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NCT Number: NCT06476847

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Aurum POP INN Clinic, Pretoria, Gauteng, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

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

Treatment and study plan

PrEP persistence

Behavioral

A light touch, once off, low cost. lay counsellor led intervention, designed to focus decision making around HIV prevention addressing present bias, salience and over optimism. The intervention package consists of evidence informed reminders, commitment pledges and planning prompts.

Primary outcomes

  1. Target population recruitment (feasibility)

    Time frame: 18 months

    The percent of participants enrolled from those that meet eligibility criteria and are offered will be assessed from screening log.

  2. Fidelity to intervention (feasibility)

    Time frame: 18 months

    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).

  3. Acceptability by intervention participants

    Time frame: 18 months

    The percent of participants that accept to participate in the intervention (set reminders/receive text messages) after being randomized to the intervention arm.

Secondary outcomes

  1. PrEP persistence at 3 months, 6 months, and 12 months

    Time frame: 4 months, 7 months, 13 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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The Role of Cognitive Biases in the Decision to Request, Offer, Accept and Continue on PrEP From a Health Care Provider and Patient Perspective (Men Who Have Sex With Men)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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