Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05777473 |
| Other study ID # |
201921 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
University of California, San Diego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
