Male Circumcision Services for HIV Prevention in the Dominican Republic
Condition: Circumcision, Male; HIV; AIDS
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of introducing voluntary medical
      male circumcision as a form of HIV prevention in high HIV prevalence areas in the Dominican
      Republic.
    

Detailed description: 
      Voluntary Medical Male circumcision (VMMC) is an effective strategy to reduce the risk of HIV
      acquisition in heterosexual men. Observational data and randomized controlled trails (RCTs)
      conducted in Africa(1,2,3) suggest that the procedure reduces the risk of HIV acquisition by
      50-76% in heterosexual males. VMMC has also been shown to reduce the incidence of other
      sexually transmitted infections (STI), including herpes simplex virus type 2 (HSV-2) and
      human papilloma virus (HPV) in men(4), and Chlamydia(5), trichomonas vaginalis (TV),
      bacterial vaginosis (BV) and HPV in their female partners(6).

      The results of the RCT's are generating increased demand for safe and affordable MC services
      in areas of moderate-to-high HIV prevalence where the MC rates are low. Latin America is a
      region where circumcision of males is uncommon(7). In the Dominican Republic (DR), which is
      the focus of this study, a 2007 nationwide household survey found that only 13.7% of men
      between the ages of 15-59 were circumcised(8).

      AIDS is the leading cause of death in the Caribbean basin among adults aged 15-44 years.
      There are approximately 240,000 people currently living with the disease, most of them
      residing in the Dominican Republic (DR) and Haiti(9). The prevalence of HIV infection in the
      DR is approximately 0.8% nationwide(8) but it is higher in selected high-risk populations,
      such as among people living in the "bateyes", the small towns surrounding sugar cane
      plantations, where the prevalence is 3.2%(10). In pregnant women seeking prenatal care at the
      main hospital in the Altagracia province HIV seroprevalence is 4.5 %(11). One of the areas of
      highest prevalence (1.2%) in the country is Region V of health, which includes the provinces
      of La Altagracia, El Seibo, Hato Mayor, La Romana and San Pedro de Macorís. Prevalence is
      also higher in the urban slums of the capital city, Santo Domingo.

      The public health impact of introducing MC as a strategy to prevent HIV/STI transmission in
      areas of high HIV/STI prevalence and low MC rates can be significant. In addition to
      decreasing the rates of HIV and other STI, the intervention could indirectly help decrease
      the rates of HPV associated cervical cancer. The study proposed here is to develop,
      implement, monitor and evaluate pilot MC services in selected sites to assess the
      acceptability, uptake, safety and demand for these services, and to use these data to
      develop, in collaboration with the Dominican Ministry of Health (MoH), a proposal to the
      National Institute of Mental Health (NIMH) for support of operations research concerning the
      safety, uptake, and efficacy of MC interventions in the DR.

        1. Specific Aims:

           Based on the results of numerous observational studies and the three RCTs the World
           Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS)
           have endorsed VMMC as a biomedical intervention for HIV prevention. As such, countries
           with a high prevalence of HIV in the population are encouraged to examine the
           feasibility of offering MC services as part of the portfolio of HIV prevention
           strategies at a national level. The specific aims for this project are:

             1. To develop culturally appropriate education materials about the benefits of VMMC
                for clients attending pilot healthcare centers.

             2. To train a core group of providers on proper surgical and counseling techniques to
                provide comprehensive VMMC services.

             3. To determine the acceptability, uptake and demand for MC services in key areas of
                high HIV prevalence.

                H1: The acceptability and uptake among high risk men will be around 60%.

             4. To assess the safety and adverse events of performing circumcision in resource
                constrained settings.

                H2: VMMC will result in a complication rate of less than 2%.

             5. To assess sexual risk behaviors, perceptions of sexual function and sexual pleasure
                in men before and after VMMC. H3: there will be no differences in risk behaviors,
                sexual function and pleasure after VMMC.

             6. Estimate point prevalence of most common STI in a subset of circumcised men and
                preserve a small sample of blood to test future scientific hypothesis and/or newer
                testing techniques as they become available.

             7. To build collaborations with the MoH and other partners in the DR and at UIC to
                develop a proposal to NIMH for operational research in the context of larger scale
                MC service provision.

