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ContraceptionIMPACT-RMANCT03226730

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

A study testing Household Visits and Small Groups in people with Contraception, run by University of California, San Diego at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Contraception
What is being tested?
Household Visits and Small Groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,898 participants
Where
2 sitesin 2 countries
Study dates
May 2016to 10 Mar 2021
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • For Men:
  • Must be the husband to an eligible adolescent participating in the study
  • Hausa or Zarma speaking
  • Providing informed consent.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

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

    San Diego, California, 92093

Other trials in United States

Niger1 site
  • Pathfinder International

    Niamey

Other trials in Niger

About this study

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.

Read the 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.

Conditions
Contraception
Being tested
Household Visits, Small Groups
Keywords
Female Adolescent, Married, West Africa, Family Planning, Contraceptive Use, Birth Spacing

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 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.

  • 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 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.

Study groups in NCT03226730
Study groupRoleWhat they receive
Arm 1: Household VisitsExperimentalArm 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.
Receives: Behavioral: Household Visits
Arm 2: Small GroupsExperimentalThis 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.
Receives: Behavioral: Small Groups
Arm 3: Household Visits + Small GroupsExperimentalIn 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.
Receives: Behavioral: Household Visits; Behavioral: Small Groups
Arm 4: ControlNo interventionThe 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.

What is being measured

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

  1. Contraception Use Questionnaire

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

    Measured: baseline and 18 month follow up

  2. Intentions to Use Contraception Questionnaire

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

    Measured: baseline and 18 month follow up

Secondary outcomes (4)
  1. Social norms regarding gender equity Questionnaire

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

    Measured: baseline and 18 month follow up

  2. Female Empowerment Questionnaire

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

    Measured: baseline and 18 month follow up

  3. Knowledge of effective contraceptive methods Questionnaire

    Change in knowledge of effective contraceptive methods, mechanisms, and common side effects

    Measured: baseline and 18 month follow up

  4. Acceptance of effective contraceptive methods Questionnaire

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

    Measured: baseline and 18 month follow up

Timeline

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

  1. First posted24 Jul 2017
  2. Study startMay 2016
  3. Primary completion10 Mar 2021
  4. Study completion10 Mar 2021

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
Masking
None (open label)
Enrolment
2,898 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226730
Sponsor's protocol ID
2016-1430
Acronym
IMPACT-RMA
Status last verified
Feb 2023
First submitted
7 Oct 2016
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37277837
  • 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.

    PubMed 31852538

Questions about this trial

What is this clinical trial studying?

A study testing Household Visits and Small Groups in people with Contraception, run by University of California, San Diego at 2 sites in 2 countries.

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 10 inclusion and 3 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: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Niger. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: baseline and 18 month follow up). 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?

On the ClinicalTrials.gov record for NCT03226730, which also lists 2 linked publications.

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 24 Feb 2023.

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