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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH118043 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to test how different types of interventions may affect how someone takes their pre-exposure prophylaxis (PrEP) medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life-Steps for PreP | Experimental | Participants in this group will receive standard of care treatment plus daily text message reminders. A subset of participants who demonstrate continued adherence challenges will also receive 4-6 weekly sessions of the Lifesteps for PrEP intervention. |
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| Standard of Care | No Intervention | Participants in this group will not receive an intervention outside the standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifesteps for PrEP | Behavioral | Four weekly nurse delivered counseling sessions plus two optional booster sessions. Sessions last approximately 40-50 minutes each. Sessions employ cognitive behavioral (CBT) techniques, motivational interviewing (MI), and psychoeducation. |
| Measure | Description | Time Frame |
|---|---|---|
| TFV-DP concentrations | Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing. | 3, 6, 9, 12, 15, and 18 months |
| Wilson Medication Adherence self-report | Medication adherence as reported by the Wilson Medication Adherence self-report. The questionnaire has a total score ranging from 0-40, with a higher score indicating greater adherence. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in PrEP care | The percentage of participant attendance at follow up visits over 18 month study participation | 3, 6, 9, 12, 15, and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A Safren, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Fenway Health |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2026 | |
| Unrelease | Apr 21, 2026 | |
| Release | Jun 23, 2026 | |
| Unrelease | Jun 24, 2026 | |
| Release | Jul 1, 2026 | |
| Unrelease | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2026 | Apr 21, 2026 | |||
| Jun 23, 2026 | Jun 24, 2026 |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Daily text message reminders | Behavioral | Participants get daily text messages on their cell phone reminding them to take their PrEP medication. |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Jul 1, 2026 | Jul 1, 2026 |
| Jul 7, 2026 |
| D001519 | Behavior |