Clinical trial NCT06081842: Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria
Official title: Strengthening Contraceptive Counseling Services, a Multi-country Study Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraception
Empowerment
Decision Making
Keywords: Family Planning, Counselling, choice
Lead sponsor: World Health Organization
Sponsor class: OTHER
Collaborators: name: Jinnah Sindh Medical University
name: University of Ibadan
First posted: 2023-10-13
Enrollment: 7920
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research entails a complex multi-site, two-stage and 5-phase: STAGE 1 is formative and will comprise of a pre-formative (phase 1) and a formative (phase 2). While the STAGE 2 is experimental and will include intervention design (phase 3), experimental (phase 4), and reflective (phase 5).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions for Pakistan and Nigeria designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.

Detailed description: The research will be a multi-intervention, three-arm, single-blinded, parallel, cluster RCT done in selected primary health centers (clusters) in Pakistan and in Nigeria. Centers will be randomly allocated to the three study arms in matched ratios (1:1:1) on the basis of the number of monthly family planning encounters, the number of available contraceptive types, the ratio of health workers per population in the clinic coverage zone, the location in urban or rural settings, and selected district-level variables that may have an influence on the study outcomes, including the unmet need for family planning, the level of literacy among women, and household income quartiles. Only data analysts will be masked to trial-arm allocation. Service providers skilled in family planning services will implement the clinical components of the contraceptive counseling package. The cluster RCT design is justified by the fact that some of the components of the intervention package to be identified in the intervention design phase will not be delivered directly to individual participants but only applied at the level of the health center, such as refresher training of service providers.

The two-part formative phase first uses participatory approaches to identify the perspectives of clients, including young people and providers, to ensure research contextualization and address each interest group's needs and priorities; clinical observations of client-provider encounters to document routine care form the second part. The design workshop of the third phase will result in the development of a package of contraceptive counseling interventions. In the fourth and experimental phase, a multi-intervention, three-arm, single-blinded, parallel cluster randomized-controlled trial will compare routine care (arm 1) with the contraceptive counseling package (arm 2) and the same package combined with wider method availability (arm 3). The fifth and reflective phase aims to analyze the package's cost-effectiveness and identify implementation barriers and enablers. The primary outcomes are clients' level of decision-making autonomy and met need for modern contraceptives.

Eligibility criteria: Inclusion Criteria:

1. Client comes to the family planning clinic with the intention to 1.a. use contraception for the first time in her life (new user), or 1.b. switch from a contraceptive method to another one (switching user), or 1.c. resume a method after not using any in the prior three months (lapse user), or 1.d. discontinue a modern method (discontinuing user);
2. Client is not coming for the resupply of a currently used method, such as pills or injectables;
3. Client has the intention to continue her follow-up at the health center during the duration of study follow-up;
4. Client does not participate in another study; and
5. Client provides informed consent.

Exclusion Criteria:

Not willing to participate in the complete duration of the trial

Primary outcomes:
measure: Change in clients' decision-making autonomy
timeFrame: Through study completion, an average of 1 year
measure: Change in clients' met need for family planning
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in modern contraceptive prevalence
timeFrame: 6 months and 12 months post enrollment
Other outcomes:
Locations:
Study officials:
References: