Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Brief Title:
A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making
Sponsor:
Boston University
Organization:
Boston University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K01MH119923-01A1 | NIH | None | None |