A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making
NCT Number: NCT06476847
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Infections
Interventions: BEHAVIORAL: PrEP persistence
Sponsor: Boston University
Collaborators: National Institute of Mental Health (NIMH)
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-11
Completion Date: 2026-06
Locations: Boston Univeristy School ofPublic Health, Global Health, Boston, Massachusetts, 02118, United States|The Aurum POP INN Clinic, City Of Tshwane, Gauteng, South Africa|The Ivan Tom's Centre for Men's Health, Cape Town, Western Cape, South Africa

Summary:
Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality that requires individuals to take a daily tablet to prevent themselves acquiring HIV. In South Africa while this is freely available in the public sector, persistence (that is continuation after initiation) is low amongst vulnerable populations, including men who have sex with men (MSM).

This study is a feasibility and acceptability study of a behavioral economics informed intervention to improve persistence amongst MSM newly initiating PrEP in South Africa. The goal of this study is to show that this approach is possible in a routine setting and gather the necessary data for a fully powered effectiveness trial.

Study participants will complete a baseline questionnaire and then be randomized to either receive standard of care (control) or to receive the intervention. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts. The intervention package aims to address present bias, optimism bias and salience. The intervention is delivered and the enrollment visit and then through mobile phone reminders / text messages. There is no further in person interaction after the initial interaction. Participants may be contacted for a telephonic enplane questionnaire. Outcome data is obtained from passive followup through routine medical record review with the primary end point being persistence at 3 months.

Primary Outcome Measures: Target population recruitment (feasibility), The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log., 18 months|Fidelity to intervention (feasibility), Percent of intervention interactions that are delivered in the first 3 months (Max interactions in 3 months = 2 visit reminders and 24 text messages (2 per week) = 26 total interactions)., 18 months|Acceptability by intervention participants, The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm., 18 months
Secondary Outcome Measures: PrEP persistence at 3 months, 6 months, and 12 months, PrEP persistence is defined as having at least a specific number of months of PrEP dispensed after study enrolment. The outcome is determined at the subsequent month to allow for variable timing around return visits.

For example persistence at 3 months is defined as having at least 90 days of PrEP dispensed by 4 months. Similarly, persistence at 6 months requires 180 days of PrEP dispensed by 7 months and persistence at 12 months requires 360 days of PrEP dispensed by 13 months., 4 months, 7 months, 13 months