Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06081842 |
Other study ID # |
WHO |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2023 |
Est. completion date |
June 2026 |
Study information
Verified date |
October 2023 |
Source |
World Health Organization |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.