A Randomized Controlled Trial Evaluating Efficacy of Promoting Voluntary Medical Male Circumcision Among Male Sexually Transmitted Diseases Patients in China

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.