Contraceptive UsageNCT04262882
Multilevel Family Planning Intervention
A study testing Multilevel Family Planning Intervention in people with Contraceptive Usage, run by The University of Texas at San Antonio at 2 sites in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Multilevel Family Planning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUganda
- Study dates
- 14 May 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant; Breastfeeding; Using a modern contraceptive method
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Katende Villages
Gombe, Butambala
Kyabadaza Villages
Gombe, Butambala
About this study
Official title: Development, Testing and Health Effects of a Multilevel Family Planning Intervention
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.
Read the 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.
- Conditions
- Contraceptive Usage
- Being tested
- Multilevel Family Planning Intervention, Time and attention matched control
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Family Planning InterventionBehavioural
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.
Time and attention matched controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Multilevel Family Planning Intervention |
| Time and attention-matched control | Active comparator | A community sanitation intervention delivered in groups of couples to increase at-home and community hygiene practices. Receives: Behavioral: Time and attention matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-months and 10-months follow-up
Secondary outcomes (11)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Baseline, 7 and 10 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start14 May 2021
- Primary completion3 May 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, San Diego State University, Yale University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Katelyn M Sileo, PhD, MPH, Principal investigator, University of Texas at San AntonioSusan M Kiene, PhD, MPH, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262882
- Sponsor's protocol ID
- 1R21HD098523-01A1
- Other IDs
- 1R21HD098523-01A1
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2020
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38835058Sileo 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.
PubMed 36564852
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Testing and Health Effects of a Multilevel Family Planning Intervention
- ClinicalTrials.gov ID
- NCT04262882
- Acronym / sponsor ID
- 1R21HD098523-01A1
- Conditions
- Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Collaborators
- Makerere University, San Diego State University, Yale University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multilevel Family Planning Intervention | Experimental | Behavioral: Multilevel Family Planning InterventionA 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 | Behavioral: Time and attention matched controlA community sanitation intervention delivered in groups of couples to increase at-home and community hygiene practices. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant; Breastfeeding; Using a modern contraceptive method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multilevel Family Planning InterventionThe 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. | Behavioural | Multilevel Family Planning Intervention |
| Time and attention matched controlThis 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. | Behavioural | Time and attention-matched control |
Primary outcome
Number of Couples With Uptake of Any High Efficacy Contraceptive Method
Time frame: 7-months and 10-months follow-up
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
11 secondary outcomes
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
Time frame: 7 and 10 months follow-up
Number of Couples With an Unintended Pregnancy
Time frame: 10-months follow-up
Change in Knowledge of Contraceptives
Time frame: Baseline, 7 and 10 months follow-up
Change in Family Planning Attitudes
Time frame: Baseline, 7 and 10 months follow-up
Change in Perceived Family Planning Norms
Time frame: Baseline, 7 and 10 months follow-up
Change in Family Planning Intentions
Time frame: Baseline, 7 and 10 months follow-up
Change in Desired Number of Children (Fertility Desires)
Time frame: Baseline, 7 and 10 months follow-up
Change in Fertility Discordance Between Partners
Time frame: Baseline, 7 and 10 months follow-up
Change in Joint Household Decision-making
Time frame: Baseline, 7 and 10 months follow-up
Change in Partner Communication About Family Planning
Time frame: Baseline, 7 and 10 months follow-up
Change in Gender Inequitable Attitudes
Time frame: Baseline, 7 and 10 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38835058Sileo 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.
- Derived from this study: PubMed 36564852Sileo 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katelyn M Sileo, PhD, MPH principal investigator
University of Texas at San Antonio
Susan M Kiene, PhD, MPH principal investigator
San Diego State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Family Planning Intervention in people with Contraceptive Usage, run by The University of Texas at San Antonio at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Couples With Uptake of Any High Efficacy Contraceptive Method (time frame: 7-months and 10-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262882, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.