NCT06048328

Brief Summary

This study will adapt the Game Changers peer advocacy training model for family planning context and pilot test the feasibility, acceptability and preliminary efficacy of the intervention to empower female contraception users to advocate for contraception use among women in their social networks who have unmet need for contraception.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_1

Timeline
44mo left

Started Nov 2027

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4.2 years until next milestone

Study Start

First participant enrolled

November 15, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

September 8, 2023

Last Update Submit

December 23, 2025

Conditions

Keywords

contraception

Outcome Measures

Primary Outcomes (1)

  • Rate of use of modern contraceptives (social network participants)

    Proportion of participants who use a modern contraceptive, abstracted from medical chart

    6 months

Secondary Outcomes (1)

  • Mean level of engagement in family planning advocacy (index participants)

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

peer-led, multi-session advocacy training group intervention

Behavioral: Game Changers for Family Planning

Wait-list control

NO INTERVENTION

Usual care/no intervention

Interventions

Game Changers for Family Planning (GC-FP) intervention. The intervention will consist of 6 group sessions. The sessions will focus on stigma reduction, disclosure decision making, knowledge, and building skills for advocacy. The 2-hour, weekly sessions will be facilitated by 2 trained peers who are MC users, and conducted in Luganda using a structured manual, and group format to facilitate: sharing of experiences to build support, modeling and motivation; group problem solving and role playing to build skills and self-efficacy; and homework between sessions to practice skills and generate experiences to be processed in the group.

Intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • MC user for past year
  • Social network member participant:
  • Not using MC, but reports trying to prevent pregnancy
  • Know about the MC use of their referring index participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Family Planning Services

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health Services

Study Officials

  • Glenn Wagner

    RAND

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn Wagner

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel randomized controlled trial, with individual randomization to receive the intervention or wait-list control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 21, 2023

Study Start (Estimated)

November 15, 2027

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The investigators will create public use data files that include a deidentified quantitative dataset that includes longitudinal participant-level survey scales and social network assessment data (related to the primary research questions around family planning, and moderators and mediators of the associations between the intervention and contraception use); and an excel spreadsheet with the qualitative codebook with representative quotes on key themes by subgroup, linked to ID. Only predictors and outcomes data (e.g., contraception use) will be shared; additional variables (e.g., socio-demographic characteristics) will not be included to prevent the potential and unintentional de-identification of participants.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
one year after completion of study, for 12 months