Clinical trial NCT05602376: Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
Official title: Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Men
Treatment Adherence
Keywords: HIV
HIV testing
Men
U=U
Viral suppression
Treatment as Prevention
Viral load
ART uptake
Undetectable
Untransmittable
Lead sponsor: Desmond Tutu HIV Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
name: University of Pennsylvania
First posted: 2022-11-02
Enrollment: 3642
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

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

Primary outcomes:
measure: ART initiation among those invited to test for HIV
timeFrame: 30-day follow-up period
measure: Proportion with viral load suppression
timeFrame: 6-month visit
Secondary outcomes:
measure: % who agree to testing
timeFrame: Baseline
measure: Proportion retained in care
timeFrame: 12-month visit
Other outcomes:
Locations:
city: East London
country: South Africa
facility: Buffalo City Metro
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Cape Town Metro
state: Western Cape
Study officials:
affiliation: Desmond Tutu Health Foundation
name: Andrew Medina-Marino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn Nursing and Perelman School of Medicine, University of Pennsylvania
name: Alison Buttenheim, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: