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Effect of U=U Messaging on HIV in South Africa (U=U)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Standard invitation to free HIV testing at mobile clinic
U=U messaging and invitation to free HIV testing at mobile clinic
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV/AIDS focused on measuring Behavioral sciences, HIV testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Desmond Tutu HIV Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of care messaging

U=U messaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HIV testing uptake
HIV testing uptake at a community-based mobile clinic

Secondary Outcome Measures

HIV positivity
This outcome indicates whether a participant who comes for testing obtains an HIV-positive result

Full Information

First Posted
April 23, 2020
Last Updated
January 12, 2021
Sponsor
University of Pennsylvania
Collaborators
Desmond Tutu HIV Foundation, Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04364165
Brief Title
Effect of U=U Messaging on HIV in South Africa
Acronym
U=U
Official Title
The Effect of Undetectable Equals Untransmittable (U=U) Messaging on HIV Testing Uptake Among South African Men: a Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Desmond Tutu HIV Foundation, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Behavioral sciences, HIV testing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1048 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care messaging
Arm Type
Experimental
Arm Description
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.
Arm Title
U=U messaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard invitation to free HIV testing at mobile clinic
Intervention Description
Participants receive standard invitation to same day HIV testing at mobile clinic.
Intervention Type
Behavioral
Intervention Name(s)
U=U messaging and invitation to free HIV testing at mobile clinic
Intervention Description
Participants receive messaging about being undetectable equals untransmittable (U=U) and invitation to same day HIV testing at mobile clinic.
Primary Outcome Measure Information:
Title
HIV testing uptake
Description
HIV testing uptake at a community-based mobile clinic
Time Frame
Approximately 40 days
Secondary Outcome Measure Information:
Title
HIV positivity
Description
This outcome indicates whether a participant who comes for testing obtains an HIV-positive result
Time Frame
Approximately 40 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Buttenheim, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dvora Joseph Davey
Organizational Affiliation
Desmond Tutu HIV Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desmond Tutu HIV Foundation
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
34739334
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of U=U Messaging on HIV in South Africa

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