Clinical trial NCT06476847: A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Pre-exposure prophylaxis (PrEP)
Persistence
Vulnerable populations
Men having sex with men (MSM)
South Africa
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-26
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Target population recruitment (feasibility)
timeFrame: 18 months
measure: Fidelity to intervention (feasibility)
timeFrame: 18 months
measure: Acceptability by intervention participants
timeFrame: 18 months
Secondary outcomes:
measure: PrEP persistence at 3 months, 6 months, and 12 months
timeFrame: 4 months, 7 months, 13 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Univeristy School ofPublic Health, Global Health
state: Massachusetts
city: Pretoria
country: South Africa
facility: The Aurum POP INN Clinic
state: Gauteng
city: Cape Town
country: South Africa
facility: The Ivan Tom's Centre for Men's Health
state: Western Cape
Study officials:
affiliation: Boston University School of Public Health,Global Health
name: Lawrence C Long, PhD MCom
role: PRINCIPAL_INVESTIGATOR
References: