Retention in PrEP Care for African American MSM in Mississippi
PrEP Uptake, Adherence, and Retention for African American MSM in Mississippi
2 other identifiers
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedDecember 2, 2021
November 1, 2021
4.7 years
April 14, 2017
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Presence of PrEP drug in blood samples
Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.
measured at 3 months
Presence of PrEP drug in blood samples
Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.
measured at 6 months
Self-reported adherence
Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)
measured at 3 months
Self-reported adherence
Self-reported adherence (with interviews) will supplement biological monitoring data at 3-month intervals, as well at the time of the intervention sessions (for both those in the intervention and comparison condition)
measured at 6 months
Secondary Outcomes (5)
PrEP Retention in Care over time
measured at 3 months
PrEP Retention in Care over time
measured at 6 months
Sexual risk behavior/behavioral adjustment
measured at baseline
Sexual risk behavior/behavioral adjustment
measured at 3 months
Sexual risk behavior/behavioral adjustment
measured at 6 months
Study Arms (2)
Treatment Arm
EXPERIMENTALRAMP PrEP initiation, adherence, and retention intervention package as well as standard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)
Control Arm
NO INTERVENTIONStandard of care (access to a financial advocate and clinical staff to support, facilitate, and assist in linkage to the established PrEP clinic at Open Arms and to facilitate initiation of, and obtaining, PrEP medications)
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age
- assigned male sex at birth
- African American race
- report having sex with another person assigned male at birth who identifies as a man within the last year
- report behavioral risk for HIV infection (consistent with the CDC guidelines for prescribing PrEP: unprotected anal intercourse (UAI) with at least one HIV-infected or unknown serostatus partner in the preceding 6 months)
- HIV-uninfected by antibody test
- able to understand and speak English (for consenting and counseling).
You may not qualify if:
- unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate
- for aims 2 and 3 only, participants who are positive for Hepatitis B antigen or diagnosed with renal insufficiency (Glomerular Filtration Rate\<50)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- University of Mississippi Medical Centercollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Open Arms Clinic
Jackson, Mississippi, 39216, United States
Related Publications (1)
Goedel WC, Coats CS, Chan PA, Sims-Gomillia CE, Brock JB, Ward LM, Mena LA, Nunn AS. A Pilot Study of a Patient Navigation Intervention to Improve HIV Pre-exposure Prophylaxis Persistence Among Black/African American Men Who Have Sex With Men. J Acquir Immune Defic Syndr. 2022 Jul 1;90(3):276-282. doi: 10.1097/QAI.0000000000002954.
PMID: 35312652DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy S Nunn, ScD
Brown University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
August 22, 2017
Study Start
September 7, 2016
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
December 2, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share