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

Desmond Tutu HIV Foundation

Status: Enrolling

Conditions: Men; Treatment Adherence; HIV Infections

Treatments: Behavioral: U=U adherence messaging scripts; Behavioral: U=U testing messaging scripts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05602376

R01MH129223 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,642 estimated patients

Sex: Male

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,642 participants in 3 patient groups

U=U testing messaging scripts

Experimental group

Description:

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

Treatment:

Behavioral: U=U testing messaging scripts

U=U adherence messaging scripts

Experimental group

Description:

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

Treatment:

Behavioral: U=U adherence messaging scripts

Standard of Care (SoC) messaging

No Intervention group

Description:

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