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

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Status: Withdrawn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)

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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.