- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07541131
Lower Intersecting HIV-related Stigmas to Facilitate Treatment as Prevention (LIFT) (LIFT)
Reducing HIV-related Intersectional Stigma and Risk Among People Who Inject Drugs in a High-risk International Setting
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Kyrgyzstan is located within a region-Eastern Europe and Central Asia (EECA)-experiencing the world's most rapidly expanding HIV epidemic. Furthermore, this regional HIV epidemic is predominantly concentrated among persons who inject drugs (PWID). PWID face unique challenges engaging in the HIV care continuum. Intersecting stigmas related to HIV, drug use, and drug treatment (i.e., methadone maintenance therapy) uniquely amplify HIV risk in this population and impede engagement in effective HIV prevention services such as needle and syringe exchange programs, methadone maintenance therapy, and HIV antiretroviral therapy (among PWID with HIV) and Pre-exposure prophylaxis (PrEP; among PWID without HIV).
Kyrgyzstan and the EECA are battling a growing HIV epidemic among PWID not seen in other regions. UNAIDS 2022 report states the EECA has one of the fastest growing HIV epidemics in the world, with a 48% increase in new infections since 2010. HIV prevalence among PWID in Kyrgyzstan is high (14.3% PWID vs. 0.2% general population), and HIV incidence is rapidly increasing among sex partners among whom the proportion of new infections increased from 63.0% in 2017 to 86.7% in 2022. Underreporting of stigmatized injection, and same-sex behaviors may partially explain this increase in HIV incidence attributed to sexual transmission. Female sex partners of PWID who reported no injection risk and HIV-negative partners had an HIV prevalence of 4.4% but an HCV prevalence of 13.0%, indicating a high probability of injection-related transmission risk.
As a regional HIV service implementation leader, Kyrgyzstan's approach can inform future EECA HIV responses. Of the 16 UNAIDS-monitored EECA nations, SSP and MMT coverage is low in most, and MMT is illegal in three. MMT was the only form of opioid use disorder medication in seven EECA nations, including Kyrgyzstan although now buprenorphine is also offered as of August 2025. The historic roots of EECA addiction treatment stem from the punitive abstinence-focused legacy of the Soviet-era Narcology system, and MMT is more often seen as an effective HIV prevention tool than an effective drug use treatment given the emergence of MMT in the region via HIV service donor funding. Kyrgyzstan is one of the few EECA nations to provide free evidence-based HIV services nationally (HIV testing, SSP, MMT, antiretroviral therapy [ART], PrEP). Yet, the full HIV prevention power of these services remains untapped. The 2021 national surveillance data report 848 of ~25,000 PWID in Kyrgyzstan are using MMT, and 56% had consistent sterile syringe access. This is concerning as HIV testing is significantly tied to the recent use of these services. Few PWID (8.4%) are estimated to have received PrEP since 2020.
Multilevel strategies to reduce stigma and improve uptake of evidence-based prevention services (e.g., MMT, PrEP) to lower HIV incidence among PWID in this region are needed. Similarly, the U.S. can learn how to increase HIV-related service use among PWID through interventions like LIFT, designed to reduce multilevel intersectional stigma.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bishkek, Kyrgyzstan
- Public Foundation Den Sooluk Nuru
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Eligible PWID will meet the following inclusion criteria:
- 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.
Eligible MMT Staff participants inclusion criteria:
All clinical, administrative, and support staff at our two clinical MMT sites and implementation sites are eligible to participate. Inclusion criteria are:
- ≥ 18 years old,
- work in one of the eligible clinics, and
- agree to participate in all intervention and assessment activities.
Exclusion Criteria:
PWID Exclusion criteria are:
- 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.
Note, to protect against unintended HIV status disclosure, PWID who are living with HIV (PWID-HIV) and who meet all other inclusion criteria will be given the option to participate in all study activities. However, PWID-HIV will not be included in our analytic sample of 68 PWID. Study staff will screen all potentially eligible PWID to confirm eligibility, schedule the baseline assessment, and confirmatory rapid HIV test before randomization, with an interviewer not affiliated with LIFT intervention activities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LIFT Intervention for People Who Use Drugs
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 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).
|
|
Active Comparator: Waitlist Control for People Who Use Drugs
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.
|
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).
|
|
Experimental: LIFT Intervention for MMT Staff
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.
|
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.
|
|
Active Comparator: Waitlist Control for MMT Staff
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall drug use stigma
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PrEP Use
Time Frame: 6 months
|
Frequency of participants in the intervention and control arm who self-report (Yes, No) taking pre-exposure prophylaxis (PrEP) post-intervention
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laramie Smith, PhD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Behavior
- Social Behavior
- Acquired Immunodeficiency Syndrome
- Social Stigma
- Mechanical Phenomena
- Physical Phenomena
- Lifting
Other Study ID Numbers
- 808215
- R34DA059327 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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