Assessing the Impact of a Digital VMMC Platform

NCT06364891 | Completed

• 2 other identifiers: VMMC NEXUSINV-047777
• Study Type: interventional
• Target: 150,383
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Voluntary Medical Male Circumcision

Outcome Measures

Primary Outcomes (3)

• Total number of VMMC's conducted in intervention vs control

  The study will compare the difference in total number of VMMC's conducted in the intervention versus the control arm

  at 12 months

• Total number of VMMC's by segment

  The total number of VMMC's conducted in both the intervention and control arm will be compared by segment (ie the specific group type the men have been assigned to).

  at 12 months

• Total number of VMMC's by age

  The total number of VMMC's conducted in both the intervention and control arm will be compared and stratified by age group.

  at 12 months

Secondary Outcomes (3)

• Costing

  12 months

• Process evaluation

  12 months

• Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere.

  3 months post study completion

Study Arms (2)

Intervention

OTHER

Mobilisers in the intervention sites will be trained to use a digital mobile application to assist with segmenting clients and providing them with targeted messaging.

Other: VMMC NEXUS Digital application

Control

OTHER

Mobilisers in the control arm have been sensitised to the segmentation process but only have access to paper based resources.

Other: VMMC NEXUS Digital application

Interventions

VMMC NEXUS Digital application OTHER

A handheld digital application which supports segmentation of potential VMMC Clients

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• living in the catchment area 18 or older

You may not qualify if:

• nil

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (1)

Ministry of Health facilities

Lusaka, Lusaka Province, 10101, Zambia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Cluster randomised control study

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 15, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

ZA (1)