Evaluating Demand Generation (Stylish Man , Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda
Condition: HIV
Study type: Interventional

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).
    

Detailed 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.
    

Intervention name(s): Mass media and Stylish Events; Mass Media
Intervention type(s): Other; Other
Intervention description(s): Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
"Stylish Man/Living Event" (SMLEvent) community mobilization/service provision. SMLEvent activities. Messages on how CHP (including behaviors such as sexual risk reduction) can make men and women feel more in control of their lives, less stressed, and more "Stylish" are interwoven through the mobilization.
The Stylish Man Van (SMV) accompanies the SMLEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages, testimonials by satisfied CHP "customers" and where appropriate their spouses.; 1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; combined prevention; demand generation