Lower Intersecting HIV-related Stigmas to Facilitate Treatment as Prevention (LIFT)

NCT07541131 | Enrolling By Invitation DMC

• 2 other identifiers: 808215R34DA059327
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to reduce HIV transmission risk among people who inject drugs (PWID) through a multilevel intervention known as LIFT. LIFT intervenes to build intragroup PWID support at the community-level to reduce overall drug use and stigma. LIFT also increases efficacy in navigating HIV services in the presence of structural stigma. Additionally, LIFT intervenes on abstinence-based drug use stigma at the health facility-level to improve clinic policy and staff interactions with clients. This is an implementation study to adapt and pilot a stigma reduction intervention with persons who inject drugs (PWID) in Kyrgyzstan. The intervention includes peer-led group sessions focused on stigma reduction and providing support to increase HIV prevention efficacy. The aim will be to adapt, refine, and pilot the intervention among PWID and methadone maintenance treatment (MMT) clinic staff. Participants will be randomized to the intervention or control arms.

Conditions

Stigma, Social; Drug Abuse Illicit; HIV (Human Immunodeficiency Virus)

Keywords

methadone maintenance treatment; stigma; HIV transmission risk; intersectional stigma; people who inject drugs; pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (4)

• Overall drug use stigma

  Changes in mean levels of overall drug use stigma among participants in the interventoin and control arm post-intervention will be measured as a mean composite score across multiple anticipated stigma sources (structural systems, family, healthcare workers, other people who inject/use drugs \[intragroup\]) and internalized drug use \[self\] stigma via the Substance Use Stigma Mechanisms Scale (SU-SMS)

  6 months

• Intragroup methadone maintenance treatment stigma

  Changes in mean levels of intragroup methadone maintenance treatment \[MMT\] stigma among participants in the intervneton and control arm post-intervention will be measured as a mean composite score from the MMT Stigma Mechanisms Scale (MMT-SMS), anticipated stigma source (other people who inject/use drugs \[intragroup\])

  6 months

• Intragroup HIV stigma

  Changes in mean levels of intragroup HIV stigma among participants in the interveniton and control arm post-intervention will be measured as a mean composite score from the HIV Stigma Mechanisms Scale (HIV-SMS), anticipated stigma source (other people who inject/use drugs \[intragroup\])

  6 months

• MOUD Use (including methadone and buprenorphine)

  Frequency of participants in the intervention and control arm who self-report (Yes, No) taking methadone or buprenorphine medications for opioid use disorder (MOUD) post-intervention

  6 months

Secondary Outcomes (1)

• PrEP Use

  6 months

Study Arms (4)

LIFT Intervention for People Who Use Drugs

EXPERIMENTAL

LIFT intervention will include 5 peer-led participatory group sessions to reduce stigma and cultivate intragroup cohesion and support to increase HIV prevention efficacy. The intervention content will focus on 1) Naming the Problem (how intersectional stigma manifests and affects health outcomes), challenging myths that drive intersectional stigma and replacing myths with facts related to 2) Fears about drug use and internalized stigma (understanding drug dependence as a health condition), 3) Fears about MMT (understanding methadone treatment as a process, not a last resort), 4) Frears about HIV (understanding the health benefits of knowing ones HIV status and PrEP as a treatment to prevent HIV), and 5) Responding to intersectional stigma (challenging stigma and recognizing human rights and other protections for people who use drugs).

Behavioral: LIFT for People Who Use Drugs

Waitlist Control for People Who Use Drugs

ACTIVE COMPARATOR

In the control district, all evidence-based HIV services will be delivered as standard of care. PWID living in the control district will have access to SSP outreach services, and MMT care can be accessed at the clinic located in the control district. Outreach workers and MMT clinic staff will not take additional steps to promote HIV testing or PrEP care referrals outside the clinic's standard practice. Once the active intervention phase is complete and the LIFT intervention group completes all study activities, PWID in the control district will be invited to participate in the same LIFT intervention activities described in the intervention arm.

