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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796963
Other study ID # 16-0851
Secondary ID R01AI114310
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date August 2017

Study information

Verified date February 2018
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1381
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Male
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (11)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Guangdong Center for Disease Prevention and Control, Guangdong Provincial Center for Skin Diseases and STI Control, London School of Hygiene and Tropical Medicine, National Institute of Allergy and Infectious Diseases (NIAID), SESH Global, Shandong Province Centers for Disease Control and Prevention, Shandong University, UNC Center for AIDS Research, UNC-South China STD Research Training Center, University of Bristol

References & Publications (2)

Tang W, Han L, Best J, Zhang Y, Mollan K, Kim J, Liu F, Hudgens M, Bayus B, Terris-Prestholt F, Galler S, Yang L, Peeling R, Volberding P, Ma B, Xu H, Yang B, Huang S, Fenton K, Wei C, Tucker JD. Crowdsourcing HIV Test Promotion Videos: A Noninferiority Randomized Controlled Trial in China. Clin Infect Dis. 2016 Jun 1;62(11):1436-1442. doi: 10.1093/cid/ciw171. Epub 2016 Apr 29. — View Citation

Zhang Y, Kim JA, Liu F, Tso LS, Tang W, Wei C, Bayus BL, Tucker JD. Creative Contributory Contests to Spur Innovation in Sexual Health: 2 Cases and a Guide for Implementation. Sex Transm Dis. 2015 Nov;42(11):625-8. doi: 10.1097/OLQ.0000000000000349. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months 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 Number of Men Reporting Condomless Sex at 3 Months Post-intervention From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary HIV Testing Social Norms 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
Secondary Change in HIV Testing Self-efficacy 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
Secondary Community Engagement/ MSM Community Affiliation 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
Secondary Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Mean Score of Anticipated HIV Stigma 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
Secondary Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing From implementation roll-out to three months after implementation of crowdsourced intervention
Secondary Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing 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
Secondary Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention From implementation roll-out to three months after implementation of crowdsourced intervention
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