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

NCT04090723 | Active Not Recruiting

• 2 other identifiers: IRB00175899U34AA026220
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Alcohol; Harmful Use; Mental Health Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of participants linked to services

  3 months

• Number of participants with pre-exposure prophylaxis (PrEP) or condom uptake

  3 months

• Number of drinking days

  At 3 months

• Number of heavy drinking days

  At 3 months

Other Outcomes (1)

• Number of condom-less sex episodes

  3 months

Study Arms (1)

Computer-delivered brief alcohol intervention (CBI-CC)

EXPERIMENTAL

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

Interventions

CBI-CC with peer navigation BEHAVIORAL

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

Computer-delivered brief alcohol intervention (CBI-CC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Cis-gender and transgender women will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Geetanjali Chander

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 14, 2021
• Primary Completion: January 25, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)