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

Primary Purpose

Adolescent Behavior, HIV/AIDS, PrEP

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Coaching
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Behavior

Eligibility Criteria

15 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • William A. Daniel Adolescent Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telehealth Intervention

Routine Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to PrEP
Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emtricitabine/tenofovir evidenced by dried blood spot sampling

Secondary Outcome Measures

Full Information

First Posted
March 28, 2019
Last Updated
November 5, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03897725
Brief Title
Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
Official Title
Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Contract terminated
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, HIV/AIDS, PrEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telehealth Coaching
Intervention Description
Telehealth coaching to promote adherence
Primary Outcome Measure Information:
Title
Adherence to PrEP
Description
Retention of adolescent females in PrEP care (attendance at follow-up visits) and adherence to emtricitabine/tenofovir evidenced by dried blood spot sampling
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Simpson, MD
Organizational Affiliation
University of Alabama at Birminghahm
Official's Role
Principal Investigator
Facility Information:
Facility Name
William A. Daniel Adolescent Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
See below
IPD Sharing Time Frame
To be determined
IPD Sharing Access Criteria
To be determined

Learn more about this trial

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

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