Overview

This trial is active, not recruiting.

Condition hiv
Treatments mass media and stylish events, mass media
Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborator Rakai Health Sciences Program
Start date August 2014
End date August 2018
Trial size 15000 participants
Trial identifier NCT02448823, AI114438, R01AI114438

Summary

The study will test a novel demand generation strategy, "Stylish Man/Stylish Living", to increase uptake of Combined HIV Prevention (CHP) in Rakai, Uganda. CHP includes evidence-based interventions, including safe voluntary medical male circumcision (VMC), antiretroviral therapy (ART), prevention of mother to child transmission (p-MTCT) 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. The investigators have preliminary evidence that CHP is reducing HIV incidence in Rakai, but coverage remains suboptimal (as elsewhere in Africa), particularly in men, reducing program impact. Our data suggest that CHP supply is not the limiting factor, but that there is a "deficit in demand".

Based on extensive qualitative research, the investigators have developed and piloted an innovative male-focused CHP demand generation strategy, the "Stylish Man/Stylish Living Program" (SMLP) which is male-friendly without excluding exclude women. The SMLP strives to "demedicalize" CHP by deemphasizing health-focused messages and instead stressing "taking charge of your life". The SMP has two distinct but 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 multimedia media (the Stylish Van, videos, music, health promoters) into which the investigators have embedded CHP promotion, and immediate access to services. In this study, the investigators will conduct a 3 year cluster randomized trial of MM plus SMLEvents (intervention arm) compared to MM alone (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. 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Mass Media (radio, posters) and annual Stylish Man/Stylish Living Event (SMLEvent), a multimedia event promoting CHP.
mass media and stylish events
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 SMEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages, testimonials by satisfied CHP "customers" and where appropriate their spouses.
(Active Comparator)
Mass media
mass media
1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.

Primary Outcomes

Measure
Community level uptake of selected combined HIV prevention services
time frame: 4 year study

Secondary Outcomes

Measure
Selected HIV risk behaviors and HIV incidence
time frame: 4 year study

Eligibility Criteria

Male or female participants from 18 years up to 49 years old.

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. 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.

Additional Information

Official title Evaluating Demand Generation (Stylish Man, Stylish Living) for HIV Prevention/Family Planning Services, Rakai, Uganda
Principal investigator Maria J Wawer, MD, MHSc
Description Assessment strategy: We propose a pragmatic cluster-randomized trial of the effects of MM+SMLEvent (intervention) versus MM alone (control) on CHP coverage. 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. In the trial control communities this will provide an assessment of the effects of mass media alone. 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 approximatley 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 years 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 SMEvent. The other ~10 clusters (control arm) will be exposed to MM for 3 years, but will not receive SMLEvents. All control communities will receive all CHP services via RHSP/MOH mobile clinics conducted annually 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 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, VMC and p-MTCT coverage since each service was introduced (7+ years for each), 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 SMEvent+MM arm. As described below, we will add questions to the RCCS to enhance the SMP evaluation. CHP use will also be validated with service statistics: since the RHSP/MOH collaboration is the primary provider of SMC in RCCS communities, RHSP monitors all ART clinics in RCCS communities, and works with MOH antenatal care clinics for p-MTCT, we have robust triangulated survey and service data to assess use of CHP. 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….. ) The reported utilization will be validated against clinic data. 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 SML Event 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: Both at the mobile SMLEvent services and in the RHSP/Ministry of Health (MOH) clinics, records will be kept of all services and referrals provided, by client's age, gender, venue and date. (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 SMEvent, 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.