Contraceptive BehaviorFPILNCT07888296
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
A study testing Self-Managed Contraceptive Care and Standard Family Planning Services (WISH-2) in people with Contraceptive Behavior and Self Administration, run by Guttmacher Institute at 1 site in South Sudan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Behavior, Self Administration
- What is being tested?
- Self-Managed Contraceptive Care and Standard Family Planning Services (WISH-2)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,736 participants
- Where
- 1 siteSouth Sudan
- Study dates
- 11 Sep 2026to May 2029
- Phase
- Interventional
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women aged 15 to 49 living within a sampled boma of Aweil East
Who cannot join
- Individuals unable to provide informed consent due to cognitive impairment or severe mental illness
- Individuals who do not share a common language with the enumerators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Sudan1 site, 1 recruiting
- Recruiting
Multi-site (household surveys) throughout Aweil East
Malualkon
August Ting Mayai, 211 913 491 544, amayai@nbc.gov.ss
August Ting Mayai
About this study
Official title: 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
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.
Read the detailed description
This study is conducting an independent evaluation of the International Rescue Committee (IRC)'s cluster-based family planning interventions.
The self-care intervention designed by the IRC is meant to augment the effects of their standard intervention in South Sudan. This study will evaluate these interventions using a randomized controlled trial (RCT) design. The study team, rather than the IRC, will randomize clusters from standard implementation areas to either continue receiving only the standard intervention, or to receive the standard intervention supplemented with the additive self-care intervention in an equal ratio. In South Sudan, randomized bomas belong to an area which has been receiving multi-method family planning service delivery programming from 2019-2024 under WISH-1 and then again beginning in 2026 under WISH-2.
The investigators will measure intervention effects using four waves of a household survey among women aged 15 to 49. The household survey is designed to have a closed longitudinal cohort with dynamic replenishment (i.e. the investigators will follow women longitudinally across each survey wave, and collect data from a cross-sectional sample at each wave to account for longitudinal participants lost to follow-up).
The trial has three co-primary outcomes: modern contraceptive prevalence, self-managed contraceptive method use, and preference-aligned fertility management. Co-primary hypothesis tests will use a Holm-Bonferroni procedure, with ordered p-values tested at alpha levels of 0.0167, 0.025, and 0.05, and each co-primary outcome judged separately. A statistical analysis plan will be finalized and dated after cluster randomization and before any outcome data are analyzed.
- Conditions
- Contraceptive Behavior, Self Administration
- Being tested
- Self-Managed Contraceptive Care, Standard Family Planning Services (WISH-2)
- Keywords
- Family Planning Impact Lab, Family Planning Services, Family Planning, Contraception, Contraceptive Usage, Contraceptive Method Switching, Self-Managed Contraception, Modern Contraceptive Use, Self-injection, DMPA-SC, Sayana Press, South Sudan
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Managed Contraceptive CareBehavioural
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.
Standard Family Planning Services (WISH-2)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Behavioral: Standard Family Planning Services (WISH-2) |
| Self-Care Intervention | Experimental | Bomas will have access to WISH-2 services as well as an additive intervention focused on self-managed contraceptives. Receives: Behavioral: Self-Managed Contraceptive Care; Behavioral: Standard Family Planning Services (WISH-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Secondary outcomes (9)
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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the 12-month contraceptive discontinuation rate, estimated from the contraceptive calendar, between baseline, midline, and endline
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.
Measured: 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 reporting physical, emotional, sexual, or economic intimate partner violence (IPV) between baseline, midline, and endline
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.
Measured: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score of a nine-item women's agency measure between baseline, midline, and endline
A nine-item self-reported measure of general agency covering decision-making over daily life, voice, capacity to act on life choices, and freedom of movement. Items ask whether the respondent can choose how to spend free time, choose which friends to spend time with, voice opinions and express views when others disagree, decide whether to go to school or to work, act on important life choices, make important decisions that change the course of life, do desired things, and go to desired places. Items were adapted from established frameworks for measuring women's and adolescent girls' agency. Each item is rated on a five-point scale from strongly agree to strongly disagree and combined into a mean score, with higher scores indicating greater agency. Administered to all women aged 15-49 at each survey wave.
Measured: 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 any reproductive coercion in the past 12 months, measured with an adapted five-item Reproductive Coercion Scale short form, between baseline, midline, and endline
Proportion of women aged 15-49 reporting at least one reproductively coercive behavior in the past 12 months, measured with five items adapted from the short form of the Reproductive Coercion Scale: being told not to use contraception; having birth control taken away or being kept from obtaining it; being made to have unprotected sex in order to become pregnant; condom removal during sex; and deliberate condom damage. Items are adapted to ask about coercion by any person, not only an intimate partner. The three sexual-behavior items are administered only to women who have ever had sex; the two contraceptive-interference items are administered to all women. The number of coercive behaviors reported (0-5) will be summarized descriptively.
