Effect of U=U Messaging on HIV in South Africa

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 18, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Standard of care messaging
    • Participants randomized into this arm 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.
  • Experimental: U=U messaging
    • Participants randomized into this arm 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.

Clinical Trial Outcome Measures

Primary Measures

  • HIV testing uptake
    • Time Frame: Approximately 40 days
    • HIV testing uptake at a community-based mobile clinic

Secondary Measures

  • HIV positivity
    • Time Frame: Approximately 40 days
    • This outcome indicates whether a participant who comes for testing obtains an HIV-positive result

Participating in This Clinical Trial

Inclusion Criteria

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

  • None

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Collaborator
    • Desmond Tutu HIV Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alison Buttenheim, PhD, Principal Investigator, University of Pennsylvania
    • Dvora Joseph Davey, Principal Investigator, Desmond Tutu HIV Foundation

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