Estimating the Impact of Comprehensive SRHR Services on Health and Development in South Sudan for the Family Planning Impact Lab

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.

We 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. we 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 before outcome data are analyzed.

• Self-Managed Contraceptive Care (Behavioral): 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 discrete 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.

Primary outcomes

• 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.
• 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; our 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 ("Do you want to be using \[current method\] as your method right now?"), and report no other method they would prefer to use; non-users are 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 (Senderowicz 2020).
• Change in the proportion and number of women using contraceptive methods (including modern or any) 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 who use, or whose partners use, any method (traditional or modern), and change in the proportion and number of women aged 15-49 who use, or whose partners use, any modern contraceptive method. Modern methods include: female and male sterilization, oral contraceptive pills, IUDs, implants, injectables, male or female condoms, patch/ring, emergency contraception, Lactational Amenorrhea Method (LAM), fertility awareness based methods (FABM) such as standard days method and Billings ovulation method, and other supply methods (diaphram, foam/jelly). Traditional methods include: periodic abstinence, withdrawal, and long-term abstinence.

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 [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 respond "you alone" or "you and your husband/partner jointly" to the question "Who would you say makes the final decision about you using 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.
• 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 respond "entirely my choice" to a question about whether their current contraceptive status reflects their own choice, free from pressure. Current users are asked whether use of their current method was the
• Change in the level of reproductive self-efficacy as measured by the Contraceptive Self-Efficacy among women in 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 CSESSA is a 10-item validated tool used to measure reproductive self-efficacy. We will assess the level of reproductive self-efficacy among women aged 15-49 in our sample at baseline, midline, and endline
• 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.
• 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).
• 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. We 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.
• 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 our study who report experiencing physical, emotional, sexual, or economic intimate partner violence in the past 12 months as assessed using the DHS domestic violence module
• Change in the mean score of a nine-item women's agency measure 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)]: 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 include: "I can choose for myself how to spend my free time"; "I can voice my opinion even when others do not agree with me"; "I can decide whether to go to school or to work"; "I am able to act on my important life choices"; "I have the power to make important decisions that change the course of my life"; "I have freedom to go places that I want to"). 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.
• Change in the proportion of women reporting any reproductive coercion using the Reproductive Coercion Scale, 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 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.

Other outcomes

• 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)]: Proportion of women aged 15-49 who respond "completely agree" or "agree" (four-point scale: completely agree, agree, disagree, completely disagree) to the statement "If I wanted to use contraception, the cost would be a barrier for me." The item is administered to all women regardless of current contraceptive use and measures perceived cost as a barrier to access; it complements supply-side unmet need (reasons for non-use among women with unmet need) and out-of-pocket cost paid by current users.
• 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)]: Among women aged 15-49 currently using a modern contraceptive method, the proportion who respond "very satisfied" or "satisfied" (five-point scale from very satisfied to very dissatisfied) to the question "How satisfied are you with using \[current method\] right now?" 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). A pre-specified sensitivity analysis includes users of any method, adding withdrawal, the rhythm method, and other fertility-awareness-based or traditional methods as captured by the instrument.

Sex: Female, ages: 15 Years to 49 Years, accepts healthy volunteers

Inclusion Criteria:

* Women aged 15 to 49 living within a sampled boma of Aweil East

Exclusion Criteria:

* 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

• Jewel Gausman, PhD, Principal investigator, Guttmacher Institute