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

NCT05602376 | Recruiting DMC

• 1 other identifier: R01MH129223
• Study Type: interventional
• Target: 3,642
• Locations: 1 country
• Sites: 2

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).

Conditions

HIV Infections; Men; Treatment Adherence

Keywords

HIV; HIV testing; Men; U=U; Viral suppression; Treatment as Prevention; Viral load; ART uptake; Undetectable; Untransmittable

Outcome Measures

Primary Outcomes (2)

• 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

  30-day follow-up period

• 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

  6-month visit

Secondary Outcomes (2)

• % who agree to testing

  Baseline

• Proportion retained in care

  12-month visit

Study Arms (3)

U=U testing messaging scripts

EXPERIMENTAL

Aim 1: Human-centred designed, behavioural nudge theory informed U=U messaging intervention to improve HIV testing uptake by men

Behavioral: U=U testing messaging scripts

U=U adherence messaging scripts

EXPERIMENTAL

Aim 2: Human-centred designed, behavioural nudge theory informed U=U messaging intervention to improve ART adherence, HIV viral suppression and retention in care

Behavioral: U=U adherence messaging scripts

Standard of Care (SoC) messaging

NO INTERVENTION

Aim 1: SoC messaging scripts will be used to both invite men for CB-HTS and to refer those that test HIV-positive for DoH clinic-based ART initiation Aim 2: SoC messaging as part of ART initiation counselling, and as part of their HIV care and treatment program

Interventions

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 testing messaging scripts

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.

U=U adherence messaging scripts

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Desmond Tutu HIV Foundation: lead
• National Institute of Mental Health (NIMH): collaborator
• National Institutes of Health (NIH): collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

Buffalo City Metro

East London, Eastern Cape, 5217, South Africa

RECRUITING

Cape Town Metro

Cape Town, Western Cape, 7405, South Africa

RECRUITING

MeSH Terms

Conditions

HIV Infections; Multiple Endocrine Neoplasia Type 1; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Health Behavior; Behavior

Study Officials

• Andrew Medina-Marino, PhD

  Desmond Tutu Health Foundation

  PRINCIPAL INVESTIGATOR

• Alison Buttenheim, PhD, MBA

  Penn Nursing and Perelman School of Medicine, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Medina-Marino, PhD

CONTACT

+27 87 821 1109; Andrew.Marino@hiv-research.org.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Aim 1: Site-testing-days will be randomised 1:1 to implement either U=U (intervention) or SoC (Control) messaging scripts for both invitation-to-test and ART initiation. Aim 2: Randomization will be stratified by the 6 study clinics, to account for possible differences in the baseline viral loads of the catchment area populations initiating ART within each clinic with individual-level randomization will be used with random block sizes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two hybrid type 1 effectiveness-implementation randomized controlled trials to evaluate the impact of U=U messages on men's uptake of community-based HIV testing and treatment initiation (Aim 1), and achievement of viral suppression (Aim 2)

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: March 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Access Criteria: Based on contractual agreement

Locations

ZA (2)