Evaluating Demand Generation for Safe Voluntary Male Circumcision (VMC) for HIV Prevention (Stylish Man), Rakai, Uganda
This trial is active, not recruiting.
|Treatments||mass media, stylish man (smevent)|
|Sponsor||Johns Hopkins Bloomberg School of Public Health|
|Collaborator||Rakai Health Sciences Program|
|Start date||October 2013|
|End date||December 2015|
|Trial size||1400 participants|
|Trial identifier||NCT02476071, 22006, OPP1111934|
The study, funded by the Bill and Melinda Gates Foundation, will test a novel demand generation strategy, "Stylish Man", to increase uptake of safe voluntary male circumcision (VMC) for HIV in Rakai, Uganda. With President's Emergency Fund for AIDS Relief (PEPFAR) funds, the Rakai Health Sciences Program (RHSP) provides VMC in Rakai District, Uganda. The investigators' ongoing 54 village Rakai Community Cohort Study (RCCS), with community HIV prevalence ranging from 6% to 42%, provides longitudinal data on rates of VMC coverage and on HIV incidence. The investigators have preliminary evidence that VMC is reducing HIV incidence in Rakai, but coverage remains suboptimal (as elsewhere in Africa), reducing program impact. The investigators' data suggest that VMC "supply" is not the limiting factor, but that there is a "deficit in demand".
Based on extensive qualitative research, the investigators have developed and piloted an innovative male-focused VMC demand generation strategy, the "Stylish Man Program" (SMP). The VMP strives to "demedicalize" VMC by de-emphasizing health-focused messages and instead stressing "taking charge of your life". The SMP has two distinct but related elements: (1) mass media (MM) via radio and posters; and (2) community-level mobilization via the "Stylish Man Event" (SMEvent) which includes multimedia media (the Stylish Van, videos, music, health promoters) into which the investigators have embedded VMC promotion, and immediate access to services. In this study, the investigators will conduct a one year cluster randomized trial of MM plus SMEvents (intervention arm) compared to MM alone (control), in 20 RCCS communities, half randomzied to the intervention and half to the control arm.
The primary outcome will be intent-to-treat community-level rates of VMC coverage by arm, ie., the percentage of non-muslim men in each arm who accept and adopt MMC. (Over 95% of Muslim men in Rakai already receive male circumcision in infancy.) As secondary outcomes, we will also monitor rates of key behaviors and HIV incidence, and compare them between arms and to rates observed in communities in each arm prior to study initiation.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Community level uptake of VMMC
time frame: 1 year
Selected HIV risk behaviors
time frame: 1 year
time frame: 1 year
Male participants from 18 years up to 49 years old.
Inclusion Criteria: - Please note: in this community randomized trial, there are no inclusion or exclusion criteria for exposure to the mass media or the Stylish Man Events; anyone in the community may hear the messages or attend the Stylish Man Event. - Criteria for interview: This intervention will be evaluated via interviews with 70 men in each of 10 intervention and 10 control villages (total n = 1,400). - Criteria for interview include being male, non-Muslim, resident in the study community, being aged 18-49, and being able and willing to sign or put a fingerprint on an informed consent form. Exclusion Criteria: - Non-residence in the community; inability or unwillingness to sign a written consent for interview, age in years below 18 or above 49. Please note: the question "Accepts healthy volunteers" does not apply here; there is no logical way of answering it in this study. We are not testing any medical or individual level intervention; all community members can be exposed to our mass media and community HIV prevention program, the Stylish Man Program. Interviews will be conducted with anyone healthy enough to comprehend and sign/fingerprint a consent form, but otherwise there are no health criteria.
