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

NCT ID: NCT04090723

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2026-11-01

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.

Conditions

HIV; Alcohol; Harmful Use; Mental Health Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBI-CC with peer navigation

Intervention Type: BEHAVIORAL

Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders

Interventions

CBI-CC with peer navigation

Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders

Intervention Type: BEHAVIORAL

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geetanjali Chander

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

U34AA026220

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00175899

Identifier Type: -

Identifier Source: org_study_id