Intervention to Enhance PrEP Persistence for Black/African American Men

This study is testing a behavioral intervention called RAMP-It-Up Initiation, Adherence, and Retention Intervention. This intervention uses facilitated strengths-based case management to help Black/African American men who have sex with men (MSM) navigate the healthcare system and overcome challenges in getting PrEP (pre-exposure prophylaxis), a daily medication that dramatically reduces the risk of getting HIV. The study wants to see if this intervention helps people start and continue taking PrEP. You may be able to join if you are an HIV-negative Black/African American man, aged 18 or older, who has had male sex partners in the past year, and has not taken PrEP for at least 30 days. The study will measure how well participants take PrEP by looking at pharmacy records and drug levels in their bodies at 3 and 12 months.

Study design
This is an interventional study with a planned enrollment of 300 participants. It is a randomized controlled trial (RCT).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with measurements taken at 3 and 12 months.

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NCT06872307

Intervention to Enhance PrEP Persistence

Recruiting
NAAges 18+InterventionalPrevention
Brown University
~300 participants
Updated 2025-03-12 on ClinicalTrials.gov
What's tested:RAMP-It-Up Initiation, Adherence, and Retention Intervention

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP Adherence - Pharmacy Fill Data
Measured over 3 and 12 Month Follow Ups
+1 more outcome measured
HIV Prevention
HIV Infection Primary
3 sites across 3 states
District of Columbia1
Mississippi1
Rhode Island1

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Eligibility criteria

Inclusion

Aged 18 years and older
Assigned male sex at birth
Identify as Black/African American
Report at least one male sex partner in the past 12 months
Meet the CDC eligibility criteria for PrEP
Have not taken PrEP for at least 30 days
Are HIV-negative based on antibody testing at the time of enrollment
Understand and speak English
Able to provide informed consent
Agree to authorize study access to their EHR and pharmacy fill data. Eligible patients who are interested in participating will be consented and enrolled into the study.

Exclusion

Under the age of 18
Assigned female sex at birth
Does not identify as Black/African American
Has not had a male sex partner in the past 12 months
Does not meet CDC eligibility criteria for PrEP
Has taken PrEP within the last 30 days
HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment
Does not understand or speak English
Unable to provide informed consent
Does not agree to authorize study access to their EHR and pharmacy fill data.
  • PrEP Adherence - Pharmacy Fill Data3 and 12 Month Follow Ups

    The primary outcome will be PrEP adherence, given adherence is the definitive marker associated with protection from HIV infection. Adherence will be measured using pharmacy fill data in order to determine whether participants have picked up their prescription on a monthly basis.

  • PrEP Adherence - Drug Levels3 and 12 Month Follow Ups

    The primary outcome will be PrEP adherence, given adherence is the definitive marker associated with protection from HIV infection. Adherence will be assessed by dried blood spot sampling for PrEP drug levels.