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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 : July 22, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Tina Y Simpson, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Adolescent Behavior HIV/AIDS PrEP Other: Telehealth Coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
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.
Other: Telehealth Coaching
Telehealth coaching to promote adherence

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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT03897725


Contacts
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Contact: Tina Simpson, MD 2056389345 tsimpson@peds.uab.edu

Locations
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United States, Alabama
William A. Daniel Adolescent Health Center Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Tina Y Simpson, MD    205-638-9345    tsimpson@peds.uab.edu   
Contact: Samantha Hill, MD    2056389345    shill@peds.uab.edu   
Sub-Investigator: Samantha Hill, MD         
Principal Investigator: Tina Simpson, MD         
Sub-Investigator: Latesha Elopre, MD         
Sub-Investigator: Mercedes Morales-Aleman, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Gilead Sciences
Investigators
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Principal Investigator: Tina Simpson, MD University of Alabama at Birminghahm

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Responsible Party: Tina Y Simpson, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03897725     History of Changes
Other Study ID Numbers: 000523914
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: See below
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: To be determined
Access Criteria: To be determined

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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