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ContraceptionNCT05777473

Tipping Point: Using Social Network Theory to Accelerate Scale and Impact

A study testing Household Visits, Small Groups and Adopt-a-Friend in people with Contraception, run by University of California, San Diego at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will assess the nature and impact of social norms and networks to promote FP (Family Planning) intervention effects among low parity, married adolescent and young women in the Maradi region of Niger. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Contraception
What is being tested?
Household Visits, Small Groups and Adopt-a-Friend
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,825 participants
Where
1 siteUnited States
Study dates
1 Dec 2020to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For Women:
  • Married
  • 15-24 years old; or mother-in-law of married adolescent (or replacement MIL)
  • Residing in the village where recruitment is taking place
  • Providing informed consent
  • For Men:
  • Must be the husband to an eligible adolescent participating in the study
  • Providing informed consent

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center on Gender Equity and Health, University of California, San Diego

    San Diego, California, 92093

Other trials in United States

About this study

This study will assess the nature and impact of social norms and networks to promote FP (Family Planning) intervention effects among low parity, married adolescent and young women in the Maradi region of Niger. Research activities will be layered on top of the USAID-funded Kulawa FP program that seeks to change FP-related behaviors among young, low parity women at scale in Niger in a subset of implementing villages. Kulawa, implemented by Save the Children U.S. (SCUS) and funded by USAID (2020-2025), will include small-group discussion for young, low parity girls coupled with community dialogues to address individual, social, and health system constraints to FP use and influence social norms that govern FP use. UCSD will not provide any services or implement any interventions as part of this study.

Read the detailed description

Research Design: The investigators will use a three-arm cluster randomized controlled trial (cRCT) to determine the effectiveness and scalability of a social network approach to increasing knowledge and uptake of family planning in low-parity, married adolescent and young women aged 15 to 24. This study will take place across 51 randomly selected villages in the Maradi region of Niger from the districts of Aguie, Gazaoua, and Tessauoua. Approximately 450 villages exist across these three districts, of which 302 meet our eligibility criteria. Eligibility criteria for selection of villages includes villages being 1) located in the Aguie, Gazaoua, or Tessauoua), 2) rural (i.e., not designated as a market town or city), 3) Hausa or Zarma-speaking, 4) total population size of the village consistent with a population of approximately 30 married adolescent girls, and 5) located within 5 km of a health clinic (i.e., centre de santé intégré). Once selected, villages will be randomized to one of three treatment arms (17 villages/arm). Depending on the arm, low parity, married adolescent and young women will receive either the standard Kulawa program (Arm 1), the Kulawa program adapted with a social network approach (Arm 2), or no FP programming (Arm 3, i.e., control). The Kulawa program adapted with a social network approach will be developed by Save the Children based on formative research and will include delivery to both female participants and one of their female alters (a nominated socially connected community member). Note that in villages selected for Arm 2, 50% of eligible participants will be randomly selected to receive the Kulawa intervention with the social network approach, to test effects of diffusion and accelerated impact. The other 50% of eligible participants in Arm 2 will receive the program, if successful, after 24 months (see below and Table 1 for details of participants).

Formative Research: The investigators will begin by collecting data for formative research and intervention development. This research will involve conducting qualitative social network interviews villages proximal to those in the treatment arm. Research aims will be to understand the best way to develop the social network intervention modification, including developing methods for identifying alters to include in the Kulawa social network intervention. Qualitative interviews will also help the investigators measure norm and behavior change among this population. Approximately 20 interviews will be conducted, 10 interviews with low parity, married adolescent and young women ages 15-24 years and 10 interviews with an influential individual that they name (female member of the community, minimum age 15 years). Each interview will take 45-60 minutes. Interviews will be audio recorded, translated, and transcribed.

Pilot: Survey assessments will include FP use and related behaviors, decision-making, personal attitudes, social norms, and social network influences. Surveys will be piloted in two villages comparable to those selected for the trial, among eligible female participants (approx. 30 per village), their nominated alters, and husbands. Based on findings, the study tools and social network intervention strategy will be refined.

Effectiveness Evaluation: The 3-arm RCT trial will take place across 51 villages (i.e., 17 villages per district) in the Maradi region of Niger randomly assigned to 1 of the 3 treatment arms. Within each village, households with eligible, married females (see Human subjects for eligibility criteria) will be enumerated by village elders. All eligible females in the villages (approx. 30/village) will be approached for recruitment (see Recruitment for details). The study will have three longitudinal waves of data collection: baseline (conducted immediately prior to the intervention), midline (conducted 12-months post the start of intervention implementation) and an endline (conducted 24-months post the start of intervention implementation). Survey interviews will be conducted with all eligible low parity, married adolescent and young women in each village (N=1530, 510 each arm, see human subjects for eligibility criteria) and take 45-60 minutes. Surveys will be conducted by a trained research assistant orally in Hausa or Zarma (at the participants choosing) who will record participant responses on a tablet computer. At each time point, participating low parity, married adolescent and young women (egos) will name a female influential to her FP decision-making (an alter) using the same approach described in the Preliminary studies. This individual (known as the first-degree alter) will also be interviewed at each time point in the same fashion as the original respondent (1530 per wave). These individuals will also nominate another influential individual (known as the second-degree alter). In treatment Arms 1 \& 2 only, the second-degree alters will also be interviewed in the same fashion (N=1020 per wave). Second-degree alters will not be interviewed in control villages. If individuals are named by multiple participants, they will not be re-interviewed. In treatment Arms 1 \& 2 only, husbands of originally recruited participants will also be surveyed (N=1020) via a verbal 45-60-minute survey interview.

