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Clinical Trials

MainTitle

Evaluating Demand Generation for Safe Voluntary Male Circumcision (VMC) for HIV Prevention (Stylish Man), Rakai, Uganda

The recruitment status of this study is unknown.

Verified June 2015

Sponsor
Johns Hopkins Bloomberg School of Public Health

Collaborator
Rakai Health Sciences Program

Information provided by (Responsible Party)
Maria Wawer, Johns Hopkins Bloomberg School of Public Health

ClinicalTrials.gov Identifier
NCT02476071

First received: May 14, 2015
Last updated: June 16, 2015
Last Verified: June 2015
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

Other : Mass media
Other : Stylish Man (SMEvent)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating Demand Generation (Stylish Man) for Safe Voluntary Male Circumcision (VMC) for HIV Prevention, Rakai, Uganda

Further study details as provided by Maria Wawer, Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures

  • Community level uptake of VMMC [ Time Frame: 1 year ]
    Percentage of non-Muslim men aged 18-49 in each study arm who accept voluntary medical male circumcision (the latter is non-experimental and is provided according to the PEPFAR/Uganda Ministry of Health standard of care)
Secondary Outcome Measures:
  • Selected HIV risk behaviors [ Time Frame: 1 year ]
    We will assess rates of key behaviors (condom use, numbers of partners) in each study arm; this is a secondary outcome
  • HIV incidence [ Time Frame: 1 year ]
    We will assess the rate of new HIV infection in men in each study arm; this is a secondary outcome

Estimated Enrollment: 1400
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Mass Media and Stylish Events
Mass Media (radio messages/posters promoting HIV prevention) plus one annual Stylish Man Event (SMEvent), a multimedia/community mobilization event promoting VMC.
Other: Mass media

Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.

Other: Stylish Man (SMEvent)
  • Stylish Man Events: community mobilization via music, contests, testimonials from satisfied VMC adopters. Messages on how VMC, in conjunction with other HIV prevention, can make men feel more in control of their lives, less stressed, and more "Stylish" are interwoven through the mobilization.
  • The Stylish Man Van (SMV) accompanies the SMEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages.

Active Comparator: Control arm: mass media only
Mass media (radio messages and posters which promote VMC for HIV prevention). .
Other: Mass media

Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.

Detailed 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.
  • 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.
  • 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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 49 Years  
    Sexes Eligible for Study: Male  
    Accepts Healthy Volunteers: No  

    Criteria

    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.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02476071

    Locations

    Uganda
    Rakai Health Sciences Program
    Kalisizo, Rakai District, Uganda

    Sponsors and Collaborators

    Johns Hopkins Bloomberg School of Public Health
    Rakai Health Sciences Program

    Investigators

    Principal Investigator: Maria J Wawer, MD, MHSc Johns Hopkins Bloomberg School of Public Health
    More Information

    More Information


    Responsible Party: Maria Wawer, Professor, Johns Hopkins Bloomberg School of Public Health  
    ClinicalTrials.gov Identifier: NCT02476071   History of Changes  
    Other Study ID Numbers: OPP1111934  
      22006  
    Study First Received: May 14, 2015  
    Last Updated: June 16, 2015  

    Keywords provided by Maria Wawer, Johns Hopkins Bloomberg School of Public Health:

    HIV prevention
    Demand for voluntary male circumcision

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.