SAVVY Intervention for HIV

(SAVVY Trial)

Overseen By Allison Agwu, MD, SCM

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Antiretrovirals

Disqualifiers: Drug resistance, Pregnancy, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve HIV treatment for adolescents and young adults currently on antiretroviral therapy (ART). The main goal is to help participants find the best treatment option, including the possibility of switching to long-acting injectable ART. Participants receive counseling on their treatment choices and assistance in accessing their preferred treatment. This study suits those on ART who have not reached viral suppression (a low level of HIV in the blood) or are already virally suppressed and seek to optimize their treatment approach. As an unphased trial, it offers participants the opportunity to explore personalized treatment options and improve their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions 'disallowed medications' as an exclusion criterion. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What prior data suggests that the SAVVY Intervention is safe for adolescents and young adults with HIV?

Research has shown that the SAVVY approach for HIV treatment, which includes both pills and long-lasting injections of antiretroviral drugs (ART), has been studied in various projects. While specific safety data on this exact approach is limited, long-lasting injectable ARTs, like those potentially used in the SAVVY study, are generally well-tolerated. The FDA has already approved these treatments for other uses, indicating their safety.

Previous studies on similar treatments have found that most people tolerate them well, though some experience mild side effects. For instance, a study on a different SAVVY approach (unrelated to ART) found more participants reported reproductive tract issues compared to a placebo group. However, this does not directly relate to the ART considered in the SAVVY study.

Overall, the SAVVY approach aims to tailor treatment to individual preferences and needs, improving outcomes while prioritizing safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAVVY Intervention for HIV because it explores a personalized approach to antiretroviral therapy (ART). Unlike traditional oral ART, which is the standard treatment for maintaining viral suppression, this intervention includes a choice for patients to switch to long-acting injectable ART (LAI-ART), providing an alternative that could improve adherence and convenience. The intervention also features the SAVVY long-acting access team (SLAT), which helps navigate the logistics and prior authorizations needed for accessing LAI-ART. This approach not only addresses viral suppression but also prioritizes patient choice and quality of life, potentially transforming how HIV is managed.

What evidence suggests that the SAVVY Intervention could be effective for improving viral suppression in adolescents and young adults with HIV?

Research has shown that the SAVVY program, which provides personalized counseling and assistance with treatment decisions, can significantly aid young people with HIV. In this trial, participants will undergo CHOICE counseling to decide whether to continue with oral ART or switch to LAI-ART, based on their viral suppression status. Studies have found that when patients actively choose their HIV treatments, they are more likely to continue their care and maintain low virus levels. Specifically, one small study found that 83% of participants who received similar support managed to control the virus. This suggests that the SAVVY approach could effectively help teens and young adults with HIV improve their health. ^{2 6 7 8 9}

Who Is on the Research Team?

Allison Agwu, MD, SCM

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults living with HIV who face challenges in achieving viral suppression. It's designed to help those struggling with the standard oral ART treatment by offering personalized options, including long-acting injectable ART.

Inclusion Criteria

Willing to sign informed consent (including communication with one's primary HIV provider)

I am on antiretroviral therapy.

Exclusion Criteria

Pregnancy

Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI would impair participation

Severe illness/hospitalization at the time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CHOICE counseling to determine ART preferences and may switch to LAI-ART if virally suppressed. Monitoring occurs every 2 weeks for 3 months for those not initially suppressed.

12 months

Baseline, 3, 6, 9, and 12 month assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of viral suppression and quality of life indicators.

12 months

Ongoing assessments

What Are the Treatments Tested in This Trial?

Interventions

• SAVVY Intervention

Trial Overview The SAVVY study tests a new approach called CHOICE counseling combined with an evidence-based tool, HIV-ASSIST, to optimize personal ART choice. It also aims to facilitate access to long-acting injectable ART and understand barriers in its uptake.

How Is the Trial Designed?

Group I: Virally suppressed at entry (VL<50 copies/mL) Experimental Treatment 1 Intervention

Participants are on ART and are currently virally suppressed. Participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. The SAVVY long-acting access team (SLAT) will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.

Group II: Not virally suppressed at entry (VL >= 50 copies/mL) Experimental Treatment 1 Intervention

Participants are on ART and are currently not virally suppressed. The participants will undergo CHOICE counseling and determine if the participant prefers to stay on oral ART or switch to LAI-ART. As the participant will not be able to switch to LAI-ART given the viremic state, the participant will have q2 week monitoring (for 3 months) of the viral load and if the participant becomes suppressed will then be offered CHOICE counseling again and can select at that point if the participant wants to stay on oral or transition to LAI-ART. The SAVVY long-acting access team will facilitate prior authorizations and other logistic matters needed to access LAI-ART. The study will not provide drug. If the participant has not become suppressed by 3 months the participant would continue to be monitored by standard of care practices. Participants will participate in a baseline, 3, 6, 9 and 12 month detailed assessment of viral suppression and quality of life indicators, etc.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

An active surveillance pilot program in Namibia successfully monitored adverse events (AEs) in 413 HIV+ adults receiving first-line antiretroviral therapy (ART), with a high recording rate of AEs during follow-up visits.

