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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
Other: Mass Media
1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
- 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
- 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.
- 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
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
|Rakai Health Sciences Program|
|Kalisizo, Rakai District, Uganda|
|Principal Investigator:||Maria J Wawer, MD, MHSc||Johns Hopkins Bloomberg School of Public Health|