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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD075630 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Patients receive usual care from their medical providers. | |
| Usual care plus cell phone reminders | Experimental | Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing. |
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| Usual care, reminders & contingency management for adherence | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cell phone reminders | Behavioral | Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing. |
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| Measure | Description | Time Frame |
|---|---|---|
| change in copies of human immunodeficiency virus per milliliter | Week 48 | |
| self-report of medication adherence | baseline | |
| self-report of medication adherence | Week 8 | |
| self-report of medication adherence | Week 16 | |
| self-report of medication adherence | Week 24 | |
| self-report of medication adherence | Week 36 | |
| self-report of medication adherence | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Rash, Ph.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030-3944 | United States | ||
| Nathan Smith Clinic, Yale-New Haven Hospital |
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| contingency management for adherence | Behavioral | Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time. |
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| New Haven |
| Connecticut |
| 06520 |
| United States |