xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06024616</url>
    </required_header>
    <id_info>
      <org_study_id>R01HD108252</org_study_id>
      <secondary_id>R01HD108252</secondary_id>
      <nct_id>NCT06024616</nct_id>
    </id_info>
    <brief_title>Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India</brief_title>
    <acronym>TARANG</acronym>
    <official_title>The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Network for Engineering and Economics Research and Management</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vikalp Sansthan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of the cluster randomized trial is to evaluate the impact of a reproductive health&#xD;
        and empowerment intervention (TARANG) compared to the standard of care health information&#xD;
        (control group) on the prevalence of contraceptive use and time-to-pregnancy (primary&#xD;
        outcomes) in Rajasthan, India.&#xD;
  &#xD;
        Participants will participate in TARANG intervention and receive the following sessions:&#xD;
  &#xD;
          1. Navigating newly formed relationships (e.g. spousal communication, healthy relationships&#xD;
             with in-laws, establishing peer network, and negotiation skills)&#xD;
  &#xD;
          2. Improving women's awareness of sexual reproductive health&#xD;
  &#xD;
          3. Challenging inequitable gender norms with an aim to reduce unintended pregnancies.&#xD;
  &#xD;
          4. Life skills education to enable them to have improved social mobility, decision-making,&#xD;
             and agency.&#xD;
  &#xD;
        Investigators will compare the TARANG intervention with the standard of care to see if it&#xD;
        delays unintended pregnancies among women.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 2024</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to pregnancy</measure>
      <time_frame>Every 6 months, up to 2 years</time_frame>
      <description>Time-to-pregnancy will be defined as the months to start of the first pregnancy. Using the pregnancy calendar data, investigators will analyze the time to pregnancy between the intervention and control areas as a continuous outcome (a number).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Contraceptive use</measure>
      <time_frame>Every 6 months, up to 2 years</time_frame>
      <description>Defined as proportion of women who currently use contraception at the time of survey. This will collected and analyzed from quantitative surveys by using retrospective contraceptive use and method type to account for continuation/ discontinuation of certain methods and account for all methods used.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Desired pregnancy</measure>
      <time_frame>Every 6 months, up to 2 years</time_frame>
      <description>Continuous outcome. Stated pregnancy intention using an adapted Desire to Avoid Pregnancy (DAP) Scale. Self-assessed preferences for having a baby will be measured using the DAP Scale. The DAP scale is a 14-item measure of a person's preferences about a future pregnancy and childbearing. Each item is scored from 0-4, with higher scores indicating a greater preference to avoid pregnancy but investigators will use the 6-items on childbirth given the needs of the target population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Individual attitudes towards intimate partner violence (IPV)</measure>
      <time_frame>Every 6 months, up to 2 years</time_frame>
      <description>7-item scale that measures attitudes towards intimate partner violence against women. To construct the index, items are summed to create a score ranging from 0-7. This has been validated in India (in the Demographic Health Surveys). To be used as a continuous outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measures of reproductive autonomy/empowerment</measure>
      <time_frame>Every 6 months, up to 2 years</time_frame>
      <description>The Women's and Girls' Sexual and Reproductive Health (SRH) Empowerment Index was adapted to have 26 relevant items for existence of choice (autonomy) sub-scales and exercise of choice (self-efficacy (SE), decision-making (DM), negotiation (NG)) subscales. To construct the index, summary scores for each domain and outcome by averaging scores for relevant items are computed. Three outcome-specific empowerment scores (sexual empowerment, contraceptive empowerment and pregnancy empowerment) can be computed by adding the relevant summary scores for the existence of choice and exercise of choice domains. Finally, to examine the contribution of empowerment across the three SRH dimensions, a multidimensional SRH additive index comprising all items included in the three empowerment subscales can be computed. To be used as continuous outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1560</enrollment>
    <condition>Pregnancy, Unplanned</condition>
    <condition>Contraceptive Behavior</condition>
    <arm_group>
      <arm_group_label>TARANG arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will participate in TARANG and receive the following a total of roughly 16 sessions:&#xD;
  Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)&#xD;
  Improving women's awareness of sexual reproductive health&#xD;
  Challenging inequitable gender norms with an aim to reduce unintended pregnancies.&#xD;
  Life skills education to enable them to have improved social mobility, decision-making, and agency.&#xD;
  The TARANG intervention will be delivered by Vikalp (a registered non-governmental organization implementing the intervention).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>TARANG</intervention_name>
