Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06364891 |
| Other study ID # |
VMMC NEXUS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
VMMC has been identified as a crucial intervention by UNAIDS to achieve the 2030 global
target of a 90% reduction in new HIV infections compared with 2010 levels. CIDRZ, a key
partner to the Ministry of Health, has worked with DesireLine to develop a mobile application
that supports mobilisers to segment potential clients and provide them with targeted
messaging based on their segmentation type. The hypothesis of our proposed study is that
targeted interventions addressing the barriers for each of the seven segments, assisted by
the Digital Mobilization Tool, will better meet the needs of potential clients and therefore
improve uptake of VMMC services, specifically among the three most-resistant segments.
The objective of this study is to evaluate the effect of a segment-targeted mobilization
intervention supported by the VMMC NEXUS Digital Mobilization Tool on the uptake of VMMC
services at 30 intervention sites, compared with 30 control sites.
The research questions are:
1. What is the effect of segment-targeted mobilization interventions designed to address
the specific psycho-behavioral barriers each of the seven segments face, supported by
the VMMC NEXUS Digital Mobilization Tool, on the overall numbers of men receiving VMMC
in each site?
2. What is the effect of the same on the numbers of men by segment receiving VMMC in each
site?
3. What is the effect of the same on the numbers of men by age receiving VMMC in each site?
Secondary goals will be the following, to the extent possible:
- Assess the incremental cost of the intervention, including by MC
- Assess and document process learnings from the intervention
- Develop a workplan to enable national and regional scale-up of the mobilization model
and NEXUS Digital Mobilization Tool if demonstrated as effective
Description:
Study design
The study is a cluster randomised study. Programmatic data will be collected at 60
health-facility sites offering VMMC:
- 30 sites randomly selected as intervention sites
- 30 sites randomly selected as control sites Mobilizers associated with the intervention
sites will mobilize men for VMMC using the segment targeted interventions for all seven
segments, supported by the VMMC NEXUS Digital Mobilization Tool. At the control sites,
mobilizers will use the current standard of care tools to engage men for VMMC; these
tools are not digital and do not contain the targeted messaging for the three
most-resistant segments. One study-supported mobilizer will be placed in each of the 60
sites to support mobilization of men for VMMC in the intervention and control sites as
described above.
Mobilizer Training and Specialization The 60 mobilizers (one for each site, control or
intervention) will be compensated with a monthly stipend and all will be trained on the
basics of VMMC as an HIV prevention method and active listening approaches to educating
clients about VMMC.
Mobilizers at the 30 intervention sites additionally will be trained on the VMMC segmentation
and barriers men face to getting VMMC. Also they will be trained on use of the VMMC NEXUS
Digital Mobilization Tool and on outreach approaches to the three most-resistant segments of
men. Data entered by the mobilizers supporting the intervention sites as a part of their
routine use of the VMMC NEXUS Digital Mobilization Tool to support their mobilization efforts
will be monitored by the CIDRZ program team. Ongoing oversight and support will be provided
to all mobilizers as part of routine management for both control and intervention sites.
Site Selection In order to control for potential differences between implementing partners,
the study will use only those sites currently receiving technical assistance from CIDRZ. To
select sites, the investigators reviewed data on the aggregate monthly number of MCs
performed over a 24-month period (October 2020 - September 2022) at 893 health facilities
that receive technical support from CIDRZ, in four provinces. Selection focused on the most
active facilities by first selecting the sites that had performed at least 10 MCs in at least
1 month within the 24-month period. This yielded 777 sites. Next, those sites that had
performed at least 10 MCs monthly in at least 18 months of the 24-month period were selected.
There were 131 of these sites. To further refine the eligibility criteria, within each
province sites were divided into rural and urban settings. Within each of these 8 categories
(4 provinces X 2 types of setting) sites that reached at least the 25th percentile of average
monthly volume of MCs were selected. This ensured a representative sample of active rural and
active urban sites within each province, accounting for the fact that the average MC volume
varies by province and setting. These sites were then randomly assigned to the intervention
group or the control group to be balanced between groups controlling for the following:
volume of Shang Ring procedures, volume of surgical procedures, volume of each of the 7
segments, province proportions and urban-rural proportions.
Methodology The study will record the number of men being engaged by the intervention
mobilization efforts vs. the number receiving VMMC will be used to evaluate "conversion
rates," both overall and by segment. The VMMC NEXUS Digital Tablet Mobilization Tool will
facilitate data collection and tracking for this metric.
For men coming into facilities for VMMC, a standardised intake form, which includes a
segmenting tool, will be used to record which segment a man belongs to and other demographic
data, including age. The intake form will also collect information on which interventions men
were exposed to before coming to the facility for VMMC. These data will be aggregated across
facilities in localities where study mobilizers are using the Digital Mobilization Tool
(intervention sites), and facilities where mobilisers are using the current standard of care
tools (control sites).
The study team will extract aggregated weekly data, including VMMC volume data by segment and
age. These data will be tracked for up to 6 months before the intervention is launched, and
then for a period of 9-12 months after, to determine whether the intervention sites produce a
higher volume of MCs than the control sites, and whether MC volumes among the three
more-resistant segments are higher at the intervention sites than at the control sites.
Process Evaluation To assess the fidelity of the implementation of the interventions a
process evaluation will be completed, including qualitative one-on-one interviews of key
stakeholders in the pilot implementation including a selection of individuals from the
following stakeholder groups: CIDRZ Mobilizers - control & intervention sites, Other
catchment area mobilizers - control & intervention sites, Clients - control and intervention
sites, Data officers, CIDRZ implementation team, CIDRZ NEXUS platform team, Providers, Intake
counselors, Site In-charges, MoH District & Province leaders, Sub-district coordinators, MoH
national VMMC program leadership, Zambia VMMC TWG members.
The following areas of the implementation process will be covered in the interviews as
appropriate for each stakeholder group: Mobilization tools, Mobilizer training and learning,
Mobilization tool content and continuous improvement of content, Data collection, local area
coordination and national coordination.
Costing Cost data for social marketing and demand mobilization interventions will be shared
by the study team and compared to the same for control sites. Example fixed and variable
costs for service delivery, e.g., provider salaries, will be used to estimate the effects of
increased volumes on per overall per MC costs based on the interventions implemented.
Because there may be a difference in the number of interactions required between a mobilizer
and a client prior to the client agreeing to proceed with MC, or the time required (number of
minutes) per interaction, we will also utilize the following additional methods:
1. Mobilizer time tracking logbooks: all mobilizers will be asked to keep a logbook of
their time for a four-week period. This is to be filled out each day and includes
information about the clients mobilized, their segmentation and the time spent per
client.
2. Mobilizer observations and interviews: researchers will observe a sample of mobilizers
to better understand how they spend their time. We propose a sample of 3-4 mobilizers
(sites) per province across all four study provinces, for a total number of 12-16
mobilizers (sites). Researchers will silently observe the mobilizers while they interact
with clients for one day (from 8:00am-12:30pm) per site. While observing, researchers
will complete a duplicate mobilizer logbook (see #1 above) for comparison, adding any
relevant notes. The aim of the observation is to better understand how mobilizers
interact with clients and to verify correct completion of the logbooks.
We will use the time tracking data combined with other study data to estimate the average
number of interactions per client at intervention and control sites and the time per
interaction. We will also compare this data with the number of clients who choose to proceed
with MC.
Relevant information on site-by-site VMMC service delivery capacities and campaign activities
will be collected on a weekly basis to control for these variables in subsequent analyses.
The following information will be collected by site: # of Dorsal Slit Surgery provider-days
in the 7-day week, # of Shang Ringy provider-days in the 7-day week, # of active CIDRZ
mobilizer-days, # of active Non-CIDRZ mobilizer-days, # of MC incentives paid to non-CIDRZ
mobilizers, # prisoner MCs, Stock out Shang Ring commodities, Shang Ring-related stockout
details, Stock outs of other MC commodities, Dorsal Slit MC-related stockout details,
Campaign week, Campaign activities, IEC materials posted or distributed in the catchment
area, Notes and other comments.
