Effect of U=U Messaging on HIV in South Africa

HIV/AIDS Clinical Trial

— U=U  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364165
• Other study ID #: 834483
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1048
• Est. completion date: August 1, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Standard invitation to free HIV testing at mobile clinic
Participants receive standard invitation to same day HIV testing at mobile clinic.
• 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.

Locations

Country	Name	City	State
South Africa	Desmond Tutu HIV Foundation	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Bill and Melinda Gates Foundation, Desmond Tutu HIV Foundation

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Testing Uptake	Number of Participants that were Invited and Came for HIV Testing	Recruitment took place over 12 days.
Secondary	HIV Positivity	Number of Participants that Came for Testing and Obtained an HIV-Positive Result	Recruitment took place over 12 days.