Behavioral Counseling for HIV Adherence

Recruiting at 1 trial location

Overseen By Seth Kalichman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Must be taking: Antiretrovirals

Disqualifiers: No phone, No internet

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-16 weeks

400 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I am on prescribed antiretroviral therapy.

Confirmed HIV positive

I have not been following my HIV medication plan as prescribed.

Exclusion Criteria

Does not have access to the internet

Does not have access to a phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral counseling sessions to improve HIV treatment adherence, with sessions either adjusted to patient needs or fixed at five weekly sessions.

5-16 weeks

Weekly sessions (phone)

Follow-up

Participants are monitored for ART adherence and HIV viral load suppression over a 12-month period.

12 months

Regular assessments

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?

Group I: Continuous Counseling Active Control 1 Intervention

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.

Group II: Fixed Counseling Active Control 1 Intervention

Receives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3085946/

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.pdf

Positive 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/s12981-025-00763-3

Insights 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03394391

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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871621007249

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-w

Association 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-hiv

Antiretroviral 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 ...

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1440807/full

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).