Clinical trial NCT03226730: Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger
Official title: Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Female Adolescent
Married
West Africa
Family Planning
Contraceptive Use
Birth Spacing
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Pathfinder International
First posted: 2017-07-24
Enrollment: 2898
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

For Women:

* Married
* 13-19 years old
* Fluent in Hausa or Zarma
* Residing in the village where recruitment is taking place with no plans to move away in next 18 months or plan to travel for more than 6 months during that period
* Providing informed consent.

For Men:

* Must be the husband to an eligible adolescent participating in the study
* Hausa or Zarma speaking
* Providing informed consent.

Exclusion Criteria:

For Women:

* Plans to move away in next 18 months or plans to travel for more than 6 months during that period;
* Currently sterilized (to enable measurement of changes in use of temporary methods of contraception from baseline to 16-months follow-up)

Primary outcomes:
measure: Contraception Use Questionnaire
timeFrame: baseline and 18 month follow up
measure: Intentions to Use Contraception Questionnaire
timeFrame: baseline and 18 month follow up
Secondary outcomes:
measure: Social norms regarding gender equity Questionnaire
timeFrame: baseline and 18 month follow up
measure: Female Empowerment Questionnaire
timeFrame: baseline and 18 month follow up
measure: Knowledge of effective contraceptive methods Questionnaire
timeFrame: baseline and 18 month follow up
measure: Acceptance of effective contraceptive methods Questionnaire
timeFrame: baseline and 18 month follow up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Center on Gender Equity and Health, University of California, San Diego
state: California
city: Niamey
country: Niger
facility: Pathfinder International
Study officials:
affiliation: Center on Gender Equity and Health, University of California, San Diego
name: Jay G Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Challa S, DeLong SM, Carter N, Johns N, Shakya H, Boyce SC, Vera-Monroy R, Aliou S, Ibrahima FA, Brooks MI, Corneliess C, Moodie C, Nouhou AM, Souley I, Raj A, Silverman JG. Protocol for cluster randomized evaluation of reaching married adolescents - a gender-synchronized intervention to increase modern contraceptive use among married adolescent girls and young women and their husbands in Niger. Reprod Health. 2019 Dec 18;16(1):180. doi: 10.1186/s12978-019-0841-3.