Determining the optimal number of counseling sessions to improve HIV treatment adherence
Official title: DOSE DETERMINATION TRIAL: The Start/Persist Studies
Run by University of Connecticut · NCT04577313 · Data updated 2026-11-12
This project will test how many behavioral counseling sessions help people with HIV who are not reliably taking ART to improve and maintain medication adherence and viral suppression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of Connecticut Academic / other |
| Locations | 2 sites (Storrs, Connecticut and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT04577313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people living with HIV who are prescribed ART but have documented low adherence and who have access to a phone and the internet.
✕Probably not a fit
People who are already adherent to ART, who lack phone or internet access, or who cannot participate in counseling sessions are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This dose-determination trial randomizes people with confirmed HIV on antiretroviral therapy but with documented low adherence to different 'doses' of behavioral self-regulation counseling to find the minimum number of sessions needed for durable viral suppression. The intervention uses evidence-based counseling delivered according to prespecified schedules and continues until adherence or suppression targets are met in some arms. The study will identify subgroups who need more or fewer sessions and will include cost analyses to guide implementation and policy decisions. Recruitment and intervention are conducted through University of Connecticut sites, including a Storrs site and an Atlanta field site, and require phone and internet access for participation.
Why it matters
Potential benefit: If successful, the results could help tailor counseling so more people achieve and maintain viral suppression while minimizing unnecessary sessions.
How similar studies have gone: Behavioral counseling approaches have improved ART adherence and viral suppression in prior work, but this is the first trial specifically designed to determine the optimal 'dose' of sessions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed HIV positive * Confirmed prescribed antiretroviral therapy * Confirmed non-adherent to anti-retroviral therapy Exclusion Criteria: * Does not have access to a phone * Does not have access to the internet
Where it's running
-
University of Connecticut
Storrs, Connecticut, United States Recruiting -
University of Connecticut Field Site
Atlanta, Georgia, United States Recruiting
Study contacts
- Study coordinator: Seth Kalichman, PhD
- Email: seth.k@uconn.edu
- Phone: 860 208 3706
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.