Family PlanningPhase 1/2GC-FPNCT06048328
Game Changers for Family Planning Peer Advocacy Program
A Phase 1/2 study testing Game Changers for Family Planning in people with Family Planning, run by RAND.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning
- What is being tested?
- Game Changers for Family Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2027to 1 Jul 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot of a Peer Advocacy Training Intervention to Reduce Unmet Need for Contraception in Uganda
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.
Read the detailed description
The investigators will conduct a pilot RCT of Game Changers for Family Planning (GC-FP) with 40 female modern contraceptive (MC) users (index participants) at one rural public clinic, with 20 randomly assigned to receive the intervention (in 2 groups of 10) and 20 to the wait-list control; enrollment and randomization will be stratified by age and relationship status. Each index will recruit up to 3 social network members (alters) with unmet need for MC (max. total=120). Data will be collected at baseline and month 6 from all participants; primary outcome is alter MC use at month 6.
- Conditions
- Family Planning
- Being tested
- Game Changers for Family Planning
- Keywords
- contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Changers for Family PlanningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | peer-led, multi-session advocacy training group intervention Receives: Behavioral: Game Changers for Family Planning |
| Wait-list control | No intervention | Usual care/no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of use of modern contraceptives (social network participants)
Proportion of participants who use a modern contraceptive, abstracted from medical chart
Measured: 6 months
Secondary outcomes (1)
Mean level of engagement in family planning advocacy (index participants)
Mean item score on self-report scale measuring engagement in family planning advocacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Nov 2027 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel randomized controlled trial, with individual randomization to receive the intervention or wait-list control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Sponsor
- Investigators
- Glenn Wagner, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048328
- Sponsor's protocol ID
- 2024-GC-FP
- Acronym
- GC-FP
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a Peer Advocacy Training Intervention to Reduce Unmet Need for Contraception in Uganda
- ClinicalTrials.gov ID
- NCT06048328
- Acronym / sponsor ID
- GC-FP / 2024-GC-FP
- Conditions
- Family Planning
- Keywords
- contraception
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- 15 Nov 2027 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct a pilot RCT of Game Changers for Family Planning (GC-FP) with 40 female modern contraceptive (MC) users (index participants) at one rural public clinic, with 20 randomly assigned to receive the intervention (in 2 groups of 10) and 20 to the wait-list control; enrollment and randomization will be stratified by age and relationship status. Each index will recruit up to 3 social network members (alters) with unmet need for MC (max. total=120). Data will be collected at baseline and month 6 from all participants; primary outcome is alter MC use at month 6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel randomized controlled trial, with individual randomization to receive the intervention or wait-list control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Game Changers for Family Planningpeer-led, multi-session advocacy training group intervention |
| Wait-list control | No intervention | –Usual care/no intervention |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- MC user for past year
- Not using MC, but reports trying to prevent pregnancy
- Know about the MC use of their referring index participant
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Changers for Family PlanningGame 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. | Behavioural | Intervention |
Primary outcome
Rate of use of modern contraceptives (social network participants)
Time frame: 6 months
Proportion of participants who use a modern contraceptive, abstracted from medical chart
1 secondary outcome
Mean level of engagement in family planning advocacy (index participants)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Family Planning
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Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
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Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
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Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
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Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
Intellectual Disability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Wagner principal investigator
RAND
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Game Changers for Family Planning in people with Family Planning, run by RAND.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenn Wagner (3234284376, gwagner@rand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of use of modern contraceptives (social network participants) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.