Contraception Counseling Considerations MTN-003 Study-Specific Training
Background and References WHO Medical Eligibility Criteria for Contraceptive Use (with 2008 update) Family Planning: A Global Handbook for Providers (USAID/JHSPH/WHO) US FDA Birth Control Guide
Background and References National family planning policies and guidelines National practitioner training and continuing education requirements Other? Increasing Access to Contraception for Clients with HIV: A Toolkit (FHI)
Study-Specific Background Protocol specified eligibility criteria for Pregnancy intentions Willingness to use an effective contraceptive method Site-specific methods for verifying surgical sterilization as part of eligibility determination Protocol-specified contraindicated methods Contraceptive methods available on site Contraceptive methods available through referral
On-Site or By Referral?
Emergency Contraception EC = back-up method for contraceptive emergencies used within the first few days after unprotected intercourse to prevent unwanted pregnancy WHO recommended regimen = 1.5 mg levonogestrel as a single dose Reduces risk of pregnancy by 60-90% when used within 5 days after unprotected intercourse (sooner = more effective) Levonogestrel ECPs prevent ovulation, not effective once process of implantation has begun, will not cause abortion Source = WHO Fact Sheet N o 244
Emergency Contraception Not appropriate for regular use as an ongoing contraceptive method due to higher method failure rate compared to other methods Meant to be used in situations such as no contraception use, contraception failure, or incorrect use Condom breakage, slippage, or incorrect use 3+ consecutive missed combined OCPs >3 hours late for progestogen-only pill >2 weeks late for progestogen-only injection IUCD expulsion Also in cases of sexual assault when the woman was not protected by an effective contraceptive method Source = WHO Fact Sheet N o 244
Contraception Counseling As with HIV counseling, client-centered approach should be taken to guide and support the participant in Making the best contraceptive method choice for her Maintaining adherence to an effective method
Client-Centered Approach Greet client and establish rapport Describe purpose of the session Emphasize confidentiality of the session Listen effectively, allow client to speak, avoid interruptions Communicate effectively, verbally and non-verbally Communicate at client’s level of understanding Use open-ended questions Clarify misconceptions Provide positive reinforcement
Contraceptive Counseling There will be much information to provide For each method How taken or administered Mode of action Level of effectiveness Possible side effects Advantages and disadvantages Use visual aids (methods and anatomy) Meet participant at her current knowledge level Dispel myths and misconceptions in the context of study participation
Contraceptive Counseling There will be much information to listen to What has she heard / what does she know about contraception and the different methods What experiences has she had with contraception What factors are most important to her for when choosing a method Are there any partner or family issues to consider
Contraceptive Counseling During Screening At Screening Part 1, Screening Part 2, and before randomization on the day of enrollment, contraceptive counseling is provided in the context of the study inclusion criteria and eligibility determination Informed consent and contraception counseling sessions should Explain which methods are acceptable for study purposes AND Emphasize that women who cannot commit to using these methods for at least 24 months should not enroll in the study (this is part of their contraceptive choice)
Contraceptive Counseling During Screening Contraceptive counseling All Screening Part 1, Screening Part 2, and Enrollment Provision of contraception (if indicated) Per site SOP at Screening Part 1 Expected at Screening Part 2 and Enrollment All staff should be clear on how provision of contraception is to be handled at Screening Part 1
Contraceptive Counseling During Follow-Up Continue client-centered approach each month If participant has no issues or problems with her chosen method, counseling sessions may be brief but Always provide clear instructions for use Always reinforce key adherence messages If participant has issues or problems In some cases only counseling and reassurance may be required In other cases, consideration of method switching may be indicated
Contraceptive Counseling During Follow-Up Some participants may wish to stop using contraception during follow-up. How should this be handled?
Contraceptive Counseling Documentation Record sufficient information and detail to support review and follow-up at each visit Use chart notes, flow sheets, and/or other documentation tools Chart flags/flyers are strongly recommended to highlight key dates (e.g., next injection) Similar flags in pharmacy system can be very helpful