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

4. august 2026 oppdatert av: Johns Hopkins Bloomberg School of Public Health
The goal of this study is to test whether a program reduce stigma will help women living HIV remain in HIV care.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Atferdsmessig: standard of care
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.
Eksperimentell: Intervention Arm
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.
Atferdsmessig: Light Inside
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HIV care engagement as assessed by the Number of participants who re-engage in HIV care
Tidsramme: 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).
6 months
Antiretroviral therapy (ART) adherence as assessed by the percentage of days covered by dispensed antiretroviral medication
Tidsramme: 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.
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Samarbeidspartnere

Fogarty International Center of the National Institute of Health

Etterforskere

  • Hovedetterforsker: Jill Owczarzak, PhD, Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

4. august 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

7. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00029819
  • 5R01TW012908 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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