      <description>TARANG is structured to be interactive to empower young women to navigate newly formed relationships, improve women's awareness on sexual reproductive health and challenge inequitable gender norms with an aim to reduce unintended pregnancies. TARANG will also provide women with life skills education to improve mobility and agency. Each TARANG intervention women's group will have ~6-7 members and may meet up to twice a month for 8 months.&#xD;
  Vikalp's moderators will also conduct light touch sessions for mothers-in-law and husbands of newly married women. In conjunction with Vikalp, the research team from NEERMAN will recruit mothers-in-law of soon-to-be-married women to participate in 4 group sessions provided weekly for 1 month before the start of the intervention for newly married women. Husbands will be provided 4 group sessions spaced roughly 2 months apart throughout the course of the 8 months the newly married women are engaged in the intervention.</description>
      <arm_group_label>TARANG arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for newly married women:&#xD;
  &#xD;
            -  Age 18-25 years at the time of the wedding&#xD;
  &#xD;
            -  Married and living in husband's house at the time of the baseline survey&#xD;
  &#xD;
            -  Does not plan to move out of the area for the period of the intervention&#xD;
  &#xD;
            -  Mother-in-law has agreed to support daughter-in-law's participation in the study&#xD;
  &#xD;
            -  Mother-in-law and husband are eligible for the study participation&#xD;
  &#xD;
          Inclusion criteria for husband:&#xD;
  &#xD;
            -  18 years or more at the time of the wedding&#xD;
  &#xD;
            -  Does not plan to move out of the village during the period of the intervention&#xD;
  &#xD;
            -  Mother and wife are eligible for the study participation&#xD;
  &#xD;
          Inclusion criteria for mother-in-law:&#xD;
  &#xD;
            -  Will have a resident daughter-in-law after recruitment but before the baseline survey&#xD;
  &#xD;
            -  Consent to participate in the study&#xD;
  &#xD;
            -  Assents for daughter-in-law to participate in the study&#xD;
  &#xD;
            -  Does not plan to move out of the village during the period of the intervention&#xD;
  &#xD;
            -  Son and the daughter-in-law are eligible for the study participation&#xD;
  &#xD;
          Exclusion criteria for newly married women:&#xD;
  &#xD;
            -  Wanting to have a child in the next 12 months at the time of baseline&#xD;
  &#xD;
            -  Cognitive ability to participate in surveys&#xD;
  &#xD;
            -  Withdrawal of consent to participate in the study&#xD;
  &#xD;
            -  Withdrawal of assent by the mother-in-law of the husband at any time&#xD;
  &#xD;
          Exclusion criteria for husband:&#xD;
  &#xD;
            -  Cognitive ability to participate in surveys&#xD;
  &#xD;
            -  Withdrawal of consent to participate in the study&#xD;
  &#xD;
            -  Withdrawal of assent by the mother or the wife at any time&#xD;
  &#xD;
          Exclusion criteria for mothers-in-law:&#xD;
  &#xD;
            -  Cognitive ability to participate in surveys&#xD;
  &#xD;
            -  Withdrawal of consent to participate in the study&#xD;
  &#xD;
            -  Withdrawal of assent by the son or the daughter-in-law&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nadia Diamond-Smith, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nadia Diamond-Smith, PhD</last_name>
      <phone>510 914-4586</phone>
      <email>nadia.diamond-smith@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sumeet R Patil, PhD</last_name>
      <phone>9540844900</phone>
      <email>srpatil@neerman.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Vikalp Sansthan</name>
        <address>
          <city>Udaipur</city>
          <state>Rajasthan</state>
          <zip>313011</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Usha Choudhary</last_name>
        <phone>9414146408</phone>
        <email>vikalporg@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Sumeet R Patil, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>At the end of the project and completion of the planned statistical analyses, UCSF and NEERMAN will create a de-identified dataset to be hosted on a public data-sharing platform per the guidance of the latest NIH data sharing. Until then, in accordance with this data-sharing agreement, co-investigators on the research team will not share the dataset with outsiders unless these individuals have signed a data-sharing agreement and this agreement is approved by the Principal and site co-investigators on the research team.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>At the end of 2027 when the main study ends, investigators will share a de-identified dataset to be hosted on OpenICPSR, a portal approved by NIH for sharing data. It will be available indefinitely.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06024616
  org study id: R01HD108252
  secondary id: R01HD108252
  nct id: NCT06024616
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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:
  
          1. Navigating newly formed relationships (e.g. spousal communication, healthy relationships
             with in-laws, establishing peer network, and negotiation skills)
  
          2. Improving women's awareness of sexual reproductive health
  
          3. Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
  
          4. 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Time to pregnancy
  time frame: Every 6 months, up to 2 years
  description: Time-to-pregnancy will be defined as the months to start of the first pregnancy. Using the pregnancy calendar data, investigators will analyze the time to pregnancy between the intervention and control areas as a continuous outcome (a number).
  measure: Contraceptive use
  time frame: Every 6 months, up to 2 years
  description: Defined as proportion of women who currently use contraception at the time of survey. This will collected and analyzed from quantitative surveys by using retrospective contraceptive use and method type to account for continuation/ discontinuation of certain methods and account for all methods used.
  measure: Desired pregnancy
  time frame: Every 6 months, up to 2 years
  description: Continuous outcome. Stated pregnancy intention using an adapted Desire to Avoid Pregnancy (DAP) Scale. Self-assessed preferences for having a baby will be measured using the DAP Scale. The DAP scale is a 14-item measure of a person's preferences about a future pregnancy and childbearing. Each item is scored from 0-4, with higher scores indicating a greater preference to avoid pregnancy but investigators will use the 6-items on childbirth given the needs of the target population.
  measure: Individual attitudes towards intimate partner violence (IPV)
  time frame: Every 6 months, up to 2 years
  description: 7-item scale that measures attitudes towards intimate partner violence against women. To construct the index, items are summed to create a score ranging from 0-7. This has been validated in India (in the Demographic Health Surveys). To be used as a continuous outcome.
  measure: Measures of reproductive autonomy/empowerment
  time frame: Every 6 months, up to 2 years
  description: The Women's and Girls' Sexual and Reproductive Health (SRH) Empowerment Index was adapted to have 26 relevant items for existence of choice (autonomy) sub-scales and exercise of choice (self-efficacy (SE), decision-making (DM), negotiation (NG)) subscales. To construct the index, summary scores for each domain and outcome by averaging scores for relevant items are computed. Three outcome-specific empowerment scores (sexual empowerment, contraceptive empowerment and pregnancy empowerment) can be computed by adding the relevant summary scores for the existence of choice and exercise of choice domains. Finally, to examine the contribution of empowerment across the three SRH dimensions, a multidimensional SRH additive index comprising all items included in the three empowerment subscales can be computed. To be used as continuous outcome.
  arm group label: TARANG arm
  arm group type: Experimental
  description: Participants will participate in TARANG and receive the following a total of roughly 16 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.
  The TARANG intervention will be delivered by Vikalp (a registered non-governmental organization implementing the intervention).
  arm group label: Control arm
  arm group type: No Intervention
  description: Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers
  intervention type: Behavioral
  intervention name: TARANG
  description: TARANG is structured to be interactive to empower young women to navigate newly formed relationships, improve women's awareness on sexual reproductive health and challenge inequitable gender norms with an aim to reduce unintended pregnancies. TARANG will also provide women with life skills education to improve mobility and agency. Each TARANG intervention women's group will have ~6-7 members and may meet up to twice a month for 8 months.
  Vikalp's moderators will also conduct light touch sessions for mothers-in-law and husbands of newly married women. In conjunction with Vikalp, the research team from NEERMAN will recruit mothers-in-law of soon-to-be-married women to participate in 4 group sessions provided weekly for 1 month before the start of the intervention for newly married women. Husbands will be provided 4 group sessions spaced roughly 2 months apart throughout the course of the 8 months the newly married women are engaged in the intervention.
  arm group label: TARANG arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nadia Diamond-Smith, PhD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Nadia Diamond-Smith, PhD
  phone: 510 914-4586
  email: nadia.diamond-smith@ucsf.edu
  last name: Sumeet R Patil, PhD
  phone: 9540844900
  email: srpatil@neerman.org
  facility: 
  contact: 
  investigator: 
  country: India
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: At the end of the project and completion of the planned statistical analyses, UCSF and NEERMAN will create a de-identified dataset to be hosted on a public data-sharing platform per the guidance of the latest NIH data sharing. Until then, in accordance with this data-sharing agreement, co-investigators on the research team will not share the dataset with outsiders unless these individuals have signed a data-sharing agreement and this agreement is approved by the Principal and site co-investigators on the research team.
  ipd info type: Study Protocol
  ipd time frame: At the end of 2027 when the main study ends, investigators will share a de-identified dataset to be hosted on OpenICPSR, a portal approved by NIH for sharing data. It will be available indefinitely.