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

Primary Purpose

HIV, Alcohol; Harmful Use, Mental Health Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBI-CC with peer navigation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer-delivered brief alcohol intervention (CBI-CC)

Arm Description

Participants will be offered only the Computer-delivered brief alcohol intervention with peer navigation from beginning of study to the end.

Outcomes

Primary Outcome Measures

Intervention Feasibility as assessed by a 4-item scale
Feasibility of the Intervention will be assessed by the Mean/Median score on a 4 item scale that measures the extent to which the new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Score ranges from 5-20 on the 4 item scale. Higher score means greater feasibility.
Intervention Acceptability as assessed by a 4-item scale
Acceptability of the Intervention will be assessed by the Mean/Median score on a 4 item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Score ranges from 5-20 on the 4 item scale. Higher score means greater acceptability.

Secondary Outcome Measures

Number of participants linked to services
Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.
Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake
Uptake of HIV pre-exposure prophylaxis or condoms by participants.
Number of drinking days
Number of drinking days over past 30 days
Number of heavy drinking days
Number of heavy drinking days over past 30 days

Full Information

First Posted
September 12, 2019
Last Updated
August 31, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04090723
Brief Title
Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum
Official Title
Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 study will examine the implementation and effects of a computer delivered brief alcohol intervention with peer navigation/Community Health Worker compared to usual care on alcohol use, linkage to health services, and uptake of HIV prevention practices.
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/Community Health Worker 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 study of CBI-CC and peer navigation among 30 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol; Harmful Use, Mental Health Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer-delivered brief alcohol intervention (CBI-CC)
Arm Type
Experimental
Arm Description
Participants will be offered only the Computer-delivered brief alcohol intervention with peer navigation from beginning of study to the end.
Intervention Type
Behavioral
Intervention Name(s)
CBI-CC with peer navigation
Intervention Description
Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders
Primary Outcome Measure Information:
Title
Intervention Feasibility as assessed by a 4-item scale
Description
Feasibility of the Intervention will be assessed by the Mean/Median score on a 4 item scale that measures the extent to which the new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Score ranges from 5-20 on the 4 item scale. Higher score means greater feasibility.
Time Frame
3 months
Title
Intervention Acceptability as assessed by a 4-item scale
Description
Acceptability of the Intervention will be assessed by the Mean/Median score on a 4 item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Score ranges from 5-20 on the 4 item scale. Higher score means greater acceptability.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants linked to services
Description
Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.
Time Frame
3 months
Title
Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake
Description
Uptake of HIV pre-exposure prophylaxis or condoms by participants.
Time Frame
3 months
Title
Number of drinking days
Description
Number of drinking days over past 30 days
Time Frame
At 3 months
Title
Number of heavy drinking days
Description
Number of heavy drinking days over past 30 days
Time Frame
At 3 months
Other Pre-specified Outcome Measures:
Title
Number of condom-less sex episodes
Description
This will be counted to assess sexual risk behavior.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cis-gender and transgender women will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geetanjali Chander
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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