NCT07725679

Brief Summary

The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women. Researchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Feb 2027

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

PrEP Adherence Monitoring

Outcome Measures

Primary Outcomes (1)

  • Urine TFV assay

    To determine the short-term adherence to PrEP between arms, we will look at the difference in the population proportions via a positive result on urine TFV assay over follow-up.

    Month 6 post-PrEP initiation

Study Arms (2)

SOC

NO INTERVENTION

Standard of Care

Intervention + SOC

ACTIVE COMPARATOR

Standard of care plus feedback on adherence

Diagnostic Test: POC urine TFV test with DLFB

Interventions

POC urine TFV test with DLFBDIAGNOSTIC_TEST

Women randomized to the intervention arm will take POC urine TFV tests and will receive drug level feedback (DLFB) alongside SOC counseling at each visit until exit.

Intervention + SOC

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV uninfected
  • Received daily oral PrEP one month prior, with a negative result on a urine assay one-month post PrEP initiation
  • Currently attending or willing to attend one of the study clinics for PrEP refills
  • Interest in continuing on oral PrEP despite adherence challenges
  • No known sero-discordant relationships
  • Living in Kiambu County and not planning to relocate for the next year

You may not qualify if:

  • Inadequate capacity to consent or complete planned study procedures
  • Do not speak English or Kiswahili
  • Test positive for HIV at screening
  • Concomitant participation in another PrEP adherence support study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jennnifer Velloza, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Morton

CONTACT

jfmorton@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate Assistant Professor: School of Medicine, Global Health

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

July 24, 2026

Record last verified: 2026-07