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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD098523-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Makerere University | OTHER |
| San Diego State University | OTHER |
| Yale University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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This study seeks to develop and evaluate a multi-level intervention to satisfy couples' unmet need for family planning in rural Uganda. The study will evaluate the acceptability, feasibility, and preliminary efficacy of the intervention at increasing contraceptive uptake and continuation and improving intermediate outcomes of knowledge, attitudes, perceived community norms, partner communication and equity among couples in rural Uganda.
In 2018, 32.6% of women of reproductive age had an unmet need for family planning in Uganda, meaning they wanted to avoid pregnancy but were not using a modern contraceptive method. Filling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. While Uganda is scaling up efforts to reduce supply-side barriers in rural areas, such as community distribution of contraceptives, couples are still faced with multi-level demand-side barriers to contraceptive use. In addition to misinformation and fear of contraceptive side-effects, relationship dynamics, peer and family influence, and broader community norms promoting large family size and traditional gender roles influence family planning. This study will pilot test a multi-level, community-based intervention, which employs transformative community dialogues to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples enhanced to simultaneously address individual and interpersonal-level determinants of family planning and link couples to family planning services. The aims of this project are to conduct a pilot quasi-experimental controlled trial to: 1) assess acceptability and feasibility of the trial procedures and intervention content; 2) the intervention's potential efficacy on contraceptive uptake and continuation and intermediate outcomes (knowledge, attitudes, perceived community norms, partner communication and equity) through 6-month follow up.
One village will be randomized to the multi-level intervention and one village to the control condition (attention-matched control intervention). Participation in the full study will last 6 months. Participants will first complete a questionnaire after enrollment, and female participants will take a pregnancy test at baseline. Participants in both study arms will participate in interviewer administered questionnaires at 3 months and 6 months follow-up, pregnancy testing at 6-months follow-up for women, and will permit the research team to access their medical records to extract information about their contraceptive use and use of family planning services. Participants in the intervention arm will participate in a series of group sessions with other couples from the community. Group sessions will last approximately 90 minutes, including community dialogues to reconstruct group norms that discourage contraceptive use enhanced with activities to improve knowledge, motivation, couple dynamics, and link couples to services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multilevel Family Planning Intervention | Experimental | A multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity). |
|
| Time and attention-matched control | Active Comparator | A community sanitation intervention delivered in groups of couples to increase at-home and community hygiene practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multilevel Family Planning Intervention | Behavioral | The intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Couples With Uptake of Any High Efficacy Contraceptive Method | Uptake of any high efficacy contraceptive method. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report | 7-months and 10-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Couples That Discontinued Use of a High Efficacy Contraceptive Method at 10-months Follow-up Among Those That Started Using a Method at 7-months Follow-up | Number of couples that discontinued use of a high efficacy contraceptive method at 10-months follow-up among those that started using a method at 7-months follow-up. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katelyn M Sileo, PhD, MPH | University of Texas at San Antonio | Principal Investigator |
| Susan M Kiene, PhD, MPH | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katende Villages | Gombe | Butambala | Uganda | |||
| Kyabadaza Villages |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38835058 | Derived | Sileo KM, Muhumuza C, Tuhebwe D, Munoz S, Wanyenze RK, Kershaw TS, Sekamatte S, Lule H, Kiene SM. "The burden is upon your shoulders to feed and take care of your children, not religion or culture": qualitative evaluation of participatory community dialogues to promote family planning's holistic benefits and reshape community norms on family success in rural Uganda. Contracept Reprod Med. 2024 Jun 4;9(1):28. doi: 10.1186/s40834-024-00290-y. | |
| 36564852 | Derived |
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Quantitative data collected in this trial (baseline, follow-up assessments) will be made available, under the following provisions: (1)The data will be fully de-identified; (2) Access to the data will be made available first to researchers and their students at the four collaborating institutions (within 3 years of study completion): The University of Texas at San Antonio, San Diego State University, the Makerere University School of Public Health (MakSPH), and Yale University; 4) 5 years after study completion, data will be made available to those requesting access outside of the four requesting institutions. Qualitative data collected as part of this trial will not be made available, as it is difficult to fully de-identify and to interpret without knowledge of the context.
