The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Rate of unintended pregnancy
研究概览
简要总结
The goal of the cluster randomized trial is to evaluate the impact of a reproductive health and empowerment intervention (TARANG) compared to the standard of care health information (control group) on the prevalence of contraceptive use and time-to-pregnancy (primary outcomes) in Rajasthan, India.
Participants will participate in TARANG intervention and receive the following sessions:
- Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
- Improving women's awareness of sexual reproductive health
- Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
- Life skills education to enable them to have improved social mobility, decision-making, and agency.
Investigators will compare the TARANG intervention with the standard of care to see if it delays unintended pregnancies among women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for newly married women:
- •Age 18-25 years at the time of the wedding
- •Married women have permanently moved in their husbands home in the most recent wedding season (recruitment month going backwards up to October of the previous year)
- •Not wanting to get pregnant within 1 year at recruitment/enrollment
- •Have not had a live birth previously and not currently pregnant
- •Women not planning to migrate out of the area for the period of the intervention
- •Has a living husband who is willing to consent and participate in the study in person or remotely (over phone)
- •Has a living, co-residing mother-in-law type person* (see definition below) who is willing to consent and participate in the study in person (A mother-in-law type of person should be staying in the same household for the period of the intervention and has consented to participate in the study. Mother-in-law is defined as any senior woman (from a previous generation of the DIL) who are responsible for their daughter-in-law and cohabiting in the same household as their daughter-in-law (Note - household would mean a family unit which shares the same kitchen). This will usually be the biological mother of the husband, but it can be stepmother, grandmother, aunt, etc.)
- •Inclusion criteria for husband:
- •18 years or more at the time of the wedding
- •Mother and wife are eligible for the study participation
- •Inclusion criteria for mother-in-law:
- •Consent to participate in the study
- •Assents for daughter-in-law to participate in the study
- •Son and the daughter-in-law are eligible for study participation
排除标准
- •for newly married women:
- •Wanting to have a child in the next 12 months at the time of baseline
- •Cognitive ability to participate in surveys
研究组 & 干预措施
TARANG arm
Participants will participate in TARANG and receive the following a total of 14 sessions:
- Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
- Improving women's awareness of sexual reproductive health
- Challenging inequitable gender norms to reduce unintended pregnancies.
- Life skills education to enable them to have improved social mobility, decision-making, and agency.
The TARANG intervention will be delivered by Vikalp (a registered non-governmental organization implementing the intervention).
干预措施: TARANG (Behavioral)
Control arm
Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers
结局指标
主要结局
Rate of unintended pregnancy
时间窗: 6 months and 18-months follow-up
Data for analysis consist of time 'at risk' - active in the study and not known to be pregnant already - and the binary outcome of 'unintended' pregnancy. The binary outcome of pregnancy will be as per self-reported answers during Demographic Health Survey style monthly calendar on whether pregnant at any time during the month, and whether the pregnancy was planned / wanted. Since eligibility is based on participants stating that they wanted to wait at least a year to get pregnant, that it was "up to god" or they didn't know, the primary outcome will assume that all pregnancies were unintended. Additional sensitivity analyses will be done with a second definition of "unintended pregnancy" to accommodate intention to change over time, so only pregnancies where respondents said they wanted to delay in the prior round will be counted as unintended.
Modern contraceptive use
时间窗: 6 months and 18-months follow-up
This will be calculated at the endline (18-months post survey) based on women's self-reported data through a detailed set of questions modeled on the Demographic Health Survey's contraceptive calendar question. For each month of the study/follow-up period, women will be asked whether they used any contraceptive method, and if yes, which type(s). A binary indicator of modern contraceptive use by month will be constructed. Modern contraceptive methods will include copper-T (intrauterine device), (Antara) injectable, emergency contraception, oral contraceptive pill, male and female condoms, male and female sterilization, lactational amenorrhea method, foam/jelly, diaphragm and standard-days method), as defined by the Demographic Health Survey in India. Person months during pregnancy and immediate postpartum will be censored for this analysis.
次要结局
- Individual attitudes towards intimate partner violence (IPV)(6 months and 18-months follow-up)
- Time to pregnancy(6 months and 18-months follow-up)
- Measures of reproductive autonomy/empowerment(6 months and 18-months follow-up)
- Desired pregnancy(6 months and 18-months follow-up)