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Multilevel Family Planning Intervention

Development, Testing and Health Effects of a Multilevel Family Planning Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04262882
Enrollment
160
Registered
2020-02-10
Start date
2021-05-14
Completion date
2023-03-01
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMultilevel Family Planning Intervention

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.

BEHAVIORALTime and attention matched control

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.

Sponsors

Makerere University
CollaboratorOTHER
San Diego State University
CollaboratorOTHER
Yale University
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
The University of Texas at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Being in a relationship and both partners providing written informed consent; women: age 18-40 (or emancipated minor); men: age 18-50; not currently using modern contraceptives and having never used a non-reversible method; one or both partners wanting to prevent pregnancy for at least the next year; living within the selected villages; Luganda speaking.

Exclusion criteria

* Pregnant; Breastfeeding; Using a modern contraceptive method

Design outcomes

Primary

MeasureTime frameDescription
Number of Couples With Uptake of Any High Efficacy Contraceptive Method7-months and 10-months follow-upUptake 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

Secondary

MeasureTime frameDescription
Number of Couples With an Unintended Pregnancy10-months follow-upBiological measure; human chorionic gonadotropin (hCG) rapid pregnancy tests taken by women at 10-months follow-up.
Change in Knowledge of ContraceptivesBaseline, 7 and 10 months follow-upScale 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
Change in Family Planning AttitudesBaseline, 7 and 10 months follow-upFamily 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.
Change in Perceived Family Planning NormsBaseline, 7 and 10 months follow-upScale 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
Change in Family Planning IntentionsBaseline, 7 and 10 months follow-upFamily 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
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-up7 and 10 months follow-upNumber 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
Change in Fertility Discordance Between PartnersBaseline, 7 and 10 months follow-upAn 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).
Change in Joint Household Decision-makingBaseline, 7 and 10 months follow-upJoint 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).
Change in Partner Communication About Family PlanningBaseline, 7 and 10 months follow-upThe 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.
Change in Gender Inequitable AttitudesBaseline, 7 and 10 months follow-upThe 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
Change in Desired Number of Children (Fertility Desires)Baseline, 7 and 10 months follow-upItem 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).

Countries

Uganda

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
70
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.
35
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.
70
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.
35
Total210

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyInvestigator withdrawal due to non-attendance of session 1 (at least 1 person in couple)146
Overall StudyLost to Follow-up10

Baseline characteristics

CharacteristicFamily Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionTime and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Total
Age, Continuous29.01 years
STANDARD_DEVIATION 6.79
30.77 years
STANDARD_DEVIATION 8.27
29.89 years
STANDARD_DEVIATION 7.59
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
70 Participants70 Participants140 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Religion
Catholic, Protestant, and Other
36 Participants22 Participants58 Participants
Religion
Muslim
34 Participants48 Participants82 Participants
Sex: Female, Male
Female
35 Participants35 Participants70 Participants
Sex: Female, Male
Male
35 Participants35 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 840 / 76
other
Total, other adverse events
0 / 840 / 76
serious
Total, serious adverse events
0 / 840 / 76

Outcome results

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

Time frame: 7-months and 10-months follow-up

Population: Couple is the unit of analysis; one outcome per couple

ArmMeasureGroupCategoryValue (COUNT_OF_UNITS)
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With Uptake of Any High Efficacy Contraceptive Method7-monthsYes, using method20 Couple
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With Uptake of Any High Efficacy Contraceptive Method7-monthsNo, not using method15 Couple
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With Uptake of Any High Efficacy Contraceptive Method10-monthsYes, using method20 Couple
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With Uptake of Any High Efficacy Contraceptive Method10-monthsNo, not using method15 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With Uptake of Any High Efficacy Contraceptive Method10-monthsNo, not using method29 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With Uptake of Any High Efficacy Contraceptive Method7-monthsNo, not using method26 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With Uptake of Any High Efficacy Contraceptive Method7-monthsYes, using method9 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With Uptake of Any High Efficacy Contraceptive Method10-monthsYes, using method6 Couple
p-value: 0.295% CI: [0.77, 3.64]Regression, Logistic
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).

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Desired Number of Children (Fertility Desires)Baseline2.90 desired additional childrenStandard Deviation 1.49
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Desired Number of Children (Fertility Desires)7-months2.38 desired additional childrenStandard Deviation 1.24
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Desired Number of Children (Fertility Desires)10-months1.83 desired additional childrenStandard Deviation 0.64
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Desired Number of Children (Fertility Desires)7-months2.47 desired additional childrenStandard Deviation 1.4
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Desired Number of Children (Fertility Desires)Baseline2.76 desired additional childrenStandard Deviation 2.59
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Desired Number of Children (Fertility Desires)10-months2.36 desired additional childrenStandard Deviation 1.38
p-value: 0.07Regression, Linear
p-value: 0.007Regression, Linear
p-value: 0.6Regression, Linear
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.

