NCT03320239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

October 17, 2017

Last Update Submit

October 20, 2017

Conditions

HIV/AIDSHIV InfectionsSocial Media

Keywords

HIVrisk assessmentHIV testingunprotected anal intercourseSocial medica

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • unprotected anal intercourse

    6 months

  • Post exposure prophylaxis (PEP)

    6 months

Study Arms (3)

the online-RASSL intervention group

EXPERIMENTAL

HIV risk assessment and tailored suggestions, free HIV testing link

Behavioral: HIV risk assessment and tailored suggestions

intervention group 2

EXPERIMENTAL

HIV risk behavior investigation and routine education

Behavioral: HIV risk behavior assessment

the control group

PLACEBO COMPARATOR

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

Behavioral: placebo control

Interventions

HIV risk assessment and tailored suggestionsBEHAVIORAL

The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link

the online-RASSL intervention group
HIV risk behavior assessmentBEHAVIORAL

It only contains HIV risk behavior assessment and routine education

intervention group 2
placebo controlBEHAVIORAL

It only contains HIV/AIDS knowledge assessment and routine education

the control group

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

national center for AIDS control and prevention

Beijing, Beijing Municipality, 10026, China

RECRUITING

Related Publications (1)

  • Luo Q, Wu Z, Mi G, Xu J, Scott SR. Using HIV Risk Self-Assessment Tools to Increase HIV Testing in Men Who Have Sex With Men in Beijing, China: App-Based Randomized Controlled Trial. J Med Internet Res. 2023 Sep 1;25:e45262. doi: 10.2196/45262.

    PMID: 37656500DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Wu Z You, PhD

    NATIONAL CENTER FOR HIV/STD CONTROL AND PREVENTION

    STUDY DIRECTOR

Central Study Contacts

Wu Z You, PhD

CONTACT

010-58900946wuzy@263.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 25, 2017

Study Start

October 12, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

CN(1)