HIV Treatment Adherence Dose Determination Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Connecticut

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed HIV positive

Confirmed prescribed antiretroviral therapy

Confirmed non-adherent to anti-retroviral therapy

Disqualifiers

Does not have access to a phone

Does not have access to the internet

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Self-Regulation Adherence Counseling

    Behavioral

    Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Continuous CounselingActive comparator 1 intervention
Group B: Fixed CounselingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Antiretroviral Therapy Adherence from Baseline to 12-Months

Medication adherence defined by percentage of medication doses taken as prescribed

Time frame
12-Month
2

Change in HIV Viral Load from Baseline to 12-months

Blood plasma HIV RNA

Time frame
12-months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Connecticut

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator