An interventional study of urine-based self-test and urine-based clinic test in HIV Risk, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
Among 654 studies in Psychological Well-Being with a site in United States — 188 open to participants now, 239 under way, 1 of them phase 3. Psychological Well-Being · United States.
Among the 654 studies in Psychological Well-Being with a site in United States, this one is the 382nd largest by planned enrollment of the 572 interventional ones that give a count, is one of 84 that started in 2026, is one of 514 with no phase, reaches primary completion later than 110 of the 237 other live ones, and was the 641st registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →188 of the 654 studies in Psychological Well-Being with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 12–80
Chestnut Health Systems · Sites in United States
Ages 18+ · Healthy volunteers
University of Massachusetts, Worcester · Sites in United States
Ages 18+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18–40 · Healthy volunteers
University of South Carolina · Sites in United States
Ages 18+ · Women only
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 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
654 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 20 · Phase 2 29 · Phase 3 10 · Phase 4 6
First in 1996; this study’s year is marked. 84 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 116 across the 572 interventional studies, 500 across the 81 observational. Of the 383 that completed or were terminated, 120 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
53 of 654 have an industry lead sponsor. The 10 most frequent:
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Wake Forest University Health Sciences has 2 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
99 of the studies in Psychological Well-Being with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07011459Tulane UniversityThe Cooking for Health Optimization and Disease Prevention (CHOP) Trial | 2026-11 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06915259University of PennsylvaniaDoula Model of Care | 2026-11 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
Add all 99 to your calendar (.ics) → With an account.
Among the 654 studies in Psychological Well-Being with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of the SHE CARES study is to better understand factors that influence engagement in HIV prevention and substance use services among women who use stimulants in North Carolina. This part of the SHE CARES study will assess agreement between a remotely completed, participant-administered urine-based test for PrEP use and an in-person laboratory reference test.
Validation study to evaluate the real-world performance of remotely completed, participant-administered urine-based self-tests (index test) compared with clinic-based laboratory reference testing among stimulant-using women who inject drugs in North Carolina. The reference standard will be plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS).
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.
Exclusion Criteria:
- Does not meet inclusion 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 use stimulants who are currently using oral PrEP or are not currently using PrEP will complete a participant-administered urine-based tenofovir self-test (index test) and clinic-based laboratory reference testing. The reference standard will be plasma tenofovir concentrations measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Diagnostic Test: urine-based self-test · Diagnostic Test: urine-based clinic test
participant-administered urine-based self-tests (index test)
plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
Sensitivity of the urine-based tenofovir self-test
Percentage of specimens positive for tenofovir by the liquid chromatography-tandem mass spectrometry reference standard that are correctly identified as positive by the self-test.
Time frame: Day 1
Specificity of the urine-based tenofovir self-test
Percentage of specimens negative for tenofovir by the liquid chromatography-tandem mass spectrometry reference standard that are correctly identified as negative by the self-test.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 6 months is below that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. 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.
Wake Forest University Health Sciences →