3 years after study completion for researchers and students within the collaborating institutions and 5 years after study completion for those outside of the collaborating institutions upon request
Upon request from the PI
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Recruitment occurred in May 2021 in 2 communities after they were selected and randomly allocated to either the intervention or comparator arm. Only 2 villages were selected as this was a pilot quasi-experimental controlled trial. Within these two clusters, participants were recruited within couple clusters (units). Recruitment was achieved through household mobilization with support from community health workers who were masked to study purpose and eligibility criteria.
| ID | Title | Description |
|---|---|---|
| FG000 | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | FH=FW is a multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity). FH=FW Intervention: The intervention is comprised of health system strengthening elements paired with community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. |
| FG001 | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | A Water, Sanitation, and Hygiene (WASH) intervention delivered in groups of couples to increase at-home and community hygiene practices. Time and attention matched control: This intervention serves as the attention-matched comparator intervention. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline sample excludes the participants withdrawn and replaced by investigators, considered the final sample of 140 individuals, or 70 couples. Individual participants are nested within couples. The unit of analysis, however, for all baseline data presented is the individual, as all demographic measures were collected from individuals.
| ID | Title | Description |
|---|---|---|
| BG000 | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | FH=FW is a multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity). FH=FW Intervention: The intervention is comprised of health system strengthening elements paired with community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Couples With Uptake of Any High Efficacy Contraceptive Method | Uptake of any high efficacy contraceptive method. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report | Couple is the unit of analysis; one outcome per couple | Posted | Count of Units | Couple | 7-months and 10-months follow-up | Couple | Couple |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention | FH=FW is a multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity). FH=FW Intervention: The intervention is comprised of health system strengthening elements paired with community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. |
Not provided
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This was a pilot quasi-experimental controlled trial with the primary aims of establishing acceptability, feasibility, and preliminary effects of the intervention on the main and secondary outcomes. Thus, the intervention needs to be tested in a fully powered cluster randomized controlled trial to establish intervention efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katelyn Sileo | University of Texas at San Antonio | 210-458-7900 | katelyn.sileo@utsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2022 | Oct 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013995 | Time |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
Not provided
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| NIH |
Not provided
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Not provided
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|
| Time and attention matched control | Behavioral | This intervention serves as the attention-matched control. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda. |
|
| 7 and 10 months follow-up |
| Number of Couples With an Unintended Pregnancy | Biological measure; human chorionic gonadotropin (hCG) rapid pregnancy tests taken by women at 10-months follow-up. | 10-months follow-up |
| Change in Knowledge of Contraceptives | Scale from the Uganda Demographic and Health Survey (DHS) aimed to assess knowledge of modern contraceptive methods; collected through interviewer-administered questionnaire. Possible range 0-1, greater scores indicate more knowledge | Baseline, 7 and 10 months follow-up |
| Change in Family Planning Attitudes | Family planning attitudes scale developed for use in Uganda to assess how participants would feel about using contraceptive methods; collected through interviewer-administered questionnaire. Scores range from 0-4 with greater scores indicating more positive attitudes towards family planning. | Baseline, 7 and 10 months follow-up |
| Change in Perceived Family Planning Norms | Scale adapted from the Family Planning Approval Index to assess the perceived acceptance of family planning and contraceptive use among partner, family, peers, and broader community; collected through interviewer-administered questionnaire. Scores range from 0-1 with greater scores indicating more positive perceived attitudes towards family planning among others | Baseline, 7 and 10 months follow-up |
| Change in Family Planning Intentions | Family planning intentions scale developed for use in Uganda to assess participants' plans to use contraceptives and family planning services in the future; collected through interviewer-administered questionnaire. Scores range between 0-4 with higher scores indicating greater intentions to use family planning services in the future | Baseline, 7 and 10 months follow-up |
| Change in Desired Number of Children (Fertility Desires) | Item from the Uganda Demographic and Health Survey (DHS) on the participants' fertility desires (i.e., desired number of additional children); collected through interviewer-administered questionnaire. This is a count variable that could range from zero upward (no limit). | Baseline, 7 and 10 months follow-up |
| Change in Fertility Discordance Between Partners | An item from the Uganda DHS on the participants' desired number of children, "How many more children do you want to have?" was used to calculate the couple variable fertility discordance by subtracting men and women's responses within couples. This was dichotomized for analysis; for couples where the product was zero, they were classified as having no discordance (0) and for couples where the produce was anything other than zero, they were classified as having discordance (1). | Baseline, 7 and 10 months follow-up |
