An interventional study of Standard invitation to free HIV testing at mobile clinic and U=U messaging and invitation to free HIV testing at mobile clinic in HIV/AIDS, sponsored by University of Pennsylvania. Completed at 1 site in South Africa. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Screening
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.
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.
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This study's enrollment of 1,048 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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.
Behavioral: Standard invitation to free HIV testing at mobile clinic
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.
Behavioral: U=U messaging and invitation to free HIV testing at mobile clinic
Participants receive standard invitation to same day 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
Number of Participants that were Invited and Came for HIV Testing
Time frame: Recruitment took place over 12 days.
HIV Positivity
Number of Participants that Came for Testing and Obtained an HIV-Positive Result
Time frame: Recruitment took place over 12 days.
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.
| Milestone | Standard of Care Messaging | U=U Messaging |
|---|---|---|
| Started | 544 | 504 |
| Completed | 68 | 112 |
| Not completed | 476 | 392 |
Number of Participants that were Invited and Came for HIV Testing
| Participants | Standard of Care Messaging | U=U Messaging |
|---|---|---|
| HIV Testing Uptake | 68 | 112 |
Number of Participants that Came for Testing and Obtained an HIV-Positive Result
| Participants | Standard of Care Messaging | U=U Messaging |
|---|---|---|
| HIV Positivity | 3 | 7 |
Collected over 1 day from recruitment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care Messaging | 0/544 (0%) | 0/544 (0%) | 0/544 (0%) |
| U=U Messaging | 0/504 (0%) | 0/504 (0%) | 0/504 (0%) |
| Age, Continuous(years) | Standard of Care Messaging | U=U Messaging | Total |
|---|---|---|---|
| Median | 34 (26 to 44) | 35 (28 to 46) | 35 (27 to 45) |
| Sex: Female, Male(Participants) | Standard of Care Messaging | U=U Messaging | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 68 | 112 | 180 |
| Race/Ethnicity, Customized(Participants) | Standard of Care Messaging | U=U Messaging | Total |
|---|---|---|---|
| Black or mixed race | 68 | 112 | 180 |
| Region of Enrollment(participants) | Standard of Care Messaging | U=U Messaging | Total |
|---|---|---|---|
| South Africa | 68 | 112 | 180 |
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Acquired Immunodeficiency Syndrome→
University of Pennsylvania