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

Last updated: February 25, 2025
Sponsor: Boston University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv Infections

Treatment

PrEP persistence

Clinical Study ID

NCT06476847
H-45113
1K01MH119923-01A1
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months

  • Initiating PrEP on the date of enrolment

  • Access to a mobile phone

  • Willing and able to provide written informed consent in English

Exclusion

Exclusion Criteria:

  • PrEP status unknown

  • Previous PrEP experience within the last year (12 months from enrolment)

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: PrEP persistence
Phase:
Study Start date:
January 23, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The Aurum POP INN Clinic

    City Of Tshwane, Gauteng
    South Africa

    Site Not Available

  • The Aurum POP INN Clinic

    Pretoria, Gauteng
    South Africa

    Active - Recruiting

  • The Ivan Tom's Centre for Men's Health

    Cape Town, Western Cape
    South Africa

    Active - Recruiting

  • Boston Univeristy School ofPublic Health, Global Health

    Boston, Massachusetts 02118
    United States

    Site Not Available

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