Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Study ID
- NCT07751978
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Light Inside — BEHAVIORALAdapted 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.
- standard of care — BEHAVIORALStandard 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.
Study Details
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.
Key Dates
- First listed
- Aug 7, 2026
- Start date
- Oct 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Standard of Care (Control)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.
- Experimental: Intervention ArmExperimental 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.
Primary Outcome Measure
HIV care engagement as assessed by the Number of participants who re-engage in HIV care [ Time Frame: 6 months ]
Central Contacts
- Jill Owczarzak, PhD667-306-8360
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