Telemedicine Contraceptive Counselling (TECC) Versus Standard Care

NCT06682065 | Recruiting DMC

• 1 other identifier: TECC
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 2

Brief Summary

Overall purpose of the PILOT and RCT: This research project aims to increase access and uptake of contraception after abortion through the systematic development and testing of a new telemedicine service for contraceptive counselling (TECC). The investigators will perform a pilot study in South Africa, and multicenter randomized controlled trial in South Africa and Kenya with the following specific aims:

Conditions

Contraceptive Usage; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Use of LARC (IUD or progestin implant) at 12 week follow-up

  Proportion of participants in each arm with using LARC (IUD or progestin implant) at 12 week follow-up

  12 weeks

Secondary Outcomes (12)

• Choice of LARC on day of consultation

  Baseline

• Use of LARC at 6 months

  6 months

• Use of LARC at 12 months

  12 months

• Unplanned pregnancy within 6 months

  6 months

• Unplanned pregnancy within 12 months

  12 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

WhatsApp algorithmic chatbot see further description

Other: Telemedicine for contraceptive counseling (TECC)

Standard Care

ACTIVE COMPARATOR

Standard of care contraceptive counseling with clinic nurse

Other: Standard Care

Interventions

Telemedicine for contraceptive counseling (TECC) OTHER

WhatsApp algorithmic chatbot that screens preferences and medical eligibility to recommend two methods, informs about all methods, allows choice out of all methods, produce summary to substitute for clinical record

Telemedicine

Standard Care OTHER

In-personcontraceptive counseling with a nurese according to clinical standard of care

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* Seeking either surgical or medical abortion * ≥ 18 years of age * Able to communicate and understand spoken and written English * With private access to a smart phone * Willing to participate in the study procedures

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Cape Town: collaborator

Study Sites (2)

Michael Mapongwana

Cape Town, South Africa

RECRUITING

Mitchell´s Plain CHC

Cape Town, South Africa

RECRUITING

MeSH Terms

Conditions

Contraception Behavior

Interventions

Telemedicine; Standard of Care

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Margit Endler, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margit Endler

CONTACT

0789106286; margit.endler@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD ObGyn

Model Details: 1:1

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: November 12, 2024
• Study Start: May 5, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)