| Change in Joint Household Decision-making | Joint household decision-making was measured with four items from the Uganda DHS that ask respondents who primarily decides on: 1) how the money they earn is used; 2) how their spouses' earnings are used; 3) decisions about healthcare for yourself; and 4) decisions about major household purchases. Response options were recoded as self and partner jointly (1) vs. all other (0). A mean score was calculated for each time point with greater scores indicating more joint decision-making (range 0-1). | Baseline, 7 and 10 months follow-up |
| Change in Partner Communication About Family Planning | The mean of two items on the frequency of communication with one's partner about family planning found predictive of family planning in Uganda in prior research. Participants were asked, in the last 12 months, "How often have you discussed the number of children you want with your partner?" and "How often have you discussed the spacing or timing of your/your partner's pregnancies with your partner." The four-point response options ranged from "Never" to "Regularly." At the two follow-up time points, the same questions were asked with the timeframe, "since the last interview." Higher scores indicate more communication. Possible scores range from 0.00-3.00. | Baseline, 7 and 10 months follow-up |
| Change in Gender Inequitable Attitudes | The mean of the 24-item Gender Equitable Men scale measured endorsement of traditional gender norms and attitudes on gender inequity, validated in Tanzania and Ghana, with good reliability in African settings. Domains include violence, sexual relationships, reproductive health and disease prevention, and domestic chores and daily life items. Higher scores indicate more inequitable gender attitudes. Possible score range = 0=3 | Baseline, 7 and 10 months follow-up |
| Gombe |
| Butambala |
| Uganda |
| Sileo KM, Muhumuza C, Sekamatte S, Lule H, Wanyenze RK, Kershaw TS, Kiene SM. The "Family Health = Family Wealth" intervention: study protocol for a pilot quasi-experimental controlled trial of a multi-level, community-based family planning intervention for couples in rural Uganda. Pilot Feasibility Stud. 2022 Dec 24;8(1):265. doi: 10.1186/s40814-022-01226-6. |
| BG001 | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | A Water, Sanitation, and Hygiene (WASH) intervention delivered in groups of couples to increase at-home and community hygiene practices. Time and attention matched control: This intervention serves as the attention-matched comparator intervention. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda. |
| BG002 | Total | Total of all reporting groups |
| Couples |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Religion | Count of Participants | Participants | Participants |
|
| OG001 | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | A Water, Sanitation, and Hygiene (WASH) intervention delivered in groups of couples to increase at-home and community hygiene practices. Time and attention matched control: This intervention serves as the attention-matched comparator intervention. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda. |
|
|
|
| Secondary | Number of Couples That Discontinued Use of a High Efficacy Contraceptive Method at 10-months Follow-up Among Those That Started Using a Method at 7-months Follow-up | Number of couples that discontinued use of a high efficacy contraceptive method at 10-months follow-up among those that started using a method at 7-months follow-up. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report | Number analyzes includes participants that began using a high efficacy contraceptive method at 7-months follow-up | Posted | Count of Units | Couples | 7 and 10 months follow-up | Couples | Couples |
|
|
|
| Secondary | Number of Couples With an Unintended Pregnancy | Biological measure; human chorionic gonadotropin (hCG) rapid pregnancy tests taken by women at 10-months follow-up. | Couple is the unit of analysis (one outcome per couple) | Posted | Count of Units | Couple | 10-months follow-up | Couple | Couple |
|
|
|
| Secondary | Change in Knowledge of Contraceptives | Scale from the Uganda Demographic and Health Survey (DHS) aimed to assess knowledge of modern contraceptive methods; collected through interviewer-administered questionnaire. Possible range 0-1, greater scores indicate more knowledge | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Family Planning Attitudes | Family planning attitudes scale developed for use in Uganda to assess how participants would feel about using contraceptive methods; collected through interviewer-administered questionnaire. Scores range from 0-4 with greater scores indicating more positive attitudes towards family planning. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Perceived Family Planning Norms | Scale adapted from the Family Planning Approval Index to assess the perceived acceptance of family planning and contraceptive use among partner, family, peers, and broader community; collected through interviewer-administered questionnaire. Scores range from 0-1 with greater scores indicating more positive perceived attitudes towards family planning among others | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Family Planning Intentions | Family planning intentions scale developed for use in Uganda to assess participants' plans to use contraceptives and family planning services in the future; collected through interviewer-administered questionnaire. Scores range between 0-4 with higher scores indicating greater intentions to use family planning services in the future | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Desired Number of Children (Fertility Desires) | Item from the Uganda Demographic and Health Survey (DHS) on the participants' fertility desires (i.e., desired number of additional children); collected through interviewer-administered questionnaire. This is a count variable that could range from zero upward (no limit). | Posted | Mean | Standard Deviation | desired additional children | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Fertility Discordance Between Partners | An item from the Uganda DHS on the participants' desired number of children, "How many more children do you want to have?" was used to calculate the couple variable fertility discordance by subtracting men and women's responses within couples. This was dichotomized for analysis; for couples where the product was zero, they were classified as having no discordance (0) and for couples where the produce was anything other than zero, they were classified as having discordance (1). | Posted | Count of Units | Couples | Baseline, 7 and 10 months follow-up | Couples | Couples |
