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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between...
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Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

Brian Mustanski1, Rana Saber2, Justin Patrick Jones2

  • 1Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, 625 N. Michigan Avenue, Floor 14, Chicago, IL 60611, United States of America; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, 625 N. Michigan Avenue, Floor 14, Chicago, IL 60611, United States of America; Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine, Northwestern University, 446 E. Ontario Street, Floor 7, Chicago, IL 60611, United States of America.

Contemporary Clinical Trials
|February 26, 2023
PubMed
Summary
This summary is machine-generated.

This study compares community-based versus direct-to-consumer recruitment for an online HIV prevention program for young men who have sex with men. Findings will inform effective eHealth HIV prevention implementation strategies.

Keywords:
Cluster randomized trialHIV preventionImplementation scienceStudy protocolType III hybrid implementation-effectivenesseHealth

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Area of Science:

  • Public Health
  • Implementation Science
  • Digital Health

Background:

  • eHealth interventions show promise for HIV risk reduction, but implementation strategies for public health scale-up remain unclear.
  • Young men who have sex with men (YMSM) are a key population for HIV prevention efforts.
  • The 'Keep It Up!' (KIU!) program is an established eHealth intervention for YMSM.

Purpose of the Study:

  • To compare two implementation strategies: community-based organizations (CBO) versus direct-to-consumer (DTC) recruitment for the KIU! program.
  • To examine how implementation strategies and determinants influence success in delivering eHealth HIV prevention.
  • To develop materials for sustaining eHealth programs post-trial.

Main Methods:

  • A Type III Hybrid Effectiveness-Implementation cluster randomized trial involving 66 counties.
  • Randomization of counties to either CBO or DTC recruitment approaches (2:1 ratio).
  • Outcome measurement using the RE-AIM model, collecting data from CBO staff, YMSM, and technology providers; mixed-methods research informed by the Consolidated Framework for Implementation Research.

Main Results:

  • The study is designed to compare the effectiveness and implementation outcomes of CBO versus DTC recruitment models.
  • It will identify key determinants influencing the variability of implementation success for eHealth HIV prevention.
  • Data collection is ongoing, focusing on RE-AIM metrics and implementation determinants.

Conclusions:

  • Understanding comparative advantages of CBO and DTC recruitment is crucial for scaling eHealth HIV prevention.
  • This trial will provide valuable insights into optimizing the implementation of digital health interventions for YMSM.
  • Findings will contribute to the broader knowledge base on implementing eHealth prevention programs effectively.