Male CircumcisionNCT02167776
From Obstacles to Opportunities for Male Circumcision in Tanzania
A study testing Church-based teaching in people with Male Circumcision, run by Weill Medical College of Cornell University at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Church-based teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTanzania
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Villages in which male circumcision is being offered by the Tanzanian Ministry of Health free of charge
- Village leader provides permission for study participation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster-randomized Study of Church-Based Intervention to Promote Male Circumcision in Tanzania
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.
Read the detailed description
The investigators will conduct a mixed-methods study that will include a community cluster randomized trial, followed by focus group discussions in both intervention and control villages after completion of the trial. This trial will be performed in 16 villages in conjunction with a voluntary medical male circumcision outreach campaign that is being offered by the Tanzanian Ministry of Health in the northwest of the country. The campaign brings a team of clinicians to perform free male circumcisions in 2-3 villages at a time. The campaign routinely provides male circumcision and voluntary HIV counseling and testing to between one hundred to two hundred men per day and typically remains in a village for 3-6 weeks until demand for circumcision decreases.
The unit of randomization in the cluster randomized trial will be the village. The investigators will work in partnership with the male circumcision outreach campaign to identify eligible village pairs that are located within 60 kilometers of one another and will be targeted by the male circumcision outreach campaign at the same time. The investigators believe that the geographic proximity of the paired villages and the start date of the male circumcision outreach campaign in the village will be the two most important factors affecting uptake of male circumcision in the villages. The geographic proximity is important for the assumption that baseline rates of male circumcision and other village characteristics are likely similar. The start date of the campaign is important because: (1) uptake of male circumcision is likely to be higher during the dry season, when there is less farming work for men to do, and (2) the investigators predict that uptake of male circumcision may increase over time as more and more men are circumcised in the Mwanza region and it increasingly becomes a societal norm.
The investigators will restrict our inclusion criteria to rural villages that have clear boundaries so that the male population is stable without influx as would be common in an urban area. In these rural regions, dirt roads and poor infrastructure lead to minimal contact between villages so it is predicted that little information will be shared between intervention and control villages.
Both intervention and control villages will receive the standard community outreach events to promote male circumcision that are provided by the Tanzanian Ministry of Health during their male circumcision outreach campaign. This may include community meetings, public education sessions by health care workers, drama, broadcast announcements by cars with megaphones, and distribution of health informational brochures. However, the standard education does not work specifically with religious leaders. Among the members of the male circumcision outreach team, only one clinician, who will provide medical teaching at the educational seminar for religious leaders, will be aware of a village's assignment as an intervention or control group.
The additional intervention that will be given to villages that are randomized to receive the intervention will be a one-day educational seminar for church leaders of that village. The seminar will focus on male circumcision and will address religious, cultural, and health implications of this practice. It will also provide teaching and tools for church leaders to use in discussing male circumcision with their congregations.
After the completion of the male circumcision outreach campaign in a village, our study team will enroll individual church leaders. Leaders from both intervention and control villages will participate in separate groups and will be led in a discussion of their perceptions of male circumcision. Church leaders, who will be invited from a variety of denominational backgrounds, will provide written informed consent for participation in the focus group discussions.
- Conditions
- Male Circumcision
- Being tested
- Church-based teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Church-based teachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Church-based teaching | Experimental | Teaching about male circumcision provided to church leaders in addition to standard teaching available from Ministry of Health. Receives: Behavioral: Church-based teaching |
| No church-based teaching | No intervention | Standard of care. Teaching about male circumcision provided by Ministry of Health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of uptake of male circumcision
Measured: 9 months
Secondary outcomes (1)
qualitative data from church attenders in intervention and control villages
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Jennifer A Downs, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167776
- Sponsor's protocol ID
- 1107011800
- Status last verified
- Jan 2017
- First submitted
- 17 Jun 2014
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Study of Church-Based Intervention to Promote Male Circumcision in Tanzania
- ClinicalTrials.gov ID
- NCT02167776
- Acronym / sponsor ID
- 1107011800
- Conditions
- Male Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct a mixed-methods study that will include a community cluster randomized trial, followed by focus group discussions in both intervention and control villages after completion of the trial. This trial will be performed in 16 villages in conjunction with a voluntary medical male circumcision outreach campaign that is being offered by the Tanzanian Ministry of Health in the northwest of the country. The campaign brings a team of clinicians to perform free male circumcisions in 2-3 villages at a time. The campaign routinely provides male circumcision and voluntary HIV counseling and testing to between one hundred to two hundred men per day and typically remains in a village for 3-6 weeks until demand for circumcision decreases.
The unit of randomization in the cluster randomized trial will be the village. The investigators will work in partnership with the male circumcision outreach campaign to identify eligible village pairs that are located within 60 kilometers of one another and will be targeted by the male circumcision outreach campaign at the same time. The investigators believe that the geographic proximity of the paired villages and the start date of the male circumcision outreach campaign in the village will be the two most important factors affecting uptake of male circumcision in the villages. The geographic proximity is important for the assumption that baseline rates of male circumcision and other village characteristics are likely similar. The start date of the campaign is important because: (1) uptake of male circumcision is likely to be higher during the dry season, when there is less farming work for men to do, and (2) the investigators predict that uptake of male circumcision may increase over time as more and more men are circumcised in the Mwanza region and it increasingly becomes a societal norm.
The investigators will restrict our inclusion criteria to rural villages that have clear boundaries so that the male population is stable without influx as would be common in an urban area. In these rural regions, dirt roads and poor infrastructure lead to minimal contact between villages so it is predicted that little information will be shared between intervention and control villages.
Both intervention and control villages will receive the standard community outreach events to promote male circumcision that are provided by the Tanzanian Ministry of Health during their male circumcision outreach campaign. This may include community meetings, public education sessions by health care workers, drama, broadcast announcements by cars with megaphones, and distribution of health informational brochures. However, the standard education does not work specifically with religious leaders. Among the members of the male circumcision outreach team, only one clinician, who will provide medical teaching at the educational seminar for religious leaders, will be aware of a village's assignment as an intervention or control group.
The additional intervention that will be given to villages that are randomized to receive the intervention will be a one-day educational seminar for church leaders of that village. The seminar will focus on male circumcision and will address religious, cultural, and health implications of this practice. It will also provide teaching and tools for church leaders to use in discussing male circumcision with their congregations.
After the completion of the male circumcision outreach campaign in a village, our study team will enroll individual church leaders. Leaders from both intervention and control villages will participate in separate groups and will be led in a discussion of their perceptions of male circumcision. Church leaders, who will be invited from a variety of denominational backgrounds, will provide written informed consent for participation in the focus group discussions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Church-based teaching | Experimental | Behavioral: Church-based teachingTeaching about male circumcision provided to church leaders in addition to standard teaching available from Ministry of Health. |
| No church-based teaching | No intervention | –Standard of care. Teaching about male circumcision provided by Ministry of Health. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Villages in which male circumcision is being offered by the Tanzanian Ministry of Health free of charge
- Village leader provides permission for study participation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Church-based teachingIn 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. | Behavioural | Church-based teaching |
Primary outcome
rate of uptake of male circumcision
Time frame: 9 months
1 secondary outcome
qualitative data from church attenders in intervention and control villages
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Downs, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Church-based teaching in people with Male Circumcision, run by Weill Medical College of Cornell University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of uptake of male circumcision (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.