Clinical trial NCT04090723: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV
Alcohol; Harmful Use
Mental Health Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-09-16
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Intervention Feasibility as assessed by a 4-item scale
timeFrame: 3 months
measure: Intervention Acceptability as assessed by a 4-item scale
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants linked to services
timeFrame: 3 months
measure: Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake
timeFrame: 3 months
measure: Number of drinking days
timeFrame: At 3 months
measure: Number of heavy drinking days
timeFrame: At 3 months
Other outcomes:
measure: Number of condom-less sex episodes
timeFrame: 3 months
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Geetanjali Chander
role: PRINCIPAL_INVESTIGATOR
References: