Retention in PrEP Care for African American MSM in Mississippi

NCT03256435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-12-02

No results posted yet for this study

Summary

Innovative and novel HIV prevention interventions are urgently needed for African American (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk individuals. Although acceptability studies have demonstrated high interested in PrEP in the US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in real world settings are likely more complex, since payment for PrEP can be a substantial financial burden.

The ADAPT\_ITT approach (an approach to adapting behavioral interventions to new populations: Assessment, Decision, Administration, Production, Topical Experts - Integration, Training, Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP) intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the country. This study will include formative research to understand the cultural and social contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from these qualitative interviews will inform the study intervention which will be tested and refined in a dynamic open pilot evaluation.

Conditions

  • Preventive Medicine
  • HIV Infections

Interventions

BEHAVIORAL

RAMP PrEP 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.

Sponsors & Collaborators

  • University of Mississippi Medical Center

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Brown University

    lead OTHER

Principal Investigators

  • Amy S Nunn, ScD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-07
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03256435 on ClinicalTrials.gov