Contraception Counseling ConsiderationsMTN-003 Study-Specific Training

Background and ReferencesWHO 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 ReferencesNational family planning policies and guidelinesNational practitioner training and continuing education requirementsOther?Increasing Access to Contraception for Clients with HIV: A Toolkit (FHI)

Study-Specific BackgroundProtocol specified eligibility criteria forPregnancy intentionsWillingness to use an effective contraceptive method Site-specific methods for verifying surgical sterilization as part of eligibility determinationProtocol-specified contraindicated methods Contraceptive methods available on siteContraceptive methods available through referral

On-Site or By Referral?

Emergency ContraceptionEC = 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 abortionSource = WHO Fact Sheet No244

Emergency ContraceptionNot appropriate for regular use as an ongoing contraceptive method due to higher method failure rate compared to other methodsMeant 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 injectionIUCD expulsionAlso in cases of sexual assault when the woman was not protected by an effective contraceptive methodSource = WHO Fact Sheet No244

Contraception CounselingAs with HIV counseling, client-centered approach should be taken to guide and support the participant in Making the best contraceptive method choice for herMaintaining adherence to an effective method

Client-Centered ApproachGreet client and establish rapportDescribe purpose of the session Emphasize confidentiality of the sessionListen effectively, allow client to speak, avoid interruptionsCommunicate effectively, verbally and non-verballyCommunicate at clients level of understandingUse open-ended questionsClarify misconceptionsProvide positive reinforcement

Contraceptive CounselingThere will be much information to provideFor each methodHow taken or administeredMode of actionLevel of effectivenessPossible side effectsAdvantages and disadvantages

Use visual aids (methods and anatomy)Meet participant at her current knowledge levelDispel myths and misconceptions

in the context of study participation

Contraceptive CounselingThere will be much information to listen toWhat has she heard / what does she know about contraception and the different methodsWhat experiences has she had with contraceptionWhat factors are most important to her for when choosing a methodAre there any partner or family issues to consider

Contraceptive CounselingDuring ScreeningAt 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 determinationInformed consent and contraception counseling sessions should Explain which methods are acceptable for study purposes ANDEmphasize 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 CounselingDuring ScreeningContraceptive counselingAll Screening Part 1, Screening Part 2, and EnrollmentProvision of contraception (if indicated) Per site SOP at Screening Part 1Expected at Screening Part 2 and EnrollmentAll staff should be clear on how provision of contraception is to be handled at Screening Part 1

Contraceptive CounselingDuring Follow-UpContinue client-centered approach each monthIf 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 messagesIf participant has issues or problemsIn some cases only counseling and reassurance may be requiredIn other cases, consideration of method switching may be indicated

Contraceptive CounselingDuring Follow-UpSome participants may wish to stop using contraception during follow-up. How should this be handled?

Contraceptive CounselingDocumentationRecord sufficient information and detail to support review and follow-up at each visitUse chart notes, flow sheets, and/or other documentation toolsChart flags/flyers are strongly recommended to highlight key dates (e.g., next injection)Similar flags in pharmacy system can be very helpful

Contraceptive CounselingDocumentation

Lets DiscussYour Comments and Questions

Re: first bullet, the inclusion requirement is for the participant to report using an effective method of contraception at enrollment, and intending to use an effective method for the next 24 months; effective methods include hormonal methods; intrauterine contraceptive device (IUCD); and sterilization (of participant or her sexual partner or partners as applicable and with verification as defined in site SOPs)

After first bullet, can pause and ask the site staff to list off the methods that are considered effective for study purposes. Probe on how they would respond to questions about why condoms are not considered effective

Re: third bullet, per protocol Section 6.8, use of spermicides, diaphragms, and contraceptive rings is contraindicated. Participants who report use of these products will be counseled regarding the use of alternative methods, but reported use of these products does not require any change in use of study products.

Ask site staff report on which of the various methods the site will be providing directly and which will be available only through referral. Sites are encouraged to provide as many methods as possible.Image #1 = Combined OCPImage #2 = Progestin only pillImage #3 = Injectable (Depo and others)Image #4 = ImplantImage #5 = IUCDImage #6 = surgical sterilizationSub-bullets are just a few examples, see WHO fact sheet for more complete listingThis is the exact same slide from the HIV C&T presentation point here is not to talk through it all again but to show that the same counseling methods and techniques are applied in more than one areaFor the highlighted text in yellow, should say that all of the above are standards aspects of FP counseling, including discussion of the relative advantages and disadvantages of each method. In the context of the study, the standard discussion of advantages and disadvantages should be expanded to explore advantages and disadvantages in the context of daily use of a study product. In general, it is expected that longer-acting methods would be good choices for study participants, to minimize adherence burden. However, it is possible that for some participants adherence to both contraception and study product could be ENHANCED by using a daily contraceptive method. Should pause and discuss site staff perceptions on this before proceeding to next topic.