Male Circumcision Against HIV Hukomboa

NCT02376348 | Completed DMC

• 1 other identifier: GH 005-000513
• Study Type: interventional
• Target: 10,782
• Locations: 1 country
• Sites: 2

Brief Summary

Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in 2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa regions by June 2012. In line with the national strategy, the target age for the program was 10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase the proportion of older men (aged 20 years and above) who become circumcised, to have greatest impact on the HIV epidemic.

Conditions

HIV

Keywords

VMMC; Adult males; HIV Prevention; Africa

Outcome Measures

Primary Outcomes (1)

• 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)

  Cluster-level summary methods will be used to assess the impact of the intervention\[19\]. The primary outcome will be the unadjusted "prevalence ratio", estimated as the .

  5-6 weeks of demand creation activities

Secondary Outcomes (1)

• 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)

  5-6 weeks

Study Arms (2)

Control

NO INTERVENTION

Individuals receiving the standard Ministry of Health Package

Intervention

EXPERIMENTAL

Individuals receiving the targeted demand creation strategy to increase adult men taking up VMMC

Behavioral: A targeted demand creation Activities

Interventions

A targeted demand creation Activities BEHAVIORAL

Sites randomized to the intervention arm will receive all activities in the control arm, plus additional demand-creation communication messages that focus on the non-HIV benefits of VMMC and the voluntary nature of HIV testing prior to VMMC ii) use of already circumcised men from the community as auxiliary peer promoters, iii) separate waiting and group education areas for men aged 20 years and above during service delivery, iv) engagement of female partners in community-based demand creation and education and counselling about wound healing and post-circumcision abstinence.

Intervention

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Uncircumcised males
• given an informed consent to participate in the study

You may not qualify if:

• \) Circumcised males

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Jhpiego: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Njombe

Njombe, Tanzania

Location

Tabora

Tabora, Tanzania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: February 3, 2014
• Primary Completion: May 4, 2015
• Study Completion: February 28, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

TA (2)