        2. Background and significance:

      b.1. Male Circumcision to Prevent HIV Transmission Male circumcision is perhaps one of the
      oldest surgical procedures performed on humans. The millenary practice of removing the male
      foreskin has cultural, religious and medical dimensions that have been widely studied. Around
      the world, the procedure is mostly performed for religious reasons in persons of the Jewish
      and Muslim faiths. Medical indications for MC include phimosis, paraphimosis and balanitis,
      among others(12). Early evidence of a relationship between MC and HIV infection came from a
      number of smaller, mostly observational studies, done in Africa(13). These historical data
      were validated with the completion of three large RCTs in South Africa, Kenya and Uganda,
      which have shown an overall decrease of 50-76% in the risk of acquiring HIV infection in
      circumcised males when compared to controls(1,2,3).

      The pathogenesis of the initial infection at the level of the foreskin involves tissue
      macrophages, cell receptors and a moist, poorly keratinized inner prepuce. The first cellular
      target of the HIV virion on the human genitalia are the tissue dendritic cells in the lamina
      propria of the submucosa(14). These cells express surface CD4 receptors and CCR5 co-receptors
      for which HIV has high affinity. In intact human skin, the dendritic cells are shielded from
      the outer environment by the relatively thick layer of keratin covering the surface of the
      epithelia. Tissue studies of the human foreskin have shown that the inner lining of the
      prepuce, exposed during a penile erection, has a thin keratin layer that is very susceptible
      to microscopic abrasions and can expose the tissue macrophages making them vulnerable to
      infection by HIV(15).

      b.2. MC for STI prevention: MC is an effective strategy to decrease the risk of infection
      with HIV and other STI in heterosexual males. A beneficial effect has also been observed in
      decreasing the risk of STI in females. The RCTs confirmed that VMMC decreases herpes simplex
      virus type 2 (HSV-2) acquisition by 29%, and HPV prevalence by 34% in men(4). Among female
      partners of circumcised men, bacterial vaginosis was reduced by 40%, and trichomonas
      vaginalis infection was reduced by 48%(6). Genital ulcer disease was also reduced among males
      and their female partners by approximately half(16).

      b.3. HIV in the Caribbean and the Dominican Republic: The significant decrease in the rate of
      HIV acquisition observed among circumcised males who participated in the African RCT is
      generating an increased demand for safe and affordable VMMC services in areas of high HIV
      prevalence where the procedure is not routinely performed. Latin America is one of such areas
      where routine circumcision of males is uncommon(7). In the Dominican Republic, only 13.7% of
      men between the ages of 15-59 years are circumcised(8). The Caribbean is the region of the
      world with the highest HIV prevalence outside of sub-Saharan Africa (1.0%)(9). Approximately
      240,000 individuals are currently living with the disease. Among the Caribbean countries, the
      Dominican Republic and Haiti report the highest prevalence in the region. According to data
      from a recent In the DR, the prevalence of HIV infection is 0.8% nationwide(8), however, the
      numbers are higher in selected populations and in certain geographic locations.

      The Dominican healthcare system is administratively divided in 9 regions, which include the
      country's 31 provinces. Region 0 of health includes the National District and the provinces
      of Santo Domingo and Monte Plata. The city of Santo Domingo is the capital and financial
      center of the DR. It has an estimated population of 2.7 million people spread in an area of
      about 1,400 KM2. 90% of the population lives in an urban setting in this province(17). The
      overall prevalence of HIV is around 0.7 % in the entire region but is higher in vulnerable
      groups such as commercial sex workers (CSW) (3.3%), Men who Have Sex with Men (MSM) (5.9%)
      and drug users (7.1%)(18).

      Regions V and VII report the highest prevalence of HIV in the country, 1.2 % and 1.5%
      respectively(8). Specific populations within these provinces have rates of HIV considerably
      higher than the national average. For instance, prevalence is 3.2% in the bateyes, the small
      communities surrounding sugar cane plantations, where a mixed population of Dominicans and
      Haitian migrant workers cohabitate. Our team has conducted preliminary studies in the
      Altagracia Province, part of Region V, since it reports the highest province-specific HIV
      rates and the lowest circumcision rates in the country. A survey of pregnant women seeking
      prenatal care at the main hospital in the province found an HIV seroprevalence of 4.5 %11.
      The prevalence of HIV is 5.2% in CSW, 7.6% in MSM and 8.5 % among drug users(18).

      c) Preliminary studies: The parent study for this project is a RCT of VMMC to reduce HIV
      incidence in Kisumu, Kenya whose principal investigator is Prof. Robert C. Bailey, a
      co-investigator in the current proposal(3). The main objective of that trial was to assess
      the effectiveness of VMMC in reducing HIV incidence in young, sexually active men. The
      protective effect found in an intent-to-treat analysis was 53% and in an as treated analysis
      adjusting for cross-overs and men found to be HIV seropositive at baseline estimated the
      protective effect to be 60%. Adverse events related to the surgical procedure were few, just
      1.5%. Behavioral disinhibition (risk compensation) on the part of circumcised men was small
      and not significant.

