Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02476071 |
| Other study ID # |
OPP1111934 |
| Secondary ID |
22006 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
November 2019 |
Study information
| Verified date |
August 2021 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
