NCT02337179

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

January 7, 2015

Last Update Submit

May 1, 2017

Conditions

Circumcision, MaleHIVAIDS

Outcome Measures

Primary Outcomes (1)

  • Number and percentage of participants who agreed to undergo circumcision after being offered.

    13 months

Secondary Outcomes (5)

  • Number and percentage of adverse events by severity (mild, moderate, severe)

    23 months

  • Number and percentage of individuals who use illicit drugs

    23 months

  • Number and percentage of men who have sex with men

    23 months

  • Number and percentage of individuals who had ≥ 2 sex partners over the last 30 days

    23 months

  • Number and percentage of individuals who experienced problems with penis and foreskin prior to circumcision

    23 months

Study Arms (1)

Voluntary medical male circumcision

EXPERIMENTAL

Eligible men will be circumcised according to protocol

Procedure: Voluntary medical male circumcision

Interventions

Voluntary medical male circumcisionPROCEDURE

Male Circumcision Under Local Anesthesia using the Forceps Guided Method

Voluntary medical male circumcision

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Uncircumcised men;
  • Aged 18-40 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Instituto Dermatologico y Cirugia de Piel

Santo Domingo, Dominican Republic

Location

Related Publications (24)

  • Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.

    PMID: 16231970BACKGROUND

  • Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.

    PMID: 17321311BACKGROUND

  • Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.

    PMID: 17321310BACKGROUND

  • Tobian AA, Serwadda D, Quinn TC, Kigozi G, Gravitt PE, Laeyendecker O, Charvat B, Ssempijja V, Riedesel M, Oliver AE, Nowak RG, Moulton LH, Chen MZ, Reynolds SJ, Wawer MJ, Gray RH. Male circumcision for the prevention of HSV-2 and HPV infections and syphilis. N Engl J Med. 2009 Mar 26;360(13):1298-309. doi: 10.1056/NEJMoa0802556.

    PMID: 19321868BACKGROUND

  • Castellsague X, Peeling RW, Franceschi S, de Sanjose S, Smith JS, Albero G, Diaz M, Herrero R, Munoz N, Bosch FX; IARC Multicenter Cervical Cancer Study Group. Chlamydia trachomatis infection in female partners of circumcised and uncircumcised adult men. Am J Epidemiol. 2005 Nov 1;162(9):907-16. doi: 10.1093/aje/kwi284. Epub 2005 Sep 21.

    PMID: 16177149BACKGROUND

  • Gray RH, Kigozi G, Serwadda D, Makumbi F, Nalugoda F, Watya S, Moulton L, Chen MZ, Sewankambo NK, Kiwanuka N, Sempijja V, Lutalo T, Kagayii J, Wabwire-Mangen F, Ridzon R, Bacon M, Wawer MJ. The effects of male circumcision on female partners' genital tract symptoms and vaginal infections in a randomized trial in Rakai, Uganda. Am J Obstet Gynecol. 2009 Jan;200(1):42.e1-7. doi: 10.1016/j.ajog.2008.07.069. Epub 2008 Oct 30.

    PMID: 18976733BACKGROUND

  • Drain PK, Halperin DT, Hughes JP, Klausner JD, Bailey RC. Male circumcision, religion, and infectious diseases: an ecologic analysis of 118 developing countries. BMC Infect Dis. 2006 Nov 30;6:172. doi: 10.1186/1471-2334-6-172.

    PMID: 17137513BACKGROUND

  • 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 )

    BACKGROUND

  • 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/

    BACKGROUND

  • 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 )

    BACKGROUND

  • Secretaria de Estado de Salud Publica. Encuesta de seroprevalencia de la infección VIH basadas en puestos centinela. 2006.

    BACKGROUND

  • 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 )

    BACKGROUND

  • Weiss HA, Quigley MA, Hayes RJ. Male circumcision and risk of HIV infection in sub-Saharan Africa: a systematic review and meta-analysis. AIDS. 2000 Oct 20;14(15):2361-70. doi: 10.1097/00002030-200010200-00018.

    PMID: 11089625BACKGROUND

  • Kahn JO, Walker BD. Acute human immunodeficiency virus type 1 infection. N Engl J Med. 1998 Jul 2;339(1):33-9. doi: 10.1056/NEJM199807023390107. No abstract available.

    PMID: 9647878BACKGROUND

  • McCoombe SG, Short RV. Potential HIV-1 target cells in the human penis. AIDS. 2006 Jul 13;20(11):1491-5. doi: 10.1097/01.aids.0000237364.11123.98.

    PMID: 16847403BACKGROUND

  • Gray RH, Serwadda D, Tobian AA, Chen MZ, Makumbi F, Suntoke T, Kigozi G, Nalugoda F, Iga B, Quinn TC, Moulton LH, Laeyendecker O, Reynolds SJ, Kong X, Wawer MJ. Effects of genital ulcer disease and herpes simplex virus type 2 on the efficacy of male circumcision for HIV prevention: Analyses from the Rakai trials. PLoS Med. 2009 Nov;6(11):e1000187. doi: 10.1371/journal.pmed.1000187. Epub 2009 Nov 24.

    PMID: 19936044BACKGROUND

  • 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 )

    BACKGROUND

  • COPRESIDA. Primera encuesta de vigilancia de comportamiento con vinculacion serologica en poblaciones vulnerables 2008. 1: 39-88.

    BACKGROUND

  • Kebaabetswe P, Lockman S, Mogwe S, Mandevu R, Thior I, Essex M, Shapiro RL. Male circumcision: an acceptable strategy for HIV prevention in Botswana. Sex Transm Infect. 2003 Jun;79(3):214-9. doi: 10.1136/sti.79.3.214.

    PMID: 12794204BACKGROUND

  • Tieu HV, Phanuphak N, Ananworanich J, Vatanparast R, Jadwattanakul T, Pharachetsakul N, Mingkwanrungrueng P, Buajoom R, Teeratakulpisarn S, Teeratakulpisarn N, Methajittiphun P, Hammer SM, Ann Chiasson M, Phanuphak P. Acceptability of male circumcision for the prevention of HIV among high-risk heterosexual men in Thailand. Sex Transm Dis. 2010 Jun;37(6):352-5. doi: 10.1097/OLQ.0b013e3181c9963a.

    PMID: 20145588BACKGROUND

  • Brito MO, Caso LM, Balbuena H, Bailey RC. Acceptability of male circumcision for the prevention of HIV/AIDS in the Dominican Republic. PLoS One. 2009 Nov 2;4(11):e7687. doi: 10.1371/journal.pone.0007687.

    PMID: 19888322BACKGROUND

  • 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.

    BACKGROUND

  • 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 )

    BACKGROUND

  • Brito MO, Lerebours L, Volquez C, Basora E, Khosla S, Lantigua F, Flete R, Rosario R, Rodriguez LA, Fernandez M, Donastorg Y, Bailey RC. A Clinical Trial to Introduce Voluntary Medical Male Circumcision for HIV Prevention in Areas of High Prevalence in the Dominican Republic. PLoS One. 2015 Sep 14;10(9):e0137376. doi: 10.1371/journal.pone.0137376. eCollection 2015.

    PMID: 26367187DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Maximo O Brito, MD, MPH

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

  • Yeycy Donastorg, MD

    Instituto Dermatologico y Cirugia de Piel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine & Vice Chair for Urban Global Health

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 13, 2015

Study Start

February 1, 2011

Primary Completion

June 1, 2014

Study Completion

April 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

US(1)DO(1)