Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting
Brief Summary: Despite decades of traditional prevention efforts based on behavior change and condom use, Ontario has seen over 700 new HIV infections annually over the past 10 years. Post-exposure prophylaxis (PEP) is one such approach, in which uninfected persons use 28 days of antiretroviral medications (ARVs) shortly after an HIV exposure to minimize the risk of acquiring HIV. PEP is highly efficacious, is considered a standard of care intervention based on medical and ethical grounds, and is supported by treatment guidelines. Yet several implementation challenges have limited its clinical and public health impact in Ontario, where no formal PEP policy exists. Our proposal seeks to optimize two aspects of delivering PEP for sexual exposures (nPEP). Results will inform the development of a standardized approach to nPEP both province-wide and elsewhere.

Thus study has pragmatic, multicenter randomized controlled trial using a 2x2 factorial design to determine whether the proportion of nPEP patients that successfully complete follow-up:

1. is higher among those receiving mobile phone-based text messaging support than among those receiving standard care; and
2. is non-inferior among those receiving care from a sexual health clinic nurse compared to those receiving hospital-based physician care.

The prospective, randomized, non-blinded, 2x2 factorial trial that will enroll 318 study participants in Toronto. In Intervention A, we will randomize half of study participants to a text messaging support service ('WelTel'), in which a trained, community-based counselor provides standardized weekly 'check-in' messages during their 12-week course of PEP follow-up. The other half will receive standard care, which does not include any form of active outreach or reminders outside of scheduled appointments. In Intervention B, we will randomize half of participants to receive nurse-led care for PEP follow-up at a local sexual health clinic; the other half will receive standard care by a hospital-based ID physician. The specific activities for each follow-up visit will be clearly defined in a medical directive. In keeping with Ontario legislation on medical directives, nurses will review cases with their authorizing physician or nurse practitioner on a routine basis.


Options:
A: Arm Label: ARM 1 = TEXT MESSAGING SUPPORT; Type: EXPERIMENTAL; Interventions: Drug: nPEP, Behavioral: Text Messaging Support | Arm Label: ARM 2 = NO TEXT MESSAGING SUPPORT; Type: EXPERIMENTAL; Interventions: Drug: nPEP | Arm Label: ARM 3 = NURSE-LED nPEP; Type: EXPERIMENTAL; Interventions: Drug: nPEP, Other: Nurse-Led nPEP | Arm Label: ARM 4 = ID PHYSICIAN-LED nPEP,; Type: ACTIVE_COMPARATOR; Interventions: Drug: nPEP | Intervention Type: DRUG; Name: nPEP; Assigned to Arm(s): ARM 1 = TEXT MESSAGING SUPPORT, ARM 2 = NO TEXT MESSAGING SUPPORT, ARM 3 = NURSE-LED nPEP, ARM 4 = ID PHYSICIAN-LED nPEP, | Intervention Type: BEHAVIORAL; Name: Text Messaging Support; Assigned to Arm(s): ARM 1 = TEXT MESSAGING SUPPORT | Intervention Type: OTHER; Name: Nurse-Led nPEP; Assigned to Arm(s): ARM 3 = NURSE-LED nPEP
B: Intervention Type: BEHAVIORAL; Name: Pulse; Assigned to Arm(s): N/A
C: Arm Label: Text-Based Adherence Game; Type: EXPERIMENTAL; Interventions: Behavioral: Text-Based Adherence Game, Behavioral: Standard of Care (SOC) | Arm Label: Standard of Care (SOC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard of Care (SOC) | Intervention Type: BEHAVIORAL; Name: Text-Based Adherence Game; Assigned to Arm(s): Text-Based Adherence Game | Intervention Type: BEHAVIORAL; Name: Standard of Care (SOC); Assigned to Arm(s): Standard of Care (SOC), Text-Based Adherence Game
D: Arm Label: Text and Voice Messages; Type: EXPERIMENTAL; Interventions: Behavioral: Text and Voice Messages | Arm Label: Interactive Phone Call; Type: EXPERIMENTAL; Interventions: Behavioral: Interactive Phone Call | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Text and Voice Messages; Assigned to Arm(s): Text and Voice Messages | Intervention Type: BEHAVIORAL; Name: Interactive Phone Call; Assigned to Arm(s): Interactive Phone Call

Answer: A