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临床试验/NCT03896776
NCT03896776已完成不适用

A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)

Northwestern University2 个研究点 分布在 1 个国家目标入组 2,125 人开始时间: 2019年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,125
试验地点
2
主要终点
Public Health Impact (reach X effectiveness)

研究概览

简要总结

This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.

详细描述

Substantial effort has gone into developing and testing the efficacy of eHealth HIV prevention interventions, but these interventions will not affect the spread of the epidemic unless implemented effectively to reach the most at-risk populations. Despite emerging evidence that eHealth approaches can be highly effective in reducing HIV risk or improving care engagement, implementation requirements do not fit within established strategies for public health scale up, leaving it an open question as to how to bring these programs into practice. To date, little to no implementation science has examined strategies to effectively scale up eHealth HIV prevention programs.

The overarching goal of this study is to address this need by developing and evaluating novel strategies for implementing eHealth HIV prevention programs. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among diverse young men who have sex with men (YMSM). KIU! was designed for YMSM who just tested HIV negative to keep it up and maintain negative status by reducing risk and enacting protections. Strong evidence of effectiveness on behavioral (decreased condomless sex) and biomedical outcomes (reduced STI incidence) makes KIU! an ideal eHealth intervention for implementation research. Lessons learned from KIU! implementation will set the pathway for implementing the many HIV eHealth programs currently undergoing efficacy testing.

Implementation strategies need to be evaluated using rigorous research designs. Through formative research with community-based organizations (CBOs), health departments, the CDC, and researchers, the investigators have identified two pragmatic implementation strategies that will be evaluated and compared:

In Strategy 1, CBOs apply for, and are selected for, funding to deliver KIU! through current HIV testing programs. Because CBOs do not have the capacity to host the technology, KIU! is hosted centrally at Northwestern and deployed by local CBO staff. Training and coaching of CBO staff on how to use the technology and integrate it into routine HIV testing is provided through capacity building assistance.

Strategy 2 is a "direct-to-consumer" (DTC) model where centralized staff at Northwestern primarily recruit participants nationally through online advertising campaigns and manage participants' engagement. HIV/STI testing kits are shipped directly to YMSM, and upon documentation of an HIV negative test result, participants are delivered KIU! This DTC model has been widely adopted in technology dissemination but it is innovative in terms of implementation of HIV prevention programs.

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 34 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • recently received an HIV negative test result OR self-report negative or unknown HIV status
  • speaks/reads English
  • has an active email address

排除标准

  • has not been on PrEP and adherent for 6 months prior

结局指标

主要结局

Public Health Impact (reach X effectiveness)

时间窗: 12 Weeks

Public Health Impact (PHI) involves the reach into the county's YMSM community, weighted by HIV risk (i.e., engagement of YMSM from higher risk communities is valued more), and effectiveness at reducing HIV risk, defined as condomless anal sex, STIs, and adherent PrEP use (i.e., three major risk factors for HIV expected to be modified by KIU!).

次要结局

未报告次要终点

研究者

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

Brian Mustanski

Director, Institute for Sexual and Gender Minority Health and Wellbeing

Northwestern University

研究点 (2)

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