The study found that 66 patients experienced a total of 119 AEs, with a notable incidence rate of 33 AEs per 100 person-years, highlighting the importance of ongoing monitoring for safety in ART regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia. Mann, M., Mengistu, A., Gaeseb, J., et al.[2018]

In a pilot study involving 18 marginally housed, substance-using individuals with HIV, the 'DAART+' intervention led to 83% of participants achieving an undetectable viral load, indicating significant effectiveness in managing their HIV.

Participants also reported modest increases in condom usage, suggesting that the intervention may positively influence risk reduction behaviors alongside improving medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary findings of an intervention integrating modified directly observed therapy and risk reduction counseling. Mitchell, CG., Freels, S., Creticos, CM., et al.[2007]

A multidisciplinary approach that included individualized and culturally sensitive interventions significantly improved adherence to an enfuvirtide-based HIV treatment regimen in a patient with a history of poor adherence.

The comprehensive strategies, which involved daily observed therapy and support for symptom management and social relationships, led to notable improvements in the patient's clinical markers and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. Nicca, D., Moody, K., Elzi, L., et al.[2007]

HIV treatment failure (HIVTF) is reported more frequently in Africa, with 19.1% of all cases coming from this region, particularly from South Africa, which accounted for 86.8% of the reports.

Children and adolescents are significantly more affected by HIVTF compared to adults, with adjusted odds ratios indicating a higher risk in these younger populations, highlighting the need for improved medical care for them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of HIV treatment failure in Africa using the WHO Pharmacovigilance data. Miantezila Basilua, J., Mesia Kahunu, G., Pochart, P., et al.[2021]

Early entry into and retention in HIV care are crucial for improving patient outcomes, as starting antiretroviral therapy (ART) early and adhering to it can significantly enhance health results.

Implementing evidence-based tools and behavioral interventions in clinical settings can optimize adherence to ART and monitor patient engagement, which is especially important for vulnerable populations like pregnant women and those with mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. Eaton, EF., Saag, MS., Mugavero, M.[2017]

A pilot training program for 70 healthcare providers in South Africa aimed at improving HIV prevention messaging unexpectedly resulted in a decrease in the delivery of prevention messages to HIV positive patients, with the overall message delivery rate dropping from 56% to 50%.

The training did not significantly affect the delivery of prevention messages to HIV negative patients, who maintained a stable message delivery rate of 32%, suggesting that the training's effectiveness may vary based on patient status and that a more focused approach to messaging could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre/post evaluation of a pilot prevention with positives training program for healthcare providers in North West Province, Republic of South Africa. Kemp, CG., de Kadt, J., Pillay, E., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06886971

Strategies to AchieVe Viral Suppression for Youth With HIV The SAVVY intervention includes CHOICE counseling and shared decision-making regarding ART preference (informed by the evidence-based HIV-ASSIST) and ...

2. trialx.com trialx.com/clinical-trials/listings/304453/strategies-to-achieve-viral-suppression-for-youth-with-hiv/

Strategies to AchieVe Viral Suppression for Youth With HIV Toward this aim, the investigators has shown that AHIV are more likely to be retained in care and achieve and maintain VS if cared for at ...

3. withpower.com withpower.com/trial/phase-hiv-infections-10-2024-120c5

SAVVY Intervention for HIV (SAVVY Trial) In a pilot study involving 18 marginally housed, substance-using individuals with HIV, the 'DAART+' intervention led to 83% of participants achieving an ...

4. reporter.nih.gov reporter.nih.gov/project-details/10632026

A randomized trial of a Community Health Worker intervention for ... CHAMPS: A randomized trial of a Community Health Worker intervention for persons living with HIV in two high priority settings. Project Number5R01NR019758-04.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0001312

SAVVY® (C31G) Gel for Prevention of HIV infection in Women Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2129116/

SAVVY® (C31G) Gel for Prevention of HIV infection in ... However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2190795/

SAVVY Vaginal Gel (C31G) for Prevention of HIV Infection We investigated the safety and effectiveness of 1.0% SAVVY in preventing male-to-female transmission of HIV in a population of young, sexually ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00001091

Safety and Effectiveness of Four Anti-HIV Drug ... The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations.

9. bmjopen.bmj.com bmjopen.bmj.com/content/12/5/e056929

Systematic review protocol of the effectiveness of HIV ... This systematic review aims to synthesise current global evidence on the effectiveness of HIV prevention interventions for reducing risky sexual behaviour among ...