Trial · NCT07902700
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline | Pre-Baseline (Month 8 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 men's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Married men aged 18-60 are asked whether they agree, partially agree, or do not agree with the statement: "A husband should have the final say about whether his wife uses contraception." The measure is summarized as the proportion of men in each response category. Men are sampled cross-sectionally at each wave, one man per household, from households not selected for the women's survey. |
| 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 8 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 and number of women aged 15 to 49 who have unmet need for family planning between baseline, midline, and endline | Pre-Baseline (Month 8 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 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 method 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 person-centered unmet need for family planning between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Person-centered unmet need classifies women with unmet need (revised DHS definition, any method, as above) who report that not using contraception is not what they want - that is, women with unmet need who want to be using a contraceptive method (Senderowicz et al., Studies in Family Planning, 2023). Its mirror, unwanted family planning - women currently using a contraceptive method who report that using is not what they want - will also be reported (Gausman et al., Studies in Family Planning, 2025). |
| 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 8 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 8 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 8 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 the mean score on a nine-item self-reported women's agency measure between baseline, midline, and endline | Pre-Baseline (Month 8 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 women's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Women aged 15-49 are asked the same item administered to men, with response options agree, partially agree, and do not agree. The measure is summarized as the proportion of women in each response category. |
| Secondary | Change in the mean score on the Gender-Equitable Men (GEM) Scale among men, between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Mean score on the Gender-Equitable Men (GEM) Scale items administered to men aged 18-60, with higher scores indicating more gender-equitable attitudes. Subscale and item-level results are reported descriptively. |
| Secondary | Change in the proportion of women and of men who report discussing family planning with their spouse or partner in the past 12 months, between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Proportion of partnered women aged 15-49, and of partnered men aged 18-60, who report discussing family planning with their spouse or partner in the past 12 months. Frequency of discussion is reported descriptively. |
| 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 8 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. Reproductive coercion is additionally monitored by arm throughout the study for participant safety. |
| 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 8 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. Intimate partner violence is additionally monitored by arm throughout the study for participant safety. |
| Other | Change in the 12-month contraceptive discontinuation rate, estimated from the contraceptive calendar, between baseline, midline, and endline | Pre-Baseline (Month 8 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. An episode ends with 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 reduced 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. |
| Other | Change in the proportion of women aged 15 to 49 with unmet need for family planning attributed to partner or family opposition, between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Women with unmet need (revised DHS definition, any method) whose reported reasons for not using contraception include opposition from their husband or partner, or opposition from other family or community members. |
| Other | Change in the proportion of current contraceptive users whose husband or partner is unaware of their contraceptive use (covert use), between baseline, midline, and endline | Pre-Baseline (Month 8 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 contraceptive method, the proportion who report that their husband or partner does not know they are using it. |
| Other | Change in mean scores on the Gender Norms Scale (G-NORM) between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Mean scores on the Gender Norms Scale (G-NORM) items measuring perceived descriptive norms (what the respondent believes others in the community do) and perceived injunctive norms (what the respondent believes others expect) related to family planning and gender roles, reported separately by subscale and for women and men. |
| Other | Change in indicators of women's economic empowerment (economic participation, control over earnings, participation in household financial decisions, and asset ownership) between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Four indicators reported separately among women aged 15-49: (1) economic participation - the proportion who did any work aside from housework in the past 12 months; (2) control over earnings - among women who earn, the proportion who decide alone or jointly with their partner how their earnings are used; (3) participation in household financial decisions - the proportion who decide alone or jointly about major household purchases; (4) asset ownership - the proportion reporting rights to use land for their own farming, business, or housing. |
| Other | Change in the proportion of men reporting participation in household tasks in the past 7 days, between baseline, midline, and endline | Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention) | Proportion of men aged 18-60 who report having cared for children, cooked, cleaned or washed clothes, fetched water or firewood, or cared for a sick household member in the past 7 days; the number of task types reported is summarized descriptively. |
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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