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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602376
• Other study ID #: R01MH129223
• Secondary ID: R01MH129223
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Desmond Tutu HIV Foundation
• Contact: Andrew Medina-Marino, PhD
• Phone: +27 87 821 1109
• Email: Andrew.Marino[@]hiv-research.org.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3642
• Est. completion date: May 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Men
• Treatment Adherence

Intervention

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
• 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.

Locations

Country	Name	City	State
South Africa	Cape Town Metro	Cape Town	Western Cape
South Africa	Buffalo City Metro	East London	Eastern Cape

Sponsors (4)

Lead Sponsor	Collaborator
Desmond Tutu HIV Foundation	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of Pennsylvania

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	% 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
Secondary	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