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Retention in PrEP Care for African American MSM in Mississippi

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ClinicalTrials.gov Identifier: NCT03256435
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
University of Mississippi Medical Center
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brown University

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.


Condition or disease Intervention/treatment Phase
Preventive Medicine HIV Infections Behavioral: RAMP PrEP initiation, adherence, and retention intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PrEP Uptake, Adherence, and Retention for African American MSM in Mississippi
Actual Study Start Date : September 7, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
RAMP 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)
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.

No Intervention: 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 Open Arms and to facilitate initiation of, and obtaining, PrEP medications)



Primary Outcome Measures :
  1. Presence of PrEP drug in blood samples [ Time Frame: measured at 1 month ]
    Blood samples will be collected from participants at 1-, 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. William Clarke's lab at Johns Hopkins University for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.

  2. Presence of PrEP drug in blood samples [ Time Frame: measured at 3 months ]
    Blood samples will be collected from participants at 1-, 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. William Clarke's lab at Johns Hopkins University for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.

  3. Presence of PrEP drug in blood samples [ Time Frame: measured at 6 months ]
    Blood samples will be collected from participants at 1-, 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. William Clarke's lab at Johns Hopkins University for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.

  4. Self-reported adherence [ Time Frame: measured at 1 month ]
    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)

  5. Self-reported adherence [ Time Frame: measured at 3 months ]
    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)

  6. Self-reported adherence [ Time Frame: measured at 6 months ]
    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)


Secondary Outcome Measures :
  1. PrEP Retention in Care over time [ Time Frame: measured at 3 months ]
    This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. "Retention in care" is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.

  2. PrEP Retention in Care over time [ Time Frame: measured at 6 months ]
    This study will employ the Center for Disease Control (CDC) guidelines for retention in PrEP care, which include PrEP clinical visits every 3 to 6 months. "Retention in care" is defined as two PrEP follow up visits by month 8 of enrollment. While participants will only be randomized after attending the first PrEP clinic visit and receive a prescription from the study clinician for FTC/TDF, it is possible that they will not fill the prescription. The investigators will obtain a medical release from the participants in order that, at each assessment time-point, the study clinician can follow up with the pharmacy to determine whether or not the prescription was filled and picked up, and the date it was picked up (to assess time to initiation). Moreover, attendance at follow up clinic visits (months 3 and 6) will be calculated to assess retention in PrEP clinical care.

  3. Sexual risk behavior/behavioral adjustment [ Time Frame: measured at 1 month ]
    This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.

  4. Sexual risk behavior/behavioral adjustment [ Time Frame: measured at 3 months ]
    This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.

  5. Sexual risk behavior/behavioral adjustment [ Time Frame: measured at 6 months ]
    This study will use the AIDS-Risk Behavior Assessment (ARBA), a validated computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to 3 types of sexual behavior (anal, oral, vaginal) and assess detailed partner-by-partner sexual risk information by partner type (transactional, casual, main) and by HIV-status, protected/unprotected sex, and whether in the context of substance use in the prior 3 months.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-35 years of age
  • assigned male sex at birth
  • African American race
  • report having sex with another male 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).

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256435


Contacts
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Contact: Amy S Nunn, ScD 401-863-6568 amy_nunn@brown.edu

Locations
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United States, Mississippi
Open Arms Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Leandro Mena, MD    601-500-7660    lmena@umc.edu   
Sponsors and Collaborators
Brown University
University of Mississippi Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Amy S Nunn, ScD Brown University

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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03256435     History of Changes
Other Study ID Numbers: R34_PrEPMississippi
5R34MH109371-03 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases