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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Withdrawn

Conditions

PrEP
Adolescent Behavior
HIV/AIDS

Treatments

Other: Telehealth Coaching

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03897725
000523914

Details and patient eligibility

About

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.

Sex

Female

Ages

15 to 21 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Telehealth Intervention
Experimental group
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.
Treatment:
Other: Telehealth Coaching
Routine Care
No Intervention group
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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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