinence), goal choice interventions highlight personal choice and goal setting to engage individuals to reduce drug and alcohol use. Goal choice interventions appear to be equally effective as those that are abstinence-based and allowing individuals to set their own treatment goals appears to increase success rates.

3.3.4.1.C. Deployment. The initial version of the e-SBI will be deployed with 50 MSM coming to Nexo for HIV testing, to be used while they await their HIV test. After undergoing informed consent, these individuals will complete the eSBI, a brief quantitative acceptability assessment, and then proceed to have their HIV test (to minimize participant distress). Afterwards, up to 25 of these participants will be randomly selected (5 with low-risk substance use, 20 with moderate or high-risk substance use) to undergo an audio-recorded IDI. These IDIs will be guided by the Theoretical Framework of Acceptability (TFA) which was derived from a review of the literature on acceptability, and views acceptability as "a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention." These IDIs will be transcribed and uploaded to Dedoose for analysis. Additionally, we will use findings from these IDIs to finetune wording for a TFA-based quantitative assessments of acceptability that we will incorporate into the assessment battery during the Stage 2 RCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Participants in Stage 1 Focus Groups (FGs) and in-depth interviews (IDIs):
  • Man who has had sex with men in the past 6 months;
  • 18 years of age or older;
  • Recently sought an HIV test at Nexo;
  • Reports using drugs least once per month in the past 6 months and/or score 4 or greater on the AUDIT C, suggesting moderate risk alcohol use.
  • Participants in Stage 1 e-SBI pilot and the Stage 2 RCT:
  • Man who has had sex with men in the past 6 months
  • 18 years of age or older;
  • Currently seeking an HIV test at Nexo
  • Additional inclusion criteria for MHP entry:
  • Score of moderate or high risk drug or alcohol use based on the ASSIST and AUDIT, respectively

排除标准

  • Exclusion Criteria for MHP entry:
  • be in need of acute detoxification, as demonstrated by physical withdrawal symptoms or a history of withdrawal, such as previous delirium tremens or seizures
  • reported regular use of opioids
  • enrolled in concurrent drug- or alcohol-related treatment.

结局指标

主要结局

Mean overall acceptability rating of e-SBI from the TFA questionnaire

时间窗: 6 months

Will use the last question on the TFA questionnaire "Overall, how acceptable is the e-SBI to you?" to calculate mean overall acceptability and percent of participants who rate acceptability at 4 or higher.

Recruitment Rate: Percent of MSM testing clients at Nexo who accept entry into the study

时间窗: 8 months

Will tabulate the percentage of MSM testing clients at Nexo who accept entry into the study vs those who refuse entry

Retention Rate: percent of participants who complete e-SBI

时间窗: 6 months

Will calculate the percent of participants who fully complete the e-SBI vs participants who do not complete the intervention

次要结局

  • the percent of MHP participants who complete all four sessions(6 months)
  • the percent of MSM with moderate or high-risk substance use who enter MHP from either RCT condition(6 months)
  • percentage of sessions conducted by each MHP counselor that meet criteria for MI proficiency(6 months)
  • Mean overall acceptability rating of MHP from the TFA questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Balan

Research Professor

Florida State University

研究点 (2)

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