Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
This study is currently recruiting participants.
Verified January 2013 by University of Connecticut Health Center
Sponsor:
University of Connecticut Health Center
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01760759
First received: August 21, 2012
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.
| Condition | Intervention |
|---|---|
|
HIV |
Drug: antiretroviral therapy Behavioral: cell phone reminders Behavioral: contingency management for adherence |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of Connecticut Health Center:
Primary Outcome Measures:
- change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: baseline ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
- self-report of medication adherence [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 165 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Usual care
Patients receive antiretroviral therapy.
|
Drug: antiretroviral therapy
Patients receive antiretroviral therapy.
|
|
Experimental: Usual care plus cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
|
Drug: antiretroviral therapy
Patients receive antiretroviral therapy.
Behavioral: cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
|
|
Experimental: Usual care, reminders & contingency management for adherence
Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
|
Drug: antiretroviral therapy
Patients receive antiretroviral therapy.
Behavioral: cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
Behavioral: contingency management for adherence
Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age > 18 years
- initiating a new antiretroviral therapy regimen but not previously received > 2 antiretroviral therapy regimens and have a viral load >1000 copies/milliliter
- one or more risk factors for poor adherence
- English speaking
- willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
- able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form
Exclusion Criteria:
- living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
- received 2 or more prior antiretroviral therapy regimens
- participating in another antiretroviral therapy adherence study
- uncontrolled psychiatric disorders
- significant cognitive impairment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760759
Contacts
| Contact: Ellen M Ciesielski | 860.679.4556 | eciesielski@uchc.edu |
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030-3944 | |
| Contact: Ellen M Ciesielski 860-679-4556 eciesielski@gmail.com | |
| Principal Investigator: Nancy M Petry, Ph.D. | |
| Nathan Smith Clinic, Yale-New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Ellen Ciesielski 860-679-4556 eciesielski@uchc.edu | |
| Principal Investigator: Merceditas Villanueva, M.D. | |
| Sub-Investigator: Frederick Altice, M.D. | |
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
| Principal Investigator: | Nancy M Petry, Ph.D. | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT01760759 History of Changes |
| Other Study ID Numbers: | 12-205-2, R01HD075630 |
| Study First Received: | August 21, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Connecticut Health Center:
|
HIV Antiretroviral therapy adherence |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013