Recruiting

Penny COPILOT

Sponsor:

University of Pennsylvania

Code:

NCT06969261

Conditions

Perinatal Opioid Use Disorder

Opioid Use Disorder

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Penny COPILOT

Study Details

Brief summary:

To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.

Conditions

Perinatal Opioid Use Disorder

Opioid Use Disorder

Study ID

NCT06969261

Start date

Jan 1, 2026

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biological females who are currently pregnant or within 6 weeks postpartum.
  • Able to read, write, and speak English at a 6th grade level.
  • Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.
  • Receiving prenatal care and OUD care at a Penn affiliated hospital.

Exclusion Criteria:

-Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Chatbot Intervention

This is a single arm study designed to assess the acceptability and feasibility of the chatbot.

Interventions

Penny COPILOT

The Penny COPILOT chatbot is an interactive short messaging system (SMS) program that provides educational and supportive content for postpartum individuals. The chatbot has been adapted to include information relevant to opioid use disorder recovery in order to decrease the risk of returning to use among people who use drugs. Messages are sent at specified intervals relevant to the postpartum course and the chatbot allows for two way messaging with an interactive lens.

Primary outcome measure

  • UCLA Loneliness Scale. [ Time Frame: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up. ]

Central Contacts and Locations

Central contacts

Sara L Kornfield, PhD

1-800-789-7366sarakorn@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania (HUP)

Recruiting

Philadelphia, Pennsylvania, United States, 19072

Contacts

Emma Farber, BA

215-746-3338emma.farber@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Maternal Health
  • Maternal Substance Use
  • Perinatal OUD
  • Chatbot
  • mHealth Interventions
  • Loneliness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-28.