An interventional study of CBI-CC with peer navigation in HIV, Alcohol; Harmful Use and Mental Health Disorder, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 12 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
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Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Additional inclusion criteria for at risk women:
Exclusion Criteria:
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
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.
Time frame: 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.
Time frame: 3 months
Number of participants linked to services
Linkage to mental health, substance use, HIV pre-exposure prophylaxis or HIV clinical services.
Time frame: 3 months
Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake
Uptake of HIV pre-exposure prophylaxis or condoms by participants.
Time frame: 3 months
Number of drinking days
Number of drinking days over past 30 days
Time frame: At 3 months
Number of heavy drinking days
Number of heavy drinking days over past 30 days
Time frame: At 3 months
Number of condom-less sex episodes
This will be counted to assess sexual risk behavior.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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