Medical Male CircumcisionImbizoNCT02352961
An Implementation Science Study Investigating Profiles of Men Interested in MMC
An observational study of Medical Male Circumcision, run by The Aurum Institute NPC at 1 site in South Africa.
Trial summary
There are both supply and demand gaps in our understanding of how best to implement MMC services. In terms of supply of MMC services, there is a need to better understand what the best way is of efficiently accessing mature men(25-49 years old) . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Male Circumcision
- What is being tested?
- Exclusive Intervention Strategy
- How many people
- 2,817 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2014to Dec 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males 18 and above accessing medical male circumcision services in Ekurhuleni North, South Africa Females 18 and above who live in the vicinity of Ekurhuleni North, South Africa
Who may be able to join
- All males who meet the following criteria will be eligible for inclusion:
- Present at Aurum's male circumcision clinic during the cross sectional component or men who indicate no interest in medical male circumcision
- Are between the ages of 25 and 49 inclusive
- Are not circumcised at the time of the interview as assessed through visual examination
- Is willing and able to provide written informed consent.
- Willing for the qualitative session to be tape recorded
Show all 21Show fewer
- Inclusion Criteria for Qualitative Component for females Women who meet the following criteria will be eligible for inclusion
- Are 18 and above (no upper age limit)
- Has a partner who is participating in the cross sectional component, is not in a relationship but lives in the vicinity of Ekurhuleni North district or is part of a women's organization within the community where the clinic is located
- Is willing and able to provide written informed consent
- Willing for the qualitative session to be tape recorded
- Inclusion Criteria Part II (Intervention Period) Inclusion Criteria for the "Exclusive Intervention Strategy" Men who meet the following criteria will be eligible for inclusion in the intervention period
- Are between the ages 25 and 49 years inclusive
- Has never been medically circumcised
- Is willing and able to provide written informed consent
- Inclusion Criteria for the "Active Follow-up Intervention" Men who meet the following criteria will be eligible for inclusion
- Are between the ages 25 and 49 years inclusive
- Has never been medically circumcised
- Is willing and able to provide written informed consent
- Has contra-indication/s to MMC on the day of presentation for MMC
- Is willing to provide contact information for retention
Who cannot join
- Men who are unable to communicate sufficiently (in English or local languages) to complete medical forms and/or research questionnaires for the cross sectional component.
- Men and women who do not in the opinion of staff obtaining consent have the capacity to provide written informed consent will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Implementation Science Study Investigating Profiles of Men Interested in Medical Male Circumcision (MMC), Barriers and Methods to Increase the Uptake of MMC Among Older Men in South Africa
There are both supply and demand gaps in our understanding of how best to implement MMC services. In terms of supply of MMC services, there is a need to better understand what the best way is of efficiently accessing mature men(25-49 years old) . The investigators also want to understand the type of service delivery approach and environment that would make mature men(25-49 years old) feel more comfortable when attending an MMC clinic. Demand of MMC requires identifying messaging that works to address mature men's (25-49 years old) issues so that they might be willing to undergo MMC. To further advance HIV prevention and advocacy of male circumcision the investigators also need to consider the perspectives of women on what approach MMC messaging should take. A combination of male and female viewpoints could inform MMC outreach messaging where IEC materials are tailored to address the barriers to MMC. Identifying the specific barriers to MMC among males and including the perspectives
Read the detailed description
Part I (Formative Period) Given these issues, in addition to establishing a baseline estimate of the ages and risk behaviours of males currently undergoing MMC at the Aurum clinic over a six month period, we include a qualitative research component. We conducted research in 2014 to establish a baseline estimate of the ages and risk behaviours of males undergoing MMC at the Aurum clinic over a six month period. The baseline estimate (Ethics reference number M130711) will be referred to as the formative Part I. The formative Part I includes a quantitative and qualitative research component. The qualitative component will include both genders and be used to develop MMC recruitment messaging tailored to mature men(25-49 years old) . Men will provide their opinion on circumcision and on what type of marketing message they feel will encourage mature men (25-49 years old) to be circumcised. Women will also provide their perspectives on male circumcision and what messaging could be used to encourage their partners or male family members to be circumcised. During this study, we explored if women have a role in promoting male circumcision to their partners, family and the community. These qualitative findings will be used to develop interventions to increase the ratio of men (25-49 years old) mature, or at least of higher risk men, undergoing MMC at the clinic. These interventions and the outcomes related to them will be presented as an amendment to this protocol after the baseline and qualitative data are collected and analysed.
