HIV Treatment Adherence Dose Determination Trial
Part of paid clinical trials in Storrs, Connecticut.
- Sponsor
- University of Connecticut
- Study ID
- NCT04577313
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Self-Regulation Adherence Counseling — BEHAVIORALTelephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2020
- Status verified
- Aug 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Continuous CounselingReceives 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.
- Active Comparator: Fixed CounselingReceives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.
Primary Outcome Measure
Change in Antiretroviral Therapy Adherence from Baseline to 12-Months [ Time Frame: 12-Month ]
Central Contacts
- Seth Kalichman, PhD860 208 3706
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | Seth Kalichman, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Connecticut Field Site | Atlanta | Georgia | 30308 |
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