An observational study in HIV/AIDS, sponsored by Drexel University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Drexel University · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 113th largest by enrollment of the 195 observational ones that give a count, is one of 68 that started in 2018, is one of 196 observational ones, and was the 1,212th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:
Nicky Mehtani, MD, MPH · Sites in United States
Ages 25–64
Columbia University · Sites in United States
Ages 18+ · Healthy volunteers
BioNTech SE · Sites in United States, South Africa
Ages 18–50 · Healthy volunteers
CAN Community Health · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,670 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 384 · Phase 2 258 · Phase 3 156 · Phase 4 81
First in 1981; this study’s year is marked. 68 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 105 is below the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
510 of 1,670 have an industry lead sponsor. The 10 most frequent:
Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.
Drexel University has 3 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
56 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Add all 56 to your calendar (.ics) → With an account.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Community sample to be recruited from a syringe exchange program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Reporting non-prescription injection drug use and any of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription.
Behavioral: 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. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
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
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
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
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
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
| Milestone | Women Who Inject Drugs (WWID) Who Are Eligible for Pre-exposure Prophylaxis (PrEP) |
|---|---|
| Started | 95 |
| Completed | 42 |
| Not completed | 53 |
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.
| Participants | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| PrEP Uptake at Week 1 | 63 |
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.
| Participants | WWID Who Are Eligible for PrEP |
|---|---|
| PrEP Uptake at Week 12 | 48 |
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
| Participants | WWID Who Are Eligible for PrEP |
|---|---|
| PrEP Adherence Based on Urinalysis at 12 Weeks | 1 |
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).
| Participants | WWID Who Are Eligible for PrEP |
|---|---|
| Non-adherence | 18 |
| Inconsistent-adherence | 9 |
| Adherence | 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.
| Participants | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| PrEP Uptake at Week 24 | 25 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women Who Inject Drugs (WWID) Who Are Eligible for PrEP. | 1/95 (1.1%) | 3/95 (3.2%) | 9/95 (9.5%) |
| Event | Women Who Inject Drugs (WWID) Who Are Eligible for PrEP. |
|---|---|
| HospitalizationGeneral disorders | 3/95 |
| Event | Women Who Inject Drugs (WWID) Who Are Eligible for PrEP. |
|---|---|
| VictimizationGeneral disorders | 9/95 |
| Age, Categorical(Participants) | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 95 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| Female | 95 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 84 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 66 |
| More than one race | 4 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | PrEP Education and Option to Accept a PrEP Prescription |
|---|---|
| United States | 95 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — N/A, Individual Participant Data (IPD) will not be shared.
Ran from Apr 2018 to primary completion in Oct 2019, 18 months.
Results were first posted in Jul 2023, 3 years 9 months after primary completion.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 18 months is below that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →