Protocol No: ECCT/23/12/05 Date of Protocol: 09-10-2023

Study Title:

Assessing acceptability of Annovera contraceptive vaginal ring use (compared to other contraceptive method use) among women seeking family planning services

Study Objectives:

The primary objectives of this study are:

1)      To assess method satisfaction in Annovera users and to compare it with satisfaction among users of other contraceptive methods (non-Annovera users) at 12 and 52 weeks of use.

2)      To compare method continuation between Annovera users and users of other contraceptive methods at 4, 12, 24, 36, and 52 weeks.

3)      To assess Annovera uptake by the proportion of women attending the site during the study period who initiated Annovera vs. initiated comparison (OC/DMPA) methods.

The Secondary Objectives of this study are:

1)      To assess various dimensions of acceptability of Annovera at 4, 12, 24, 36 and 52 weeks

2)      To determine characteristics associated with willingness to try Annovera (vs. to use other contraceptive methods)

3)      To determine characteristics associated with satisfaction with Annovera (vs. with dissatisfaction with Annovera)

4)      To assess reasons for contraceptive method selection and discontinuation in Annovera users and users of other contraceptive methods.

Laymans Summary:

This research study will look at whether women would accept to use the Annovera vaginal ring as a Family Planning method. This study will compare the use of the Annovera vaginal ring with other Family planning methods like oral contraceptive pills (OCPs) or depot medroxyprogesterone acetate (DMPA).

In this study, women ages 18-45 years who accept to use the Annovera vaginal ring as a Family Planning method or another form of family planning method (OCPs or DMPA) will be asked to come to the research site six times during the year they are in the study. The scheduled study visits will comprise in-person clinic visits at baseline for screening and enrolment and at week 52 (end of study visit), and phone follow-up visits at weeks 4, 12, 24, and 36 while on the preferred family planning method.

The Annovera vaginal ring is the first and only contraceptive that provides an entire year of protection against unintended pregnancy while fully under a woman’s control. The ring is portable and discreet, and the woman inserts and removes it herself making it an ideal self-care contraceptive method for those who face barriers accessing health facilities.

Abstract of Study:

Background: Despite the dramatic rise in use of modern contraception globally over the past 50 years, approximately 48% of all pregnancies are unintended and more than 214 million women of reproductive age in low- and middle-income countries (LMICs) still have unmet need for modern contraception, with the highest proportion located in sub-Saharan Africa. Women in many LMICs have limited contraceptive choices with over half of all modern contraceptive use provided by one or two methods. Expanding method choice would better meet the needs and reproductive intentions of more women and couples, raise overall contraceptive use, and reduce unintended pregnancies.

Objectives: The primary objective of this study is to evaluate and compare the acceptability of the Annovera Vaginal Ring to other contraceptive methods (specifically, oral contraceptives i.e. OCPs and DMPA) over 52 weeks of use. Women choosing Annovera will be compared against women choosing OCPs and DMPA as these are the two most widely used non-LARC contraceptive methods in both study countries and are thus most likely to be the method chosen by people who may otherwise choose Annovera.

Methods: In the study, women ages 18-45 years who accept Annovera or another form of contraception (OCPs or DMPA) will be surveyed six times during a year of product use – surveys at baseline and at weeks 4, 12, 24, 36, and 52 of method use.  Women attending family planning visits at the Kibera D.O Health Centre in Nairobi will be enrolled into the study and given the option of choosing either the Study Product (Annovera vaginal ring) or a contraceptive of their choice (either OCPs or DMPA) with 100 Annovera users and 100 non-Annovera users. Another 100 Annovera users and 100 users of other contraceptives will be enrolled under a separate study protocol at a site in Zimbabwe. The Zimbabwe-specific protocol has been submitted to the Zimbabwe regulatory authorities separately as the KEMRI team is not involved in the conduct of their study.

Study outcomes: The primary endpoints of the study are method satisfaction (proportion of women who report being satisfied or “very satisfied” with Annovera and with the other contraceptive methods), method continuation (cumulative probability of continuing Annovera, or the other contraceptive method for 52 weeks) and method uptake (proportion of women who initiate Annovera method among all women who newly initiated contraception or switched from another method). .

Study duration: The study is expected to last approximately 24 months from screening of the first participant to final follow up of the last participant visit. The length of study participation will be approximately one year for Annovera users and non-users. The treatment period for each Annovera user will be 12 months from initiation of Annovera use through 52 weeks or 13 4-week cycles of use.