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

Not Applicable

Not yet recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Intervention group	PrEP persistence	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.

Primary Outcome Measures

Name	Time	Method
Target population recruitment (feasibility)	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)	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	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 Outcome Measures

Name	Time	Method
PrEP persistence at 3 months, 6 months, and 12 months	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.

Locations (3): Boston Univeristy School ofPublic Health, Global Health
🇺🇸
Boston, Massachusetts, United States
The Aurum POP INN Clinic
🇿🇦
Pretoria, Gauteng, South Africa
The Ivan Tom's Centre for Men's Health
🇿🇦
Cape Town, Western Cape, South Africa

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial