FPIL
Estimating the Impact of Comprehensive SRHR Services on Health and Development in South Sudan: A Cluster Randomized Controlled Trial of a Contraceptive Self-Care Intervention for the Family Planning Impact Lab
Sponsor study identifier
interventional
2,736
1 country
1
Study Start
September 11, 2026
Actual (reported)Primary Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Since 2019, the International Rescue Committee (IRC) has led family planning programming under the Women's Integrated Sexual Health (WISH) program, funded by the United Kingdom's Foreign, Commonwealth, and Development Office. This study will assess contraceptive-related outcomes in communities in South Sudan where the IRC is implementing a standard set of family planning services. Approximately one year into their standard implementation, the IRC will develop additional interventions to augment the standard, which this study will evaluate over the subsequent three years. This additive intervention will aim to optimize last-mile service delivery by increasing access to self-managed family planning methods, such as oral contraceptive pills, emergency contraception, and self-injectable contraception. This study is independent of the IRC and is one of four studies in the Guttmacher Institute's Family Planning Impact Lab (FPIL). FPIL intends to produce experimental research, estimating the causal impact of various family planning interventions on women's broader health, wellbeing, and development outcomes in South Sudan, Somalia, Chad, and Sierra Leone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2026
Actual (reported)October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in the proportion and number of women reporting use of self-managed contraceptive methods (self-administered injectable, OCPs, emergency contraception, condoms, fertility-awareness based methods) between baseline, midline, and endline
Change in the proportion and number of women aged 15-49 who report current use of a self-managed contraceptive method, following WHO guidance on self-care interventions: self-administered injectable contraception (DMPA-SC), oral contraceptive pills, emergency contraception, male and female condoms, and fertility awareness-based methods (standard days method, Billings ovulation method, rhythm method, and other fertility awareness-based methods). The denominator is all women; a method-specific breakdown will be reported. A pre-specified sensitivity analysis excludes condoms. The three co-primary outcomes are tested with a Holm-Bonferroni procedure (ordered p-values tested at 0.0167, 0.025, and 0.05), with each co-primary judged separately.
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline
Bomas in this arm will only have access to the standard family planning intervention implemented under WISH-2. This will be used as the control arm.
Bomas will have access to WISH-2 services as well as an additive intervention focused on self-managed contraceptives.
This intervention is designed to expand access to self-managed family planning methods among women and girls in settings with weak last-mile service delivery. Contraceptive self-care - encompassing self-administered injectable contraception, oral contraceptive pills, emergency contraception, and other user-controlled methods - offers a complementary model of service delivery that can bypass structural barriers by placing tools and decision-making directly in the hands of users. Self-care approaches are particularly important for women experiencing intimate partner violence or reproductive coercion, for whom discreet and self-managed contraception may be the only accessible option. Intervention mechanisms will include a network of trained self-care promoters; targeted information, education, and communication (IEC) materials, direct commodity provision; facility provider training on self-care counseling; and client decision-support tools.
Multi-site (household surveys) throughout Aweil East
Malualkon, South Sudan
Jewel Gausman, PhD
Guttmacher Institute
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
September 11, 2026
Actual (reported)Change in the proportion and number of non-pregnant women aged 15-49 whose contraceptive use or non-use is aligned with their preferences, adapted from the preference-aligned fertility management indicator developed by Holt and colleagues; the study instrument elicits current use before contraceptive preference, whereas the original index elicits preference first. Users are classified as aligned if they want to be using a method, want to be using their current method, and report no other method they would prefer to use; non-users are classified as aligned if they want not to be using a method. A pre-specified sensitivity analysis classifies women reporting any pressure on their use or non-use as discordant.
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15 to 49 using a modern contraceptive method (modern contraceptive prevalence) between baseline, midline, and endline
Change in the proportion and number of women aged 15-49 who use, or whose partners use, a modern contraceptive method. Modern methods comprise female and male sterilization, copper and hormonal IUDs, implants, provider-administered and self-administered injectables, oral contraceptive pills, male and female condoms, emergency contraception, foam/jelly, the Lactational Amenorrhea Method, fertility awareness-based methods (standard days method, Billings ovulation method), and other modern methods reported through an open response (e.g., patch/ring, diaphragm). Any-method contraceptive prevalence - adding withdrawal, the rhythm method, other traditional and fertility awareness-based methods, and probe-identified users - will be reported as a pre-specified variant.
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women who report making the final decision about contraceptive use alone or jointly with their partner, between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women reporting that their contraceptive use or non-use was entirely their own choice, between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the level of reproductive self-efficacy as measured by the Contraceptive Self-Efficacy Scale for Sub-Saharan Africa (CSESSA) between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in proportion and number of women aged 15 to 49 who have unmet need for family planning between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15 to 49 with supply-side unmet need for family planning between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women who report that cost would be a barrier to them accessing a contraceptive method between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of current modern contraceptive method users who report being satisfied or very satisfied with their current method, between baseline, midline, and endline
Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
The IRC's standard WISH-2 family planning service delivery package, implemented by the IRC independently of the study team in all study bomas. The package strengthens facility-based family planning services through provider training, commodity availability, service integration, and community mobilization, with services delivered through static, outreach, and community-based channels.
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Primary Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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