An interventional study of Health education booklet plus video plus brief counseling and Health education booklet only in Behavior, Health, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention
Among 14 studies in Health Behavior with a site in Hong Kong — none open to participants now, none under way, none of them phase 3. Health Behavior · Hong Kong.
Among the 14 studies in Health Behavior with a site in Hong Kong, this one is the 10th largest by enrollment, is one of 2 that started in 2017, is one of 14 with no phase, and was the 7th registered.
968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.
Browse Health Behavior studies →None of the 14 studies in Health Behavior with a site in Hong Kong is open now. The open studies under Health Behavior, anywhere →
Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.
This study: 18 Years to 60 Years · male · healthy volunteers too.
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14 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2017.
This study's enrollment of 244 is above the median of 150 across 825 interventional studies indexed under Health Behavior.
Median enrollment 434 across the 14 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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None of the 14 has an industry lead sponsor. The 4 most frequent:
Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Chinese University of Hong Kong has 8 studies filed under Health Behavior — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Health Behavior with a site in Hong Kong, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Study Design A parallel-group and non-blinded RCT is conducted. Face-to-face interview is conducted at baseline in the collaborating STD clinics. A 5-minute telephone survey is conducted six months afterwards by blinded interviewers. Up to five calls will be made at different timeslots during weekdays/weekends before considering a case as loss-to-follow up.
Participants Inclusion criteria are: 1) Chinese male aged ≥18 years, 2) uncircumcised, 3) 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), and 4) willingness to leave contact information (mobile and/or electronic) with the investigators and be followed up at Month 6. Men who had ever had oral or anal sex with men and those who were known to be HIV positive are excluded.
Recruitment procedures To avoid selection bias, all male sexually transmitted disease patients (MSTDP) attending the five participating clinics during the study period are invited to participate in the study. A clinician ensures the eligibility of the prospective participants to join the study in a consultation room and refers them to the trained counselors who are STD clinicians. The interviewers then brief the participants about the study, assure them that refusals would not affect their right to use any services and that they can quit any time without being questioned. Written informed consent will be sought. Ethics approval was obtained from the Ethics Committee of Guangdong Provincial Dermatology Hospital, Guangzhou, China.
The baseline survey and random allocation process After completion the baseline face-to-face interview, participants will be randomized 1:1 to either the intervention group or the control group. Computer-generated random allocation codes are produced and sealed in opaque envelopes by a research staff with no involvement in recruitment or baseline survey. One envelope will be drawn and opened in front of the participant by the counselors. The counselors then inform the participant which group he is assigned to. Block randomization with block size of eight is used.
The Control Group After randomization took place, the control group will receive an education booklet introducing voluntary medical male circumcision. The contents include: 1) harms of STD infection on men and their female sex partners (e.g., STD infection increases risk of HIV acquisition), 2) benefit of VMMC in reducing risk of HIV and STD infection in men, and the indirect protective effects for their female sex partners, 3) basic information of VMMC, including cost, hospitals that offer VMMC, common side effects and recovery time. If the participants are willing to take up VMMC, the counselors will facilitate them to make an appointment for check-up and surgery.
The Intervention Group
In addition to the educational booklet received by the control group, the intervention group will receive the following health promotion:
Measures Outcomes and confounders Potential confounders include socio-demographics, utilization of HIV/STD prevention services, STD history, foreskin condition and condomless sex with regular female sex partners (RP: defined as their wives or stable girlfriends), female sex workers (FSW: defined as a female who exchanged sex for money) and non-regular female sex partners (NRP: defined as a female who was neither FSW nor RP) since exhibiting STD symptoms or receiving an STD diagnosis. The primary outcome was whether the participant has taken up VMMC within the 6-month follow-up period. Secondary outcomes are perceptions related to VMMC based on the Theory of Planned Behavior (scores of the Positive Attitude Scale, the Negative Attitude Scale, the Subjective Norm Scale and the Perceived Behavioral Control Scale).
Process evaluation Process evaluation of health promotion will also be conducted at Month 6. Participants in both groups will be asked: 1) whether the content of the health promotion is clear, 2) whether the materials (video or booklet) is attractive to them, 3) whether the health promotion has increased their understanding about the benefit of VMMC and willingness to take up VMMC. Participants in the intervention group are asked an additional question about their satisfaction of the counseling session.
Post-surgical experience At Months 6, circumcised participants will be asked whether they have any surgical complication, and whether they have sought medical consultation due to such complications. Sexually active circumcised participants will be asked whether they have reduce condom use with RP, NRP or FSW, or increase number of such female sex partners after taking up VMMC.
Sample size planning In a single-arm, non-blinded test-of-concept trial, 19.9% had taken up VMMC during the 4-month follow-up period after exposing to a similar intervention (i.e., watching a 10-minute video clip and receiving brief consultation and a health education booklet). In this study, assuming 20% of the participants will take up VMMC in the intervention group within the 6-month follow period, the sample size of 71 per group would allow us to detect a between-group difference in the uptake of VMMC of 15% or above (a=0.05, 2-sided test with statistical power of 0.8; PASS). Taking into account an expected drop-out rate of 40% at Month 6, a sample size of 119 per group was required. The total sample size would be 238.
Statistical analysis Baseline between-group differences will be compared by using Chi-square test. Intention-to-treat analysis will be used for outcome analyses. Relative risk (RR), absolute risk reduction (ARR), and number needed to treat (NNT) statistics will be used to test between-group difference in primary outcome. Wilcoxon signed-ranked test will be used to test the between-group difference in secondary outcomes. Within-group difference will be tested by using McNemar test. SPSS version 16.0 will be used, and p values \<0.05 will be considered as statistically significant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants in the intervention group will receive a health education booklet, watch a 10-minute video and receive counseling provided by the clinicians
Participants in the intervention group will only receive a health education booklet
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
Time frame: 6 months
Ran from Jan 2017 to primary completion in Apr 2018, 15 months.
Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 15 months is close to that.
Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →