Human Immunodeficiency VirusNCT05404750
Harm Reduction in HIV Primary Care for PLWH Who Use Drugs
An observational study of Human Immunodeficiency Virus and Substance Use, run by University of Pittsburgh at 3 sites in United States.
Trial summary
People living with HIV (PLWH) who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load, resulting in secondary infections and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Substance Use, Stigma, Social
- What is being tested?
- Harm Reduction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 641 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2022to 30 Jun 2027
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Providers of services to people living with or at high risk for HIV. Providers include all members of the healthcare team; i.e., reception, nurses, clinical providers, social workers, and pharmacists. Providers must have worked in one of our study settings for at lease one year. 2. Patients living with HIV who have receive care at one of our study sites with lifetime or current use of illicit drugs (excluding marijuana), or of prescription drugs for non-medical reasons.
Who may be able to join
- Providers' Inclusion Criteria
- Working at one of our 3 study sites (UPMC HIV/AIDS Program, Positive Health Clinic, or 1917 Clinic) or one of their partner sites offering substance use treatment (Internal Medicine Recovery Engagement Program, Center for Inclusion Health, or UAB's Outpatient-Based Opioid Treatment Clinic) for at least one year
- Providing service or care to PLWH or people who use drugs at high risk for HIV acquisition
- Working in one of the following positions: front desk/patient engagement, social worker, nurse, medical assistant, advanced practice provider, or physician
- Able to verbally consent, read, and speak English
- Patient Inclusion Criteria
Show all 11Show fewer
- Living with HIV
- Age 18 or older
- Able to verbally consent, read, and speak English
- Receiving HIV medical care from one of the study sites for at least one year
- Lifetime or recent use (past 3 months) of illicit substances (excluding marijuana) or prescription drugs for non-medical reasons in accordance with the NIDA-Modified ASSIST 2.0.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35222
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of Harm Reduction Care in HIV Clinical Settings on Stigma and Health Outcomes
People living with HIV (PLWH) who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load, resulting in secondary infections and increased mortality. The proposed study will used mixed methods to explore (a) the relationship between healthcare providers' attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational harm reduction; (b) the degree to which relational harm reduction moderates the effect of intersectional stigma experienced in healthcare settings on patients' perceptions of their relationship with providers; (c) the degree to which structural HR moderates the relationship between the patient-provider relationship and clinical outcomes, and (d) whether patient-perceived HR approaches to care are directly associated with HIV clinical outcomes. The study will also use these findings to inform the development and pre-testing of an intervention to operationalize harm reduction in HIV clinical settings, using stakeholder-engaged and human-centered design approaches, presenting a novel path to reducing HIV health inequities for PLWH who use drugs.
Read the detailed description
This observational study takes place across three study sites and will explore the extent to which harm reduction care mitigates stigma experienced in healthcare settings and contributes to improved clinical outcomes. This will be explored via the following aims.
Aim 1. Explore the relationship between healthcare providers' stigmatizing attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational HR to elucidate the context for intervention development. Providers (n=125) working HIV clinics in Birmingham, AL and Pittsburgh, PA will be surveyed to understand subjective responses around preparedness for and delivery of HR care to PLWH who use drugs. A sequential explanatory mixed-methods approach will be utilized; surveys will be followed by semi-structured interviews (n=40) with multiple provider types in both regions to further explore HR perspectives and inform intervention development. It is hypothesized that providers with less stigmatizing attitudes toward serving people who use drugs are more likely to be accepting of relational and structural HR practices.
Aim 2. Explore the interplay between patient-perceived HR and stigma and clinical outcomes; specifically, the degree to which (a) relational HR moderates the effect of intersectional stigma experienced in healthcare settings (HIV- and substance use-related stigma and racial discrimination) on patients' perceptions of their relationship with providers, (b) structural HR moderates the relationship between the patient-provider relationship and clinical outcomes (ART adherence, retention in care, HIV and HCV viral suppression), and (c) patient-perceived HR care is directly associated with HIV clinical outcomes (see Figure 1). After qualitatively evaluating PAPHRS with HIV clinical and HR providers (n=20) and PLWH who use drugs (n=36), PLWH who use drugs (n=500) who receive care in the study sites will be surveyed to assess their perceptions of providers' relational HR care; experiences of intersectional stigma; and perceived quality of relationships with their providers. Other potential stigmatized identities (e.g., HCV) will be explored via patient focus groups (n=36). It is hypothesized that the effect of intersectional stigma on the patient-provider relationship is attenuated in higher degrees of relational HR care; structural HR attenuates the effect of poor patient-provider relationships on clinical outcomes; and higher degrees of HR care are associated with better clinical outcomes.
Aim 3. Using human-centered design approaches, develop and pre-test an intervention to operationalize HR care for PLWH who use drugs in HIV clinical settings. Results from Aims 1 and 2 will be shared with with stakeholders (n=20, PLWH who use drugs, clinical and HR providers) to develop an intervention. Acceptability and feasibility of the intervention design will be assessed with providers (n=12) in both regions.
