CTN 287: OPT-IN

About The Study

CTN 287 seeks to optimize care delivery and adherence to medications and follow-up through two interventions for people potentially exposed to HIV who are prescribed post-exposure prophylaxis (PEP). The first is a text message program that aims to keep patients engaged in care. The second investigates the potential for trained nurses in sexual health clinics to administer PEP and follow-up.

About The Disease

PEP dramatically reduces the transmission of HIV to people who have potentially been exposed to the virus. However, up to 24 per cent of people taking PEP do not complete the 28-day course of medication or are lost to follow-up. In addition, approximately 50 per cent do not show up for recommended follow-up testing at four months. Mobile phone-based text messaging may offer a simple, innovative solution to address these issues, but has not been studied in HIV PEP; this type of intervention will be tested in Stage 1 of this study.

Because PEP is delivered by a specialist physician, the cost can also be quite high. Sexual health nurses are ideally suited to provide this type of care, and nurse-led care would be significantly less expensive than current practices; this type of intervention will be tested in Stage 2 of this study.

Study Approach

CTN 287 is a randomized, controlled trial designed to test the efficacy of two interventions. Study researchers will recruit, HIV-negative adults who have started PEP treatment following a non-occupational exposure — 116 for Stage 1, 318 for Stage 2. In Stage 1 of the study, participants presenting for PEP care will be randomized to receive text message support for PEP or standard of care (no text message support). In Stage 2, participants presenting for PEP care will be randomized to receive nurse-led care in a sexual health clinic or standard of care (physician-led care in a hospital-based clinic).

All participants will receive a 28-day course of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF: Biktarvy®) during both stages of the study. Success of the interventions will be defined as the completion of a full course of PEP medications and communication of final HIV test results. The study team will also investigate other outcomes related to PEP, like other sexually transmitted and blood-borne infections and patient satisfaction, as well as the safety and tolerability of Biktarvy®.