Actively Recruiting
Telemedicine Contraceptive Counselling (TECC) Versus Standard Care - a Pilot and Randomized Controlled Trial of Periabortion Contraceptive Counseling
Led by Karolinska Institutet · Updated on 2024-11-12
510
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
U
University of Cape Town
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research project is focused on improving access to and use of contraception after abortion by developing and testing a new telemedicine service for contraceptive counseling called TECC. The study involves both a pilot phase and a multicenter randomized controlled trial conducted in South Africa and Kenya. The goals include designing a user-friendly online counseling service, comparing the uptake of long-acting reversible contraception (LARC) after telemedicine counseling versus in-person counseling, and evaluating satisfaction, preference, and outcomes such as recurrent unintended pregnancy and abortion. The pilot study involves 30 women seeking abortion who will test the TECC service while waiting for their abortion consultation, followed by surveys and in-depth interviews to assess acceptability. The randomized controlled trial will include 510 women who will be randomly assigned to either the TECC telemedicine counseling or standard in-person contraceptive counseling by a nurse. Follow-up assessments occur at 12 weeks, 6 months, and 12 months to measure uptake and continuation of LARC or other contraceptives, satisfaction, decision-making, and pregnancy outcomes. Participants will be involved in surveys, interviews, and follow-ups through online tools and phone calls. The main outcome is the use of LARC at 12 weeks, with additional measures including method choice, satisfaction, agency in decision making, and rates of unintended pregnancy and abortion up to 12 months. The study uses validated scales and mixed methods to fully understand the effectiveness and acceptability of the telemedicine counseling approach.
CONDITIONS
Brief Title
Telemedicine Contraceptive Counselling (TECC) Versus Standard Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seeking either surgical or medical abortion
- 18 years of age or older
- Able to communicate and understand spoken and written English
- With private access to a smart phone
- Willing to participate in the study procedures
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single session at enrollment
Participants receive contraceptive counseling either through a telemedicine service (TECC) using their phones while waiting for their abortion consultation or through in-person counseling with a clinic nurse according to standard care.
1 visit (in-person) with telemedicine use during wait time or standard nurse counseling
Duration - 12 months
Participants complete follow-up surveys through online links at 12 weeks, 6 months, and 12 months to assess uptake and continued use of contraception, satisfaction, preference for counseling, and reproductive outcomes.
Online follow-up surveys at 12 weeks, 6 months, and 12 months
Trial Site Locations
Total: 2 locations
1
Michael Mapongwana
Cape Town, South Africa
Actively Recruiting
2
Mitchell´s Plain CHC
Cape Town, South Africa
Actively Recruiting
Research Team
M
Margit Endler
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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