Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05547048 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

StatusRecruiting
PhasePhase 4
Started2023-07-25
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
Study Status v12
Primary completion moved earlier: 2027-06-01 → 2027-04-01
Completion moved earlier: 2027-06-30 → 2027-04-01
2026-05-18
Study Status, Eligibility v11
Primary completion date2027-04-01→2027-06-01
Completion date2027-04-01→2027-06-30
Eligibility criteria-4 characters
Inclusion Criteria: cis-womenwoman have access to a working mobile or landline phone Lifetime [...]
2025-05-13
Study Status, Study Design v10
PhasePhase 3→Phase 4
2025-04-15
Study Status, Eligibility v9
Eligibility criteria-27 characters
Inclusion Criteria: cis-women have access to a working mobile or landline phone Lifetime CJ-involvedinvolvement (currently on probation, parole, intensive pretrial or community supervision, or are within 12 months after release from prison/jail) are confirmed HIV-negative by point-of-care 3rd generation [...]
2024-07-22
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 2 sites
Show 7 earlier versions
2024-05-01
Study Status, Eligibility v7
Start date2023-06-10→2023-07-25
Eligibility criteria+5 characters
[...] intensive pretrial or community supervision, or are within 6012 daysmonths after release from prison/jail are confirmed HIV-negative by point-of-care 4th3rd generation HIV Ag/Abantibody test meet clinical criteria for PrEP have opioid use disord [...]
2023-10-03
Study Status v6
Re-verified, no change to tracked fields
2023-07-21
Study Status, Study Design v5
PhasePhase 4→Phase 3
2023-07-11
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Design, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
PhaseNot applicable→Phase 4
Start dateestimated 2023-06-01→confirmed 2023-06-10
Study sitesdetails revised at 2 of 2 sites
2023-05-15
Study Status v3
Primary completion date2027-11-30→2027-04-01
Completion date2027-11-30→2027-04-01
2023-03-30
Study Status v2
Re-verified, no change to tracked fields
2022-09-26
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria-107 characters
Inclusion Criteria: 1) cis-women; 2) ages 18-49y (because they experience the highest HIV risk); 3) have access to a working mobile or landline phone; 4) CJ-involved (currently on probation, parole, intensive pret [...] vision, or are within 60 days after release from prison/jail; 5) are confirmed HIV-negative by point-of-care 4th generation HIV Ag/Ab test; 6) meet clinical criteria for PrEP; and 7) have opioid use disorder (regardless of baseline treatment status) Exclusion Criteria: 1) unable or unwilling to provide informed consent; 2) pregnant or breast-feeding; 3) currently taking PrEP at [...] [...]
Secondary endpoints2 entries, revised
ChangeNumber of participants who are adherent to PrEP Number of participants who engage in PrEP Adherence Change in Opioidopioid use disorder treatment cascade engagement
Primary endpoints1 entry, revised
ChangeNumber inof participants who initiate PrEP initiation
2022-09-15
Original filing
Yale University
487 trials monitored
See 35 trials at risk
The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.
Trial Details
NCT Number NCT05547048
Lead Sponsor Yale University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions HIV, Opioid Use Disorder, eHealth
Enrollment 250 participants
Start Date 2023-07-25
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-03