Trial · NCT07888296
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | 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 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. |
| Secondary | 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 | 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 | 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 a statement that cost would be a barrier to using contraception if the participant wanted to use it. 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. |
| Other | 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) when asked how satisfied they are with using their current 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). 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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