From Obstacles to Opportunities for Male Circumcision in Tanzania

NCT02167776 | Completed

• 1 other identifier: 1107011800
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Male circumcision has been demonstrated by three randomized trials to be a highly effective method of HIV prevention, leading the World Health Organization to recommend its widespread implementation. The investigators' prior work in Tanzania has shown that the acceptability and uptake of male circumcision depends highly on religious beliefs. The investigators hypothesize that the uptake of male circumcision can be increased in villages in which male circumcision is offered in conjunction with church-based teaching and practice, compared with villages in which male circumcision is not promoted through churches. The investigators will conduct a community randomized trial in rural Tanzania, where the government is systematically providing free male circumcision via campaigns in villages in which rates of circumcision are low. Prior to the start of the campaign, villages will be randomized to receive or not to receive church-based and culturally-informed promotion of male circumcision. All villages will receive the standard non-church-based health education that accompanies male circumcision campaigns. The investigators will compare rates of male circumcision, both by self-report and by demographic data collected at the time of circumcision, among men and boys before and after the campaign in intervention villages with church involvement versus control villages without church involvement.

Conditions

Male Circumcision

Outcome Measures

Primary Outcomes (1)

• rate of uptake of male circumcision

  9 months

Secondary Outcomes (1)

• qualitative data from church attenders in intervention and control villages

  9 months

Other Outcomes (1)

• age-specific rates of male circumcision uptake

  9 months

Study Arms (2)

Church-based teaching

EXPERIMENTAL

Teaching about male circumcision provided to church leaders in addition to standard teaching available from Ministry of Health.

Behavioral: Church-based teaching

No church-based teaching

NO INTERVENTION

Standard of care. Teaching about male circumcision provided by Ministry of Health.

Interventions

Church-based teaching BEHAVIORAL

In villages that are randomized to receive the intervention, Christian church leaders of both genders and all denominations will be invited to attend an educational seminar about male circumcision. This seminar will last for one day in each intervention village, and will use a curriculum that the investigators' team developed in 2012 based on prior focus group work. Seminars will be conducted in Kiswahili (the national language) and co-taught by a Tanzanian pastor and a Tanzanian clinician who works with the male circumcision outreach campaign. Church leaders will be taught medical, historical, religious, tribal, and social aspects of male circumcision and given tools to lead their congregations in the understanding and practice of male circumcision.

Church-based teaching

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Villages in which male circumcision is being offered by the Tanzanian Ministry of Health free of charge
• Village leader provides permission for study participation

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Bugando Medical Centre and catchment area

Mwanza, Tanzania

Location

Study Officials

• Jennifer A Downs, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

TA (1)