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Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum

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ClinicalTrials.gov Identifier: NCT04090723
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Unhealthy alcohol use among women with and at risk for HIV can interrupt critical steps in the HIV prevention and care continuum, is associated with HIV transmission risk behaviors, and contributes to health disparities. Thus it is critical to accurately identify alcohol use and implement alcohol interventions among women with and at risk for HIV to optimize health outcomes. The proposed pilot randomized clinical trial will examine the implementation and effects of a computer delivered brief alcohol intervention with peer navigation compared to usual care on alcohol use, linkage to health services, and uptake of HIV prevention practices.

Condition or disease Intervention/treatment Phase
HIV Alcohol; Harmful Use Mental Health Disorder Behavioral: CBI-CC with peer navigation Behavioral: Usual Care Not Applicable

Detailed Description:
Women account for 1 in 4 people living with HIV (PLWH) in the United States, and while African American (AA) women comprise only 14% of the US female population, African American women account for greater than 60% of women living with HIV (WLWH). Unhealthy alcohol use interrupts critical steps in the HIV prevention and care continuum (HPACC) and thus contributes to significant health disparities among at-risk and WLWH. The investigators have developed theory-based, in-person and computer-delivered brief interventions (CBI) for at risk and WLWH with alcohol use, demonstrating drinking reduction. However behavioral and structural barriers to optimal uptake of alcohol interventions and engagement in the HPACC remain, including mental health comorbidity and low knowledge, access, and use of HIV prevention practices such as HIV pre-exposure prophylaxis (PrEP). The goals of this proposal are two-fold: 1) to build on the investigators' current community partnerships to determine how to optimally implement evidence based alcohol treatment for at risk and WLWH in Baltimore, and 2) to determine whether the addition of information, motivational and peer navigator support related to comorbid mental health, and HIV prevention practices can enhance CBI and improve alcohol and HPACC outcomes among at risk and WLWH. To achieve these goals the investigators will use a Community Based Participatory Research (CBPR) approach, engaging patient and community stakeholders during all aspects of study development, and community pilot testing. In collaboration with the investigators' Community Advisory Board (CAB), the investigators will: 1) adapt the investigators' current CBI to address gaps in the HIV prevention and care continuum (CBI-CC). The investigators will conduct focus groups with both at risk and WLWH to tailor intervention manuals. 2) The investigators will conduct a pilot randomized controlled trial (RCT) of CBI-CC and peer navigation among 60 at-risk or WLWH with unhealthy alcohol use. The investigators hypothesize that the CBI-CC will result in reduction in drinking and heavy drinking days, increase linkage to substance use, and mental health services and HIV pre exposure prophylaxis (PrEP), and increase use of HIV prevention practices including condoms and PrEP. Through this U34 planning grant the investigators will partner with key stakeholders in the community to build capacity to deliver effective, evidence-based interventions at the nexus of alcohol and HIV for at risk and WLWH with alcohol misuse, and improve engagement in the HIV prevention and care continuum.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 arm Randomized trial with waitlist control
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Waitlist Control Group
Waitlist control group participants will receive the usual care from start of study with intervention offered at 3 months.
Behavioral: CBI-CC with peer navigation
Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders

Behavioral: Usual Care
Usual care provided by clinical site

Experimental: Computer-delivered brief alcohol intervention (CBI-CC)
Participants will be offered only the Computer-delivered brief alcohol intervention with peer navigation from beginning of study to the end.
Behavioral: CBI-CC with peer navigation
Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders




Primary Outcome Measures :
  1. Number of drinking days [ Time Frame: At 3 months ]
    Number of drinking days over past 30 days

  2. Number of heavy drinking days [ Time Frame: At 3 months ]
    Number of heavy drinking days over past 30 days


Secondary Outcome Measures :
  1. Number of participants linked to services [ Time Frame: 3 months ]
    Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.

  2. Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake [ Time Frame: 3 months ]
    Uptake of HIV pre-exposure prophylaxis or condoms by participants.


Other Outcome Measures:
  1. Number of condomless sex episodes [ Time Frame: 3 months ]
    This will be counted to assess sexual risk behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis-gender and transgender women will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At risk and Women with HIV ≥18 years
  • Alcohol misuse, defined as >7 standard drinks per week or > 3 drinks per occasion in the last three months or AUDIT-C ≥3
  • Able to understand English
  • Able to read at a 5th grade level.

Additional inclusion criteria for at risk women:

  • sex under the influence of alcohol or
  • exchanging sex for money or other resources or
  • unprotected vaginal or anal sex or illicit drug use in the last 12 months

Exclusion Criteria:

  • Pregnant (will be referred immediately to alcohol, mental health, substance use treatment as needed)
  • Non-English speaking
  • Unable to receive text messages
  • Actively psychotic, or otherwise not able to participate in the computer delivered brief intervention.

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): NCT04090723


Contacts
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Contact: Geetanjali Chander, MD 4432872030 gchande1@jhmi.edu
Contact: Hutton, PhD 443-287-2874 hhutton@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Jennifer Gaver    443-287-9858    jgaver1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Geetanjali Chander Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04090723     History of Changes
Other Study ID Numbers: IRB00175899
U34AA026220 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Mental Disorders