Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
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ClinicalTrials.gov Identifier: NCT01760759 |
Recruitment Status
:
Recruiting
First Posted
: January 4, 2013
Last Update Posted
: January 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: antiretroviral therapy Behavioral: cell phone reminders Behavioral: contingency management for adherence | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 165 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 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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
Contact: Ruth Fetter | 860.679.4556 | fetter@uchc.edu |
United States, Connecticut | |
University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030-3944 | |
Contact: Ruth Fetter 860-679-4556 fetter@uchc.edu | |
Principal Investigator: Nancy M Petry, Ph.D. | |
Nathan Smith Clinic, Yale-New Haven Hospital | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Ruth Fetter 860-679-4556 fetter@uchc.edu | |
Principal Investigator: Merceditas Villanueva, M.D. | |
Sub-Investigator: Frederick Altice, M.D. |
Principal Investigator: | Nancy M Petry, Ph.D. | UConn Health |
Responsible Party: | Nancy Petry, Professor, UConn Health |
ClinicalTrials.gov Identifier: | NCT01760759 History of Changes |
Other Study ID Numbers: |
12-205O-2 R01HD075630 ( U.S. NIH Grant/Contract ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | January 12, 2018 |
Last Verified: | January 2018 |
Keywords provided by Nancy Petry, UConn Health:
HIV Antiretroviral therapy adherence |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |