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

No results posted yet for this study

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
  • University of Pennsylvania

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602376 on ClinicalTrials.gov