Background: The purpose of this protocol is to evaluate the acceptability of a progesterone vaginal ring (PVR) as a contraceptive among women in sub-Saharan Africa.  Clinical trials have proven the PVR to be an effective contraceptive; furthermore, it is currently registered in 8 countries in Latin America.  Although proven safe and effective in clinical trials, there is a need to assess acceptability prior to introduction into country programs.  To this end, the Council is planning to conduct PVR acceptability studies in Kenya, Nigeria and Senegal, for which we are seeking Institutional Review Board (IRB) approval. 

The acceptability study is one component of a number of activities as part of pre-introductory efforts.  Other activities include global and national consultations, assessments and documentation of the regulatory and procurement frameworks, and market segmentation and demand analysis.  As part of the acceptability assessment described in this protocol, information will be gathered from various stakeholders to evaluate factors influencing acceptability; respondents will be PVR users, health care providers, and community members. Both quantitative and qualitative data will be gathered from the participants through a variety of instruments.

Study participants and data collection: Women aged 18-35 who are (1) 6-9 weeks postpartum, (2) still amenorrheic,(3) breastfeeding fully/nearly fully and wish to breastfeed a minimum of four times per day through two ring cycles (6 months), and (4) willing to participate in the study will provide informed consent before any other study procedures commence. Consenting women who meet the criteria for admission will be screened by a medical provider andthose who are eligible will be enrolled in the study. Participants will be provided with2 rings (on separate visits) and counseled on use and compliance with study protocol, after which they will initiate use of the method.  Participating women will return twice for follow-up visits (at months 3 and 6), at which time they will be interviewed about perceptions and experiences with using the PVR and have relevant medical checkups.  Additionally, 5 participants in each country, who have given informed consent, will give in-depth interviews (IDIs) about their user experience with the PVR to a trained data collector at months 1, 3, and 6. Upon completion of the study, women will be offered another contraceptive method if desired. Participation is voluntary and women are free to leave the study at any point if they chose to do so.

Health care providers (HCPs) from the 18 identified sites in Kenya, Nigeria and Senegal will be trained on insertion and removal of the PVR as well as principles of the International Conference on Harmonization Good Clinical Practice (ICH GCP) standards, referred to as “GCP” in this document, for conducting the study. Consenting HCPs will be asked to complete a pre- and post-training questionnaire, as well as one at the conclusion of the study, to evaluate and track changes in knowledge and attitudes regarding the PVR.

A minimum of 1 focus group discussion (FGD) will be convened in each country to evaluate key community members’ perceptions about the PVR.  Participants, not necessarily in the same group discussion, will consist of women aged 18-49, community elders, religious leaders, breastfeeding support group members (if they exist), health committee members, and family members such as mothers, mothers-in-laws, and husbands. Participantswill sign an informed consent before taking part in the FGD. Qualitative data gleaned from key community members will provide valuable insight into factors influencing the acceptability of the PVR in a particular community. 

Ethical issues: Informed consent will be taken from all study participants—users, providers, and community members. Potential participants will be counseled about the study and only those who can give informed consent will be enrolled. The informed consent form, approved by the Population Council’s IRB and the local IRB, must be obtained from each participant prior to performing any procedures outlined in the protocol. 

Risks to users, providers, and community: There are minimal risks involved with the use of the PVR during this acceptability study.  The PVR is a product that has been clinically studied and found to be safe and effective; it is also approved for use in several Latin American countries.  The most significant risk is an unintended pregnancy arising from improper screening by providers or non-adherence to use instructions by the user.  We aim to mitigate screening risks by enrolling women (1) who are 6-9 weeks postpartum and hence less likely to be ovulating (2) are still amenorrheic and (3) who have a negative pregnancy test result.  We aim to mitigate risks due to non-adherence by counseling all users about the conditions under which the PVR is effective and the options they would have should pregnancy occur. They will be informed that they will be treated free of charge and managed according to hospital practice with their consent.  PVR users who become pregnant will be advised to discontinue use and will be referred for antenatal care services at the facility or any other facility of their choice. Other risks to the user are associated with vaginal discharge or discomfort. These will be managed and treated free of cost to the user. All user information is for study purposes only and will remain confidential.

There are no risks posed to providers or community members participating in the FDGs. They are free to discontinue participation at any time without fear of consequences, and all information shared by them will be confidential.

Remuneration:  Remuneration will be nominal and will use standard guidelines used in the country.    Compensation study participants will receive includes reimbursement for travel to and from the study sites for follow up visits, interviews, or FGDs.  This will be KSh. 300 per participant per visit in Kenya. FGD participants will also receive refreshments.