An Implementation Science Study Investigating Profiles of Men Interested in MMC (Imbizo)
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|ClinicalTrials.gov Identifier: NCT02352961|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment|
|Medical Male Circumcision||Other: Exclusive Intervention Strategy|
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 Type :||Observational|
|Actual Enrollment :||2817 participants|
|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|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
- Other: Exclusive Intervention Strategy
The "Exclusive Intervention Strategy" aimed at men aged 25 - 49 years and "Active Follow-up strategy"
- 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.
- Risk behaviours [ Time Frame: 6 months ]Identify risk behaviours (e.g. multiple partners; inconsistent condom use and STI symptoms) of men currently presenting at the Aurum MMC clinic.
- Compare risk behaviours to national prevalence [ Time Frame: 6 months ]Compare risk behaviours of men presenting for MMC with that of national prevalence estimates of risk behaviour.
- Risk profile, age and source of recruitment [ Time Frame: 6 months ]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.
- Factors associated with the intervention [ Time Frame: 6 months ]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.
- Socio-demographic factors [ Time Frame: 6 months ]Identify socio-demographic factors associated with HIV risk behaviours, among mature men (25-49 years).
- Effectiveness of active follow-up [ Time Frame: 6 months ]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
- Cost effectiveness [ Time Frame: 6 months ]To determine the cost-effectiveness of this intervention among mature men (25-49 years).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352961
|The Aurum Institute|
|Gauteng, South Africa, 1632|
|Principal Investigator:||Salome Charalambous, MBBCH, PhD||Aurum Institute|