      Drs. Brito and Bailey conducted a feasibility study of healthcare facilities in the
      Altagracia province in the Dominican Republic during June and July of 2007. A total of 37
      healthcare facilities were surveyed. The study found that most facilities lacked appropriate
      equipment to perform surgical procedures and only four (11%) had a surgical theater. 43
      healthcare workers, the majority of them physicians (91%), were interviewed for the study.
      Only 23 % of the personnel had experience performing MC and a significant number of providers
      (76%) believed they needed comprehensive training in the procedure prior to starting a MC
      program. Quantitative and qualitative studies to assess the acceptability of MC among men,
      women and providers in the Altagracia Province were conducted in 2008. In these studies, 73%
      of men thought that MC improved hygiene and approximately one third knew that it reduces the
      risk of penile cancer or STI. Only a small percentage (21%) knew that MC helps prevent HIV
      infection. When first asked, 29% of participants reported that they would be willing to be
      circumcised if the procedure was offered to them. However, after an educational session
      detailing the benefits of the procedure for HIV and STI prevention, the acceptability
      increased to 67%. Such increment was also observed in previous studies done in Botswana(19)
      and Thailand(20)where acceptability increased from 61 % to 81% and from 14% to 66%,
      respectively, after a similar information session. In multivariate analysis, the strongest
      predictors of men's acceptability of circumcision, before the information session, were
      Haitian nationality (OR=1.86, 95% CI 1.01-3.41), thinking that circumcision improves hygiene
      (OR=2.78, 95% CI 1.29-6.0) and not believing that having a circumcision decreases sexual
      pleasure (OR=2.18, 95% CI 1.20-3.94). These results have been published (21, 22).

      We also conducted 13 focus group discussions (FGD), 6 with women and 7 with men, each
      consisting of 6-10 participants (mean=7.9, SD=1.3). One additional FGD was conducted with six
      physicians, two males and four females, working in rural clinics around the province.
      Findings of this qualitative study showed that a significant number of participants might be
      willing to be circumcised, or agree with circumcision for their partners, to improve hygiene,
      prevent diseases and treat medical conditions, such as phimosis, which can result in pain
      during intercourse. These results are consistent with our quantitative study on men's
      acceptability of MC. Perhaps one of the most important findings of the FGD was the
      enthusiastic endorsement of MC by women, a fact that has potential implications for the
      successful implementation of a circumcision program in the country (22).

      Overall, our preliminary data suggest that men are willing to be circumcised provided they
      receive information about the benefits of the procedure. Before recommending the introduction
      of VMMC services as part of a comprehensive package of HIV and other STI prevention
      strategies, these findings need to be confirmed by studying the uptake of VMMC among sexually
      active men in selected clinics that serve clients in high prevalence areas. In addition,
      there is need to identify potential barriers to offering MC services in high risk communities
      prior to proposing to implement a large-scale intervention. In order to properly address
      these concerns, we will conduct a pilot study that will provide the necessary preliminary
      data to design a proposal to the NIMH to conduct operational research around a large-scale
      implementation project.

      d) Experimental design and methods: d.1. Pilot study design The study will be conducted at
      two sites: the STI clinic at Instituto Dermatologico and Cirugia de Piel (IDCP) in Santo
      Domingo and the Clínica de Familia in La Romana, Dominican Republic. These sites have been
      selected on the basis of: 1) high numbers of male clients at risk for HIV and STI infection
      in communities served by the clinics; 2) high level of acceptability of MC among men in the
      communities served by the clinics (bateyes of Altagracia); 3) the availability of service
      providers willing to be trained; 4) the availability of equipment; and 5) the availability of
      infrastructure, including a minor surgical theater, sterilization facilities and HIV
      voluntary counseling and testing (VCT) and STI management.

      During the first phase of the study, culturally appropriate educational material will be
      created in Spanish by the principal investigator and local collaborators. Focus Group
      Discussions (FGD) and in-depth interviews will be conducted with members of the community to
      learn the educational needs of the community and to assess their opinions on how to best
      deliver the information on MC that will be contained in the educational materials.