Part II (Intervention Period) Findings from the formative period will be used to develop interventions to increase the ratio of men (25-49 years)mature, or at least of higher risk men, undergoing MMC at the clinic. During this proposed intervention period we would like to evaluate the effectiveness of those interventions and the outcomes related to them. These proposed interventions will directly address the barriers to MMC that challenge uptake of MMC among mature men (25-49 years). Additionally, epidemiologic research will be conducted among men attending our MMC clinic to evaluate whether mature men (25-49 years) exhibit, as is presumed, higher risk profiles for HIV. We will also explore the cost-effectiveness of this strategy.
- Conditions
- Medical Male Circumcision
- Being tested
- Exclusive Intervention Strategy
- Keywords
- Unrecognised condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Intervention StrategyOther
The "Exclusive Intervention Strategy" aimed at men aged 25 - 49 years and "Active Follow-up strategy"
What is being measured
The primary outcome is the main question the study is designed to answer.
Current proportion of mature men (25-49 years) presenting for and undergoing MMC
To describe the current proportion of mature men (25-49 years) presenting for and undergoing MMC compared to all men (18 and above) during a 6 month period when routine service delivery and outreach messaging will be employed at one Aurum site.
Measured: 6 months
Particular barriers to MMC among men (25-49 years)
To describe the particular barriers to MMC among men (25-49 years) regardless of circumcision status, develop tailored messaging and outreach materials promoting MMC to mature men.
Measured: 6 months
Barriers to MMC and using the perspective of women
To investigate the particular barriers to MMC and using the perspective of women develop tailored messaging and outreach materials promoting MMC to mature men.
Measured: 6 months
Effectiveness of offering an "Exclusive Intervention Strategy"
Evaluate the effectiveness of offering an "Exclusive Intervention Strategy" comprised of customized services to mature (25-49 years) men. To achieve this aim we will compare the proportion of mature men (25-49 years) presenting for MMC during the formative and intervention periods.
Measured: 6 months
Secondary outcomes (7)
Risk behaviours
Identify risk behaviours (e.g. multiple partners; inconsistent condom use and STI symptoms) of men currently presenting at the Aurum MMC clinic.
Measured: 6 months
Compare risk behaviours to national prevalence
Compare risk behaviours of men presenting for MMC with that of national prevalence estimates of risk behaviour.
Measured: 6 months
Risk profile, age and source of recruitment
Describe the risk profile, age and sources of recruitment of men presenting at the clinic. To achieve this aim we will examine each of these factors over time.
Measured: 6 months
Factors associated with the intervention
Identify whether the intervention is associated with HIV risk behaviours (for example multiple partners), having adjusted for age. This is to identify if the intervention has resulted in men attending for MMC with a different risk profile over and above any anticipated age differences.
Measured: 6 months
Socio-demographic factors
Identify socio-demographic factors associated with HIV risk behaviours, among mature men (25-49 years).
