Health TrialsbyHealthPanel

Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging

ConditionsHIV InfectionsMenTreatment Adherence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age15+
SponsorDesmond Tutu HIV Foundation

About this trial

This study will evaluate the impact of U=U messaging and counseling on gaps in the HIV care cascade for men, including testing uptake and ART initiation (Aim 1), achieving viral suppression and retention in care (Aim 2) in two provinces in South Africa. The U=U message communicates the compelling idea that PLHIV who take ART and have an undetectable viral load (\<200 copies/mL) cannot sexually transmit HIV. Additionally, the investigators will conduct a multi-method evaluation to inform future implementation of U=U messaging interventions (Aim 3).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

male

aged ≥15 years

present a study issued invitation card to site receptionist

ability to provide informed consent.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • U=U testing messaging scripts

    Behavioral

    On site testing days randomized to the intervention, trained health promoters employed by the mobile testing venues will use U=U messaging scripts to invite men in the vicinity to seek HIV testing services on that day. On intervention days, the U=U messaging will also be used by counselors at the testing venue when referring those who test HIV positive to clinic-based ART initiation services provided by the local Department of Health

  • U=U adherence messaging scripts

    Behavioral

    After receiving standard ART initiation and adherence counselling from a DoH clinic nurse per South African National Guidelines, RCs will deliver a U=U message and hand participants a small business card with a brief U=U message on it. Participants will then receive monthly SMS booster messages (but can opt out) and monthly in-clinic booster messages during routine medical refill visits, again with a business card for messaging reinforcement.

Treatment groups

3,642 Participants
are divided into 3 treatment groups
Group A: U=U testing messaging scriptsExperimental treatment 1 intervention
Group B: U=U adherence messaging scriptsExperimental treatment 1 intervention
Group C: Standard of Care (SoC) messagingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ART initiation among those invited to test for HIV

Proportions of ART initiation among all people invited to test in each study arm over the year of Aim 1 data collection

Time frame
30-day follow-up period
2

Proportion with viral load suppression

Proportions of people who have documented viral suppression at the 6-month visit in each study arm during Aim 2

Time frame
6-month visit

Secondary outcomes

1

% who agree to testing

Proportions of testing uptake among all people invited to test in each study arm over the year of Aim 1 enrolment.

Time frame
Baseline
2

Proportion retained in care

Proportions of people who have a recorded viral load at their 12-month visit in each study arm during Aim 2.

Time frame
12-month visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Desmond Tutu HIV Foundation

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

National Institutes of Health (NIH)

Collaborator

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov
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