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临床试验/NCT06103370
NCT06103370招募中不适用

Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
4
主要终点
Proportion of HIV testing for Network Members

研究概览

简要总结

The goal of this clinical trial is to evaluate the effectiveness of a social network intervention to recruit people who inject drugs and their networks for HIV testing and linkage to HIV prevention and treatment services in Maryland. Study aims are to determine the effectiveness of a social network driven intervention to increase:

  • HIV testing (primary);
  • PrEP knowledge;
  • Uptake of HIV services and pre-exposure prophylaxis (PrEP);
  • Uptake of medication for opioid use disorder (MOUD) initiation.

Eligible participants who access syringe service programs (SSPs) serving two counties in Maryland and their risk network members (NMs) will be recruited using an established network inventory and coupon recruitment method. When an index successfully recruits NMs, the index-NM cluster will be randomized to either a peer-educator intervention arm or an equal-attention control arm. Index participants randomized to the peer-educator intervention arm will complete a training program adapted with stakeholder input to context that emphasizes effective communication, frequent HIV testing, and awareness of evidence-based HIV prevention and treatment services. An important innovation to the network intervention will be training indexes to use and distribute HIV self-test kits and naloxone to their NMs. Index participants randomized to the equal-attention control arm will receive training sessions focused on the opioid overdose epidemic and will not include any training to serve as a peer educator. All participants (indexes and NMs) will complete study assessments at baseline and at 3 and 9 months. We will compare the peer-educator intervention group and the equal-attention control group on rates of HIV testing, knowledge of PrEP options and resources, and rates of initiation of HIV treatment, PrEP, and MOUD treatment since the previous assessment (past 3 or 6 months).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Inclusion criteria for index participants:
  • Aged 18 or older
  • Self-reported injection drug use in the prior month
  • Accessed services at the SSP in the prior 3 months
  • Willing to undergo training and attend weekly booster group sessions
  • Able to recruit at least 1 drug use Network Member (NM) into study
  • Willing to talk with peers about PWID topics such as HIV prevention and care
  • Not previously enrolled in the study as index or NM
  • English-speaking
  • Inclusion criteria for network member participants:
  • Aged 18 or older
  • Self-reported injection drug use in the prior month
  • Have a valid coupon or able to recall the 3-digit ID number
  • Not previously enrolled in the study as index or NM
  • English-speaking
  • Exclusion criteria:
  • Individuals lacking the capacity to consent

排除标准

  • 未提供

结局指标

主要结局

Proportion of HIV testing for Network Members

时间窗: 3 months, 9-months

Proportion of Network Members (both study arms) who report that they conducted HIV testing since the previous study assessment (i.e., in the prior 3 or 6 months).

次要结局

  • Proportion of HIV testing for Index and Network Members(3- and 9-month follow-up)
  • Proportion of HIV testing for Index Members(3- and 9-month follow-up)
  • Change in Knowledge of PrEP options(3- and 9-month follow-up)
  • Proportion of HIV negative participants who have used PrEP(3- and 9-month follow-up)
  • Proportion of participants using anti-retroviral therapy (ART)(3- and 9-month follow-up)
  • Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake(3- and 9-month follow-up)
  • Proportion of HIV testing for Index and Network Members(3- and 9-month follow-up)
  • Proportion of HIV testing for Index Members(3- and 9-month follow-up)
  • Change in Knowledge of PrEP options(3- and 9-month follow-up)
  • Proportion of participants using anti-retroviral therapy (ART)(3- and 9-month follow-up)
  • Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake(3- and 9-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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