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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04090723
• Other study ID #: IRB00175899
• Secondary ID: U34AA026220
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 1, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• HIV
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• CBI-CC with peer navigation
Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of condom-less sex episodes	This will be counted to assess sexual risk behavior.	3 months
Primary	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
Primary	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	Number of participants linked to services	Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.	3 months
Secondary	Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake	Uptake of HIV pre-exposure prophylaxis or condoms by participants.	3 months
Secondary	Number of drinking days	Number of drinking days over past 30 days	At 3 months
Secondary	Number of heavy drinking days	Number of heavy drinking days over past 30 days	At 3 months