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Recruiting NCT05602376

NCT05602376 Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging

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Clinical Trial Summary
NCT ID NCT05602376
Status Recruiting
Phase
Sponsor Desmond Tutu HIV Foundation
Condition HIV Infections
Study Type INTERVENTIONAL
Enrollment 3,642 participants
Start Date 2023-03-31
Primary Completion 2026-12-31

Eligibility & Interventions

Sex Male only
Min Age 15 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
U=U testing messaging scriptsU=U adherence messaging scripts

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 3,642 participants in total. It began in 2023-03-31 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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).

Eligibility Criteria

Inclusion Criteria: AIM 1: 1. male 2. aged ≥15 years 3. present a study issued invitation card to site receptionist 4. ability to provide informed consent. AIM 2: 1. cis-gender men 2. aged ≥15 years 3. newly initiating ART (i.e., treatment naïve) or re-initiating ART after 6 months of being lost-to-care 4. live in Buffalo City or Cape Town Metro Health Districts 5. provide written informed consent

Contact & Investigator

Central Contact

Andrew Medina-Marino, PhD

✉ Andrew.Marino@hiv-research.org.za

📞 +27 87 821 1109

Principal Investigator

Andrew Medina-Marino, PhD

PRINCIPAL INVESTIGATOR

Desmond Tutu Health Foundation

Frequently Asked Questions

Who can join the NCT05602376 clinical trial?

This trial is open to male participants only, aged 15 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05602376 currently recruiting?

Yes, NCT05602376 is actively recruiting participants. Contact the research team at Andrew.Marino@hiv-research.org.za for enrollment information.

Where is the NCT05602376 trial being conducted?

This trial is being conducted at East London, South Africa, Cape Town, South Africa.

Who is sponsoring the NCT05602376 clinical trial?

NCT05602376 is sponsored by Desmond Tutu HIV Foundation. The principal investigator is Andrew Medina-Marino, PhD at Desmond Tutu Health Foundation. The trial plans to enroll 3,642 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology