- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269952
Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences
There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2). PWID are exposed to substantial health risks that are directly linked to injection drug use, such as blood borne viruses (hepatitis and HIV), overdoses and skin and tissue infections. Additionally psychiatric disorders are common and PWID's general health is often neglected (3,4,5).
In Sweden, harm reduction units such as needle and syringe programs (NSP) have scaled-up in recent years. In Stockholm the first NSP opened in 2013 and the second in 2018. In 2022, 4600 individuals were enrolled in the program since it opened, of which approximately 25% were women. Around 2000 were active participants, defined as having visited the program at least once during the last 12 months. In 2021 54% of the participants stated amphetamine as the last drug injected, 31% heroin, 4% buprenorphine and 11% other drugs. Most participants were between 30-49 years of age. In addition to distribution of sterile needles and injection paraphernalia, the NSP staff (nurses, doctors, midwifes, counselors) provides services such as testing for blood borne viruses, vaccinations, wound care, take-home naloxone, reproductive health services, counselling, support in contact with social service and referrals for substance use disorder treatment and hepatitis C/HIV treatment.
Gender-based violence (GBV) is a global health issue and WHO estimates that one in three women globally have been exposed to some sort of partner violence during their lifespan (7). Intimate partner violence (IPV) is defined as violent behavior between two people who have a close relationship, such as partners, ex-partners, siblings, relatives, friends and alike. In Sweden around 14% of women and 5% of men are exposed to physical violence in an intimate partner relationship during their lifespan however 20-25% of women and around 17% of men are exposed to psychological violence during their lifespan (8; 9). The prevalence of IPV among PWID is estimated to be significantly higher than in the general population (10). A study from USA found the risk of IPV to be three times higher and the prevalence estimated between 35-57% (7). In international studies, IPV exposure is found to be a significant risk factor for needle sharing among WWID (11, 12). There are other well-known consequences of IPV including impact on sexual and reproductive health rights, physical and psychological wellbeing, increased risk of contracting HIV and hepatitis C (13; 14). IPV exposure disproportionately affects WWID worldwide, however studies in Sweden on IPV exposure in the PWID population is scarce. To date there are studies that address this among women with substance use disorders but none with an exclusive focus on PWID or WWID. In clinical research of women diagnosed with substance use disorders (SUD) with psychiatric comorbidities and social challenges, one study indicates that the majority (91%, n=79) of women had been exposed to some form of IPV (15). Another study of women with SUD (n=52), 50% reported exposure of serious violence and the majority (96%) reported exposure to psychological violence (10). There are different types of IPV; psychological, physical, sexual, financial, latent, digital, neglect, honor related, aftermath of IPV (16). Our research team has previously carried out a qualitative interview study among WWID at the Stockholm NSP in 2019 to investigate reasons and barriers for participation among women (17). The interviews illustrated that IPV is common. In the proposed studies, for this doctoral thesis, we have chosen to focus on physical, sexual, psychological and financial violence among PWID motivated by findings in our previous research.
PWID and specifically WWID are regarded as groups who are especially vulnerable for IPV exposure and should therefore be prioritized in the national efforts to prevent IPV (15). However, there are no studies estimating the prevalence and frequency of IPV among PWID in Sweden. Previous international studies suggest that PWID are exposed to IPV to a greater extent than the general population, and women with substance use disorders are exposed to an alarming degree of violence (15). In Sweden there are no tailored interventions for PWID or WWID who are exposed to IPV, it is reasonable to believe that there is a need for a multi-faceted program for PWID exposed to IPV, however this is still unexplored.
The overall aim of this project is to increase knowledge about IPV among PWID and WWID as particularly vulnerable groups in regards to IPV. More specifically, the aim is to investigate the prevalence and frequency of different types of IPV among PWID at the Stockholm NSP and to explore the experiences' of IPV, needs and preferences for IPV support among WWID to facilitate tailored support and prevention programs for those exposed.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Malin Värmå Falk
- Phone Number: +46812347115
- Email: malin.varma-falk@regionstockholm.se
Study Locations
-
-
-
Stockholm, Sweden
- Recruiting
- Needle syringe program
-
Contact:
- Malin Värmå Falk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: at least 18 years of age, injecting drugs, participating in the needle syringe program in Sweden
-
Exclusion Criteria:
- under the age of 18
- heavily intoxicated
- psychotic symptoms
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
People who inject drugs
People who inject drugs, over 18 years of age, that participate in the needle syringe program in Stockholm, Sweden
|
No intervention.
The participants are asked questions from and questionnaire and later also interviewed guide by an interview-guide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants exposed to physical intimate partner violence
Time Frame: 1 year
|
A questionnaire will be used to collect data on exposure to different types of intimate partner violence.
In this case physical intimate partner violence
|
1 year
|
|
Number of participants exposed to psychological intimate partner violence
Time Frame: 1 year
|
A questionnaire will be used to collect data on exposure to psychological intimate partner violence, during the last 12 months and the participants whole lifespan.
|
1 year
|
|
Number of participants exposed to sexual intimate partner violence
Time Frame: 1 year
|
A questionnaire will be used to collect data on exposure to sexual intimate partner violence, during the last 12 months and the participants whole lifespan.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susanne Strömdahl, M.D, Associate Professor, Karolinska Institutet
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
Other Study ID Numbers
- MVarmafalk
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on People Who Inject Drugs
-
Heather HendersonUniversity of South Florida; Gilead Sciences; Tampa General HospitalNot yet recruitingPeople Who Inject Drugs | PrEP Adherence
-
Institut National de la Santé Et de la Recherche...AIDES; Nouvelle AubeWithdrawnPeople Who Inject DrugsFrance
-
City University of New York, School of Public HealthNational Institute on Drug Abuse (NIDA); Weill Medical College of Cornell University and other collaboratorsCompletedHepatitis C | HCV Coinfection | People Who Inject Drugs | PWIDUnited States
-
Center For Hepatitis C, Atlanta, GAActive, not recruitingChronic Hepatitis C | People Who Inject DrugsUnited States
-
McMaster UniversityHAMSMaRT; Keeping Six; YWCA HamiltonNot yet recruitingInfections | Peer Support | Injection-related Infections | People Who Infect Drugs (PWID)Canada
-
Hellenic Scientific Society for the Study of AIDS...Gilead SciencesCompletedHIV Positive People Who Inject DrugsGreece
-
University of California, San DiegoRecruitingPeople Who Use Opioids/People With Opioid Use Disorder (OUD)United States
-
Istanbul Saglik Bilimleri UniversityNot yet recruitingPeople Who Do Regular Conditioning WorkTurkey (Türkiye)
-
Hospital Comarcal de IncaCompletedElderly (People Aged 65 or More) | Polypharmacy (People Under Treatment With 5 or More Drugs)Spain
-
Regione del Veneto - AULSS n. 7 PedemontanaCompletedDeprescribing | Hospitalization | Elderly (People Aged 65 or More) | Polypharmacy (People Under Treatment With 5 or More Drugs)Italy
Clinical Trials on No intervention
-
Hopital FochNot yet recruitingInterstitial Lung DiseaseFrance
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Huashan HospitalZhejiang Cancer Hospital; Shanghai Zhongshan Hospital; Tongji Hospital; Qilu Hospital... and other collaboratorsRecruitingHead and Neck Squamous Cell Carcinoma | Patient Derived Organoid | Drug Sensitive Test in VitroChina
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown