Evaluating Demand Generation for Safe Voluntary Male Circumcision (VMC) for HIV Prevention (Stylish Man), Rakai, Uganda

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02476071
• Date of registration: 14/05/2015
• Prospective Registration: No
• Primary sponsor: Johns Hopkins Bloomberg School of Public Health
• Public title: Evaluating Demand Generation for Safe Voluntary Male Circumcision (VMC) for HIV Prevention (Stylish Man), Rakai, Uganda
• Scientific title: Evaluating Demand Generation (Stylish Man) for Safe Voluntary Male Circumcision (VMC) for HIV Prevention, Rakai, Uganda
• Date of first enrolment: July 2013
• Target sample size: 17386
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02476071
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Uganda

Contacts

• Name: Maria J Wawer, MD, MHSc
• Affiliation: Johns Hopkins Bloomberg School of Public Health

Key inclusion & exclusion criteria

Inclusion Criteria:

- Please note: in this community randomized trial, there are no inclusion or exclusion
criteria for exposure to the mass media or the Stylish Man Events; anyone in the
community may hear the messages or attend the Stylish Man Event.

- Criteria for interview: This intervention will be evaluated via interviews with 70 men
in each of 10 intervention and 10 control villages (total n = 1,400).

- Criteria for interview include being male, non-Muslim, resident in the study
community, being aged 18-49, and being able and willing to sign or put a fingerprint
on an informed consent form.

Exclusion Criteria:

- Non-residence in the community; inability or unwillingness to sign a written consent
for interview, age in years below 18 or above 49.

Please note: the question "Accepts healthy volunteers" does not apply here; there is no
logical way of answering it in this study. We are not testing any medical or individual
level intervention; all community members can be exposed to our mass media and community
HIV prevention program, the Stylish Man Program. Interviews will be conducted with anyone
healthy enough to comprehend and sign/fingerprint a consent form, but otherwise there are
no health criteria.



Age minimum: 18 Years
Age maximum: 49 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Other: Stylish Man (SMEvent)

Other: Mass media

Primary Outcome(s)

Community level uptake of VMMC [Time Frame: 1 year]

Secondary Outcome(s)

HIV incidence [Time Frame: 1 year]

Selected HIV risk behaviors [Time Frame: 1 year]

Secondary ID(s)

22006

OPP1111934

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rakai Health Sciences Program