HIV/AIDS
Conditions
Keywords
Behavioral sciences, HIV testing
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.
Interventions
BEHAVIORALStandard invitation to free HIV testing at mobile clinic
Participants receive standard invitation to same day HIV testing at mobile clinic.
BEHAVIORALU=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.
Sponsors
Desmond Tutu HIV Foundation
Bill and Melinda Gates Foundation
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men at least 18 years of age within the vicinity of the mobile Tutu Tester HIV testing mobile clinic
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Uptake | Recruitment took place over 12 days. | Number of Participants that were Invited and Came for HIV Testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Positivity | Recruitment took place over 12 days. | Number of Participants that Came for Testing and Obtained an HIV-Positive Result |
Countries
South Africa
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Messaging 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. | 68 |
| U=U Messaging 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. | 112 |
| Total | 180 |
Baseline characteristics
| Characteristic | U=U Messaging | Total | Standard of Care Messaging |
|---|---|---|---|
| Age, Continuous | 35 years | 35 years | 34 years |
| Race/Ethnicity, Customized Black or mixed race | 112 Participants | 180 Participants | 68 Participants |
| Region of Enrollment South Africa | 112 participants | 180 participants | 68 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 112 Participants | 180 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 544 | 0 / 504 |
| other Total, other adverse events | 0 / 544 | 0 / 504 |
| serious Total, serious adverse events | 0 / 544 | 0 / 504 |
Outcome results
Primary
HIV Testing Uptake
Number of Participants that were Invited and Came for HIV Testing
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Messaging | HIV Testing Uptake | 68 Participants |
| U=U Messaging | HIV Testing Uptake | 112 Participants |
p-value: 0.0195% CI: [1.44, 2.78]Regression, Logistic
Secondary
HIV Positivity
Number of Participants that Came for Testing and Obtained an HIV-Positive Result
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Messaging | HIV Positivity | 3 Participants |
| U=U Messaging | HIV Positivity | 7 Participants |
p-value: 0.4195% CI: [0.36, 5.78]Regression, Logistic