Analysis \& Dissemination: Difference-in-differences models will be used to detect the differences between baseline and follow-up across different arms. Geographic analysis will also be conducted to test for the effect of geographic factors on behavior and norm adoption. Data will be disseminated after each wave of data collection to local, national, regional, and global stakeholders.

Conditions
Contraception
Being tested
Household Visits, Small Groups, Adopt-a-Friend
Keywords
Contraception Behavior, Female Adolescent, Married, West Africa, Family Planning, Contraceptive Use, Birth Spacing
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Household VisitsBehavioural

    Household visits will be conducted to build trust in the health system, educate regarding different forms of modern contraception, (how administered, how they work, availability), dispel related myths (i.e., those regarding infertility), promote the health advantages of birth spacing, and create related dialogue among adolescent wives and other household members present during these visits. The community health worker will provide and resupply oral contraceptive pills and condoms to interested participants and will accompany the married adolescent to the nearest health facility for other forms of contraception, if requested to do so. To complement the household visits to married female adolescents, male community health workers will conduct home visits to discuss healthy timing and spacing of pregnancy with husbands of adolescent females, provide education on different forms of contraception, and discuss concerns husbands may have regarding use of contraception.

  • Small GroupsBehavioural

    In the wife-only groups, adolescent wives will be convened by trained adult female community members to learn and discuss a broad range of gender and health-related topics, with a focus on modern contraception, and cultivate self-efficacy, social support and life skills. The small groups will be led by trained female small group mentors who are trained peers and will follow a designated curriculum consisting of different topics each week. The husband groups will focus on fostering reflection and dialogue to contribute to more equitable gender norms, support for contraception use for HTSP, positive health seeking behavior for them and their families, and increased couples communication and joint SRH decision-making.

  • Adopt-a-FriendBehavioural

    The "Adopt a Friend" approach aims to promote the dissemination and discussion of new information and ideas among peers who are not directly involved in program activities. This involves asking each participant to choose a friend with whom she will share what she learns in home visits and her reflections. Adolescent girls will support each other in seeking sexual and reproductive health information or services if needed.

Study groups in NCT05777473
Study groupRoleWhat they receive
KulawaExperimentalThis arm will receive the standard Kulawa intervention. Kulawa is a USAID-funded program that seeks to change FP-related behaviors among young, low parity women at scale in Niger. Kulawa, implemented by Save the Children U.S. aims to increase use of quality FP services of all WRA, including young women ages 15-24 years, in 15 districts of Niger across 3 regions (Tillaberi, Maradi, and Zinder), covering a population of 12.5 million. Kulawa will address individual, social, and health system constraints to FP use through interventions to change behavior and influence social norms that govern FP use and related gender outcomes as well as interventions to improve FP service availability and quality. Kulawa SBC programming at the community-level will include small groups for young, low parity women and girls (ages 15-24) and community dialogues.
Receives: Behavioral: Household Visits; Behavioral: Small Groups
Kulawa SN (Tipping Point)ExperimentalThis arm will receive the Kulawa intervention, with a social network-informed intervention (KulawaSN) layered on top. In this arm 50% of eligible women will be paired with an alter to receive the adapted intervention. The social network intervention will involve pairing up young married adolescents and women with someone identified as influential in their social networks and enrolling them in the Kulawa FP programming together.
Receives: Behavioral: Household Visits; Behavioral: Small Groups; Behavioral: Adopt-a-Friend
ControlNo interventionThis arm will serve as the control condition. Individuals in these villages will receive neither intervention (including any other FP-relevant SBC program)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contraception Use Questionnaire (individual items, not a scale)

    Change in use of effective methods of contraception

    Measured: Baseline, 12-month Midline, and 24-month Endline

  2. Intentions To Use Contraception Questionnaire (individual items, not a scale)

    Change in behavioral intentions regarding effective contraceptive use

    Measured: Baseline, 12-month Midline, and 24-month Endline

Secondary outcomes (3)
  1. Social Norms regarding gender equity Questionnaire (individual items, not a scale)

    Change in social norms regarding husbands physical and sexual violence toward wives, women's autonomy and husbands control related to family life

    Measured: Baseline, 12-month Midline, and 24-month Endline

  2. Female Empowerment Questionnaire (individual items, not a scale)

    Change in autonomy, decision-making, freedom from violence and control, especially with regard to contraceptive use

    Measured: Baseline, 12-month Midline, and 24-month Endline

  3. Acceptance of effective contraceptive methods Questionnaire (individual items, not a scale)

    Change in attitudes and beliefs regarding use of contraceptive methods for birth spacing

    Measured: Baseline, 12-month Midline, and 24-month Endline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start1 Dec 2020
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

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
Factorial
Model description
Three-arm cluster randomized controlled trial (cRCT)
Masking
None (open label)
Enrolment
3,825 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777473
Sponsor's protocol ID
201921
Status last verified
May 2024
First submitted
22 Feb 2023
Last updated
23 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Household Visits, Small Groups and Adopt-a-Friend in people with Contraception, run by University of California, San Diego at 1 site in United States.

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 8 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: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Results are not available in the source record.

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?

Contraception Use Questionnaire (individual items, not a scale) (time frame: Baseline, 12-month Midline, and 24-month Endline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 May 2024.

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