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

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).

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Treatment Adherence; Men
• Intervention / Treatment: Behavioral: U=U testing messaging scripts; Behavioral: U=U adherence messaging scripts

Detailed Description

Increasing the coverage of HIV testing and treatment among people living with HIV (PLHIV) is essential for ending the global AIDS epidemic. Unfortunately, compared to women, men living with HIV (MLHIV) are less likely to know their HIV status, start anti retroviral treatment, or achieve viral suppression. Given that new HIV infections among women are driven, in part, by men's testing and treatment gaps, reducing the gender gap in testing uptake, treatment initiation and achievement of viral suppression by men must be prioritized in order to accelerate the decline in HIV incidence among women, improve men's HIV-related health outcomes and achieve the UNAIDS 95-95-95 goals by 2030.

In this study, the investigators evaluate the effectiveness of Undetectable Equals Untransmittable or "U=U" messaging for closing the gender gap in the HIV cascade. Particularly for men, the U=U message has the potential to accelerate progress towards the 95-95-95 targets by: 1) reducing anxiety associated with HIV testing (1st 95); 2) encouraging people who test HIV positive to initiate ART (2nd 95); and 3) reducing fear of transmitting HIV to sexual partners by promoting treatment adherence to achieve viral suppression (3rd 95). While there is a growing knowledge of Treatment as Prevention (TasP)/U=U among PLWH in Western countries, the reach and penetration of the U=U message in sub-Saharan Africa has been limited and few studies have tested the impacted of accessible U=U messages on ART uptake and adherence in sub-Saharan Africa.

Building on the investigators prior work on U=U messaging informed by behavioral economics and human-centered design, they propose to conduct 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). The investigators will also conduct a multi-method evaluation to inform future implementation of U=U messaging interventions. To improve the generalizability of the findings, the study will be conducted in two provinces in South Africa (Western and Eastern Cape). If effective, the intervention can shape global HIV testing and treatment counselling guidelines and practices. The expert, multi-institutional collaborations will allow for the application of previous research findings, leverage unique implementation platforms and resources, and rapidly disseminate the findings.

• Study Type: Interventional
• Enrollment (Estimated): 3642
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Medina-Marino, PhD; Phone Number: +27 87 821 1109; Email: Andrew.Marino@hiv-research.org.za

Study Locations

• South Africa
  • Eastern Cape
    • East London, Eastern Cape, South Africa, 5217
      • Recruiting
      • Buffalo City Metro
      • Contact: Andrew Medina-Marino, PhD; Phone Number: +27 87 821 1109; Email: Andrew.Marino@hiv-research.org.za
      • Principal Investigator: Andrew Medina-Marino, PhD
      • Principal Investigator: Alison Buttenheim, PhD, MBA
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7405
      • Recruiting
      • Cape Town Metro
      • Contact: Andrew Medina-Marino, PhD; Phone Number: +27 87 821 1109; Email: Andrew.Marino@hiv-research.org.za
      • Principal Investigator: Andrew Medina-Marino, PhD
      • Principal Investigator: Alison Buttenheim, PhD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: U=U testing messaging scripts; 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; 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
Experimental: U=U adherence messaging scripts; 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; 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.
No Intervention: Standard of Care (SoC) messaging; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	Baseline
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.	12-month visit

Collaborators and Investigators

• Sponsor: Desmond Tutu HIV Foundation
• Collaborators: National Institute of Mental Health (NIMH); University of Pennsylvania; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Andrew Medina-Marino, PhD, Desmond Tutu Health Foundation; Principal Investigator: Alison Buttenheim, PhD, MBA, Penn Nursing and Perelman School of Medicine, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Viral suppression; HIV testing; Men; Viral load; U=U; Treatment as Prevention; ART uptake; Undetectable; Untransmittable
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: R01MH129223 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Based on contractual agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No