About this trial

The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 13-24 years, inclusive;

Reports anal or vaginal sex in the past year;

Is not living with HIV;

Weighs at least 35 kilograms (77 pounds);

Disqualifiers

Has counter-indications for PrEP according to guidelines and approved local label;

Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;

Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;

Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or

Trial design

Design model

Parallel

Treatments tested in this trial

LYPS
Other intervention
The LYPS intervention combines the use of a CHP to deliver PrEP services at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van) with an android-based smartphone or iphone app to support PrEP use between CHP visits.
Enhanced Standard of Care
Other intervention
Clinic-based PrEP services per usual standard of care (e.g., HIV and STI testing, clinical assessments for signs and symptoms of HIV and PrEP safety) with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.

Treatment groups

272 Participants

are divided into 2 treatment groups

Group A: LYPS InterventionExperimental treatment 1 intervention

Group B: Enhanced Standard of Care (eSOC) Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PrEP adherence at 6 months

Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.

Time frame

6 months

2

PrEP persistence at 6 months

Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 6 months.

Time frame

6 months

Secondary outcomes

1

PrEP adherence at 9 months

Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.

Time frame

9 months

2

PrEP persistence at 9 months

Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 9 months.

Time frame

9 months

Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts