Recruiting

RAMP-IT-UP

Sponsor:

Brown University

Code:

NCT06872307

Conditions

HIV Prevention

HIV Infection Primary

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

RAMP-It-Up Initiation, Adherence, and Retention Intervention

Study Details

Brief summary:

The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young men. The intervention was found to be highly acceptable and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits.

Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among men in real-world community health center settings (CHCs).

Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among men attending CHCs compared to standard of care. The investigators will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1.

Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence , which aligns with federal Ending the HIV Epidemic and National HIV/AIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV and PrEP research in real-world clinical settings.

Conditions

HIV Prevention

HIV Infection Primary

Study ID

NCT06872307

Start date

Oct 1, 2024

Status verified date

Oct, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Aged 18 years and older
  • Assigned male sex at birth
  • 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 Criteria:

  • Under the age of 18
  • Assigned female sex at birth
  • 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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of Care (Control Arm)

Standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at study sites and to facilitate initiation of, and obtaining, PrEP medications)

experimental: RAMP-It-Up intervention

The RAMP-It-Up intervention focuses on personalized navigation informed by strengths-based case management. RAMP-It-Up consists of a brief in-person patient navigation session, ongoing bidirectional communication as needed, short (10-minute) phone or text message check-ins with the navigator, strengths-based case management strategies to overcome barriers, optional daily medication text reminders, transportation assistance to clinical visits as needed, and monthly calls to patients' pharmacies to assess prescription pick-up, allowing the navigator to provide real-time support in addressing barriers to PrEP initiation, adherence, and retention in care.

Interventions

RAMP-It-Up Initiation, Adherence, and Retention Intervention

The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills

Primary outcome measure

  • PrEP Adherence - Pharmacy Fill Data [ Time Frame: 3 and 12 Month Follow Ups ]
  • PrEP Adherence - Drug Levels [ Time Frame: 3 and 12 Month Follow Ups ]

Central Contacts and Locations

Central contacts

Dr. Amy Nunn, ScD

401-863-6568amy_nunn@brown.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Leandro Mena, MD

(601) 918-1194leandro.antonio.mena@emory.edu

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Thomas Dobbs, MD

(601) 984-5560tdobbs@umc.edu

The Rhode Island Public Health Institute

Recruiting

Providence, Rhode Island, United States, 02907

Contacts

Amy Nunn, ScD

401-863-6568amy.nunn@riphi.org

More Information

Sponsor

Brown University

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • pre-exposure prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Brown University on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.