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Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men (online-RASSL)

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ClinicalTrials.gov Identifier: NCT03320239
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC

Tracking Information
First Submitted Date  ICMJE October 17, 2017
First Posted Date  ICMJE October 25, 2017
Last Update Posted Date October 25, 2017
Actual Study Start Date  ICMJE October 12, 2017
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
The proportion of HIV testing during the study period [ Time Frame: 1 month ]
The numerator is the number of participants who come to the specific HIV testing clinics for HIV test during the study period, the denominator is the number of participants randomized per group.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • unprotected anal intercourse [ Time Frame: 6 months ]
    Questionaire will be used to collect the frequency of unprotected anal intercourse at month 1, month 3 and month 6 after the study starts.
  • Post exposure prophylaxis (PEP) [ Time Frame: 6 months ]
    Questionaire will be used to collect data on whether participants use PEP at month 1, month 3 and month 6.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men
Official Title  ICMJE Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial
Brief Summary The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20% HIV testing proportion during the six months follow-up period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV/AIDS
  • HIV Infections
  • Social Media
Intervention  ICMJE
  • Behavioral: HIV risk assessment and tailored suggestions
    The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link
  • Behavioral: HIV risk behavior assessment
    It only contains HIV risk behavior assessment and routine education
  • Behavioral: placebo control
    It only contains HIV/AIDS knowledge assessment and routine education
Study Arms  ICMJE
  • Experimental: the online-RASSL intervention group
    HIV risk assessment and tailored suggestions, free HIV testing link
    Intervention: Behavioral: HIV risk assessment and tailored suggestions
  • Experimental: intervention group 2
    HIV risk behavior investigation and routine education
    Intervention: Behavioral: HIV risk behavior assessment
  • Placebo Comparator: the control group
    The placebo control: HIV/AIDS knowledge assessment, routine education
    Intervention: Behavioral: placebo control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2017)
4500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male at birth.
  • Having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment.
  • An age of 18 years or older.
  • Living in Beijing, China.
  • Self-reporting HIV negative or unknown.
  • Willingly participating into the baseline survey and the six months follow ups.
  • Agreeing not to share the research link to others.
  • Owning a mobile phone and having had downloaded the social networking Application Blued before enrollment.

Exclusion Criteria:

  • Not accepting blood sampling within the study period.
  • Reporting injecting drugs use in the past six months before enrollment.
  • Being currently involved in other HIV behavioral interventions for MSM.
  • Having a specific plan to leave from Beijing in the next 6 months.
  • Self-reporting female.
  • Other reasons the investigators deem make participation either detrimental to the participants or the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wu Z You, PhD 010-58900946 wuzy@263.net
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03320239
Other Study ID Numbers  ICMJE risk assessment
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Center for AIDS/STD Control and Prevention, China CDC
Study Sponsor  ICMJE National Center for AIDS/STD Control and Prevention, China CDC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wu Z You, PhD NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION
PRS Account National Center for AIDS/STD Control and Prevention, China CDC
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP