Telemedicine Contraceptive Counselling (TECC) Versus Standard Care - a Pilot and Randomized Controlled Trial of Periabortion Contraceptive Counseling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 510
- Locations
- 2
- Primary Endpoint
- Use of LARC (IUD or progestin implant) at 12 week follow-up
Study Overview
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:
Detailed Description
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:
- To design and test a user-friendly online service for contraceptive counseling informed by systematic research into the preference and experience of women in our study setting.
- To compare uptake of long-acting reversible contraception (LARC) after TECC and in-person contraceptive counseling.
- To compare rates of choice, uptake, and continuation of LARC or any contraceptive, satisfaction, preference for counseling, recurrent unintended pregnancy, and recurrent abortion after TECC and in-person contraceptive counseling.
PILOT STUDY Objective: To assess the acceptability of a new online e-health service for contraceptive counselling i.e., telemedicine contraceptive counseling (TECC)
Design: A mixed methods pilot study developing and testing a new TECC service preceding a randomized controlled trial Setting and duration: The study will take place at Mitchell's Plain's community health center (CHC) in Western Cape, between February November 2023 and December 2023.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Telemedicine
WhatsApp algorithmic chatbot see further description
Intervention: Telemedicine for contraceptive counseling (TECC) (Other)
Standard Care
Standard of care contraceptive counseling with clinic nurse
Intervention: Standard Care (Other)
Outcomes
Primary Outcomes
Use of LARC (IUD or progestin implant) at 12 week follow-up
Time Frame: 12 weeks
Proportion of participants in each arm with using LARC (IUD or progestin implant) at 12 week follow-up
Secondary Outcomes
- 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)
- Recurrent abortion within 6 months(6 months)
- Recurrent abortion within 12 months(12 months)
- Preference for counseling model(Baseline)
- Satisfaction with contraceptive counseling(Baseline)
- Decision-competence after contraceptive counseling(Baseline)
- Agency in contraceptive decision making(Baseline)
- Change of contraceptive method(12 months)
Investigators
Margit Endler
Associate Professor, MD ObGyn
Karolinska Institutet