|
|
|
|
| Secondary | Change in Joint Household Decision-making | Joint household decision-making was measured with four items from the Uganda DHS that ask respondents who primarily decides on: 1) how the money they earn is used; 2) how their spouses' earnings are used; 3) decisions about healthcare for yourself; and 4) decisions about major household purchases. Response options were recoded as self and partner jointly (1) vs. all other (0). A mean score was calculated for each time point with greater scores indicating more joint decision-making (range 0-1). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Partner Communication About Family Planning | The mean of two items on the frequency of communication with one's partner about family planning found predictive of family planning in Uganda in prior research. Participants were asked, in the last 12 months, "How often have you discussed the number of children you want with your partner?" and "How often have you discussed the spacing or timing of your/your partner's pregnancies with your partner." The four-point response options ranged from "Never" to "Regularly." At the two follow-up time points, the same questions were asked with the timeframe, "since the last interview." Higher scores indicate more communication. Possible scores range from 0.00-3.00. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| Secondary | Change in Gender Inequitable Attitudes | The mean of the 24-item Gender Equitable Men scale measured endorsement of traditional gender norms and attitudes on gender inequity, validated in Tanzania and Ghana, with good reliability in African settings. Domains include violence, sexual relationships, reproductive health and disease prevention, and domestic chores and daily life items. Higher scores indicate more inequitable gender attitudes. Possible score range = 0=3 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 and 10 months follow-up |
|
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene) | A Water, Sanitation, and Hygiene (WASH) intervention delivered in groups of couples to increase at-home and community hygiene practices. Time and attention matched control: This intervention serves as the attention-matched comparator intervention. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda. | 0 | 76 | 0 | 76 | 0 | 76 |
Not provided
Not provided
| 10-months |
|
| Regression, Linear |
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| <0.001 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| 0.41 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 0.40 | Standard Error of the Mean | 0.07 | 2-Sided | Superiority |
| 10-months |
|
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | Adjusted for multiple comparisons; this value is for the 7-month follow-up | Mean Difference (Final Values) | 1.08 | Standard Error of the Mean | 0.14 | 2-Sided | Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | Adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 0.79 | Standard Error of the Mean | 0.14 | 2-Sided | Superiority |
| 10-months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| <0.001 |
P value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| 0.31 |
| Standard Error of the Mean |
| 0.06 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 0.19 | Standard Error of the Mean | 0.05 | 2-Sided | Superiority |
| 10 months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| <0.001 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| 0.68 |
| Standard Error of the Mean |
| 0.12 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | 0.04 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 0.20 | Standard Error of the Mean | 0.10 | 2-Sided | Superiority |
| 10-months |
|
| Regression, Linear |
| 0.60 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| -0.16 |
| Standard Error of the Mean |
| 0.32 |
| 2-Sided |
| Superiority |
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | 0.07 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | Slope | -0.53 | Standard Error of the Mean | 0.07 | 2-Sided | Superiority |
| 10-months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| 0.05 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| Odds Ratio (OR) |
| 1.36 |
| 2-Sided |
| 95 |
| 0.99 |
| 1.85 |
| Superiority |
| Regression, Logistic | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | 0.71 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | Odds Ratio (OR) | 0.96 | 2-Sided | 95 | 0.75 | 1.22 | Superiority |
| 10-months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| 0.07 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| 0.13 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 0.21 | Standard Error of the Mean | 0.06 | 2-Sided | Superiority |
| 10-months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| <0.001 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| 1.19 |
| Standard Error of the Mean |
| 0.18 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | 0.001 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | 1.65 | Standard Error of the Mean | 0.19 | 2-Sided | Superiority |
| 10-months |
|
Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. |
| 0.008 |
P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up |
| unstandardized beta |
| -0.13 |
| Standard Error of the Mean |
| 0.05 |
| 2-Sided |
| Superiority |
| Regression, Linear | Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data. | <0.001 | P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up | unstandardized beta | -0.17 | Standard Error of the Mean | 0.04 | 2-Sided | Superiority |