|Official title||Evaluating Demand Generation (Stylish Man) for Safe Voluntary Male Circumcision (VMC) for HIV Prevention, Rakai, Uganda|
|Principal investigator||Maria J Wawer, MD, MHSc|
|Description||Assessment strategy: The investigators propose a pragmatic cluster-randomized trial of the effects of MM+SMEvent (intervention) versus MM alone (control) on VMC coverage. In addition, RCCS data from before and after trial initiation will provide data on trends in VMC coverage, HIV incidence and key behaviors in both arms before and during the trial. In the trial control communities this will provide an assessment of the effects of mass media alone. The "pragmatic" approach allows modification of the SMP components based on feedback and iterative assessments, as would be the case in normal program practice. Cluster randomized trial component: - 20 Rakai Community Cohort Study (RCCS) communities will be randomized into the intervention arm and into the control arm (10 communities in each arm). The clusters will be stratified by community characteristics (e.g., fishing villages, main road hubs, agrarian villages), and randomized within strata. Intervention arm: ~ ten clusters will be randomly assigned to receive the SMEvent activities once during the one year study, in addition to the ongoing district-wide MM. The SMEvents will include the community mobilization as described above, carried out in conjunction with mobile service camps conducted at the time of the SMEvent. The other ~10 communities (control arm) will be exposed to MM over the year, but will not receive an SMEvents. All control communities will receive VMC through a standard mobile service camp, in order to enhance comparability of services in both arm. Services in both arms will be offered per Uganda CDC PEPFAR guidelines. Pre-post component: The MM campaign on radio which covers a large proportion of the population of Rakai cannot be randomized. However, the RCCS provides longitudinal information on population-level rates of VMC coverage since the service was introduced (7+ years ago), as well as data on behaviors (condom use, numbers of partners, etc…) and HIV incidence. Thus, within control arm communities, the investigators have data required to determine what proportion of the population are exposed to the mass media, and whether the MM is associated with increased VMC demand and adoption. The rate of service uptake in the RCCS has essentially plateaued for over the past 3 RCCS rounds, so an upward inflection following MM startup will suggest program effects. The investigators will also conduct a pre-post comparison in the SMEvent+MM arm. As described below, the investigators will add questions to the RCCS to enhance the SMP evaluation. VMC uptake will also be assessed through service statistics, since the RHSP/MOH collaboration is the primary provider of VMC in RCCS communities. Methods of data collection: 1. The annual RCCS community survey will be used to collect data from a random sample of 70 resident non-Muslim men aged 18-49 per community ~700 men per arm, or ~1,400 men in all). The RCCS will continue to collect detailed data on VMC adoption, sociodemographics, behaviors (including numbers and types of partners, condom use). The investigators will add a module in the RCCS to evaluate exposure to the SMP (mass media, SMEvent), perceptions of components of the SMP (both positive and negative), perceptions of VMC services and the degree to which they are acceptable within the respondent's family, peer group and community; whether the respondent has had conversations with partners, family and/or peers about VMC. whether an individual accepted VMC as a result of the campaign, and if so, what was (were) the main influence(s) (i.e., information, found out peers were using services, friends or spouses encouraged uptake as a result of the campaign, easier access to the service, etc….. ) The reported utilization will be validated against clinic data. Although HIV incidence is not a primary study outcome, HIV testing will be conducted within the RCCS (as is the standard practice) using a three rapid test algorithm,with EIA and/or PCR confirmation of all newly identified HIV+ in-migrants and all new seroconverters. Serum samples from the RCCS will be archived at -80 C for future studies such as community viral load, under future grants. The investigators will conduct the RCCS survey approximately 2-3 months after the SMEvent in intervention communities. The RCCS will be conducted at approximately the same time in the matched control communities, to enhance comparability. 2. Process data: Records will be kept of each SMP activity: radio spots and interviews, scheduling of SMEvent activities, etc. SMEvent process data will include estimates of the number of participants each day, with photos taken to assist with the count. Approximately 12 short anonymous "spot interviews" will be conducted daily at the SMEvent site daily with younger and older men, to gauge interest in the activities, positive and negative perceptions, and suggestions for improvement. 3. Clinic-based evaluation: Both at the mobile SMEvent services and in the standard mobile clinics in control communities, records will be kept of all services by client's age, venue and date. (Client medical records will include the individual's name, but will be retained separately from research records.) Clients will be asked what motivated them to accept a service (some SMP component, other people were getting services, encouragement from someone influenced by the SMP, factors unrelated to the SMP, etc…) Cost data: The investigators do not propose a formal cost benefit analysis. However, the cost of the campaign will be closely tracked (cost of each radio spot, personnel/materials for the SMEvent, fuel, administrative and support costs, additional cost to PEPFAR of extended evening service hours, etc…). The focus will be on service-related costs, with research outlays tracked separately.|
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