NCT04364165

Effect of U=U Messaging on HIV in South Africa

The Effect of Undetectable Equals Untransmittable (U=U) Messaging on HIV Testing Uptake Among South African Men: a Randomized Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,048 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This cluster randomized trial will investigate whether messaging about being undetectable equals untransmittable (U=U) designed through a participatory, user-centered approach increases HIV testing uptake within men in Klipfontein Mitchells Plain (KMP) district in Cape Town, South Africa.

Detailed description

This study will investigate the effect of participatory, user designed messaging to increase knowledge about U=U on HIV testing uptake within men in the Klipfontein Mitchells Plain (KMP) district, a resource-limited, densely populated, high HIV disease burden area in Cape Town, through a cluster randomized trial design. The study will be conducted in two phases: Phase 1 is a participatory, human-centered design framework will be used to develop U=U messages to increase HIV testing uptake in men. Phase 2 is a cluster randomized trial that will determine the effect of U=U messaging on HIV testing uptake. The primary outcome will be HIV testing uptake at a community-based mobile clinic. Secondary outcomes will include the proportion of males tested who are HIV-positive (and newly HIV positive). Men in the intervention group will receive invitation cards for mobile HIV testing that contain U=U messages. Men in the control group will receive invitation cards for mobile HIV testing that contain standard messaging. Mobile clinic days (i.e. clusters of men receiving invitation cards on a single day) will be the unit of randomization. Recruitment will be conducted by trained mobile clinic staff at high foot-traffic sites in the KMP community. Recruitment efforts will be focus on young men in multiple mobile testing sites that are located in areas within KMP.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
BEHAVIORAL	Standard invitation to free HIV testing at mobile clinic	Participants receive standard invitation to same day HIV testing at mobile clinic.
BEHAVIORAL	U=U messaging and invitation to free HIV testing at mobile clinic	Participants receive messaging about being undetectable equals untransmittable (U=U) and invitation to same day HIV testing at mobile clinic.

Timeline

• Start date: 2020-03-02
• Primary completion: 2020-03-18
• Completion: 2020-08-01
• First posted: 2020-04-27
• Last updated: 2024-02-26
• Results posted: 2024-02-26

Locations

1 site across 1 country: South Africa