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Male Circumcision Services for HIV Prevention in the Dominican Republic

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ClinicalTrials.gov Identifier: NCT02337179
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Instituto Dermatologico y Cirugia de Piel
Information provided by (Responsible Party):
Maximo Brito, University of Illinois at Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Circumcision, Male HIV AIDS Procedure: Voluntary medical male circumcision Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 539 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study to Introduce Male Circumcision (MC) Services to Prevent HIV Infection in Two High Prevalence Areas of the Dominican Republic (DR)
Actual Study Start Date : February 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Voluntary medical male circumcision
Eligible men will be circumcised according to protocol
Procedure: Voluntary medical male circumcision
Male Circumcision Under Local Anesthesia using the Forceps Guided Method




Primary Outcome Measures :
  1. Number and percentage of participants who agreed to undergo circumcision after being offered. [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. Number and percentage of adverse events by severity (mild, moderate, severe) [ Time Frame: 23 months ]
  2. Number and percentage of individuals who use illicit drugs [ Time Frame: 23 months ]
  3. Number and percentage of men who have sex with men [ Time Frame: 23 months ]
  4. Number and percentage of individuals who had ≥ 2 sex partners over the last 30 days [ Time Frame: 23 months ]
  5. Number and percentage of individuals who experienced problems with penis and foreskin prior to circumcision [ Time Frame: 23 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Uncircumcised men;
  2. Aged 18-40 years

Exclusion Criteria:

  1. Foreskin covering less than half of the glans;
  2. Bleeding disorders;
  3. Keloid formation;
  4. Other conditions that might unduly increase the risks of elective surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337179


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Dominican Republic
Instituto Dermatologico y Cirugia de Piel
Santo Domingo, Dominican Republic
Sponsors and Collaborators
University of Illinois at Chicago
Instituto Dermatologico y Cirugia de Piel
Investigators
Principal Investigator: Maximo O Brito, MD, MPH University of Illinois at Chicago
Study Director: Yeycy Donastorg, MD Instituto Dermatologico y Cirugia de Piel

Publications:
CESDEM. Encuesta Demográfica y de Salud, República Dominicana. 2007. (accessed January 2, 2010 at (http://www.cesdem.com/html/encuesta_demografica_y_de_salud_2007.pdf )
Joint United Nations Programme on HIV /AIDS. 2009 Report on the global AIDS epidemic. (Accessed February 2, 2010 , at http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/
CESDEM. Encuesta Sociodemográfica y sobre VIH/SIDA en los Bateyes Estatales de la República Dominicana. 2007. (accessed January 2, 2009 at http://www.cesdem.com/html/encuesta_sociodemografica_y_sobre_vih_sida_en_los_bateyes_estatales_de_la_republica_dominicana.pdf )
Secretaria de Estado de Salud Publica. Encuesta de seroprevalencia de la infección VIH basadas en puestos centinela. 2006.
UNAIDS. Male circumcision: global trends and determinants of prevalence, safety and acceptability. (accessed February 23, 2010 at ( http://whqlibdoc.who.int/publications/2007/9789241596169_eng.pdf )
ONE. VIII Censo nacional de poblacion y vivienda 2002. (accessed February 23, 2010 at(http://onedatabase.indotel.net.do/cgibin/RpWebEngine.exe/PortalAction?&MODE=MAIN&BASE=CPV2002&MAIN=WebServerMain.inl )
COPRESIDA. Primera encuesta de vigilancia de comportamiento con vinculacion serologica en poblaciones vulnerables 2008. 1: 39-88.
H.V.Tieu, et al. Acceptability of male circumcision for prevention of HIV among high-risk heterosexual men in Thailand : AIDS 2008 - XVII International AIDS Conference: Abstract no. MOPE0547.
Brito M, Luna M, Bailey RC. Feasibility of introducing male circumcision (MC) in the Dominican Republic : AIDS 2008 - XVII International AIDS Conference: Abstract no. MOPE0548.
WHO. Manual for MC under local anesthesia 2009. (accessed February 23, 2010 at(http://www.who.int/hiv/pub/malecircumcision/local_anaesthesia/en/index.html )

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maximo Brito, Associate Professor of Medicine & Vice Chair for Urban Global Health, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02337179     History of Changes
Other Study ID Numbers: 2010-0863
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017