HIVLight InsideNCT07751978
Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs
A study testing Light Inside in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
Trial summary
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Light Inside
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 18 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Ukrainian Institute on Public Health Policy
Kyiv, Kyiv Oblast, 01054
Tetiana Kiriazova, PhD, +380 44 209-21-41, kiriazova@uiphp.org.ua
About this study
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.
Read the detailed description
This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.
- Conditions
- HIV
- Being tested
- Light Inside, standard of care
- Keywords
- HIV, women who use drugs, HIV care engagement, cognitive behavioral interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light InsideBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Light Inside |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start18 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Jill Owczarzak, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751978
- Sponsor's protocol ID
- IRB00029819
- Other IDs
- 5R01TW012908
- Acronym
- Light Inside
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of an Intersectional Stigma Reduction Intervention to Increase HIV Care Engagement Among Women Who Use Drugs
- ClinicalTrials.gov ID
- NCT07751978
- Acronym / sponsor ID
- Light Inside / IRB00029819
- Conditions
- HIV
- Keywords
- HIV, women who use drugs, HIV care engagement, cognitive behavioral interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.
Detailed description
This study will evaluate the feasibility, acceptability, and preliminary efficacy of a behavioral intervention designed to reduce intersectional HIV- and drug use-related stigma and improve HIV care engagement among women living with HIV who use drugs in Ukraine. A total of 100 eligible women will be randomized to either the intervention or a control condition. Participants in both groups will receive standard HIV care and a one-time consultation with a social worker, complete baseline, 3-month, and 6-month assessments, and have HIV care outcomes assessed. Participants assigned to the intervention will additionally attend five small-group sessions focused on stigma coping, cognitive-behavioral skills, communication, social support, and HIV care engagement, with an optional individual session involving a support person. The study will examine effects on HIV care engagement, antiretroviral therapy adherence, and stigma-related psychosocial outcomes to inform a future fully powered randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control) | Active comparator | Behavioral: standard of careStandard 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. |
| Intervention Arm | Experimental | Behavioral: Light InsideExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light InsideAdapted 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. | Behavioural | Intervention Arm |
| standard of careStandard 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. | Behavioural | Standard of Care (Control) |
Primary outcome
HIV care engagement as assessed by the Number of participants who re-engage in HIV care
Time frame: 6 months
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).
Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill Owczarzak, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Inside in people with HIV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Owczarzak, PhD (667-306-8360, jillowczarzak@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV care engagement as assessed by the Number of participants who re-engage in HIV care (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.