Measured: 6 months
Effectiveness of active follow-up
Evaluate the effectiveness of an active follow-up system on completion of MMC among mature men (25-49 years) who present for MMC but who are initially referred for care due to contra-indication to MMC
Measured: 6 months
Cost effectiveness
To determine the cost-effectiveness of this intervention among mature men (25-49 years).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical Male CircumcisionStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 2,817 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Aurum Institute NPC
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Salome Charalambous, MBBCH, PhD, Principal investigator, Aurum Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352961
- Sponsor's protocol ID
- AUR2-4-121
- Acronym
- Imbizo
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publications will be shared and made available
Publications
Chetty-Makkan CM, Grund JM, Muchiri E, Price MA, Latka MH, Charalambous S. High risk sexual behaviours associated with traditional beliefs about gender roles among men interested in medical male circumcision in South Africa. AIDS Res Ther. 2021 Jun 22;18(1):33. doi: 10.1186/s12981-021-00359-7.
PubMed 34158082Grund JM, Chetty-Makkan CM, Ginindza S, Munyai R, Kisbey-Green H, Maraisane M, Charalambous S. Effectiveness of an "Exclusive Intervention Strategy" to increase medical male circumcision uptake among men aged 25-49 years in South Africa. BMC Public Health. 2018 Jul 13;18(1):868. doi: 10.1186/s12889-018-5729-6.
PubMed 30005663
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Science Study Investigating Profiles of Men Interested in Medical Male Circumcision (MMC), Barriers and Methods to Increase the Uptake of MMC Among Older Men in South Africa
- ClinicalTrials.gov ID
- NCT02352961
- Acronym / sponsor ID
- Imbizo / AUR2-4-121
- Conditions
- Medical Male Circumcision
- Keywords
- Unrecognised condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,817 participants (actual)
- Lead sponsor
- The Aurum Institute NPCUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Feb 2015 (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.
There are both supply and demand gaps in our understanding of how best to implement MMC services. In terms of supply of MMC services, there is a need to better understand what the best way is of efficiently accessing mature men(25-49 years old) . The investigators also want to understand the type of service delivery approach and environment that would make mature men(25-49 years old) feel more comfortable when attending an MMC clinic. Demand of MMC requires identifying messaging that works to address mature men's (25-49 years old) issues so that they might be willing to undergo MMC. To further advance HIV prevention and advocacy of male circumcision the investigators also need to consider the perspectives of women on what approach MMC messaging should take. A combination of male and female viewpoints could inform MMC outreach messaging where IEC materials are tailored to address the barriers to MMC. Identifying the specific barriers to MMC among males and including the perspectives
Detailed description
Part I (Formative Period) Given these issues, in addition to establishing a baseline estimate of the ages and risk behaviours of males currently undergoing MMC at the Aurum clinic over a six month period, we include a qualitative research component. We conducted research in 2014 to establish a baseline estimate of the ages and risk behaviours of males undergoing MMC at the Aurum clinic over a six month period. The baseline estimate (Ethics reference number M130711) will be referred to as the formative Part I. The formative Part I includes a quantitative and qualitative research component. The qualitative component will include both genders and be used to develop MMC recruitment messaging tailored to mature men(25-49 years old) . Men will provide their opinion on circumcision and on what type of marketing message they feel will encourage mature men (25-49 years old) to be circumcised. Women will also provide their perspectives on male circumcision and what messaging could be used to encourage their partners or male family members to be circumcised. During this study, we explored if women have a role in promoting male circumcision to their partners, family and the community. These qualitative findings will be used to develop interventions to increase the ratio of men (25-49 years old) mature, or at least of higher risk men, undergoing MMC at the clinic. These interventions and the outcomes related to them will be presented as an amendment to this protocol after the baseline and qualitative data are collected and analysed.
