Skip to main content
Clinical Trials/NCT02337179
NCT02337179CompletedNot Applicable

A Pilot Study to Introduce Male Circumcision (MC) Services to Prevent HIV Infection in Two High Prevalence Areas of the Dominican Republic (DR)

University of Illinois at Chicago2 sites in 2 countries539 target enrollmentStarted: February 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
539
Locations
2
Primary Endpoint
Number and percentage of participants who agreed to undergo circumcision after being offered.

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Uncircumcised men;
  • •Aged 18-40 years

Exclusion Criteria

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

Arms & Interventions

Voluntary medical male circumcision

Experimental

Eligible men will be circumcised according to protocol

Intervention: Voluntary medical male circumcision (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: 13 months

Secondary Outcomes

  • 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)
  • Number and percentage of individuals who use illicit drugs(23 months)
  • Number and percentage of adverse events by severity (mild, moderate, severe)(23 months)
  • Number and percentage of men who have sex with men(23 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maximo Brito

Associate Professor of Medicine & Vice Chair for Urban Global Health

University of Illinois at Chicago

Study Sites (2)

Loading locations...

Similar Trials