Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
NCT05602376 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3642
Last updated 2024-11-01
Summary
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).
Conditions
- HIV Infections
- Men
- Treatment Adherence
Interventions
- BEHAVIORAL
-
U=U testing messaging scripts
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
- BEHAVIORAL
-
U=U adherence messaging scripts
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.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
National Institutes of Health (NIH)
collaborator NIH - collaborator OTHER
-
Desmond Tutu HIV Foundation
lead OTHER
Principal Investigators
-
Andrew Medina-Marino, PhD · Desmond Tutu Health Foundation
-
Alison Buttenheim, PhD, MBA · Penn Nursing and Perelman School of Medicine, University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2026-12-31
- Completion
- 2027-05-31
Countries
- South Africa
Study Locations
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