A RCT Promoting Voluntary Medical Male Circumcision
Condition: Behavior, Health
Study type: Interventional

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.
    

Detailed description: 
      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:

        1. Watch a 10-minute video promoting VMMC: in the video, a well-known STD clinician talks
           about severity of STD infection and benefits of VMMC, and gave reminders about the
           importance of consistent condom use even after taking up VMMC. He also expresses his
           support to the participants for taking up VMMC. One MSTDP who had taken up VMMC
           presented a testimonial in the video about his positive experience with VMMC, including
           mild pain and surgical complications of VMMC, improvement in sexual pleasure and sexual
           functioning after taking up VMMC, and support received from his peers and female sex
           partners with respect to VMMC.

        2. Receive a brief counseling promoting VMMC: the counselors would discuss with those who
           consider taking up VMMC about their concerns, and encourage them to make a specific plan
           to take up VMMC; the counselors also remind those who show no intention to take up VMMC
           in the next six months about the risk of HIV/STD infection and the benefit of taking up
           VMMC. If the participants are willing to take up VMMC, the counselors will facilitate
           them to make an appointment for check-up and surgery.

      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.
    

Intervention name(s): Health education booklet plus video plus brief counseling; Health education booklet only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: uptake of voluntary medical male circumcision