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Clinical Trials/NCT06476847
NCT06476847
Active, not recruiting
Not Applicable

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)

Boston University2 sites in 2 countries106 target enrollmentJanuary 23, 2025
ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Boston University
Enrollment
106
Locations
2
Primary Endpoint
Target population recruitment (feasibility)
Status
Active, not recruiting
Last Updated
6 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 23, 2025
End Date
September 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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).

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

  • PrEP persistence at 3 months, 6 months, and 12 months(4 months, 7 months, 13 months)

Study Sites (2)

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