- Conditions
- Human Immunodeficiency Virus, Substance Use, Stigma, Social
- Being tested
- Harm Reduction
- Keywords
- Harm Reduction, Patient-Provider Relationship
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Social Stigma, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harm ReductionBehavioural
Harm reduction aims to reduce negative effects of risky health behaviors without necessarily terminating the behaviors completely.Though often thought of as structural approaches (e.g., policy or syringe services), Harm reduction is also a relational approach to care focusing on non-punitive patient-provider interactions to promote autonomy. The degree to which harm reduction care is offered in study settings and is associated with clinical outcomes is the focus of this study.
| Study group | Role | What they receive |
|---|---|---|
| Providers | Individuals providing service or care to PLWH or people who use drugs at high risk for HIV acquisition working at our study sites in one of the following positions: front desk/patient engagement, social worker, nurse, medical assistant, advanced practice provider, or physician. | |
| Patients | PWLH with current or lifetime substance use who receive care at one of our study sites. Receives: Behavioral: Harm Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Viral Load
Viral load will be assessed as a continuous and dichotomous variable (virally suppressed <200 copies/ml)
Measured: Retrospective, past 5 years
Secondary outcomes (5)
Retention in care - Missed Visits
Proportion of missed versus kept HIV primary care visits
Measured: Retrospective, past 5 years
Retention in care - Kept visits
At least 2 kept HIV primary care visits separated ≥90 days during a 12-month period
Measured: Retrospective, past 5 years
Hepatitis C Viral Load
HCV Viral suppression
Measured: Retrospective, past 5 years
HIV Adherence
Self-report of ART adherence - CASE Index
Measured: Retrospective, past 5 years
Retention in Substance use treatment
Retention in MOUD or behavioral health treatment for diagnosis of substance use disorder. We will calculate the proportion of kept to scheduled visits.
Measured: Retrospective, past 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Allegheny Health Network, University of Alabama at Birmingham, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Mary Hawk, University of Pittsburgh
- Investigators
- Mary Hawk, DrPH, Principal investigator, University of PittsburghEmma Kay, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404750
- Sponsor's protocol ID
- STUDY21090002
- Other IDs
- R01DA054832
- Status last verified
- Jul 2026
- First submitted
- 19 May 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Creasy SL, Egan JE, Krier S, Townsend J, Ward J, Hawk M, Kay ES. "Let me hear what you're needing": exploring how HIV providers conceptualize patient-provider interactions with people with HIV who use drugs using a harm reduction framework. Ther Adv Infect Dis. 2025 Feb 27;12:20499361251323721. doi: 10.1177/20499361251323721. eCollection 2025 Jan-Dec.
PubMed 40017794Kay ES, Creasy S, Batey DS, Coulter R, Egan JE, Fisk S, Friedman MR, Kinsky S, Krier S, Noble V, Turan B, Turan JM, Yu L, Hawk M. Impact of harm reduction care in HIV clinical settings on stigma and health outcomes for people with HIV who use drugs: study protocol for a mixed-methods, multisite, observational study. BMJ Open. 2022 Sep 16;12(9):e067219. doi: 10.1136/bmjopen-2022-067219.
PubMed 36113946
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Harm Reduction Care in HIV Clinical Settings on Stigma and Health Outcomes
- ClinicalTrials.gov ID
- NCT05404750
- Acronym / sponsor ID
- STUDY21090002
- Conditions
- Human Immunodeficiency Virus, Substance Use, Stigma, Social
- Keywords
- Harm Reduction, Patient-Provider Relationship
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 641 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Allegheny Health Network, University of Alabama at Birmingham, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jun 2022 (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.
People living with HIV (PLWH) who use drugs experience significant health disparities including lower rates of retention in HIV care and higher rates of unsuppressed viral load, resulting in secondary infections and increased mortality. The proposed study will used mixed methods to explore (a) the relationship between healthcare providers' attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational harm reduction; (b) the degree to which relational harm reduction moderates the effect of intersectional stigma experienced in healthcare settings on patients' perceptions of their relationship with providers; (c) the degree to which structural HR moderates the relationship between the patient-provider relationship and clinical outcomes, and (d) whether patient-perceived HR approaches to care are directly associated with HIV clinical outcomes. The study will also use these findings to inform the development and pre-testing of an intervention to operationalize harm reduction in HIV clinical settings, using stakeholder-engaged and human-centered design approaches, presenting a novel path to reducing HIV health inequities for PLWH who use drugs.
Detailed description
This observational study takes place across three study sites and will explore the extent to which harm reduction care mitigates stigma experienced in healthcare settings and contributes to improved clinical outcomes. This will be explored via the following aims.
