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

Primary Purpose

HIV/AIDS, HIV Infections, Social Media

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HIV risk assessment and tailored suggestions
HIV risk behavior assessment
placebo control
Sponsored by
National Center for AIDS/STD Control and Prevention, China CDC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV, risk assessment, HIV testing, unprotected anal intercourse, Social medica

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • national center for AIDS control and preventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

the online-RASSL intervention group

intervention group 2

the control group

Arm Description

HIV risk assessment and tailored suggestions, free HIV testing link

HIV risk behavior investigation and routine education

The placebo control: HIV/AIDS knowledge assessment, routine education

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Post exposure prophylaxis (PEP)
Questionaire will be used to collect data on whether participants use PEP at month 1, month 3 and month 6.

Full Information

First Posted
October 17, 2017
Last Updated
October 20, 2017
Sponsor
National Center for AIDS/STD Control and Prevention, China CDC
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1. Study Identification

Unique Protocol Identification Number
NCT03320239
Brief Title
Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men
Acronym
online-RASSL
Official Title
Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men in Beijing: a Social Media-based Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for AIDS/STD Control and Prevention, China CDC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HIV Infections, Social Media
Keywords
HIV, risk assessment, HIV testing, unprotected anal intercourse, Social medica

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the online-RASSL intervention group
Arm Type
Experimental
Arm Description
HIV risk assessment and tailored suggestions, free HIV testing link
Arm Title
intervention group 2
Arm Type
Experimental
Arm Description
HIV risk behavior investigation and routine education
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
The placebo control: HIV/AIDS knowledge assessment, routine education
Intervention Type
Behavioral
Intervention Name(s)
HIV risk assessment and tailored suggestions
Intervention Description
The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link
Intervention Type
Behavioral
Intervention Name(s)
HIV risk behavior assessment
Intervention Description
It only contains HIV risk behavior assessment and routine education
Intervention Type
Behavioral
Intervention Name(s)
placebo control
Intervention Description
It only contains HIV/AIDS knowledge assessment and routine education
Primary Outcome Measure Information:
Title
The proportion of HIV testing during the study period
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
unprotected anal intercourse
Description
Questionaire will be used to collect the frequency of unprotected anal intercourse at month 1, month 3 and month 6 after the study starts.
Time Frame
6 months
Title
Post exposure prophylaxis (PEP)
Description
Questionaire will be used to collect data on whether participants use PEP at month 1, month 3 and month 6.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Z You, PhD
Phone
010-58900946
Email
wuzy@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Z You, PhD
Organizational Affiliation
NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION
Official's Role
Study Director
Facility Information:
Facility Name
national center for AIDS control and prevention
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10026
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zunyou Wu, PHD
Phone
010-58900946
Email
wuzy@263.net

12. IPD Sharing Statement

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Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men

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