Trial Outcomes & Findings for Effect of U=U Messaging on HIV in South Africa (NCT NCT04364165)
NCT ID: NCT04364165
Last Updated: 2024-02-26
Results Overview
Number of Participants that were Invited and Came for HIV Testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1048 participants
Primary outcome timeframe
Recruitment took place over 12 days.
Results posted on
2024-02-26
Participant Flow
Peer promoters were trained to deliver brief messages to men at selected high foot-traffic sites in the KMP community. Males ≥ 18 years of age within the vicinity of the mobile Tutu Tester HIV testing van and willing to consent to participate in the study were eligible for inclusion.
Unit of analysis: Mobile clinic days
Participant milestones
| Measure |
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.
Standard invitation to free HIV testing at mobile clinic: 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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
544 20
|
504 20
|
|
Overall Study
COMPLETED
|
68 5
|
112 7
|
|
Overall Study
NOT COMPLETED
|
476 15
|
392 13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of U=U Messaging on HIV in South Africa
Baseline characteristics by cohort
| Measure |
Standard of Care Messaging
n=68 Participants
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.
Standard invitation to free HIV testing at mobile clinic: Participants receive standard invitation to same day HIV testing at mobile clinic.
|
U=U Messaging
n=112 Participants
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.
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.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
35 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or mixed race
|
68 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
68 participants
n=5 Participants
|
112 participants
n=7 Participants
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Recruitment took place over 12 days.Population: The unit of randomization was Mobile Clinic Days; analysis of outcome measures summarizes the individual Number of Participants, or number of men who received the intervention.
Number of Participants that were Invited and Came for HIV Testing
Outcome measures
| Measure |
Standard of Care Messaging
n=544 Participants
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.
Standard invitation to free HIV testing at mobile clinic: Participants receive standard invitation to same day HIV testing at mobile clinic.
|
U=U Messaging
n=504 Participants
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.
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.
|
|---|---|---|
|
HIV Testing Uptake
|
68 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Recruitment took place over 12 days.Population: The unit of randomization was Mobile Clinic Days; analysis of outcome measures summarizes the individual Number of Participants, or number of men who received the intervention.
Number of Participants that Came for Testing and Obtained an HIV-Positive Result
Outcome measures
| Measure |
Standard of Care Messaging
n=68 Participants
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.
Standard invitation to free HIV testing at mobile clinic: Participants receive standard invitation to same day HIV testing at mobile clinic.
|
U=U Messaging
n=112 Participants
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.
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.
|
|---|---|---|
|
HIV Positivity
|
3 Participants
|
7 Participants
|
Adverse Events
Standard of Care Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
U=U Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place