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

Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; HIV/AIDS; Social Media
• Intervention / Treatment: Behavioral: HIV risk assessment and tailored suggestions; Behavioral: HIV risk behavior assessment; Behavioral: placebo control

• Study Type: Interventional
• Enrollment (Anticipated): 4500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10026
      • Recruiting
      • national center for AIDS control and prevention
      • Contact: Zunyou Wu, PHD; Phone Number: 010-58900946; Email: wuzy@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the online-RASSL intervention group; HIV risk assessment and tailored suggestions, free HIV testing link	Behavioral: HIV risk assessment and tailored suggestions; The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link
Experimental: intervention group 2; HIV risk behavior investigation and routine education	Behavioral: HIV risk behavior assessment; It only contains HIV risk behavior assessment and routine education
Placebo Comparator: the control group; The placebo control: HIV/AIDS knowledge assessment, routine education	Behavioral: placebo control; It only contains HIV/AIDS knowledge assessment and routine education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of HIV testing during the study period	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
unprotected anal intercourse	Questionaire will be used to collect the frequency of unprotected anal intercourse at month 1, month 3 and month 6 after the study starts.	6 months
Post exposure prophylaxis (PEP)	Questionaire will be used to collect data on whether participants use PEP at month 1, month 3 and month 6.	6 months

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Investigators: Study Director: Wu Z You, PhD, NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: HIV; risk assessment; HIV testing; unprotected anal intercourse; Social medica
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: Risk Assessment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No