      We plan to conduct the FGD in the communities served by the Instituto Dermatologico and the
      Clinica de Familia, the two main study sites. The plan is to assemble groups of 6-12
      participants from the population living in these communities. Community leaders, health
      promoters, teachers and primary care physicians will be asked to help identify and invite
      volunteers from their respective communities to participate in the study. There will be no
      difference in the recruitment process for men and women. They will be recruited from the same
      venues (schools, clubs, community centers) . Participants will be invited to participate by
      research personnel with the help of local leaders. These local leaders may be of both genders
      and will help recruit participants from either gender. The focus groups will be
      gender-specific. The moderator will explain the purpose of the study to participants. Verbal
      consent will be obtained from all participants and an information sheet outlining the
      objectives of the study, their privacy and confidentiality rights and our contact information
      will be distributed. The document will highlight the voluntary nature of the subject's
      participation and their right to leave the discussion at anytime if they so desire. The study
      meets the definition of "minimal risk", therefore, we are requesting a waiver of written
      consent. We believe this will further preserve the confidentiality of the participants. The
      goal is to conduct no more than 15 FGD. Participants in the FGD will be divided by gender. We
      plan to recruit approximately the same number of men and women for the FGD.

      In addition to the FGD, several in-depth individual interviews may be conducted using the
      same guide than in the FGD. A script will be followed to conduct the FGD. The discussions
      will be stimulated by using a list of carefully crafted questions on the subject of MC. These
      questions are designed to obtain information on the following aspects relevant to our
      investigation:

        1. Perception of the population about the frequency of MC in community men.

        2. Opinions on the best way to educate men in the community about the benefits of
           circumcision.

        3. Opinions about the content of the educational materials educational and how information
           should be delivered.

        4. Where should these educational material be posted or distributed to capture the most
           number of men.

        5. Opinions on the best venue to organize educational sessions featuring a circumcised man
           that would be available to answer question from men in the community about his
           satisfaction with his circumcision.

        6. Perceptions about who would be a good person to educate men about the benefits of
           circumcision in the community.

        7. Opinions on the best way to involve women in the community in a campaign to recruit men
           for circumcision.

      The moderator and a research assistant (RA) will lead the discussions. All FGD will be
      audiotaped and detailed notes will be taken. The content of the recordings will be
      transcribed shortly after the end of the meeting. The PI, a native Spanish speaker, will be
      responsible for translating the recordings from Spanish to English. The English-version
      transcripts will be coded using the program ATLAS.ti vers. 5.2 based on template of topical
      categories drawn from questions and issues covered in the discussion guides and from themes
      emerging from the discussions themselves. The interviews will be conducted by one of the
      co-investigators. Verbal consent will be obtained and a document containing information about
      the study will be provided to the participants. All data obtained during this study,
      including recordings and notes will be de-indentified. The names of the participants will not
      be recorded to protect their confidentiality.

      Data Management All notes, audio recordings and study material obtained during the FGD and
      interviews will be kept in a locked filing cabinet in an office at the Instituto
      Dermatologico, Dominican Republic and in the PI's office at the UIC campus upon the
      investigator's return to Chicago. All data will be de-identified to preserve confidentiality.
      Names will not be recorded. Verbal informed consent will be sought; there will be no signed
      consent forms to identify individuals. The participants have the right to review the audio
      recordings. If a participant requests to listen to the recordings, one of the
      co-investigators will schedule an appointment for the subject to come to the research site
      and, in an unoccupied office, will playback the recording for him/her and answer all the
      questions that the subject may have. If the participant wishes to erase part or all of
      his/her responses, it will be done on the spot, in his/her presence, using the digital
      recorder. The data obtained during these FGD and interviews will inform the design of the
      educational materials. Once created, these materials will be tested for clarity and
      appropriateness of language by soliciting input from community health promoters and peer
      advocates working at the IDCP. Once it is determined that the educational materials are
      suitable to distribute to clients, we will submit to the Institutional Review Board for
      approval. Once approved, pamphlets and posters will be printed and distributed at the site
      clinics and the surrounding communities.

      During the second phase, selected providers will be trained. This will include counselors in
      HIV counseling and testing, and medical doctors by an experienced urologist on the
      appropriate technique for VMMC using the "Manual for Male Circumcision Under Local
      Anesthesia" published by WHO, UNAIDS. Supervision and evaluation of trainees will be
      conducted following the protocol used during the parent RCT.

