An Implementation Science Study Investigating Profiles of Men Interested in MMC

NCT02352961 | Completed

• 1 other identifier: AUR2-4-121
• Study Type: observational
• Target: 2,817
• Locations: 1 country
• Sites: 1

Brief 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) . 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

Conditions

Medical Male Circumcision

Keywords

Unrecognised condition

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (7)

• Risk behaviours

  6 months

• Compare risk behaviours to national prevalence

  6 months

• Risk profile, age and source of recruitment

  6 months

• Factors associated with the intervention

  6 months

• Socio-demographic factors

  6 months

Interventions

Exclusive Intervention Strategy OTHER

The "Exclusive Intervention Strategy" aimed at men aged 25 - 49 years and "Active Follow-up strategy"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Are aged 18 years or older (no upper age limit)
• Have never been completely medically circumcised (as opposed to partial circumcision)
• Willing and able to give their written informed consent so that the information collected during the clinic visit can be analysed for research purposes.
• 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
• 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
• Are between the ages 25 and 49 years inclusive
• Has never been medically circumcised
• Is willing and able to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Aurum Institute NPC: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

The Aurum Institute

Gauteng, Gauteng, 1632, South Africa

Location

Related Publications (2)

• 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.

  PMID: 34158082 DERIVED

• Grund 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.

  PMID: 30005663 DERIVED

Study Officials

• Salome Charalambous, MBBCH, PhD

  Aurum Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)