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

Boston University

Status: Active, not recruiting

Conditions: HIV Infections

Treatments: Behavioral: PrEP persistence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06476847

H-45113

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

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: PrEP persistence

Control group

No Intervention group

Description:

Usual care for high risk men newly initiating PrEP in South Africa.