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Behavioral Intervention

Behavioral Counseling for HIV Adherence

N/A
Recruiting
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed prescribed antiretroviral therapy
Confirmed non-adherent to anti-retroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine how many behavioral counseling sessions are needed to help people with HIV stick to their treatment.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves counseling rather than medication, traditional side effects aren't expected. However, participants may experience emotional or psychological discomfort discussing their condition during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on prescribed antiretroviral therapy.
Select...
I have not been following my HIV medication plan as prescribed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Antiretroviral Therapy Adherence from Baseline to 12-Months
Change in HIV Viral Load from Baseline to 12-months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Continuous CounselingActive Control1 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 CounselingActive Control1 Intervention
Receives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,733 Total Patients Enrolled
University of ConnecticutLead Sponsor
189 Previous Clinical Trials
160,448 Total Patients Enrolled

Media Library

Behavioral Self-Regulation Adherence Counseling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04577313 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Continuous Counseling, Fixed Counseling
Human Immunodeficiency Virus Infection Clinical Trial 2023: Behavioral Self-Regulation Adherence Counseling Highlights & Side Effects. Trial Name: NCT04577313 — N/A
Behavioral Self-Regulation Adherence Counseling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577313 — N/A
~77 spots leftby Nov 2025