NCT04364165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,048

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

July 1, 2023

Enrollment Period

16 days

First QC Date

April 23, 2020

Results QC Date

September 8, 2021

Last Update Submit

July 24, 2023

Conditions

HIV/AIDS

Keywords

Behavioral sciencesHIV testing

Outcome Measures

Primary Outcomes (1)

  • HIV Testing Uptake

    Number of Participants that were Invited and Came for HIV Testing

    Recruitment took place over 12 days.

Secondary Outcomes (1)

  • HIV Positivity

    Recruitment took place over 12 days.

Study Arms (2)

Standard of care messaging

EXPERIMENTAL

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

U=U messaging

EXPERIMENTAL

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

Interventions

Standard invitation to free HIV testing at mobile clinicBEHAVIORAL

Participants receive standard invitation to same day HIV testing at mobile clinic.

Standard of care messaging
U=U messaging and invitation to free HIV testing at mobile clinicBEHAVIORAL

Participants receive messaging about being undetectable equals untransmittable (U=U) and invitation to same day HIV testing at mobile clinic.

U=U messaging

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men at least 18 years of age within the vicinity of the mobile Tutu Tester HIV testing mobile clinic

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

  • 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.

    PMID: 34739334DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Philip Smith
Organization
Desmond Tutu Health Foundation (DTHF)
philip.smith@hiv-research.org.za
+27 21 650 1895

Study Officials

  • Alison Buttenheim, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Dvora Joseph Davey

    Desmond Tutu HIV Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

March 2, 2020

Primary Completion

March 18, 2020

Study Completion

August 1, 2020

Last Updated

February 26, 2024

Results First Posted

February 26, 2024

Record last verified: 2023-07

Locations

ZA(1)