ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2025-01-23
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06476847

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Not currently on pre exposure prophylaxis (PrEP); no PrEP within the last 12 months
  2. * Initiating PrEP on the date of enrolment
  3. * Access to a mobile phone
  4. * Willing and able to provide written informed consent in English
  1. * PrEP status unknown
  2. * Previous PrEP experience within the last year (12 months from enrolment)

Contacts and Locations

Principal Investigator

Lawrence C Long, PhD MCom
PRINCIPAL_INVESTIGATOR
Boston University School of Public Health,Global Health

Study Locations (Sites)

Boston Univeristy School ofPublic Health, Global Health
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Lawrence C Long, PhD MCom, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-01-23
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Pre-exposure prophylaxis (PrEP)
  • Persistence
  • Vulnerable populations
  • Men having sex with men (MSM)
  • South Africa

Additional Relevant MeSH Terms

  • HIV Infections