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning AttitudesBaseline2.76 score on a scaleStandard Deviation 0.51
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning Attitudes7-months3.56 score on a scaleStandard Deviation 0.39
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning Attitudes10-months3.27 score on a scaleStandard Deviation 0.32
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning AttitudesBaseline2.58 score on a scaleStandard Deviation 0.55
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning Attitudes7-months2.23 score on a scaleStandard Deviation 0.62
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning Attitudes10-months2.22 score on a scaleStandard Deviation 0.57
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
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

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning IntentionsBaseline3.14 score on a scaleStandard Deviation 0.43
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning Intentions7-montha3.65 score on a scaleStandard Deviation 0.42
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Family Planning Intentions10 months3.22 score on a scaleStandard Deviation 0.36
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning IntentionsBaseline2.20 score on a scaleStandard Deviation 0.59
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning Intentions7-montha2.02 score on a scaleStandard Deviation 0.97
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Family Planning Intentions10 months2.12 score on a scaleStandard Deviation 0.63
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Cox
p-value: 0.04Regression, Linear
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).

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (COUNT_OF_UNITS)
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Fertility Discordance Between PartnersBaseline15 Couples
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Fertility Discordance Between Partners7-months19 Couples
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Fertility Discordance Between Partners10-months3 Couples
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Fertility Discordance Between PartnersBaseline18 Couples
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Fertility Discordance Between Partners7-months12 Couples
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Fertility Discordance Between Partners10-months27 Couples
p-value: 0.005Regression, Logistic
p-value: 0.0595% CI: [0.99, 1.85]Regression, Logistic
p-value: 0.7195% CI: [0.75, 1.22]Regression, Logistic
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

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Gender Inequitable AttitudesBaseline1.41 score on a scaleStandard Deviation 0.24
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Gender Inequitable Attitudes7-months1.32 score on a scaleStandard Deviation 0.18
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Gender Inequitable Attitudes10-months1.33 score on a scaleStandard Deviation 0.12
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Gender Inequitable AttitudesBaseline1.70 score on a scaleStandard Deviation 0.2
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Gender Inequitable Attitudes7-months1.74 score on a scaleStandard Deviation 0.12
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Gender Inequitable Attitudes10-months1.80 score on a scaleStandard Deviation 0.09
p-value: <0.001Regression, Linear
p-value: 0.008Regression, Linear
p-value: <0.001Regression, Linear
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).

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Joint Household Decision-makingBaseline0.75 score on a scaleStandard Deviation 0.29
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Joint Household Decision-making7-months0.97 score on a scaleStandard Deviation 0.17
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Joint Household Decision-making10-months1.00 score on a scaleStandard Deviation 0
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Joint Household Decision-makingBaseline0.84 score on a scaleStandard Deviation 0.26
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Joint Household Decision-making7-months0.91 score on a scaleStandard Deviation 0.23
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Joint Household Decision-making10-months0.87 score on a scaleStandard Deviation 0.19
p-value: 0.001Regression, Linear
p-value: 0.07Regression, Linear
p-value: <0.001Regression, Linear
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

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Knowledge of ContraceptivesBaseline0.63 score on a scaleStandard Deviation 0.32
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Knowledge of Contraceptives7-months0.99 score on a scaleStandard Deviation 0.26
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Knowledge of Contraceptives10-months1.00 score on a scaleStandard Deviation 0
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Knowledge of ContraceptivesBaseline0.52 score on a scaleStandard Deviation 0.22
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Knowledge of Contraceptives7-months0.62 score on a scaleStandard Deviation 0.15
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Knowledge of Contraceptives10-months0.59 score on a scaleStandard Deviation 0.16
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
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.

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Partner Communication About Family PlanningBaseline1.89 score on a scaleStandard Deviation 0.73
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Partner Communication About Family Planning7-months2.84 score on a scaleStandard Deviation 0.34
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Partner Communication About Family Planning10-months2.61 score on a scaleStandard Deviation 0.48
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Partner Communication About Family PlanningBaseline1.82 score on a scaleStandard Deviation 0.46
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Partner Communication About Family Planning7-months1.61 score on a scaleStandard Deviation 0.54
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Partner Communication About Family Planning10-months0.91 score on a scaleStandard Deviation 0.7
p-value: 0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: 0.001Regression, Linear
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

Time frame: Baseline, 7 and 10 months follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Perceived Family Planning Norms7-months0.96 score on a scaleStandard Deviation 0.12
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Perceived Family Planning NormsBaseline0.86 score on a scaleStandard Deviation 0.21
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionChange in Perceived Family Planning Norms10-months0.95 score on a scaleStandard Deviation 0.13
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Perceived Family Planning NormsBaseline0.93 score on a scaleStandard Deviation 0.21
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Perceived Family Planning Norms7-months0.75 score on a scaleStandard Deviation 0.36
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Change in Perceived Family Planning Norms10-months0.87 score on a scaleStandard Deviation 0.28
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
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

Time frame: 7 and 10 months follow-up

Population: Number analyzes includes participants that began using a high efficacy contraceptive method at 7-months follow-up

ArmMeasureValue (COUNT_OF_UNITS)
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber 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-up2 Couples
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)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-up3 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.

Time frame: 10-months follow-up

Population: Couple is the unit of analysis (one outcome per couple)

ArmMeasureCategoryValue (COUNT_OF_UNITS)
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With an Unintended PregnancyYes, unintended pregnancy1 Couple
Family Health = Family Wealth (FH=FW), Multilevel Family Planning InterventionNumber of Couples With an Unintended PregnancyNo unintended pregnancy34 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With an Unintended PregnancyYes, unintended pregnancy1 Couple
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)Number of Couples With an Unintended PregnancyNo unintended pregnancy34 Couple

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026