Measured: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start11 Sep 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive BehaviorStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bomas within Aweil East will be randomized to either only have access to the IRC's standard family planning intervention or have access to the standard intervention supplemented with a self-care intervention.
- Masking
- None (open label)
- Enrolment
- 2,736 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guttmacher Institute
- Sponsor type
- University, hospital or other
- Collaborators
- IMPACT Initiatives
- Responsible party
- Sponsor
- Investigators
- Jewel Gausman, PhD, Principal investigator, Guttmacher Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888296
- Sponsor's protocol ID
- 01-647-31-22-00
- Acronym
- FPIL
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07888296
- Acronym / sponsor ID
- FPIL / 01-647-31-22-00
- Conditions
- Contraceptive Behavior, Self Administration
- Keywords
- Family Planning Impact Lab, Family Planning Services, Family Planning, Contraception, Contraceptive Usage, Contraceptive Method Switching, Self-Managed Contraception, Modern Contraceptive Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,736 participants (estimated)
- Lead sponsor
- Guttmacher InstituteUniversity, hospital or other
- Collaborators
- IMPACT Initiatives
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 22 Oct 2026 (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.
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.
Detailed description
This study is conducting an independent evaluation of the International Rescue Committee (IRC)'s cluster-based family planning interventions.
The self-care intervention designed by the IRC is meant to augment the effects of their standard intervention in South Sudan. This study will evaluate these interventions using a randomized controlled trial (RCT) design. The study team, rather than the IRC, will randomize clusters from standard implementation areas to either continue receiving only the standard intervention, or to receive the standard intervention supplemented with the additive self-care intervention in an equal ratio. In South Sudan, randomized bomas belong to an area which has been receiving multi-method family planning service delivery programming from 2019-2024 under WISH-1 and then again beginning in 2026 under WISH-2.
The investigators will measure intervention effects using four waves of a household survey among women aged 15 to 49. The household survey is designed to have a closed longitudinal cohort with dynamic replenishment (i.e. the investigators will follow women longitudinally across each survey wave, and collect data from a cross-sectional sample at each wave to account for longitudinal participants lost to follow-up).
The trial has three co-primary outcomes: modern contraceptive prevalence, self-managed contraceptive method use, and preference-aligned fertility management. Co-primary hypothesis tests will use a Holm-Bonferroni procedure, with ordered p-values tested at alpha levels of 0.0167, 0.025, and 0.05, and each co-primary outcome judged separately. A statistical analysis plan will be finalized and dated after cluster randomization and before any outcome data are analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bomas within Aweil East will be randomized to either only have access to the IRC's standard family planning intervention or have access to the standard intervention supplemented with a self-care intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard Family Planning Services (WISH-2)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. |
| Self-Care Intervention | Experimental | Behavioral: Self-Managed Contraceptive Care, Behavioral: Standard Family Planning Services (WISH-2)Bomas will have access to WISH-2 services as well as an additive intervention focused on self-managed contraceptives. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women aged 15 to 49 living within a sampled boma of Aweil East
Key exclusion criteria (2 listed)
- Individuals unable to provide informed consent due to cognitive impairment or severe mental illness
- Individuals who do not share a common language with the enumerators
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 |
|---|---|---|
| Self-Managed Contraceptive CareThis 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. | Behavioural | Self-Care Intervention |
| Standard Family Planning Services (WISH-2)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. | Behavioural | Control, Self-Care Intervention |
Primary outcome
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
Time frame: 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.
Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline
Time frame: 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.
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
Time frame: 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.
9 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the 12-month contraceptive discontinuation rate, estimated from the contraceptive calendar, between baseline, midline, and endline
Time frame: 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 reporting physical, emotional, sexual, or economic intimate partner violence (IPV) between baseline, midline, and endline
Time frame: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score of a nine-item women's agency measure between baseline, midline, and endline
Time frame: 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 any reproductive coercion in the past 12 months, measured with an adapted five-item Reproductive Coercion Scale short form, between baseline, midline, and endline
Time frame: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jewel Gausman, PhD principal investigator
Guttmacher Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Managed Contraceptive Care and Standard Family Planning Services (WISH-2) in people with Contraceptive Behavior and Self Administration, run by Guttmacher Institute at 1 site in South Sudan.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Jewel Gausman, PhD ((212) 248-1111, jgausman@guttmacher.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Pre-baseline (Month 9 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)). The study lists 3 primary outcomes in all. 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 27 Oct 2026.