Aim 1. Explore the relationship between healthcare providers' stigmatizing attitudes towards working with PLWH who use drugs and providers' acceptance and practice of structural and relational HR to elucidate the context for intervention development. Providers (n=125) working HIV clinics in Birmingham, AL and Pittsburgh, PA will be surveyed to understand subjective responses around preparedness for and delivery of HR care to PLWH who use drugs. A sequential explanatory mixed-methods approach will be utilized; surveys will be followed by semi-structured interviews (n=40) with multiple provider types in both regions to further explore HR perspectives and inform intervention development. It is hypothesized that providers with less stigmatizing attitudes toward serving people who use drugs are more likely to be accepting of relational and structural HR practices.
Aim 2. Explore the interplay between patient-perceived HR and stigma and clinical outcomes; specifically, the degree to which (a) relational HR moderates the effect of intersectional stigma experienced in healthcare settings (HIV- and substance use-related stigma and racial discrimination) on patients' perceptions of their relationship with providers, (b) structural HR moderates the relationship between the patient-provider relationship and clinical outcomes (ART adherence, retention in care, HIV and HCV viral suppression), and (c) patient-perceived HR care is directly associated with HIV clinical outcomes (see Figure 1). After qualitatively evaluating PAPHRS with HIV clinical and HR providers (n=20) and PLWH who use drugs (n=36), PLWH who use drugs (n=500) who receive care in the study sites will be surveyed to assess their perceptions of providers' relational HR care; experiences of intersectional stigma; and perceived quality of relationships with their providers. Other potential stigmatized identities (e.g., HCV) will be explored via patient focus groups (n=36). It is hypothesized that the effect of intersectional stigma on the patient-provider relationship is attenuated in higher degrees of relational HR care; structural HR attenuates the effect of poor patient-provider relationships on clinical outcomes; and higher degrees of HR care are associated with better clinical outcomes.
Aim 3. Using human-centered design approaches, develop and pre-test an intervention to operationalize HR care for PLWH who use drugs in HIV clinical settings. Results from Aims 1 and 2 will be shared with with stakeholders (n=20, PLWH who use drugs, clinical and HR providers) to develop an intervention. Acceptability and feasibility of the intervention design will be assessed with providers (n=12) in both regions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Providers | – | –Individuals providing service or care to PLWH or people who use drugs at high risk for HIV acquisition working at our study sites in one of the following positions: front desk/patient engagement, social worker, nurse, medical assistant, advanced practice provider, or physician. |
| Patients | – | Behavioral: Harm ReductionPWLH with current or lifetime substance use who receive care at one of our study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Providers of services to people living with or at high risk for HIV. Providers include all members of the healthcare team; i.e., reception, nurses, clinical providers, social workers, and pharmacists. Providers must have worked in one of our study settings for at lease one year. 2. Patients living with HIV who have receive care at one of our study sites with lifetime or current use of illicit drugs (excluding marijuana), or of prescription drugs for non-medical reasons.
Key inclusion criteria (11 listed)
- Providers' Inclusion Criteria
- Patient Inclusion Criteria
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Harm ReductionHarm reduction aims to reduce negative effects of risky health behaviors without necessarily terminating the behaviors completely.Though often thought of as structural approaches (e.g., policy or syringe services), Harm reduction is also a relational approach to care focusing on non-punitive patient-provider interactions to promote autonomy. The degree to which harm reduction care is offered in study settings and is associated with clinical outcomes is the focus of this study. | Behavioural | Patients |
Primary outcome
HIV Viral Load
Time frame: Retrospective, past 5 years
Viral load will be assessed as a continuous and dichotomous variable (virally suppressed <200 copies/ml)
5 secondary outcomes
Retention in care - Missed Visits
Time frame: Retrospective, past 5 years
Retention in care - Kept visits
Time frame: Retrospective, past 5 years
Hepatitis C Viral Load
Time frame: Retrospective, past 5 years
HIV Adherence
Time frame: Retrospective, past 5 years
Retention in Substance use treatment
Time frame: Retrospective, past 5 years
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 10 Jul 2026.
- Derived from this study: PubMed 40017794Creasy SL, Egan JE, Krier S, Townsend J, Ward J, Hawk M, Kay ES. "Let me hear what you're needing": exploring how HIV providers conceptualize patient-provider interactions with people with HIV who use drugs using a harm reduction framework. Ther Adv Infect Dis. 2025 Feb 27;12:20499361251323721. doi: 10.1177/20499361251323721. eCollection 2025 Jan-Dec.
- Derived from this study: PubMed 36113946Kay ES, Creasy S, Batey DS, Coulter R, Egan JE, Fisk S, Friedman MR, Kinsky S, Krier S, Noble V, Turan B, Turan JM, Yu L, Hawk M. Impact of harm reduction care in HIV clinical settings on stigma and health outcomes for people with HIV who use drugs: study protocol for a mixed-methods, multisite, observational study. BMJ Open. 2022 Sep 16;12(9):e067219. doi: 10.1136/bmjopen-2022-067219.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mary Hawk, DrPH principal investigator
University of Pittsburgh
Emma Kay, PhD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and Substance Use, run by University of Pittsburgh at 3 sites in United States.
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 11 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Viral Load (time frame: Retrospective, past 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404750, which also lists 2 linked publications.
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 10 Jul 2026.