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Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South

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ClinicalTrials.gov Identifier: NCT03897725
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Tina Y Simpson, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date November 26, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Adherence to PrEP [ Time Frame: 1 year ]
Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emtricitabine/tenofovir evidenced by dried blood spot sampling
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Adherence to PrEP [ Time Frame: 1 year ]
Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emitricitabine/tenofovir evidenced by dried blood spot sampling
Change History Complete list of historical versions of study NCT03897725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
Official Title  ICMJE Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South
Brief Summary This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2) Determine the acceptability and preliminary effectiveness of a telehealth intervention to promote adherence in adolescents.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Adolescent Behavior
  • HIV/AIDS
  • PrEP
Intervention  ICMJE Other: Telehealth Coaching
Telehealth coaching to promote adherence
Study Arms  ICMJE
  • Experimental: Telehealth Intervention
    Study participants will be randomized into either the control or experimental group. Participants in the intervention group will receive routine care which will follow the schedule from previous adolescent PrEP studies where participants are recommended to follow up at 4, 8, and 12 weeks and then every 3 months following initiation of PrEP. This group will also receive SMS texting every 4 weeks between in-person visits (weeks 16, 20, 28,32, 40, 44) reminding them to pick up their medication. The experimental group will also be seen in follow up every month for the first 3 months and then spaced out to visits every 3 months. The SMS texting will occur every 4 weeks between in-person visits, the experimental group will also have 2 tele-health visits (which will be conducted within a participant's home using an app) that will occur every 4 weeks between each of the traditional in-person visits to provide more frequent monitoring and counseling regarding adherence.
    Intervention: Other: Telehealth Coaching
  • No Intervention: Routine Care
    The control group will follow the schedule from previous adolescent PrEP studies where participants are recommended to follow up at 4, 8, and 12 weeks and then every 3 months following initiation of PrEP.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females between 15 to 21 years old
  • Established patients at the Adolescent Health Center
  • HIV negative

Exclusion Criteria:

  • HIV positive patients
  • patients weighing less than 35kg
  • patients with creatinine clearance <60 ml/min
  • patients with documented osteopenia or osteoporosis or history of pathologic fractures
  • patients with previous allergic reactions to either emtricitabine or tenofovir
  • patients who are on post-exposure prophylaxis for HIV (they can become eligible after completion of therapy)
  • patients with hepatic impairment
  • For patients who become pregnant, they may be able to continue on PrEP after a discussion with their obstetrics/gynecology (OB/GYN) provider.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tina Simpson, MD 2056389345 tsimpson@peds.uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897725
Other Study ID Numbers  ICMJE 000523914
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: See below
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: To be determined
Access Criteria: To be determined
Responsible Party Tina Y Simpson, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Tina Simpson, MD University of Alabama at Birminghahm
PRS Account University of Alabama at Birmingham
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP