Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02448823
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2014-09-23
Brief Title:
Evaluating Demand Generation Stylish Man Stylish Living for HIV PreventionFamily Planning Services Rakai Uganda
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Evaluating Demand Generation Stylish Man Stylish Living for HIV PreventionFamily Planning Services Rakai Uganda
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study tests a novel demand generation strategy Stylish ManStylish 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 Presidents 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 ManStylish 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 ManStylish 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 45 year cluster randomized trial of MMmobile service campsSMLEvents intervention arm compared to MMmobile 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
Based on extensive qualitative research we developed an innovative male-focused CHP demand generation strategy the Stylish ManStylish 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 ManStylish 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 45 year cluster randomized trial of MMmobile service campsSMLEvents intervention arm compared to MMmobile 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 MMmobile service campsSMLEvent intervention versus MMmobile 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 18000 of whom we estimate approximately 15000 will be interviewed via the RCCS as a component of intervention evaluation The clusters will be stratified by community characteristics eg 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 RHSPMinistry 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 MOHRHSP 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 careART 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 SMLEventMM 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 respondents family peer group and community whether the respondent has had conversations with partners family andor 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 influences ie 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 andor 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 armby services and referrals provided clients 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 individuals 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 careART 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 RHSPMOH 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 personnelmaterials 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
We propose a pragmatic cluster-randomized trial of the effects of MMmobile service campsSMLEvent intervention versus MMmobile 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 18000 of whom we estimate approximately 15000 will be interviewed via the RCCS as a component of intervention evaluation The clusters will be stratified by community characteristics eg 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 RHSPMinistry 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 MOHRHSP 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 careART 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 SMLEventMM 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 respondents family peer group and community whether the respondent has had conversations with partners family andor 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 influences ie 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 andor 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 armby services and referrals provided clients 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 individuals 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 careART 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 RHSPMOH 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 personnelmaterials 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI114438 | NIH | None | httpsreporternihgovquickSearchR01AI114438 |