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Evaluating Demand Generation (Stylish Man , Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda

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ClinicalTrials.gov Identifier: NCT02448823
Recruitment Status : Active, not recruiting
First Posted : May 20, 2015
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Rakai Health Sciences Program
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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).


Condition or disease Intervention/treatment Phase
HIV Other: Mass media and Stylish Events Other: Mass Media Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating Demand Generation (Stylish Man, Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda
Study Start Date : August 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stylish Events and Mass Media
Mass Media (radio, posters) and annual Stylish Man/Stylish Living Event (SMLEvent), a multimedia event promoting CHP.
Other: Mass media and Stylish Events
  1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
  2. "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.


Active Comparator: Control arm: mass media only
Mass media
Other: Mass Media
1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.




Primary Outcome Measures :
  1. Community level uptake of selected combined HIV prevention services (HIV testing and counseling services, VMMC, referral for HIV care/ART, family planning. [ Time Frame: 5 year study ]
    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

  2. Service statics in mobile service camps in each study arm [ Time Frame: 5 year study ]
    Data will be recorded regarding the numbers and characteristics of clients accepting HIV counseling and testing services, VMMC, referral for ART, and family planning, by age, gender and community.


Secondary Outcome Measures :
  1. Selected HIV risk behaviors and HIV incidence [ Time Frame: 5 year study ]
    We will assess rates of key behaviors and HIV incidence over time; these are secondary outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Please note: the question above ("accepts health volunteers") is not really applicable to this community randomized trial. We are not enrolling anyone into the trial, and we are not testing any individual level interventions: by definition, all community members can be exposed to the messages on radio and posters, and anyone can come to the Stylish Man/Stylish Living event. We will interview approximately 15,000 persons in the study communities about their exposure to the Stylish Program and regarding their use of CHP services, as part of our ongoing, longitudinal Rakai Community Cohort Study (RCCS), in which we have already been asking about use of CHP services since they were first introduced, starting in approximately 2004. However, being interviewed in the RCCS is in no way dependent on having been exposed to the Stylish Program. We will also collect service statistics at mobile CHP service delivery camps in both arms. However, we already routinely conduct such camps throughout RCCS communities and offer standard-of-care CHP services. The one difference will be that in the intervention arm communities, community mobilization and multimedia information will be provided via the SMLEvents.

Inclusion Criteria:

  • Residents aged 18-49 years in the 50 communities. (Please note: this is a community-randomized trial)

Exclusion Criteria:

  • All community residents may attend the events and by definition, will be exposed to mass media. However, only persons aged 18-49 who sign or fingerprint a written informed consent will be interviewed in the RCCS as part of the evaluation nested within the RCCS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448823


Locations
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Uganda
Rakai Health Sciences Program
Kalisizo, Rakai District, Uganda
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Rakai Health Sciences Program
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Maria J Wawer, MD, MHSc Johns Hopkins Bloomberg School of Public Health

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02448823     History of Changes
Other Study ID Numbers: AI114438
R01AI114438 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV
combined prevention
demand generation