Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria

Abstract

Background: High-quality contraceptive counselling can accelerate global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of interventions designed to strengthen in Pakistan and Nigeria and determine their effectiveness in increasing client-level decision-making, autonomy and meeting of contraceptive needs.

Methods: A multisite, two-stage and five-phase intervention design will start with a pre-formative, formative, design, experimental and reflective phase. The pre-formative phase will map potential study sites and establish the sampling frame. The two-part formative phase will first use participatory approaches to identify clients' perspectives, including young couples and providers, to ensure research contextualisation and address each interest group's needs and priorities followed by clinical observations of client-provider encounters to document routine care. The design workshop in the third phase will result in the development of a package of contraceptive counselling interventions. In the fourth experimental phase, a multi-intervention, three-arm, single-blinded, parallel cluster randomised-controlled trial will compare routine care (arm 1) with the contraceptive counselling package (arm 2) and the same package combined with wider methods availability (arm 3). The study aims to enrol a total of 7920 participants. The reflective phase aims to identify implementation barriers and enablers. The outcomes are clients' level of decision-making autonomy and use of modern contraceptives.

Ethics and dissemination: Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (Protocol ID Pakistan: ERC 006232 and Nigeria ERC: 006523). Each study site is required and has obtained the necessary ethical and regulatory approvals that are required in each specific country. Findings will be presented at local, national and international conferences and disseminated by peer-review publications.

Trial registration number: NCT06081842.

Keywords: Clinical Trial; Decision Making; Health Services; Public health.

Figure 1

Overall study model.

Figure 2

Flow diagram of the cluster randomised controlled trial in each study country.

Figure 3

Schedule of enrolment, interventions and assessments for the cluster randomised controlled trial phase in each study country (SPIRIT template). SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.