Trial Outcomes & Findings for Multilevel Family Planning Intervention (NCT NCT04262882)
NCT ID: NCT04262882
Last Updated: 2024-04-25
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
7-months and 10-months follow-up
Results posted on
2024-04-25
Participant Flow
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.
Unit of analysis: Couples
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
84 42
|
76 38
|
|
Overall Study
COMPLETED
|
69 35
|
70 35
|
|
Overall Study
NOT COMPLETED
|
15 7
|
6 3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Investigator withdrawal due to non-attendance of session 1 (at least 1 person in couple)
|
14
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Multilevel Family Planning Intervention
Baseline characteristics by cohort
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=35 Couples
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=35 Couples
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.
|
Total
n=70 Couples
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.01 years
STANDARD_DEVIATION 6.79 • n=99 Participants
|
30.77 years
STANDARD_DEVIATION 8.27 • n=107 Participants
|
29.89 years
STANDARD_DEVIATION 7.59 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Religion
Catholic, Protestant, and Other
|
36 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Religion
Muslim
|
34 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7-months and 10-months follow-upPopulation: Couple is the unit of analysis; one outcome per couple
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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=35 Couple
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=35 Couple
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.
|
|---|---|---|
|
Number of Couples With Uptake of Any High Efficacy Contraceptive Method
10-months · No, not using method
|
15 Couple
|
29 Couple
|
|
Number of Couples With Uptake of Any High Efficacy Contraceptive Method
7-months · Yes, using method
|
20 Couple
|
9 Couple
|
|
Number of Couples With Uptake of Any High Efficacy Contraceptive Method
7-months · No, not using method
|
15 Couple
|
26 Couple
|
|
Number of Couples With Uptake of Any High Efficacy Contraceptive Method
10-months · Yes, using method
|
20 Couple
|
6 Couple
|
SECONDARY outcome
Timeframe: 7 and 10 months follow-upPopulation: Number analyzes includes participants that began using a high efficacy contraceptive 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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=20 Couples
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=9 Couples
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.
|
|---|---|---|
|
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
|
2 Couples
|
3 Couples
|
SECONDARY outcome
Timeframe: 10-months follow-upPopulation: Couple is the unit of analysis (one outcome per couple)
Biological measure; human chorionic gonadotropin (hCG) rapid pregnancy tests taken by women at 10-months follow-up.
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=35 Couple
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=35 Couple
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.
|
|---|---|---|
|
Number of Couples With an Unintended Pregnancy
Yes, unintended pregnancy
|
1 Couple
|
1 Couple
|
|
Number of Couples With an Unintended Pregnancy
No unintended pregnancy
|
34 Couple
|
34 Couple
|
SECONDARY outcome
Timeframe: Baseline, 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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Knowledge of Contraceptives
7-months
|
0.99 score on a scale
Standard Deviation 0.26
|
0.62 score on a scale
Standard Deviation 0.15
|
|
Change in Knowledge of Contraceptives
Baseline
|
0.63 score on a scale
Standard Deviation 0.32
|
0.52 score on a scale
Standard Deviation 0.22
|
|
Change in Knowledge of Contraceptives
10-months
|
1.00 score on a scale
Standard Deviation 0.00
|
0.59 score on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Family Planning Attitudes
Baseline
|
2.76 score on a scale
Standard Deviation 0.51
|
2.58 score on a scale
Standard Deviation 0.55
|
|
Change in Family Planning Attitudes
7-months
|
3.56 score on a scale
Standard Deviation 0.39
|
2.23 score on a scale
Standard Deviation 0.62
|
|
Change in Family Planning Attitudes
10-months
|
3.27 score on a scale
Standard Deviation 0.32
|
2.22 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline, 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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Perceived Family Planning Norms
Baseline
|
0.86 score on a scale
Standard Deviation 0.21
|
0.93 score on a scale
Standard Deviation 0.21
|
|
Change in Perceived Family Planning Norms
7-months
|
0.96 score on a scale
Standard Deviation 0.12
|
0.75 score on a scale
Standard Deviation 0.36
|
|
Change in Perceived Family Planning Norms
10-months
|
0.95 score on a scale
Standard Deviation 0.13
|
0.87 score on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline, 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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Family Planning Intentions
Baseline
|
3.14 score on a scale
Standard Deviation 0.43
|
2.20 score on a scale
Standard Deviation 0.59
|
|
Change in Family Planning Intentions
7-montha
|
3.65 score on a scale
Standard Deviation 0.42
|
2.02 score on a scale
Standard Deviation 0.97
|
|
Change in Family Planning Intentions
10 months
|
3.22 score on a scale
Standard Deviation 0.36
|
2.12 score on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Desired Number of Children (Fertility Desires)
Baseline
|
2.90 desired additional children
Standard Deviation 1.49
|
2.76 desired additional children
Standard Deviation 2.59
|
|
Change in Desired Number of Children (Fertility Desires)
7-months
|
2.38 desired additional children
Standard Deviation 1.24
|
2.47 desired additional children
Standard Deviation 1.40
|
|
Change in Desired Number of Children (Fertility Desires)
10-months
|
1.83 desired additional children
Standard Deviation 0.64
|
2.36 desired additional children
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Baseline, 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).
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=35 Couples
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=35 Couples
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.
|
|---|---|---|
|
Change in Fertility Discordance Between Partners
Baseline
|
15 Couples
|
18 Couples
|
|
Change in Fertility Discordance Between Partners
7-months
|
19 Couples
|
12 Couples
|
|
Change in Fertility Discordance Between Partners
10-months
|
3 Couples
|
27 Couples
|
SECONDARY outcome
Timeframe: Baseline, 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).
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Joint Household Decision-making
Baseline
|
0.75 score on a scale
Standard Deviation 0.29
|
0.84 score on a scale
Standard Deviation 0.26
|
|
Change in Joint Household Decision-making
7-months
|
0.97 score on a scale
Standard Deviation 0.17
|
0.91 score on a scale
Standard Deviation 0.23
|
|
Change in Joint Household Decision-making
10-months
|
1.00 score on a scale
Standard Deviation 0.00
|
0.87 score on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline, 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.
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Partner Communication About Family Planning
Baseline
|
1.89 score on a scale
Standard Deviation 0.73
|
1.82 score on a scale
Standard Deviation 0.46
|
|
Change in Partner Communication About Family Planning
7-months
|
2.84 score on a scale
Standard Deviation 0.34
|
1.61 score on a scale
Standard Deviation 0.54
|
|
Change in Partner Communication About Family Planning
10-months
|
2.61 score on a scale
Standard Deviation 0.48
|
0.91 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, 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
Outcome measures
| Measure |
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
n=69 Participants
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.
|
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
n=70 Participants
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.
|
|---|---|---|
|
Change in Gender Inequitable Attitudes
Baseline
|
1.41 score on a scale
Standard Deviation 0.24
|
1.70 score on a scale
Standard Deviation 0.20
|
|
Change in Gender Inequitable Attitudes
7-months
|
1.32 score on a scale
Standard Deviation 0.18
|
1.74 score on a scale
Standard Deviation 0.12
|
|
Change in Gender Inequitable Attitudes
10-months
|
1.33 score on a scale
Standard Deviation 0.12
|
1.80 score on a scale
Standard Deviation 0.09
|
Adverse Events
Family Health = Family Wealth (FH=FW), Multilevel Family Planning Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Time and Attention-matched Comparator Intervention (Water, Sanitation, and Hygiene)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place