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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol; Harmful Use; HIV; Mental Health Disorder
• Intervention / Treatment: Behavioral: CBI-CC with peer navigation

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants linked to services	Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.	3 months
Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake	Uptake of HIV pre-exposure prophylaxis or condoms by participants.	3 months
Number of drinking days	Number of drinking days over past 30 days	At 3 months
Number of heavy drinking days	Number of heavy drinking days over past 30 days	At 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of condom-less sex episodes	This will be counted to assess sexual risk behavior.	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Geetanjali Chander, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): January 25, 2024
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: IRB00175899; U34AA026220 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No