Effect of U=U Messaging on HIV in South Africa

University of Pennsylvania

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: U=U messaging and invitation to free HIV testing at mobile clinic; Behavioral: Standard invitation to free HIV testing at mobile clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT04364165

834483

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,048 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,048 participants in 2 patient groups

Standard of care messaging

Experimental group

Description:

On mobile clinic days randomized to standard of care messaging, participants will receive standard invitation cards distributed at the Tutu Tester containing basic information encouraging HIV testing. Messages will encourage men to come in for HIV testing at the mobile clinic on the same day. A mobile clinic recruiter will deliver the standard invitation card and share a brief script including the standard Tutu Tester message that free HIV testing is available at the Tutu Tester, with no further information or motivation to test.

Treatment:

Behavioral: Standard invitation to free HIV testing at mobile clinic

U=U messaging

Experimental group

Description:

On mobile clinic days randomized to U=U messaging, participants will receive the U=U invitation cards distributed at the Tutu Tester that will seek to assuage the fears of testing HIV positive by conveying the message that HIV treatment makes it possible for HIV positive people to be untransmittable and to live normal lives. Messages will encourage men to come in for HIV testing at the mobile clinic on the same day. A mobile clinic recruiter will deliver the U=U invitation card and share a brief script asking people if they knew they could control HIV and that pills exist that can keep them healthy and ensure they don't transmit the virus to their sex partners, and that free HIV testing is available at the Tutu Tester.

Treatment:

Behavioral: U=U messaging and invitation to free HIV testing at mobile clinic