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临床试验/NCT05678556
NCT05678556招募中不适用

Effectiveness of Relationship Education for Reducing HIV Incidence in Men Who Have Sex With Men

Northwestern University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
HIV infection

研究概览

简要总结

The purpose of this study is to upgrade an existing relationship education and HIV prevention program. This program is designed for gay, bisexual, queer, and transgender and non-binary people who partner with cisgender men. This means the program is designed for gay, bisexual and queer men, including both cisgender and transgender men. It is also designed for transgender and non-binary people who partner with cisgender men, including both transfeminine and transmasculine people. The investigators aim to test the effectiveness of this updated program among couples and single people.

Participants will complete online surveys and get tested for Chlamydia and Gonorrhea. Participants will be tested for urethral and rectal Chlamydia and Gonorrhea. Participants will also complete at-home point-of-care HIV testing, with confirmatory testing for preliminary positive results. They will also participate in our program on relationship education and HIV prevention. Study staff will follow up with participants for up to 2 years.

All participants will be randomized into one of two different conditions: the all2GETHER program or no program. "Randomized" means that it is completely up to chance which condition participants will be put into. Participants have a 50% chance of being assigned to either condition, similar to a coin toss. Participants should expect that they will be in this research study for 2 years. Participation in this study will be done remotely - participants will never need to come into a research lab.

详细描述

The investigators will conduct a randomized controlled trial (RCT) with 5000 HIV-negative individuals, anticipating half of the individuals will have a serious partner, and half of those partnered individuals will enroll with their partner. After completing the baseline assessment, participants will be randomized to either the all2GETHER intervention package or follow-up only control, and they will be followed 24 months post-intervention. Only individuals participating with their partner will receive dyadic skills coaching sessions, while single and individual partnered MSM will receive the upgraded all2GETHER web app program only. all2GETHER web app delivers all core intervention content and uses diverse media (e.g., videos, interactive activities, quizzes) to deliver relationship education (e.g., effective communication, conflict resolution) and HIV prevention (e.g., behavioral/biomedical prevention, relationship agreements).

Eligibility Screening. Participants will be recruited via paid advertisement on traditional social media (e.g., Facebook, Instagram), geospatial dating apps (e.g., Grindr), and organic social media engagement (e.g., posts in Reddit threads). Online screening - online recruitment materials will be linked directly to the online eligibility screener. Potential participants will be greeted with a brief description of the project and will be asked if they are willing to answer some questions to assess their eligibility. Participants who meet initial eligibility criteria will be shown a message telling them that they are preliminarily eligible for the study and asked to provide their contact information. Those participants in a relationship will be asked to provide contact information for themselves and for their partner. If they do not consent to give contact information for their partner, the participant will be responsible for ensuring the partner also completes the screener. The investigators will make every effort to enroll the dyad - if partnered individuals cannot enroll their partner, they may participate as individuals.

Individual and Couple Confirmation. For couples - staff will confirm dyads as an actual couple, which involves separate calls to each partner with a series of questions about their relationship. Upon determining eligibility, and whether participation will be individual or dyadic, participants will be emailed a link to informed consent and baseline self-report questionnaire.

Baseline Assessment. Eligible participants will receive a link via email to access the online informed consent and baseline survey. Informed consent (assent for 16-17 year olds) will be completed just prior to completion of the baseline self-report questionnaire, via REDCap. Participants will be presented with the full online consent form. If they consent by clicking the 'I Agree' button at the bottom of the page, their consent will be recorded in our database. After obtaining consent/assent, participants will complete the baseline survey, which will take 45-50 minutes to complete. After completing the baseline survey, participants will be mailed HIV/STI testing kits. Participants will self-collect specimens using our team's established procedures, and return specimens for processing.

Randomization. After completing the baseline assessment, participants will be randomized to either the all2GETHER intervention package or follow-up only control, and they will be followed 24 months post-intervention. The all2GETHER intervention package will be tailored based on 2 decision rules: 1) Relationship status and (among partnered MSM) 2) individual v. dyadic participation. Only dyads will receive dyadic skills coaching sessions, while single and individual partnered MSM will receive the upgraded all2GETHER web app program only. Participating dyads will further receive 2 individualized couple sessions focused on skill implementation, emphasizing communication and problem-solving (Session 1) and sexual health (Session 2).

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 34 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Cisgender men, transgender women and men, non-binary individuals
  • •Had condomless anal sex with 2 or more serodiscordant/unknown-status cisgender male partners in the last 6 months
  • •Aged 16-34 years
  • •Lab-test confirmed HIV-negative
  • •Read and speak English at 8th grade level or better
  • •Internet access
  • •Agree to audio recording of intervention sessions
  • •Provides address to receive HIV/STI test supplies
  • •For dyads, both partners may enroll if they meet the above criteria- partners who are aged 35+ and/or HIV-positive may enroll in a more limited capacity

排除标准

  • •Participants assigned female at birth who identify as women are not eligible

研究组 & 干预措施

Experimental Arm

Experimental

all2GETHER is an HIV prevention and relationship education program designed for young MSM. all2GEHTER consists of 3 online didactic skills modules and 2 videoconference-based skills coaching sessions The 3 online modules focus on developmental skills related to sexual health and relationship functioning, including HIV prevention in couples, communication skills, coping skills, problem-solving and acceptance. Individualized couple sessions focus on implementation of skills specific to the needs of each couple.

干预措施: all2GETHER (Behavioral)

Control Arm

No Intervention

Participants will receive no intervention, but have access to HIV prevention resources from the CDC website and national databases. We will also assess exposure to other interventions that may be naturally occurring in participants' local context, which can be used to describe the sample and as a covariate (as necessary).

结局指标

主要结局

HIV infection

时间窗: 24-months

Incidence of HIV confirmed via lab processed but self-administered collection

次要结局

  • Condomless Anal Sex(24-months)
  • Relationship Functioning(24-months)
  • Sexually transmitted infections(24-months)
  • Pre-Exposure Prophylaxis Use(24-months)

研究者

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

Michael E. Newcomb

Associate Professor

Northwestern University

研究点 (1)

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