HIV InfectionsNCT05602376
Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
A study testing U=U testing messaging scripts and U=U adherence messaging scripts in people with HIV Infections and Men, run by Desmond Tutu HIV Foundation at 2 sites in South Africa.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Men, Treatment Adherence
- What is being tested?
- U=U testing messaging scripts and U=U adherence messaging scripts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,642 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 31 Mar 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- AIM 1:
- male
- aged ≥15 years
- present a study issued invitation card to site receptionist
- ability to provide informed consent.
- AIM 2:
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa2 sites, 2 recruiting
- Recruiting
Cape Town Metro
Cape Town, Western Cape, 7405
Andrew Medina-Marino, PhD, +27 87 821 1109, Andrew.Marino@hiv-research.org.za
Andrew Medina-Marino, PhD
- Recruiting
Buffalo City Metro
East London, Eastern Cape, 5217
Andrew Medina-Marino, PhD, +27 87 821 1109, Andrew.Marino@hiv-research.org.za
Andrew Medina-Marino, PhD
About this study
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).
Read the 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.
- Conditions
- HIV Infections, Men, Treatment Adherence
- Being tested
- U=U testing messaging scripts, U=U adherence messaging scripts
- Keywords
- HIV, HIV testing, Men, U=U, Viral suppression, Treatment as Prevention, Viral load, ART uptake, Undetectable, Untransmittable
- Medical subject headings
- HIV Infections, Multiple Endocrine Neoplasia Type 1, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U=U testing messaging scriptsBehavioural
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 scriptsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-month visit
Secondary outcomes (2)
% 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.
Measured: 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.
Measured: 12-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start31 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,642 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Andrew Medina-Marino, PhD, Principal investigator, Desmond Tutu Health FoundationAlison Buttenheim, PhD, MBA, Principal investigator, Penn Nursing and Perelman School of Medicine, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602376
- Sponsor's protocol ID
- R01MH129223
- Other IDs
- R01MH129223
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
- ClinicalTrials.gov ID
- NCT05602376
- Acronym / sponsor ID
- R01MH129223
- Conditions
- HIV Infections, Men, Treatment Adherence
- Keywords
- HIV, HIV testing, Men, U=U, Viral suppression, Treatment as Prevention, Viral load, ART uptake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,642 participants (estimated)
- Lead sponsor
- Desmond Tutu HIV FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of Pennsylvania
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| U=U testing messaging scripts | Experimental | Behavioral: U=U testing messaging scriptsAim 1: Human-centred designed, behavioural nudge theory informed U=U messaging intervention to improve HIV testing uptake by men |
| U=U adherence messaging scripts | Experimental | Behavioral: U=U adherence messaging scriptsAim 2: Human-centred designed, behavioural nudge theory informed U=U messaging intervention to improve ART adherence, HIV viral suppression and retention in care |
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- male
- aged ≥15 years
- present a study issued invitation card to site receptionist
- ability to provide informed consent.
- cis-gender men
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U=U testing messaging scriptsOn 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 | Behavioural | U=U testing messaging scripts |
| U=U adherence messaging scriptsAfter 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. | Behavioural | U=U adherence messaging scripts |
Primary outcome
ART initiation among those invited to test for HIV
Time frame: 30-day follow-up period
Proportions of ART initiation among all people invited to test in each study arm over the year of Aim 1 data collection
Proportion with viral load suppression
Time frame: 6-month visit
Proportions of people who have documented viral suppression at the 6-month visit in each study arm during Aim 2
2 secondary outcomes
% who agree to testing
Time frame: Baseline
Proportion retained in care
Time frame: 12-month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Medina-Marino, PhD principal investigator
Desmond Tutu Health Foundation
Alison Buttenheim, PhD, MBA principal investigator
Penn Nursing and Perelman School of Medicine, University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U=U testing messaging scripts and U=U adherence messaging scripts in people with HIV Infections and Men, run by Desmond Tutu HIV Foundation at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Medina-Marino, PhD (+27 87 821 1109, Andrew.Marino@hiv-research.org.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART initiation among those invited to test for HIV (time frame: 30-day follow-up period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.