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Clinical Trial Summary

The main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa).


Clinical Trial Description

The World Health Organization and the United Nations Programme on HIV/AIDS recommend voluntary adult medical male circumcision as an intervention against HIV in Africa since 2007 and has estimated that achieving 80% male circumcision coverage would have a major public health impact. Despite evidence of its effectiveness, feasibility, cost-effectiveness and acceptability, its roll-out in Eastern and Southern Africa, the region where HIV prevalence is highest in the world, remains slow. Developing and testing innovative strategies to accelerate voluntary adult medical male circumcision roll-out is thus necessary. As a target community of this prevention method, Orange Farm (Gauteng Province) is a prime setting to conduct operational research. The team presenting this project conducted the first voluntary adult medical male circumcision randomized trial (ANRS-1265), successfully led the ANRS-12126 voluntary adult medical male circumcision roll-out, and has just completed the ANRS-12285 study on voluntary adult medical male circumcision and HIV incidence. Due to the roll-out, male circumcision prevalence increased from 12% in 2008 to 53% in 2011 in the township, but to date this prevalence has remained stagnant.

The main objective of this study is to reach 80% circumcised men in randomized clusters of Orange Farm (Gauteng Province), a township where voluntary adult medical male circumcision roll-out is ongoing since 2007.

Existing communication strategies will be revised and supplemented by personalised individual discussions to increase motivation for voluntary adult medical male circumcision and translate it into actual uptake.

The project consists of: 1) A preparatory phase to establish collaborations and prepare the communication activities, 2) a survey phase during which a) a mass communication campaign will be launched and b) 300 uncircumcised men selected from randomized clusters of Orange Farm will be recruited and undergo a baseline assessment including voluntary adult medical male circumcision general counselling, and 3) a follow-up phase during which repeated motivational interviews will be conducted to address their individual reasons for not being circumcised. Financial incentive will also be tested in a randomized trial.

Willing men will be referred to the free local voluntary adult medical male circumcision clinic and asked to attend an interview on the reasons that motivated them to become circumcised. At the end of the study, male circumcision prevalence among participants will be calculated. Factors associated with voluntary adult medical male circumcision uptake will be studied.

The survey phase will include a total of 600 uncircumcised and circumcised adult men. Among them, an expected 200 uncircumcised men will be included in the follow-up phase.

Participants will receive a financial compensation for their participation.

The study will last about 4 months. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02511548
Study type Interventional
Source Progressus
Contact Bertran Auvert, MD, PhD
Email bertran.auvert@uvsq.fr
Status Not yet recruiting
Phase Phase 3
Start date August 2015
Completion date June 2016

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