HIV Treatment Adherence Dose Determination Trial
DOSE DETERMINATION TRIAL: The Start/Persist Studies
2 other identifiers
interventional
400
1 country
2
Brief Summary
The proposed research will conduct the first dose-determination trial to find the optimal number of behavioral counseling sessions (dose) needed to achieve and sustain optimal HIV treatment adherence. The results of this study will determine how much intervention is needed for whom and at what cost to guide health policy and implementation of behavioral interventions designed to improve durable viral suppression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Sep 2020
Longer than P75 for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
August 29, 2025
August 1, 2025
6.2 years
September 23, 2020
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Antiretroviral Therapy Adherence from Baseline to 12-Months
Medication adherence defined by percentage of medication doses taken as prescribed
12-Month
Change in HIV Viral Load from Baseline to 12-months
Blood plasma HIV RNA
12-months
Study Arms (2)
Continuous Counseling
ACTIVE COMPARATORReceives 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.
Fixed Counseling
ACTIVE COMPARATORReceives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.
Interventions
Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.
Eligibility Criteria
You may qualify if:
- Confirmed HIV positive
- Confirmed prescribed antiretroviral therapy
- Confirmed non-adherent to anti-retroviral therapy
You may not qualify if:
- Does not have access to a phone
- Does not have access to the internet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Connecticut
Storrs, Connecticut, 06269, United States
University of Connecticut Field Site
Atlanta, Georgia, 30308, United States
Related Publications (1)
Kalichman SC, Kalichman MO, Cherry C, Eaton LA, Cruess D, Schinazi RF. Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):47-54. doi: 10.1097/QAI.0000000000001020.
PMID: 27105048BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
October 6, 2020
Study Start
September 1, 2020
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Data sets masked for all patient level identifying information.