Behavioral Counseling for HIV Adherence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal number of phone counseling sessions needed to help people with HIV adhere to their medication plans. The focus is on identifying the most effective number of sessions to keep the virus under control. The trial will test two groups: one with up to 16 flexible sessions and another with a fixed set of five sessions. Individuals diagnosed with HIV, prescribed antiretroviral therapy, and experiencing difficulty adhering to their medication plan might be suitable candidates. Participants need access to a phone and the internet to join. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for HIV patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, since it focuses on improving adherence to your existing HIV treatment, you will likely continue your current antiretroviral therapy.
What prior data suggests that this behavioral counseling is safe for improving HIV adherence?
A previous study showed that phone-based self-regulation counseling helped people take their medication more regularly compared to those who did not receive this counseling. This suggests that the counseling is manageable and effective in helping people follow their HIV treatment plan.
Another study found that cognitive behavioral therapy, a type of talk therapy, helped people reduce risky behaviors and increased their confidence in taking their medications. This indicates that similar therapies can be safe and helpful.
Overall, these findings suggest that behavioral counseling is safe for improving adherence to HIV medication. No major safety issues have been reported in these studies, making this type of support a promising option for those wanting to stay on track with their treatment.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it investigates two innovative approaches to improving HIV medication adherence through behavioral counseling. Unlike the standard fixed counseling methods that apply a one-size-fits-all approach, the continuous counseling method offers up to 16 weekly sessions that adapt to each patient's progress and needs, aiming for optimal adherence and viral suppression. This personalized approach could lead to better health outcomes by tailoring support to individual requirements. Meanwhile, the fixed counseling arm provides a structured but less flexible option, giving researchers a chance to compare the effectiveness of adaptive versus fixed counseling strategies.
What evidence suggests that this behavioral counseling is effective for HIV adherence?
This trial will compare two approaches to Behavioral Self-Regulation Adherence Counseling for HIV treatment adherence. Research has shown that this type of counseling can help individuals adhere better to their HIV treatment plans. One study found that this counseling improved self-reported adherence and reduced the amount of HIV in the blood. Another study demonstrated that taking medication as prescribed can make antiviral treatments up to 90% more effective. These findings suggest that behavioral counseling plays a crucial role in helping individuals maintain their health by closely following their treatment plans.12678
Are You a Good Fit for This Trial?
This trial is for individuals who are HIV positive, have been prescribed antiretroviral therapy but are not sticking to their treatment plan. Participants must have access to the internet and a phone to be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive behavioral counseling sessions to improve HIV treatment adherence, with sessions either adjusted to patient needs or fixed at five weekly sessions.
Follow-up
Participants are monitored for ART adherence and HIV viral load suppression over a 12-month period.
What Are the Treatments Tested in This Trial?
Interventions
- Behavioral Self-Regulation Adherence Counseling
Trial Overview
The study is testing how many sessions of behavioral self-regulation adherence counseling are needed for effective HIV treatment adherence. It aims to find the right balance that improves long-term viral suppression and informs health policies.
How Is the Trial Designed?
2
Treatment groups
Active Control
Receives up to 16 weekly behavioral counseling sessions over the phone to achieve optimal medication adherence. Counseling adjusts to patient needs and determines the dose to achieve optimal adherence / HIV suppression, in contrast to the fixed dose condition that does not adjust to patient response.
Receives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Connecticut
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Brief Behavioral Self-Regulation Counseling for HIV ...
The intervention demonstrated significant improvements in self-reported adherence to HIV treatment and reductions in HIV viral load. Phone-delivered voice ...
2.
lgbtq.ph.ucla.edu
lgbtq.ph.ucla.edu/wp-content/uploads/2025/05/UTF-8positive_steps__enhancing_medication_adherence_and.8-11.pdfPositive STEPS: Enhancing Medication Adherence and
We conducted a 2-arm RCT from March 2018 to March. 2023 to examine the efficacy of a behavioral and technology- based intervention, “positive ...
3.
aidsrestherapy.biomedcentral.com
aidsrestherapy.biomedcentral.com/articles/10.1186/s12981-025-00763-3Insights into medication adherence among HIV-positive patients
Medication adherence can increase the likelihood of success in antiviral treatments by up to 90% [11]. In this regard, evidence has shown that ...
The Effectiveness of SMS in Improving Antiretroviral ...
Adolescents on ART have lower viral suppression rates (49%) when compared with both adults and younger children (72.8% and 57%) and this is one of the most ...
Promising outcomes from a cognitive behavioral therapy ...
Those who received TXT-CBT reduced HIV-risk behaviors and increased their self-efficacy related to medication adherence. •. TXT-CBT is a potentially scalable ...
6.
aidsrestherapy.biomedcentral.com
aidsrestherapy.biomedcentral.com/articles/10.1186/s12981-024-00657-wAssociation of ART regimen and adherence to viral suppression
This study aimed to determine whether certain ART medications are more “forgiving” of poor adherence in achieving viral suppression.
7.
clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/adherence-antiretroviral-therapy-children-and-adolescents-living-hivAntiretroviral Adherence in Children and Adolescents with ...
With modern ART, the level of adherence needed to achieve viral suppression may be as low as 80% to 85%.4,5 However, emerging data indicate that ...
Associations of stigma, loneliness, and treatment self ...
Introduction: Medication adherence contributes to poor HIV outcomes, especially among people with HIV and Substance use disorder (SUD).
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