HIV/AIDSNCT03304912
Packaging PrEP to Prevent HIV Among WWID
An observational study of HIV/AIDS, run by Drexel University at 1 site in United States.
Trial summary
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- PrEP Education and option to accept a PrEP prescription
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 8 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample to be recruited from a syringe exchange program.
Who may be able to join
- HIV sero-negative
- Females
- Age ≥18 years
- Reporting non-prescription injection drug use and any of the following:
- Syringe sharing
- Injecting drugs with a HIV-positive partner
Show all 11Show fewer
- Recent opioid agonist treatment but still injecting drugs
- Sex exchange
- Inconsistent condom use
- Recent bacterial sexually transmitted infection (STI)
- and/or sex with a HIV-positive partner
Who cannot join
- HIV seropositivity
- Currently taking PrEP
- Pregnant, breastfeeding or trying to become pregnant
- Previous enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University Dornsife School of Public Health
Philadelphia, Pennsylvania, 19104
About this study
Official title: Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.
Read the detailed description
This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested.
- Conditions
- HIV/AIDS
- Being tested
- PrEP Education and option to accept a PrEP prescription
- Keywords
- Pre-Exposure Prophylaxis, Injection Drug Use
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Education and option to accept a PrEP prescriptionBehavioural
Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
| Study group | Role | What they receive |
|---|---|---|
| Women who inject drugs who are eligible for PrEP | Women who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription. Receives: Behavioral: PrEP Education and option to accept a PrEP prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake at Week 1
Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
Measured: 1 week
Secondary outcomes (4)
PrEP Uptake at Week 12
Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
Measured: 12 weeks
PrEP Adherence Based on Urinalysis at 12 Weeks
Protection effective emtricitabine (FTC) concentration (>1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks
Measured: 12 weeks
PrEP Adherence Based on Self-report at 12 Weeks
Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, "How many PrEP pills have you missed in the past 7 days?," had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).
Measured: 12 weeks
PrEP Uptake at Week 24
Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start3 Apr 2018
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Roth, Drexel University
- Investigators
- Alexis M Roth, PhD, MPH, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304912
- Sponsor's protocol ID
- 1R21DA043417-01A1
- Status last verified
- Jun 2023
- First submitted
- 29 Sep 2017
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A, Individual Participant Data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs
- ClinicalTrials.gov ID
- NCT03304912
- Acronym / sponsor ID
- 1R21DA043417-01A1
- Conditions
- HIV/AIDS
- Keywords
- Pre-Exposure Prophylaxis, Injection Drug Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Posted 12 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.
Detailed description
This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who inject drugs who are eligible for PrEP | – | Behavioral: PrEP Education and option to accept a PrEP prescriptionWomen who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample to be recruited from a syringe exchange program.
Key inclusion criteria (11 listed)
- HIV sero-negative
- Females
- Age ≥18 years
- Reporting non-prescription injection drug use and any of the following:
Key exclusion criteria (4 listed)
- HIV seropositivity
- Currently taking PrEP
- Pregnant, breastfeeding or trying to become pregnant
- Previous enrollment in the study
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 |
|---|---|---|
| PrEP Education and option to accept a PrEP prescriptionParticipants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum). | Behavioural | Women who inject drugs who are eligible for PrEP |
Primary outcome
PrEP Uptake at Week 1
Time frame: 1 week
Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.
4 secondary outcomes
PrEP Uptake at Week 12
Time frame: 12 weeks
PrEP Adherence Based on Urinalysis at 12 Weeks
Time frame: 12 weeks
PrEP Adherence Based on Self-report at 12 Weeks
Time frame: 12 weeks
PrEP Uptake at Week 24
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. N/A, Individual Participant Data (IPD) will not be shared.
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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.
Alexis M Roth, PhD, MPH principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Drexel University at 1 site 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 4 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: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PrEP Uptake at Week 1 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2023.