Crowdsourcing A Public Health Campaign

August 15, 2019 updated by: University of North Carolina, Chapel Hill

Institute for Global Health & Infectious Diseases (IGHID) 11604 - Crowdsourcing to Promote HIV Testing: A Stepped Wedge Randomized Controlled Trial to Evaluate Promoting HIV Testing in China

The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). The crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based MSM engagement. The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test uptake campaigns in eliciting HIV test uptake.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will use an adaptation of the stepped wedge randomized controlled trial design. A total of eight major metropolitan cities will implement the crowdsourced intervention. These cities will be chosen based on the following criteria: 1) previous Centers for Disease Control and Prevention (CDC) MSM sentinel surveillance site; 2) capacity for campaign implementation; 3) capacity for intervention implementation at the community level. Four cities will implement more intensive in-person events to promote engagement (Guangzhou, Shenzhen in Guangdong Province, Qingdao, and Jinan in Shandong Province) during survey intervention stage. The Randomized controlled trial (RCT) will be evaluated using two different sources of data: 1) online survey data from MSM in the eight cities prior to and after the intervention; 2) CDC routine surveillance data in the eight cities prior to and after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1381

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Currently living and planning to live in one of the eight cities used in the study in the next 12 months.
  • Not living with HIV
  • No HIV test in the past three months
  • Born biologically male and identify as either male or transgender female
  • Had anal or oral sex with men at least once during their lifetime
  • 16 years or older
  • Willing to provide cell phone number
  • Complete the informed consent document

Exclusion Criteria:

  • Women are excluded from this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Intervention
Men will be exposed immediately to a comprehensive intervention promoting HIV testing.
Behavioral: Crowdsourced intervention
The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.
Experimental: Delayed Intervention
Men will be exposed to a comprehensive intervention promoting HIV testing after a delay period.
Behavioral: Crowdsourced intervention
The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.
Behavioral: Traditional intervention campaign
The pre-intervention period will include conventional HIV testing campaigns organized by local CDC, Community-Based Organization (CBO), and partners. These are typically designed by experts and social marketing companies.
Other Names:
  • Conventional HIV testing campaign

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
This will be assessed by self-report during a follow-up survey
From implementation roll-out to three months after implementation of crowdsourced intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Men Reporting Condomless Sex at 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
HIV Testing Social Norms
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
HIV testing social norms will be measured using six survey items that are each on a five-point Likert scale. Increased HIV testing social norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly. Number of men who report higher score of social norms when comparing their pre-intervention and post-intervention values
From implementation roll-out to three months after implementation of crowdsourced intervention
Change in HIV Testing Self-efficacy
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms
From implementation roll-out to three months after implementation of crowdsourced intervention
Community Engagement/ MSM Community Affiliation
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Number of men, defined as an increase in closer affiliation with the MSM community (i.e., tongzhi circle, gay online networks or groups) when comparing their pre-intervention and post-intervention periods.
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Mean Score of Anticipated HIV Stigma
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Measured by a 7-item version of the anticipated HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future. All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate greater anticipated stigma.
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
Frequency of men, defined as the number of men who reported using mobile apps in the past three months to give or receive information about HIV testing comparing their pre-intervention and post-intervention engagement
From implementation roll-out to three months after implementation of crowdsourced intervention
Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention
Time Frame: From implementation roll-out to three months after implementation of crowdsourced intervention
From implementation roll-out to three months after implementation of crowdsourced intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
London School of Hygiene and Tropical Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
Shandong University
University of Bristol
Guangdong Center for Disease Prevention and Control
UNC-South China STD Research Training Center
UNC Center for AIDS Research
SESH Global
Guangdong Provincial Center for Skin Diseases and STI Control
Shandong Province Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph D Tucker, MD, PhD, jdtucker@med.unc.edu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-0851
  • R01AI114310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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