      Study subjects will be recruited in a variety of ways. In Santo Domingo, fliers will be
      posted in bars and night clubs frequented by men at high risk for HIV/STI acquisition. A
      group of volunteer commercial sex workers working on an HIV vaccine trial will be asked to
      refer their clients for the study. Men seeking care for STI at the clinic will also be
      invited to participate. In La Romana, men attending the Clínica de Familia will be invited to
      participate. In addition, a group of outreach workers will visit the "bateyes", the
      communities surrounding sugar cane fields where migrant laborers live, to educate men about
      MC and invite them to participate in the study.

      Men between 18-40 years will be provided with information about the study and will be invited
      to participate. If they express an interest in participating, informed consent will be
      obtained. The participant will go over the consent form with the counselor, who will assess
      his level of understanding and answer any questions. If there are no temporary or permanent
      excluding conditions, the participant will be asked to give informed consent for enrollment
      in the study. Men who elect to be circumcised will be fully informed about the benefits and
      risks of the procedure, as well as the surgical method to be used. After the informed consent
      is signed, a "Locator Information Form" containing confidential data such as subject's name
      and address will be completed. Only selected research staff will have access to this
      information, which will be filed separate from the rest of the study forms. A de-identified
      "demographic information form and behavioral questionnaire" will be completed next.

      Testing for HIV infection will be carried out using a rapid test. The test kits to be used
      are the synthetic peptide test, Determine HIV 1/2, and the recombinant antigen test Unigold
      HIV 1/2 Recombinant. Results are provided to the clients, with appropriate counseling, at the
      same visit. Participants are taught to observe, read and interpret the tests for themselves
      in the company of the counselor. Men with positive results will be informed of their HIV
      status and will be followed-up at the study clinic and referred for a confirmatory HIV-ELISA
      and, if confirmed, for HIV treatment. Serologic testing for HSV-2, hepatitis B surface
      antigen (HBV), and hepatitis C antibody (HCV) will be performed using an ELISA test. A serum
      Rapid Plasma Reagin test (RPR) will be performed to test for syphilis. Chlamydia and
      gonorrhea testing will be performed in urine using a Polymerase Chain Reaction (PCR) assay.
      All participants who test positive for Chlamydia, syphilis and gonorrhea will be offered
      treatment free of charge. Participants who test positive for HSV-2 and have active genital
      lesions will be offered treatment free of charge. Those who test positive but have no active
      lesions will be counseled on safe sex practices and the risk of transmission to their
      partners as there is no recommended treatment for asymptomatic individuals infected with
      HSV-2. HIV, HBV, and HCV positive participants will be referred for evaluation and treatment
      at Clinica de la Familia in La Romana as these are chronic diseases that require long term
      treatment usually covered under government programs. If a participant is found to have a
      treatable STD and he does not return to the site, he will be called by the study
      investigators using the phone number provided by the participant at enrolment to ensure
      treatment is provided. If there is a temporary, medically curable condition present, such
      that it would be advisable to defer potential surgery, then the participant will be treated
      and asked to return for re-evaluation for study eligibility when he is cured. Men found to
      have an STD or to be HIV-positive will be referred for immediate care. Once enrollment is
      completed, participants will be given an appointment for the surgery.

      Circumcision will be performed soon after informed consent, preferably within a few days. All
      surgeries will be done under local anesthesia in a clinic by trained clinicians, using the
      standardized forceps-guided method described by Krieger and colleagues and contained in the
      WHO MC manual(23). Circumcised men will be counseled to refrain from sex for six weeks
      post-surgery and counseled about risk of HIV infection through open wounds during the healing
      process. They will be checked for complications and asked about their sexual activity seven
      days after the procedure. Men without complications will be followed six months after surgery
      with behavioral risk assessment, HIV testing and counseling. Men may come to the study sites
      for unscheduled visits at any time during the 6 month follow-up. All men will be counseled at
      enrollment and all follow-up visits to reduce their risk for HIV infection by consistent
      condom use and, where applicable, reductions in numbers of sex partners. Counselling on
      condom use and sexual risk reduction will be provided by trained, experienced,
      native-speaking counsellors.

      MC services will be offered at the selected two sites for 1 year. The estimated cost per
      circumcision is $40. We expect to recruit five clients per week at each site for a total
      convenience sample of 575 subjects in one year. During the second year of the project, we
      will continue to assess behavioral risk factors for the first six months and work on
      analyzing the data during the last semester of the project.

      Circumcision Procedure Prior to surgery, the clinician will obtain a complete medical history
      and perform a physical exam.

