Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04316715|
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adherence, Medication||Behavioral: Lifesteps for PrEP Behavioral: Daily text message reminders||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care|
|Actual Study Start Date :||September 3, 2020|
|Estimated Primary Completion Date :||August 1, 2024|
|Estimated Study Completion Date :||August 1, 2024|
Experimental: Life-Steps for PreP
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.
Behavioral: Lifesteps for PrEP
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.
Behavioral: Daily text message reminders
Participants get daily text messages on their cell phone reminding them to take their PrEP medication.
No Intervention: Standard of Care
Participants in this group will not receive an intervention outside the standard of care.
- TFV-DP concentrations [ Time Frame: 3, 6, 9, 12, 15, and 18 months ]Medication adherence as reported by Tenofovir diphosphate (TFV-DP) concentrations measured using dried blood spot (DBS) testing.
- Wilson Medication Adherence self-report [ Time Frame: up to 18 months ]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.
- Retention in PrEP care [ Time Frame: 3, 6, 9, 12, 15, and 18 months ]The percentage of participant attendance at follow up visits over 18 month study participation
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): NCT04316715
|Contact: Marc Puccinelli, Ph.D.||firstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Marc Puccinelli, Ph.D. 305-243-3508 email@example.com|
|Principal Investigator: Steven A Safren, Ph.D.|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Contact: Jairan Sadeghi, BSN 857-313-6978 firstname.lastname@example.org|
|Principal Investigator: Kenneth Mayer, MD|
|Principal Investigator:||Steven A Safren, Ph.D.||University of Miami|