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NCT03651453
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
NA trial testing Decision aid in HIV Infections in 164 participants. Completed in 11 June 2020.
11 June 2020
Quick facts
| Lead sponsor | Yale University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 164 |
| Start date | 15 October 2018 |
| Primary completion | 11 June 2020 |
| Estimated completion | 11 June 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Decision aid
- Standard care — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
- Substance Abuse — all drugs for Substance Abuse →
Sponsor
Yale University
Who can join
18 and older, female only, with HIV Infections or Substance Abuse. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
"A good mother": Impact of motherhood identity on women's substance use and engagement in treatment across the lifespan.
Adams ZM, Ginapp CM, Price CR, Qin Y, et al · · 2021 · cited 41× · PMID 34118710 · DOI 10.1016/j.jsat.2021.108474 -
Women's Decision-Making about PrEP for HIV Prevention in Drug Treatment Contexts.
Qin Y, Price C, Rutledge R, Puglisi L, et al · · 2020 · cited 25× · PMID 31918605 · DOI 10.1177/2325958219900091 -
Preference for and Efficacy of a PrEP Decision Aid for Women with Substance Use Disorders.
Meyer J, Price C, Tracey D, Sharpless L, et al · · 2021 · cited 22× · PMID 34511887 · DOI 10.2147/ppa.s315543 -
Overlapping needs for sexual and reproductive health and HIV prevention in women with substance use disorders.
Gibson B, Hoff E, Haas A, Adams ZM, et al · · 2022 · cited 8× · PMID 35023410 · DOI 10.1177/17455065211070543
Verify or expand the search:
- PubMed search for NCT03651453
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Decision aid
Trials testing the same drug.
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- NCT06247371 — Impact of a Novel Heart Failure Medication Decision Aid · NA · completed
- NCT06382194 — Decision Making Tool for Firearm Storage · NA · completed
- NCT06189807 — Pregnancy and Contraception Education in Chronic Kidney Disease (PACE-CKD) · NA · active not recruiting
- NCT05182008 — A Patient Decision Aid for Method of Early Abortion: a Randomized Control Trial · NA · completed
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
- NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting
Other Yale University trials
Trials by the same sponsor.
- NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
- NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
- NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
- NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
- NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03651453 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yale University
- Last refreshed: 28 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03651453.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing