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A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoint(s) modified Show 4 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Sep 2026 to Feb 28, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoint revised
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 106
    • Study sites: 3 to 2
    • Primary and study completion dates: Jun 2026 to Sep 2026
    v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2025 to Jan 23, 2025
    • Site details revised at 3 of 3 sites
    v4
  4. Notable Start date: Nov 2024 to Feb 2025
    • Site details revised at 1 of 3 sites
    v3
  5. Notable Start date: Aug 2024 to Nov 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06476847
Lead Sponsor Boston University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
HIV Infections
Related terms HIV Infections
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov