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NCT04364165 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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.
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