Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs

NCT07751978 | Not Yet Recruiting

• 2 other identifiers: IRB000298195R01TW012908
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.

Conditions

HIV

Keywords

HIV, women who use drugs, HIV care engagement, cognitive behavioral interventions

Outcome Measures

Primary Outcomes (2)

• HIV care engagement as assessed by the Number of participants who re-engage in HIV care

  Number of participants who re-engage in HIV care, defined as attending at least one HIV clinical care visit within 6 months after study enrollment, as documented in the Medical Information System (MIS).

  6 months

• Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication

  ART adherence, measured as the percentage of days covered by dispensed antiretroviral medication during the 6 months after study enrollment, based on Medical Information System pharmacy records.

  6 months

Study Arms (2)

Standard of Care (Control)

ACTIVE COMPARATOR

Standard of Care (Control Arm): Participants randomized to the control arm will continue to receive standard HIV and substance use care available through the participant's usual healthcare providers. In addition, participants will receive a one-time consultation with a social worker (in person or remotely) and complete study assessments at baseline, 3 months, and 6 months. No stigma-reduction intervention sessions will be provided.

Behavioral: standard of care

Intervention Arm

EXPERIMENTAL

Experimental Intervention Arm: Participants randomized to the intervention arm will continue to receive standard HIV and substance use care, a one-time consultation with a social worker, and complete study assessments at baseline, 3 months, and 6 months. In addition, they will participate in five in-person, small-group sessions delivered over approximately 2-3 weeks that focus on reducing HIV- and drug use-related stigma through cognitive-behavioral coping skills, communication and social support strategies, and HIV care engagement. Participants may also complete an optional individual session with a psychologist facilitator and a support person.

Behavioral: Light Inside

Interventions

Light Inside BEHAVIORAL

Adapted intersectional stigma reduction intervention consisting of five facilitator-led, small-group sessions delivered over approximately 2-3 weeks. The intervention uses cognitive-behavioral strategies to reduce HIV- and drug use-related stigma by strengthening adaptive coping, cognitive restructuring, communication skills, social support, and HIV care self-efficacy to improve HIV care engagement and antiretroviral therapy adherence. Participants may also complete an optional individual session with a psychologist facilitator and a support person.

Intervention Arm

standard of care BEHAVIORAL

Standard of Care: Participants will continue to receive standard HIV and substance use care available through their usual healthcare providers. In addition, they will receive a one-time consultation with a social worker, delivered either in person or remotely, to provide support and linkage to available services.

Standard of Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as female. Eligible participants are adult women (18 years of age or older) living with HIV who have a history of injection drug use documented in the national Medical Information System.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female; Age 18 years or older;
• Registered in the national Medical Information System (MIS) as having received an HIV-positive diagnosis;
• Registered in the MIS with injection drug use (IDU) as the probable mode of HIV transmission or with a documented history of injection drug use at any clinical visit.

You may not qualify if:

• Unable to provide informed consent;
• Unable to provide informed consent due to intoxication, the effects of drug use, or severe psychiatric impairment at the time of consent.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Fogarty International Center of the National Institute of Health: collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jill Owczarzak, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Owczarzak, PhD

CONTACT

667-306-8360; jillowczarzak@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08