Trial · NCT07888296

Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)

NCT07888296, Not applicable, Recruiting, Guttmacher Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab). Trials, record NCT07888296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888296

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
NCT number: NCT07888296
Status: Recruiting
Phases: Not applicable
Enrollment: 2,736 participants, estimated
Lead sponsor: Guttmacher Institute
Conditions: Contraceptive Behavior, Self Administration
Interventions: Self-Managed Contraceptive Care, Standard Family Planning Services (WISH-2)
First posted: 2026-10-22
Last updated: 2026-10-27

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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 15-49 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.
Primary	Change in the proportion and number of women using preference-aligned fertility management 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 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.
Primary	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	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 15-49 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.
Secondary	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)	Proportion of women aged 15-49 who report that the final decision about their contraceptive use is made by themselves alone or jointly with their husband or partner, in response to a question asking who makes the final decision about the participant's use of contraception. Responses indicating that a partner, parent/guardian, in-laws, a health care provider, or another person decides alone or jointly are classified as not having decision-making autonomy.
Secondary	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)	Proportion of non-pregnant women aged 15-49 who report that their current contraceptive status is entirely their own choice, free from pressure. Current users are asked whether use of their current method was their own choice, with no one having pressured or strongly encouraged them to use that particular method; non-users are asked whether not using a method is their own choice, with no one having pressured them into not using. The remaining response options indicate experiencing some pressure but agreeing, or feeling pressured. The measure operationalizes freedom from pressure as a component of contraceptive autonomy.
Secondary	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)	The Contraceptive Self-Efficacy Scale for Sub-Saharan Africa (CSESSA) is a 10-item validated tool used to measure reproductive self-efficacy. The investigators will assess the level of reproductive self-efficacy among women aged 15-49 in the sample at baseline, midline, and endline.
Secondary	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)	Unmet need follows the revised DHS definition (Bradley et al. 2012), which underlies UN SDG indicator 3.7.1. A woman has unmet need if she is fecund; wants to stop childbearing, delay the next birth by at least two years, or is undecided about timing - or is pregnant or postpartum amenorrheic following a mistimed or unwanted pregnancy - and is not using any contraceptive method. Unmet need for modern methods adds women using a traditional method. The headline estimate is unmet need for modern methods among all women exposed to the risk of pregnancy: currently married or in union (assumed exposed), or unmarried and sexually active (intercourse in the past 30 days). DHS-conventional variants report unmet need for any and for modern methods, among currently married women and among all sexually active women. SDG indicator 3.7.1 (demand satisfied with modern methods) will be computed from these components and reported. Probe-identified traditional-method users are classified as users.
Secondary	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)	Supply-side unmet need classifies women with unmet need (revised DHS definition, any method, as above) who report at least one access-related reason for non-use, following Senderowicz and Maloney (Population and Development Review, 2022). Access-related reasons captured by the survey are: knows no method; knows no source; lack of access or distance; cost; preferred method not available; no method available. Women with unmet need who cite only demand-side reasons (e.g., opposition to use, side-effect or health concerns) constitute demand-side unmet need, the complement of supply-side unmet need among women with unmet need. A pre-specified sensitivity analysis instead restricts to women with unmet need who report wanting to use contraception (Senderowicz et al., Studies in Family Planning, 2023).
Secondary	Change in the 12-month contraceptive discontinuation rate, estimated from the contraceptive calendar, 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 proportion of episodes of modern contraceptive method use discontinued within 12 months of initiation, estimated from the survey's month-by-month contraceptive calendar using single-decrement life-table methods, following DHS analytic conventions. The investigators define the end of an episode at the first calendar month of non-use; a switch to another modern method in the same or immediately following month is treated as continued contraceptive use in the overall rate and as method-specific discontinuation in method-level rates. Overall and method-specific 12-month discontinuation rates will be reported, distinguishing discontinuation while still in need of contraception from discontinuation due to no need (e.g., seeking pregnancy). The calendar administered at each wave covers at least the preceding 12 months, so each assessment reflects use episodes observable in that window.
Secondary	Change in the proportion and number of women reporting physical, emotional, sexual, or economic intimate partner violence (IPV) 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 15-49 in the study who report experiencing physical, emotional, sexual, or economic intimate partner violence in the past 12 months, as assessed using an adapted DHS domestic violence module.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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