Behavioral: LIFT for People Who Use Drugs

LIFT Intervention for MMT Staff

EXPERIMENTAL

The LIFT intervention will be comprised of 2-day participatory trainings focused on reducing the drivers of stigma within healthcare settings and will cover the following topics: 1) Building awareness and knowledge of what drug use stigma looks like in maintenance vs. abstinence-focused MMT services, 2) Reducing HIV transmission and promoting healthier options with clients via PrEP and SSP health promotion service referrals, 3) Building stress management, empathy, and reducing social distancing in the clinic setting, and 4) Understanding institutional maintenance of stigma reduction practices and focusing on developing internal clinic policies and practices.

Behavioral: LIFT for MMT Providers

Waitlist Control for MMT Staff

ACTIVE COMPARATOR

In the control district, all evidence-based HIV services will be delivered as standard of care. The MMT clinic in the control district will still provide MMT care and SSP outreach services can be accessed at the clinic located in the intervention district. Outreach workers and MMT clinic staff will not take additional steps to promote HIV testing or PrEP care referrals outside the clinic's standard practice. Once the active intervention phase is complete and the LIFT intervention group completes all study activities, MMT providers in the control district will be invited to participate in the same LIFT intervention activities described in the intervention arm.

Behavioral: LIFT for MMT Providers

Interventions

LIFT for People Who Use Drugs BEHAVIORAL

LIFT intervention will include 5 peer-led participatory group sessions to reduce stigma and cultivate intragroup cohesion and support to increase HIV prevention efficacy. The intervention content will focus on 1) Naming the Problem (how intersectional stigma manifests and affects health outcomes), challenging myths that drive intersectional stigma and replacing myths with facts related to 2) Fears about drug use and internalized stigma (understanding drug dependence as a health condition), 3) Fears about MMT (understanding methadone treatment as a process, not a last resort), 4) Frears about HIV (understanding the health benefits of knowing ones HIV status and PrEP as a treatment to prevent HIV), and 5) Responding to intersectional stigma (challenging stigma and recognizing human rights and other protections for people who use drugs).

LIFT Intervention for People Who Use Drugs; Waitlist Control for People Who Use Drugs

LIFT for MMT Providers BEHAVIORAL

The LIFT intervention will be comprised of 2-day participatory trainings focused on reducing the drivers of stigma within healthcare settings and will cover the following topics: 1) Building awareness and knowledge of what drug use stigma looks like in maintenance vs. abstinence-focused MMT services, 2) Reducing HIV transmission and promoting healthier options with clients via PrEP and SSP health promotion service referrals, 3) Building stress management, empathy, and reducing social distancing in the clinic setting, and 4) Understanding institutional maintenance of stigma reduction practices and focusing on developing internal clinic policies and practices.

LIFT Intervention for MMT Staff; Waitlist Control for MMT Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• reports injecting drugs or using drugs with someone who was injecting in the past 12 months before enrollment,
• is currently using illicit drugs (salts, synthetics, pharmaceuticals or opioids) including poly drug use,
• ≥ 18 years old,
• live in one of the two eligible districts
• report no intentions to move from Bishkek in the next 18 months,
• baseline rapid HIV test confirming HIV-negative status, and
• agree to participate in all intervention and assessment activities.
• ≥ 18 years old,
• work in one of the eligible clinics, and
• agree to participate in all intervention and assessment activities.

You may not qualify if:

• initiated injection drug use in the past 6 months,
• report not currently using illicit drugs,
• are \< 18 years old,
• live outside the two eligible districts,
• intend to move outside Bishkek in the next 18 months,
• do not agree to participate in all community-level intervention activities (i.e., five peer-led group sessions, four survey assessments over 18 months), or are confirmed to be living with HIV by self-report or baseline rapid test.

Sponsors & Collaborators

• University of California, San Diego: lead
• Johns Hopkins University: collaborator
• RTI International: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Public Foundation Den Sooluk Nuru

Bishkek, Kyrgyzstan

Location

MeSH Terms

Conditions

Social Stigma; Acquired Immunodeficiency Syndrome

Interventions

Lifting

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Laramie Smith, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 21, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)