NCT03414710

Brief Summary

A parallel-group, non-blinded randomized controlled trial was conducted. Participants were uncircumcised heterosexual male sexually transmitted disease patients attending the four collaborative public sexually transmitted diseases clinics in three Chinese cities. Those who were known to be HIV positive were excluded. After completion the baseline face-to-face interview, 238 participants will be randomized 1:1 into the intervention group and the control group. Participants in the control group will receive a health education booklet introducing voluntary medical male circumcision. In addition to the health education booklet received by the control group, the intervention group watched a 10-minute video and received a brief counseling delivered by the clinicians. Participants will be followed up by telephone six months afterwards.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

January 23, 2018

Last Update Submit

September 5, 2018

Conditions

Behavior, Health

Keywords

uptake of voluntary medical male circumcision

Outcome Measures

Primary Outcomes (1)

  • Uptake of voluntary medical male circumcision

    At month 6, participants will be asked whether they have taken up voluntary medical male circumcision within the 6-month follow-up period

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Health education booklet plus video plus brief counseling In addition to the educational booklet received by the control group, the intervention group will receive the following health promotion: 1. Watch a 10-minute video promoting VMMC 2. Receive a brief counseling promoting VMMC If the participants are willing to take up VMMC, the counselors will facilitate them to make an appointment for check-up and surgery.

Behavioral: Health education booklet plus video plus brief counseling

Control group

ACTIVE COMPARATOR

Health education booklet only After randomization took place, the control group will receive an education booklet introducing voluntary medical male circumcision. If the participants are willing to take up VMMC, the counselors will facilitate them to make an appointment for check-up and surgery.

Behavioral: Health education booklet only

Interventions

Health education booklet plus video plus brief counselingBEHAVIORAL

Participants in the intervention group will receive a health education booklet, watch a 10-minute video and receive counseling provided by the clinicians

Intervention group
Health education booklet onlyBEHAVIORAL

Participants in the intervention group will only receive a health education booklet

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese male aged ≥18 years
  • uncircumcised
  • diagnosis of any one of the five types of STDs listed in the national surveillance system: Primary, secondary or latent syphilis (determined by Treponemapallidum Particle Assay and Toluidine Red Untreated Serum Test), genital warts (diagnosed by presence of clinical symptoms and supported by biopsy), genital herpes (diagnosed clinically, supported by ELISA), or gonorrhea or NGU (diagnosed by using Polymerase Chain Reaction)
  • willingness to leave contact information (mobile and/or electronic) with the investigators and be followed up at Month 6

You may not qualify if:

  • Men who had ever had oral or anal sex with men
  • known to be HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Behaviours Research, the Chinese University of Hong Kong

Hong Kong, 666888, Hong Kong

Location

Related Publications (1)

  • Wang Z, Yang L, Hao C, Jiang H, Zhu J, Luo Z, Zheng Z, Lau JTF. A Randomized Controlled Trial Evaluating Efficacy of a Brief Setting-Based and Theory-Based Intervention Promoting Voluntary Medical Male Circumcision Among Heterosexual Male Sexually Transmitted Disease Patients in China. AIDS Behav. 2019 Sep;23(9):2453-2466. doi: 10.1007/s10461-019-02610-9.

    PMID: 31321636DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Zixin Wang, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

January 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

HK(1)