Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South

Status: Withdrawn
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 21
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Females between 15 to 21 years old

• Established patients at the Adolescent Health Center

• HIV negative

Locations
United States
Alabama
William A. Daniel Adolescent Health Center
Birmingham
Time Frame
Start Date: December 1, 2020
Completion Date: September 30, 2022
Treatments
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.
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.
Authors
Latesha Elopre, Samantha Hill, Tina Simpson, Mercedes Morales-Aleman
Related Therapeutic Areas
Sponsors
Collaborators: Gilead Sciences
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov