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

October 22, 2025 updated by: Boston University

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • The Aurum POP INN Clinic
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Univeristy School ofPublic Health, Global Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants randomized into this group will receive a behavioral economics informed intervention to improve persistence among amongst high risk men newly initiating PrEP in South Africa.
Behavioral: PrEP persistence
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.
No Intervention: Control group
Usual care for high risk men newly initiating PrEP in South Africa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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).
18 months
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months, 7 months, 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Lawrence C Long, PhD MCom, Boston University School of Public Health,Global Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-45113
  • 1K01MH119923-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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