      A brief description of the procedure follows. The patient lies on his back in a comfortable
      position. The pubic area is shaved clean with a disposable razor and the hair is picked up
      with a dressing tape. The surgeon scrubs up and puts on 2 pairs of sterile gloves. The
      client's skin is prepared with Betadine solution, making sure that the inner surface of the
      prepuce and the glans are clean and the skin is dry. The outer pair of gloves is then
      removed. The client is draped with two drapes and a center "O" towel, and then, using 2%
      lidocaine without epinephrine, a dorsal nerve block and a field block with special attention
      to the ventral nerve, is performed. Normally, no more than 10ml of 2% lidocaine will be used.
      The anesthetic effect of the nerve block is checked, and revised if necessary. The prepuce is
      held with two mosquito forceps, one on each lateral aspect, then a curved mark is made with
      sterile disposable marking pens, outlining the planned surgical cut. The mark is made one cm
      proximal to the coronal sulcus all round, and parallel to the coronal sulcus. The prepuce is
      clamped along the mark with a Kocher clamp while retracting the glans, ensuring that the
      glans itself is not clamped. The prepuce is excised using a surgical blade along the mark.
      Bleeders are identified, clamped and tied. They are sutured, and if necessary ligated, using
      3/0 plain catgut. After ligating all the bleeders, the area is irrigated with normal saline
      and then inspected for more bleeders, which are identified and tied. Using 3/0 chromic catgut
      on a taper 4/8 circle needle, a U-shaped horizontal mattress stitch is made on the ventral
      side of the penis (frenulum) to join the skin at the "V" shaped cut, which is then tied and
      tagged with a mosquito forceps. Using vertical mattress stitches, four quarters are tagged,
      and a vertical mattress stitch added, after which a simple stitch is put at the center of
      every two mattress stitches (a total of at least 16 stitches). The area is irrigated with
      normal saline and other simple stitches added as required. The wound is dressed with
      Sofratulle, then with a regular dressing bandage and a strapping. The client is advised to
      rest for 30 minutes, and if stable, discharged home on mild analgesics. Upon completion of
      the procedure the surgeon completes a procedure form. The excised foreskin tissue is taken to
      the laboratory with no identifiers, discarded with other laboratory waste, and incinerated
      with other biological waste within three days. Participants will be given verbal and written
      instructions on postoperative wound care and counseled to refrain from sexual activity for at
      least six weeks after the procedure. They will also be encouraged to come to the clinic or
      contact a clinician at any time with medical problems.

      Day 7 Post Circumcision Visit: Circumcised men will be asked to return to the clinic 7 days
      after the procedure to check the wound, to see if it is healing properly, to check for
      complications, and to ask about their sexual activity, their level of pain, resumption of
      work or other activities, and their satisfaction with the procedure and care at the clinic.
      As with all visits, any adverse events will be recorded. Blood and urine will be collected
      for STD testing at this visit.

      Six month post operative visit: During this visit a brief exam to confirmed proper wound
      healing will be performed. A behavioral and satisfaction questionnaire will be administered.

      Unscheduled Follow-up Visits: Ad hoc clinic visits will be encouraged to check and treat for
      complications of the procedure. At such visits, medical examinations and laboratory testing
      will be conducted as indicated, and appropriate treatment provided free of charge. Medical
      referral will be made if required.

      d.2. Data analysis Each enrolled participant will be assigned a confidential code, which will
      be used in all study forms. Only the principal investigators and research assistants will
      have access to the "locator information form" containing personal information. This form,
      which links the subject's confidential code to his name, will be stored in separate locked
      filing cabinets at the local principal investigator's offices. The locator information forms,
      which contain the personal information on the subjects, will be kept for 1.5 years in case we
      need to contact one of the subjects for an unexpected occurrence or with a question. After
      the end of that period, these locator forms will be destroyed at the research offices at the
      respective study sites using a micro cut shredder. Data will be coded and entered into
      computer datasets by trained personnel. Data extracted from questionnaires will be tabulated
      and analyzed using SAS statistical software version 9.1. and will be analyzed at the
      University of Illinois, College of Medicine, in Chicago by the principal investigator A
      questionnaire asking specific demographic information will be administered. The following
      variables will be recorded: age, religion, place of residence (urban/rural), education level,
      occupation and marital status. Simple descriptive statistics will be calculated and the
      effect of these variables on the willingness, uptake and rate of adverse events of VMMC will
      be estimated. In addition, we plan to estimate the effect of demographic characteristics on
      sexual behavior and disinhibition after the procedure.
    

Intervention name(s): Voluntary medical male circumcision
Intervention type(s): Procedure
Intervention description(s): Male Circumcision Under Local Anesthesia using the Forceps Guided Method
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention