Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02448823 |
| Other study ID # |
AI114438 |
| Secondary ID |
R01AI114438 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
November 2019 |
Study information
| Verified date |
April 2019 |
| 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 tests a novel demand generation strategy, "Stylish Man/Stylish Living", to increase
uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes safe voluntary medical
male circumcision (VMMC), antiretroviral therapy (ART), and behavioral interventions. With
President's Emergency Fund for AIDS Relief (PEPFAR) funds, the Rakai Health Sciences Program
(RHSP) provides CHP in Rakai District, Uganda. Our ongoing 54 village Rakai Community Cohort
Study (RCCS), with community HIV prevalence ranging from 6% to 42%, provides longitudinal
data on rates of CHP coverage and on HIV incidence. There is preliminary evidence that CHP is
reducing HIV incidence in Rakai, but CHP coverage remains suboptimal, particularly in men.
Data suggest that CHP supply is not the limiting factor, but that there is a "deficit in
demand".
Based on extensive qualitative research, we developed an innovative male-focused CHP demand
generation strategy, the "Stylish Man/Stylish Living Program" (SMLP) which is male-friendly
without excluding women. SMLP strives to "demedicalize" CHP by de-emphasizing health-focused
messages and instead stressing "taking charge of your life". It has two related elements: (1)
mass media (MM) via radio and posters; and (2) community-level mobilization via the "Stylish
Man/Stylish Living Event" (SMLEvent) which includes CHP promotion through multimedia (the
Stylish Van, videos, music, health promoters) and immediate access to services (mobile camps
which offer VMMC camps, HIV testing and counseling services, referral for ART, and
contraceptive services). In this study, the investigators will conduct a 4.5 year cluster
randomized trial of MM/mobile service camps+SMLEvents (intervention arm) compared to
MM/mobile service camps conducted without SMLEvents (control), in 25 RCCS communities per arm
aggregated into ~10 clusters per arm (50 communities in all). The primary outcome will be
intent-to-treat community-level rates of CHP coverage by arm, and service statistics on use
of mobile camp services by arm. The investigators 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 (secondary outcomes).
Description:
Assessment strategy:
We propose a pragmatic cluster-randomized trial of the effects of MM/mobile service
camps+SMLEvent (intervention) versus MM/mobile service camps without SMLEvents (control) on
CHP coverage and on usage of mobile camp services by arm. In addition, RCCS data from before
and after trial initiation will provide data on trends in CHP coverage, HIV incidence and key
behaviors in both arms before and during the trial. The "pragmatic" approach allows
modification of the SMLP components based on feedback and iterative assessments, as would be
the case in normal program practice.
Cluster randomized trial component:
- 50 Rakai Community Cohort Study (RCCS) communities will be divided into ~20 clusters of
2-3 villages in close geographic proximity per arm. The total population of all 50
communities is ~18,000, of whom we estimate approximately 15,000 will be interviewed via
the RCCS as a component of intervention evaluation. 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 SMLEvent activities
once ~ annually for 3 cycles in addition to the ongoing district-wide MM. The SMLEvents will
include the community mobilization as described above, carried out in conjunction with mobile
service camps conducted at the time of the SMLEvent.
The other ~10 clusters (control arm) will be exposed to MM for 3 cycles but will not receive
SMLEvents. All control communities will be offered all CHP services via RHSP/Ministry of
Health (MOH) mobile clinics conducted for the same 3 cycles in conjunction with RCCS survey
rounds.
Both intervention and control arm clusters will continue to have year-round access to
existing MOH/RHSP clinic CHP services. Services in both arms will be offered per Uganda
Centers for Disease Control and Prevention (CDC) PEPFAR guidelines. Both arms will thus have
equivalent access to CHP.
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
HIV care/ART for the general population and for pregnant women (p-MTCT), VMMC and family
planning, as well as data on behaviors (condom use, numbers of partners, etc…) and HIV
incidence, since 1994. Thus, within control arm communities, we have data required to
determine what proportion of the population are exposed to the mass media, and whether the MM
is associated with increased demand and among which population subgroups. 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. We will also conduct a pre-post
comparison in the SMLEvent+MM arm.
As described below, we will add questions to the RCCS to enhance the SMP evaluation. CHP
uptake will also be assessed with mobile camp service statistics in both study arms.
Methods of data collection:
1. Annual RCCS community surveillance surveys, among all consenting individuals aged 15-49
in the 50 RCCS communities (aggregated into ~10 clusters per trial arm).
The RCCS will continue to collect detailed data on sociodemographics, behaviors
(including numbers and types of partners, condom use with each, whether the partner is
from within the community or another geographic setting), egocentric sexual network,
pregnancy since the last RCCS survey round, health status and use of HCT, condoms, ART,
P-MTCT, and VMC. We will add a module in the RCCS to evaluate exposure to the SMLP (mass
media, SMLEvent), perceptions of components of the SMLP (both positive and negative),
perceptions of different CHP 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 any CHP services; whether an
individual accepted any service or adopted any self-reported behavioral change 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….. ) HIV testing will be
conducted at each RCCS survey round, 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 -800C for future studies such as
community viral load, under future grants. Women will be asked about pregnancy status;
those who are uncertain will be offered a urinary hCG pregnancy test (this is offered
routinely in the RCCS). Pregnant HIV+ women will be referred for p-MTCT.
Since the RCCS routinely collects serum for HIV testing and CD4, we will track HIV
incidence, and immunologic status through the RCCS, complementing the clinic-based
evaluation described below.
2. Process data:
Records will be kept of each SMLP activity: radio spots and interviews, scheduling of
SMLEvent activities, etc. SMLEvent 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 SMLEvent site daily
with younger and older men and women, to gauge interest in the activities, positive and
negative perceptions, and suggestions for improvement.
3. Clinic-based evaluation:
In both study arms, we will collect service statistics from the mobile CHP camps (mobile
camps plus SMLEvents in the intervention arm, and stand-alone service camps in the control
arm)by services and referrals provided, client's age, gender, venue and date. Please note:
the sand-alone mobile camps int he control arm will be announced to the community
approximately two weeks prior to their occurrance, in order to ensure potential clients are
aware of them; however, this notification will not include the multimedia and community
mobilization associated with the SMLEvents. (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 SMLP component, other people were getting
services, encouragement from someone influenced by the SMLP, factors unrelated to the SMLP,
etc…) We will track whether persons referred for HIV care/ART present to our HIV clinics (and
conversely, we will ask about clinic attendance during each RCCS survey rounds). Routine HIV
clinic data collection includes tracking of visits, questions on adherence, and CD4 cell
count every 6 months. PEPFAR does not currently fund HIV viral load, but samples from the
RHSP/MOH clinics are tested for viral load annually with International Center for Excellence
in Research (ICER) funds. These data will complement the RCCS data, providing a comprehensive
indication of ART coverage and long term treatment outcomes.
Cost data:
We 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 SMLEvent, 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. We will compare overall costs per unit ART, VMC and p-MTCT coverage, in the
intervention versus the control arm and in relation to PEPFAR costs per client to date.
Other known NCT identifiers
