Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
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ClinicalTrials.gov Identifier: NCT01760759 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : September 13, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV | Behavioral: cell phone reminders Behavioral: contingency management for adherence | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus |
Actual Study Start Date : | November 2012 |
Actual Primary Completion Date : | April 2019 |
Actual Study Completion Date : | April 2019 |
Arm | Intervention/treatment |
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No Intervention: Usual care
Patients receive usual care from their medical providers.
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Experimental: Usual care plus cell phone reminders
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
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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.
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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. |
- change in copies of human immunodeficiency virus per milliliter [ Time Frame: Week 48 ]
- self-report of medication adherence [ Time Frame: baseline ]
- self-report of medication adherence [ Time Frame: Week 8 ]
- self-report of medication adherence [ Time Frame: Week 16 ]
- self-report of medication adherence [ Time Frame: Week 24 ]
- self-report of medication adherence [ Time Frame: Week 36 ]
- self-report of medication adherence [ Time Frame: Week 48 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age > 18 years
- initiating or on an antiretroviral therapy regimen and have a viral load >200 copies/mL in the past 6 months
- 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
- participating in another antiretroviral therapy adherence study
- uncontrolled psychiatric disorders
- significant cognitive impairment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760759
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030-3944 | |
Nathan Smith Clinic, Yale-New Haven Hospital | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Carla Rash, Ph.D. | UConn Health |
Responsible Party: | Carla Rash, Assistant Professor, UConn Health |
ClinicalTrials.gov Identifier: | NCT01760759 |
Other Study ID Numbers: |
12-205O-2 R01HD075630 ( U.S. NIH Grant/Contract ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | September 13, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Antiretroviral therapy adherence |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |