HIV/AIDS
Conditions
Keywords
Pre-Exposure Prophylaxis, Injection Drug Use
Brief 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. 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.
Interventions
BEHAVIORALPrEP Education and option to accept a PrEP prescription
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).
Sponsors
Drexel University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV sero-negative * Females * Age ≥18 years * Reporting non-prescription injection drug use and any of the following: 1. Syringe sharing 2. Injecting drugs with a HIV-positive partner 3. Recent opioid agonist treatment but still injecting drugs 4. Sex exchange 5. Inconsistent condom use 6. Recent bacterial sexually transmitted infection (STI) 7. and/or sex with a HIV-positive partner
Exclusion criteria
* HIV seropositivity * Currently taking PrEP * Pregnant, breastfeeding or trying to become pregnant * Previous enrollment in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake at Week 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake at Week 12 | 12 weeks | 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. |
| PrEP Adherence Based on Urinalysis at 12 Weeks | 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 |
| PrEP Adherence Based on Self-report at 12 Weeks | 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). |
| PrEP Uptake at Week 24 | 24 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
10 participants were withdrawn following enrollment because we were unable to draw blood in order to be able to prescribe PrEP medication.
Participants by arm
| Arm | Count |
|---|---|
| PrEP Education and Option to Accept a PrEP Prescription 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. | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 95 |
| other Total, other adverse events | 9 / 95 |
| serious Total, serious adverse events | 3 / 95 |
Outcome results
Primary
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.
Time frame: 1 week
Population: Of the 95 WWID who were offered a PrEP prescription, 89 women returned at week 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Uptake at Week 1 | 63 Participants |
Secondary
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).
Time frame: 12 weeks
Population: Number of women responding to adherence measure on survey
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Adherence Based on Self-report at 12 Weeks | Non-adherence | 18 Participants |
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Adherence Based on Self-report at 12 Weeks | Inconsistent-adherence | 9 Participants |
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Adherence Based on Self-report at 12 Weeks | Adherence | 24 Participants |
Secondary
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
Time frame: 12 weeks
Population: Women with available urine-analysis data that self-reported PrEP use at 3-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Adherence Based on Urinalysis at 12 Weeks | 1 Participants |
Secondary
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.
Time frame: 12 weeks
Population: Number of WWID returning to care at week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Uptake at Week 12 | 48 Participants |
Secondary
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.
Time frame: 24 weeks
Population: Number of women returning to care at week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PrEP Education and Option to Accept a PrEP Prescription | PrEP Uptake at Week 24 | 25 Participants |