Part II (Intervention Period) Findings from the formative period will be used to develop interventions to increase the ratio of men (25-49 years)mature, or at least of higher risk men, undergoing MMC at the clinic. During this proposed intervention period we would like to evaluate the effectiveness of those interventions and the outcomes related to them. These proposed interventions will directly address the barriers to MMC that challenge uptake of MMC among mature men (25-49 years). Additionally, epidemiologic research will be conducted among men attending our MMC clinic to evaluate whether mature men (25-49 years) exhibit, as is presumed, higher risk profiles for HIV. We will also explore the cost-effectiveness of this strategy.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males 18 and above accessing medical male circumcision services in Ekurhuleni North, South Africa Females 18 and above who live in the vicinity of Ekurhuleni North, South Africa
Key inclusion criteria (21 listed)
- Present at Aurum's male circumcision clinic during the cross sectional component or men who indicate no interest in medical male circumcision
- Are between the ages of 25 and 49 inclusive
- Are not circumcised at the time of the interview as assessed through visual examination
- Is willing and able to provide written informed consent.
- Willing for the qualitative session to be tape recorded
Key exclusion criteria (2 listed)
- Men who are unable to communicate sufficiently (in English or local languages) to complete medical forms and/or research questionnaires for the cross sectional component.
- Men and women who do not in the opinion of staff obtaining consent have the capacity to provide written informed consent will be excluded from the research.
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 |
|---|---|---|
| Exclusive Intervention StrategyThe "Exclusive Intervention Strategy" aimed at men aged 25 - 49 years and "Active Follow-up strategy" | Other | – |
Primary outcome
Current proportion of mature men (25-49 years) presenting for and undergoing MMC
Time frame: 6 months
To describe the current proportion of mature men (25-49 years) presenting for and undergoing MMC compared to all men (18 and above) during a 6 month period when routine service delivery and outreach messaging will be employed at one Aurum site.
Particular barriers to MMC among men (25-49 years)
Time frame: 6 months
To describe the particular barriers to MMC among men (25-49 years) regardless of circumcision status, develop tailored messaging and outreach materials promoting MMC to mature men.
Barriers to MMC and using the perspective of women
Time frame: 6 months
To investigate the particular barriers to MMC and using the perspective of women develop tailored messaging and outreach materials promoting MMC to mature men.
Effectiveness of offering an "Exclusive Intervention Strategy"
Time frame: 6 months
Evaluate the effectiveness of offering an "Exclusive Intervention Strategy" comprised of customized services to mature (25-49 years) men. To achieve this aim we will compare the proportion of mature men (25-49 years) presenting for MMC during the formative and intervention periods.
7 secondary outcomes
Risk behaviours
Time frame: 6 months
Compare risk behaviours to national prevalence
Time frame: 6 months
Risk profile, age and source of recruitment
Time frame: 6 months
Factors associated with the intervention
Time frame: 6 months
Socio-demographic factors
Time frame: 6 months
Effectiveness of active follow-up
Time frame: 6 months
Cost effectiveness
Time frame: 6 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 28 Jan 2016.
- Derived from this study: PubMed 34158082Chetty-Makkan CM, Grund JM, Muchiri E, Price MA, Latka MH, Charalambous S. High risk sexual behaviours associated with traditional beliefs about gender roles among men interested in medical male circumcision in South Africa. AIDS Res Ther. 2021 Jun 22;18(1):33. doi: 10.1186/s12981-021-00359-7.
- Derived from this study: PubMed 30005663Grund JM, Chetty-Makkan CM, Ginindza S, Munyai R, Kisbey-Green H, Maraisane M, Charalambous S. Effectiveness of an "Exclusive Intervention Strategy" to increase medical male circumcision uptake among men aged 25-49 years in South Africa. BMC Public Health. 2018 Jul 13;18(1):868. doi: 10.1186/s12889-018-5729-6.
- Individual participant dataSharing planned: Yes. Publications will be shared and made available
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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.
Salome Charalambous, MBBCH, PhD principal investigator
Aurum Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Male Circumcision, run by The Aurum Institute NPC at 1 site in South Africa.
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 21 inclusion and 2 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 28 Jan 2016. 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 South Africa. 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?
Current proportion of mature men (25-49 years) presenting for and undergoing MMC (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352961, which also lists 2 linked publications.
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 28 Jan 2016.