Evaluating Demand Generation (Stylish Man, Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,386
- 试验地点
- 1
- 主要终点
- Community level uptake of selected combined HIV prevention services (HIV testing and counseling services, VMMC, referral for HIV care/ART, family planning.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- •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.
研究组 & 干预措施
Stylish Events and Mass Media
Mass Media (radio, posters) and annual Stylish Man/Stylish Living Event (SMLEvent), a multimedia event promoting CHP.
干预措施: Mass media and Stylish Events (Other)
Control arm: mass media only
Mass media
干预措施: Mass Media (Other)
结局指标
主要结局
Community level uptake of selected combined HIV prevention services (HIV testing and counseling services, VMMC, referral for HIV care/ART, family planning.
时间窗: 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
时间窗: 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.
次要结局
- Selected HIV risk behaviors and HIV incidence(5 year study)