Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03226730 |
Other study ID # |
2016-1430 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2016 |
Est. completion date |
March 10, 2021 |
Study information
Verified date |
February 2023 |
Source |
University of California, San Diego |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and
qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents
(RMA) Interventions developed and implemented by Pathfinder International to increase
contraception use and contraception use intentions among married adolescent girls ages 13-19
in three rural districts of the Dosso region of Niger. Intervention models
(gender-synchronized household visits and small groups) will be tested using a randomized
4-arm outcome evaluation design; Arm 1 will receive household visits, Arm 2 will receive
small groups; Arm 3 will receive household visits plus small groups, and Arm 4 will serve as
the control group and will not receive any intervention. The quantitative component will
consist of collecting quantitative baseline, 16-months follow-up, and 27-months survey data
from randomly selected married adolescent girls (n=1200) and their husbands (n=1200) who are
participating in each Arm of the study. Qualitative elements will include ethnography at two
time points and semi-structured in-depth interviews half way through intervention
implementation. A costing and cost effectiveness analysis will also be conducted to evaluate
which intervention provides the largest gain in the primary outcomes for each dollar spent.
Description:
This study entails a quasi-experimental, mixed-methods (i.e., complementary quantitative and
qualitative) outcome evaluation to assess the efficacy of the Reaching Married Adolescents
(RMA) Interventions to increase contraception use and contraception use intentions among
married adolescent girls ages 13-19 in three rural districts of the Dosso region of Niger.
Two intervention models (gender-synchronized household visits and small groups) will be
tested using a randomized 4-arm outcome evaluation design; Arm 1 will receive household
visits, Arm 2 will receive small groups; Arm 3 will receive household visits plus small
groups, and Arm 4 will serve as the control group and will not receive any intervention. The
quantitative component will consist of collecting quantitative baseline and 16-months
follow-up survey data from randomly selected married adolescent girls (n=1200) and their
husbands (n=1200) who are participating in each Arm of the study. Qualitative elements will
include ethnography at two time points and semi-structured in-depth interviews half way
through intervention implementation. A costing and cost effectiveness analysis will also be
conducted to evaluate which intervention provides the largest gain in the primary outcomes
for each dollar spent.
Quasi-Experimental Quantitative Evaluation Design. The 4-arm RMA outcome evaluation will take
place across 48 villages clustered within the 3 districts (i.e., 16 villages per district) in
the Dosso region of Niger; specifically, Loga, Doutchi and Dosso. Each of the 3 districts
will be assigned to 1 of the 3 intervention conditions. Within each district, 16 comparable
villages (i.e., rural, Hausa or Zarma-speaking, at least 1000 inhabitants, similar wealth
distribution profile, and located within the specified range of distance from health
facilities providing effective contraception) will be randomly selected to be assigned to
either the district-specific intervention arm or to the control condition. A stratified
randomization approach will be used, in which villages will be stratified into two groups
based on the village having or not having a health center co-located in their village.
Specifically, within each district, 8 villages will be randomly selected among those that
have a co-located health center, and 8 villages will be randomly selected from among those
villages that do not have a co-located health center (all within the parameters listed
above). Within each of these 2 groupings of 8 villages, 2 villages will be randomly selected
to be assigned to the control arm. Thus, 12 villages will be assigned to the intervention and
4 will be assigned to serve as control villages in each district. Each village will act as a
cluster, with the unit of analysis being the married female adolescent (ages 13-19 years).
Qualitative Evaluation Design. This evaluation study will employ qualitative methods to
complement the proposed quantitative evaluation design. The first method employed will be
ethnography (i.e., participant observation, in-depth interviewing, informal discussions) to
explore the processes related to changing understanding, intentions and behaviors related to
use of modern contraception in the context of participating in the RMA interventions. Three
villages in Arm 3 receiving the full complement of the RMA programs (i.e., male and female
household visits, and male and female groups) will be the source for ethnographic
observational field notes, informal group discussion field notes, and informal interview
field notes. Three pairs of trained, local research assistants (6 total; 2 per village) will
live with families of adolescent wife participants who are living in three separate villages
and will participate in the daily life of the families and broader community (cooking,
cleaning, farming, etc.) for a period of two month total, one month corresponding with 3
months and 14 months after program initiation. Research assistants will observe but not
participate in household visit and small group interventions. Additionally, they will conduct
informal, open-ended interviews and consultations with key respondents throughout the
community (male and female RMA participants, older adults including in-laws, local political,
business and religious leaders).
Findings of the ethnographic phase will inform a semi-structured interview phase to capture
narratives regarding intervention acceptability and the roles of the RMA program in increased
knowledge, altered intention and changed behaviors regarding decisions on use of modern
contraception, inclusive of a focus on issues of gender equity and persistent barriers to
contraception acceptance and use. Forty-eight adolescent wives and husbands of adolescent
wives participating in the RMA program, and key informants (e.g., village leaders, health
providers, etc.) from intervention Arms 1 and 2 will provide semi-structured interview data
(n=24 interviews per study arm). Semi-structured interviews (60 minutes) will be conducted
approximately 8 months after implementation is initiated. These data will, in turn, inform
the foci of the second round of ethnography to be collected at 14 months post program
initiation.
Costing and cost-effectiveness will be calculated for each study arm. If one or more
intervention arms are found to be effective at increasing contraception use or intention to
use contraception, the investigators will compare the cost effectiveness of achieving the
outcomes using the WHO-CHOICE methodology.
The study will take place over the course of 4 years total; rolling recruitment and baseline
data collection will take place over a period of 3 months, the intervention will be
implemented across 16 months with a rolling start and finish, follow-up (27 months) and
endline (45 months) data collection will take place over 3 months. Qualitative ethnography
data collection will take place at two time periods; at 3 months and 14 months after
intervention implementation begins, one month at each time point. Semi-structured interviews
will be conducted approximately half-way between the beginning and end of the intervention
implementation, in month 8.