Clinical trial NCT04364165: Effect of U=U Messaging on HIV in South Africa
Official title: The Effect of Undetectable Equals Untransmittable (U=U) Messaging on HIV Testing Uptake Among South African Men: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Behavioral sciences
HIV testing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Desmond Tutu HIV Foundation
name: Bill and Melinda Gates Foundation
First posted: 2020-04-27
Enrollment: 1048
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men at least 18 years of age within the vicinity of the mobile Tutu Tester HIV testing mobile clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: HIV Testing Uptake
timeFrame: Recruitment took place over 12 days.
Secondary outcomes:
measure: HIV Positivity
timeFrame: Recruitment took place over 12 days.
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
state: Western Cape
Study officials:
affiliation: University of Pennsylvania
name: Alison Buttenheim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmond Tutu HIV Foundation
name: Dvora Joseph Davey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith PJ, Joseph Davey DL, Schmucker L, Bruns C, Bekker LG, Medina-Marino A, Thirumurthy H, Buttenheim AM. Participatory Prototyping of a Tailored Undetectable Equals Untransmittable Message to Increase HIV Testing Among Men in Western Cape, South Africa. AIDS Patient Care STDS. 2021 Nov;35(11):428-434. doi: 10.1089/apc.2021.0101.