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

ConditionHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Does not meet the inclusion criteria;

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard of Care (Control)Active comparator 1 intervention
Group B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months
2

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Ukrainian Institute on Public Health PolicyRecruiting01054, Kyiv, Kyiv OblastUkraineUkraine

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator