Effect of U=U Messaging on HIV in South Africa

NCT ID: NCT04364165

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1048 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-08-01

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard of care messaging

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.

Group Type: EXPERIMENTAL

Standard invitation to free HIV testing at mobile clinic

Intervention Type: BEHAVIORAL

Participants receive standard invitation to same day HIV testing at mobile clinic.

U=U messaging

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Participants receive messaging about being undetectable equals untransmittable (U=U) and invitation to same day HIV testing at mobile clinic.

Interventions

Standard invitation to free HIV testing at mobile clinic

Participants receive standard invitation to same day HIV testing at mobile clinic.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Desmond Tutu HIV Foundation

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Buttenheim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Dvora Joseph Davey

Role: PRINCIPAL_INVESTIGATOR

Desmond Tutu HIV Foundation

Locations

Desmond Tutu HIV Foundation

Cape Town, Western Cape, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 34739334 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

834483

Identifier Type: -

Identifier Source: org_study_id