Evaluating Household Visits and Small Groups to Increase Contraception Use Among Married Adolescent Girls in Rural Niger

NCT03226730 | Completed

• 1 other identifier: 2016-1430
• Study Type: interventional
• Target: 2,898
• Locations: 2 countries
• Sites: 2

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.

Conditions

Contraception

Keywords

Female Adolescent; Married; West Africa; Family Planning; Contraceptive Use; Birth Spacing

Outcome Measures

Primary Outcomes (2)

• Contraception Use Questionnaire

  Change in use of effective methods of contraception (methods assessed individually)

  baseline and 18 month follow up

• Intentions to Use Contraception Questionnaire

  Change in behavioral intentions regarding effective contraceptive use (next 3 months)

  baseline and 18 month follow up

Secondary Outcomes (4)

• Social norms regarding gender equity Questionnaire

  baseline and 18 month follow up

• Female Empowerment Questionnaire

  baseline and 18 month follow up

• Knowledge of effective contraceptive methods Questionnaire

  baseline and 18 month follow up

• Acceptance of effective contraceptive methods Questionnaire

  baseline and 18 month follow up

Study Arms (4)

Arm 1: Household Visits

EXPERIMENTAL

Arm 1 will receive gender synchronized household visits (i.e., visits by a female community health worker to the participating married adolescent female and visits by a male community health worker to the participating husband of the married adolescent female). Approximately 10-12 visits with wives and 4-6 visits with husbands are expected to take place over the course of the project. Study Arms 1-3 will additionally receive community enabling environment activities and adolescent-specific service delivery activities to support adolescent contraception use. Community enabling environment activities will include engaging religious leaders, community leaders, and familial gatekeepers of the married adolescent wives, such as in-laws, in community dialogues on a monthly basis.

Behavioral: Household Visits

Arm 2: Small Groups

EXPERIMENTAL

This arm will receive, in addition to the community-level components, gender synchronized group-based interventions (i.e., separate group-based interventions for husbands of adolescent wives and adolescent wives, themselves). Male-only and female-only small groups for participating husbands and wives will be held separately on bimonthly and monthly intervals, respectively. In this project, each small group will consist of 10-15 participants and will be held in places participants have deemed safe spaces (e.g., a place that has auditory and visual privacy, is safe for girls to walk to, has been designated by community leaders as a protected place for girls to meet). Approximately 8-10 female small groups and 4-6 male groups are expected to take place over the course of the project.

Behavioral: Small Groups

Arm 3: Household Visits + Small Groups

EXPERIMENTAL

In addition to the community enabling environment components, this arm will receive a combination of household visit and small groups intervention components, as described above for Arms 1 and 2, in order to understand the combined effect of these two interventions on the outcomes of interest.

Behavioral: Household Visits; Behavioral: Small Groups

Arm 4: Control

NO INTERVENTION

The fourth arm will serve as the control condition. Individuals in these villages will not receive the household, small group, or community-enabling environment intervention components.

Interventions

Household Visits BEHAVIORAL

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 relais 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 relais 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.

Arm 1: Household Visits; Arm 3: Household Visits + Small Groups

Small Groups BEHAVIORAL

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 developed by Pathfinder International and derived from Population Council/UNFPA's Safe Spaces curriculum. The husband groups will follow a curriculum adapted from Promundo's Program P6 and supplemented by the tools and activities developed by Pathfinder International. These groups of husbands 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.

Arm 2: Small Groups; Arm 3: Household Visits + Small Groups

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For Women:
• Married
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• Bill and Melinda Gates Foundation: collaborator
• Pathfinder International: collaborator

Study Sites (2)

Center on Gender Equity and Health, University of California, San Diego

San Diego, California, 92093, United States

Location

Pathfinder International

Niamey, Niger

Location

Related Publications (2)

• Silverman JG, Brooks MI, Aliou S, Johns NE, Challa S, Nouhou AM, Tomar S, Baker H, Boyce SC, McDougal L, DeLong S, Raj A. Effects of the reaching married adolescents program on modern contraceptive use and intimate partner violence: results of a cluster randomized controlled trial among married adolescent girls and their husbands in Dosso, Niger. Reprod Health. 2023 Jun 5;20(1):83. doi: 10.1186/s12978-023-01609-9.

  PMID: 37277837 DERIVED

• 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.

  PMID: 31852538 DERIVED

Study Officials

• Jay G Silverman, PhD

  Center on Gender Equity and Health, University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: July 24, 2017
• Study Start: May 1, 2016
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NI (1)