Long-Acting Injectable HIV PrEP PROs (IMPACT)

Anupama Raghuram MD

Status: Not yet enrolling

Conditions: HIV Pre-exposure Prophylaxis

Treatments: Other: Interview and survey to evaluate patient reported outcomes between the two medications.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07379658

25-N0026

Details and patient eligibility

About

The goal of this observational study is to learn about the real world effectiveness, patient satisfaction and clinical outcomes of LAI PrEP with lenacapavir (LEN) versus cabotegravir (CAB) through surveys and interviews.

Participants receiving or initiating LAI PrEP part of their regular medical care will complete surveys and interviews at three study visits over the course of 12 months.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 and older

2. Deemed eligible for HIV PrEP per healthcare provider

3. Receiving or initiating LAI PrEP, defined as:

   1. Current use of CAB or LEN LAI PrEP at study entry
   2. Initiation of either CAB or LEN LAI PrEP within 30 days of study enrollment

4. Receiving PrEP services in Louisville, KY

5. Able to provide informed consent and complete study assessments

Exclusion criteria

1. HIV diagnosis prior to enrollment
2. Currently on oral PrEP with no plans to switch to LAI PrEP
3. Hypersensitivities to LEN or CAB
4. Pregnant or planning to become pregnant
5. PI discretion

Trial design

128 participants in 2 patient groups

LEN LAI PrEP

Description:

Those receiving or initiating LEN LAI PrEP

Treatment:

Other: Interview and survey to evaluate patient reported outcomes between the two medications.

CAP LAI PrEP

Description:

Those receiving or initiating CAB LAI PrEP

Treatment:

Other: Interview and survey to evaluate patient reported outcomes between the two medications.