Male Circumcision Against HIV Hukomboa

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02376348
• Date of registration: 24/02/2015
• Prospective Registration: No
• Primary sponsor: National Institute for Medical Research, Tanzania
• Public title: Male Circumcision Against HIV Hukomboa
• Scientific title: Increasing Uptake of Voluntary Medical Male Circumcision Among Men Aged 20-34 Years in Njombe & Tabora Regions, Tanzania: A Cluster Randomised Controlled Trial
• Date of first enrolment: February 3, 2014
• Target sample size: 10782
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02376348
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: Single (Care Provider).
• Phase: N/A

Countries of recruitment

Tanzania

Key inclusion & exclusion criteria

Inclusion Criteria:

Sites

- an outreach VMMC health facility,

- a site selected by Jhpiego for outreach VMMC campaign,

- a site that has not had previous outreach services (to enable the results to be
generalizable to future new outreach) or have not had VMMC outreach services in the
previous 6 months, and

- physically distant from other potential study sites to minimise contamination (spill
over) of activities in the intervention communities into control communities.

The parent sites from different clusters must be at least 20km away from each other,
regardless of whether they are randomised to be control or intervention sites.

Clients

1. Uncircumcised males

2. given an informed consent to participate in the study

Exclusion Criteria:

1) Circumcised males



Age minimum: 10 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Behavioral: A targeted demand creation Activities

Primary Outcome(s)

Impact of intervention on proportion of male clients aged 20-34 years (ratio of the geometric mean proportion of clients aged 20-34 years in the 10 intervention facilities versus that in the 10 control facilities) [Time Frame: 5-6 weeks of demand creation activities]

Secondary Outcome(s)

Comparison of population attending for circumcision with general male population (proportion of males reporting the below risk factors will be compared to proportion of males reporting the same in the 2010 Tanzania Demographic and Health Survey) [Time Frame: 5-6 weeks]

Secondary ID(s)

GH 005-000513

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jhpiego

Centers for Disease Control and Prevention

London School of Hygiene and Tropical Medicine