<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/NCT04472884</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00010797</org_study_id>
    <secondary_id>1R01NR019220-01A1</secondary_id>
    <nct_id>NCT04472884</nct_id>
  </id_info>
  <brief_title>mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding</brief_title>
  <official_title>mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenyatta National Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jomo Kenyatta University of Agriculture and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In high HIV prevalence regions, women are at high risk for HIV during pregnancy and&#xD;
      breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission,&#xD;
      the World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure&#xD;
      prophylaxis (PrEP) to HIV-negative pregnant and postpartum women in high-burden settings.&#xD;
      Although most pregnant Kenyan women with HIV risk factors accept PrEP when offered, &gt;50%&#xD;
      discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date,&#xD;
      no intervention studies to improve PrEP adherence include pregnant or postpartum women. The&#xD;
      investigators adapted an SMS communication platform (mWACh) to send PrEP-tailored,&#xD;
      theory-based SMS to facilitate adherence among pregnant women who initiate PrEP. In a&#xD;
      non-randomized pilot, the investigators found that mWACh-PrEP recipients were more likely to&#xD;
      persist with PrEP use and to self-report high adherence. The investigators propose a&#xD;
      randomized trial to determine the effect of the mWACh-PrEP tool on PrEP adherence during&#xD;
      pregnancy through the postpartum period. The investigators will also gather data on cost and&#xD;
      delivery using the Proctor Implementation Outcomes Framework to expedite translation into&#xD;
      routine practice. The overarching hypothesis is that mWACh-PrEP will improve PrEP adherence&#xD;
      among mothers at-risk for HIV, be acceptable to patients and providers, and be&#xD;
      cost-effective. The study will be executed via the following aims:&#xD;
&#xD;
      Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy&#xD;
      through the postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct&#xD;
      a 2-arm randomized trial comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic&#xD;
      adherence counseling) among HIV-uninfected pregnant women with high HIV acquisition risk&#xD;
      (defined by validated risk score) who initiate PrEP. The primary outcome will be adherence at&#xD;
      6 months postpartum (TFV hair levels &gt;0.038 ng/mg; consistent with 7 pills/ week). Secondary&#xD;
      outcomes will include sexually transmitted infection (STI) incidence, adherence cofactors,&#xD;
      and prevention-effective adherence (time-varying alignment of adherence with risk behaviors).&#xD;
      Exploratory outcomes will include HIV incidence and perinatal outcomes by arm. Hypothesis:&#xD;
      mWACh-PrEP will increase PrEP adherence compared to SOC.&#xD;
&#xD;
      Aim 2- Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC.&#xD;
      Using the Proctor framework, we assess acceptability and feasibility by conducting interviews&#xD;
      and focus-groups with ANC-PrEP users, providers, and health planners. Hypothesis: Indications&#xD;
      for readiness of mWACh-PrEP will be identified.&#xD;
&#xD;
      Aim 3- Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV&#xD;
      infection and disability-adjusted life-year (DALY) averted. We use data from Aims 1 and&#xD;
      conduct micro-costing and time-and-motion studies to estimate the cost of mWACh-PrEP from a&#xD;
      payer perspective. The incremental cost-effectiveness ratio (ICER) per HIV infection and DALY&#xD;
      averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC&#xD;
      outcomes with improve ICERs for mWACh-PrEP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 14, 2022</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</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>% of participants with detectable TFV levels in hair &gt;0.038 ng/mg (PrEP adherence)</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>PrEP adherence will be measured with a binary endpoint (Yes/No) based on hair samples from 6-month postpartum visits. Detectable TFV levels in hair &gt;0.038 ng/mg (consistent with 7 doses/week) will be considered adherent. If a participant stopped PrEP use or exited the study before 6 months postpartum (ie had no hair sample collected), the participant will be considered non-adherent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% of participants with detectable TFV levels in hair &gt;0.038 ng/mg (Sustained PrEP adherence)</measure>
    <time_frame>9-months postpartum</time_frame>
    <description>Binary endpoint (Yes/No) of detectable TFV levels in hair &gt;0.038 ng/mg (consistent with 7 doses/week) at 9-months postpartum (3 months after cessation of mWACh messaging). Same definition of non-adherence as above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of participants with &lt;90% PrEP adherence or discontinuation (Predictors of non-adherence)</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>Factors associated with poor adherence (outcomes of &lt;90% adherent on PrEP or discontinuation) will include demographics, relationship/partner characteristics, psychosocial factors, socioeconomic status, low health/HIV literacy, fear of disclosure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of STI diagnoses</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>Frequency of STI (syphilis, gonorrhea, chlamydia) detection at follow-up visits will be compared between randomization arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of HIV acquisition</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>Frequency of HIV diagnosis at follow-up visits will be compared between randomization arms</description>
  </other_outcome>
  <other_outcome>
    <measure>% of participants who experience preterm birth, neonatal death, and infant growth faltering</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>Frequency of preterm birth, neonatal death, and infant growth faltering outcomes will be compared between randomization arms</description>
  </other_outcome>
  <other_outcome>
    <measure>% of participants who offer male partners expedited partner therapy (EPT)</measure>
    <time_frame>6-months postpartum</time_frame>
    <description>Among women with STI diagnoses, frequency of offering male partners EPT will be compared between randomization arm</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>HIV Infections</condition>
  <condition>Pregnancy Related</condition>
  <condition>Adherence, Medication</condition>
  <arm_group>
    <arm_group_label>mWACh-PrEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mWACh-PrEP</intervention_name>
    <description>Participants randomized to mWACh-PrEP will be registered into the system, in addition to receipt of SOC services. Women registered into the mWACh-PrEP platform will indicate their preferences for message delivery including a preferred name for messaging, language (English or Kiswahili or Dholuo), and day of the week and time for SMS delivery. Once registered, women will receive weekly automated push messages on the day/time of their choice from enrollment through 6-months postpartum. All automated push messages will include participant nickname, clinic and nurse name, an educational message or actionable advice targeting PrEP adherence and continuation and/or maternal and child health (MCH) topics, and a question related to the content. SMS topics will include adherence encouragement, PrEP efficacy and safety, self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications) and visit reminders.</description>
    <arm_group_label>mWACh-PrEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>All participants will receive SOC services for MCH and PrEP that will include health education, clinical assessments, laboratory safety monitoring, STI (syphilis, gonorrhea, and chlamydia) screening and treatment (including expedited partner treatment for</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_label>mWACh-PrEP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women presenting for routine antenatal care (ANC) who are:&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  24-32 weeks gestation&#xD;
&#xD;
          -  No documented tuberculosis infection&#xD;
&#xD;
          -  HIV negative (based on ANC HIV testing)&#xD;
&#xD;
          -  Plan to reside in area for at least one year postpartum&#xD;
&#xD;
          -  Plan to receive antenatal, postnatal, and infant care at study facility&#xD;
&#xD;
          -  Initiated PrEP during routine ANC&#xD;
&#xD;
          -  Have an HIV risk score &gt;6 (based on Pintye et al 2017).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not plan to remain in the study site catchment area for at least 1 year&#xD;
&#xD;
          -  Do not have mobile phones.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Jillian Pintye, RN, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jillian Pintye, RN, MPH, PhD</last_name>
    <phone>(206) 543-8736</phone>
    <email>jpintye@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kisumu County Referral Hospital</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Abuna</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lumumba Sub County Hospital</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Abuna</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Migosi Sub County Hospital</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Abuna</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yala Sub County Hospital</name>
      <address>
        <city>Siaya</city>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felix Abuna</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Jillian Pintye</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pre-exposure prophylaxis</keyword>
  <keyword>HIV prevention</keyword>
  <keyword>PrEP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04472884
org study id: STUDY00010797
secondary id: 1R01NR019220-01A1
nct id: NCT04472884
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In high HIV prevalence regions, women are at high risk for HIV during pregnancy and
      breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission,
      the World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure
      prophylaxis (PrEP) to HIV-negative pregnant and postpartum women in high-burden settings.
      Although most pregnant Kenyan women with HIV risk factors accept PrEP when offered, >50%
      discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date,
      no intervention studies to improve PrEP adherence include pregnant or postpartum women. The
      investigators adapted an SMS communication platform (mWACh) to send PrEP-tailored,
      theory-based SMS to facilitate adherence among pregnant women who initiate PrEP. In a
      non-randomized pilot, the investigators found that mWACh-PrEP recipients were more likely to
      persist with PrEP use and to self-report high adherence. The investigators propose a
      randomized trial to determine the effect of the mWACh-PrEP tool on PrEP adherence during
      pregnancy through the postpartum period. The investigators will also gather data on cost and
      delivery using the Proctor Implementation Outcomes Framework to expedite translation into
      routine practice. The overarching hypothesis is that mWACh-PrEP will improve PrEP adherence
      among mothers at-risk for HIV, be acceptable to patients and providers, and be
      cost-effective. The study will be executed via the following aims:

      Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy
      through the postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct
      a 2-arm randomized trial comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic
      adherence counseling) among HIV-uninfected pregnant women with high HIV acquisition risk
      (defined by validated risk score) who initiate PrEP. The primary outcome will be adherence at
      6 months postpartum (TFV hair levels >0.038 ng/mg; consistent with 7 pills/ week). Secondary
      outcomes will include sexually transmitted infection (STI) incidence, adherence cofactors,
      and prevention-effective adherence (time-varying alignment of adherence with risk behaviors).
      Exploratory outcomes will include HIV incidence and perinatal outcomes by arm. Hypothesis:
      mWACh-PrEP will increase PrEP adherence compared to SOC.

      Aim 2- Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC.
      Using the Proctor framework, we assess acceptability and feasibility by conducting interviews
      and focus-groups with ANC-PrEP users, providers, and health planners. Hypothesis: Indications
      for readiness of mWACh-PrEP will be identified.

      Aim 3- Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV
      infection and disability-adjusted life-year (DALY) averted. We use data from Aims 1 and
      conduct micro-costing and time-and-motion studies to estimate the cost of mWACh-PrEP from a
      payer perspective. The incremental cost-effectiveness ratio (ICER) per HIV infection and DALY
      averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC
      outcomes with improve ICERs for mWACh-PrEP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: % of participants with detectable TFV levels in hair >0.038 ng/mg (PrEP adherence)
time frame: 6-months postpartum
description: PrEP adherence will be measured with a binary endpoint (Yes/No) based on hair samples from 6-month postpartum visits. Detectable TFV levels in hair >0.038 ng/mg (consistent with 7 doses/week) will be considered adherent. If a participant stopped PrEP use or exited the study before 6 months postpartum (ie had no hair sample collected), the participant will be considered non-adherent
measure: % of participants with detectable TFV levels in hair >0.038 ng/mg (Sustained PrEP adherence)
time frame: 9-months postpartum
description: Binary endpoint (Yes/No) of detectable TFV levels in hair >0.038 ng/mg (consistent with 7 doses/week) at 9-months postpartum (3 months after cessation of mWACh messaging). Same definition of non-adherence as above.
measure: % of participants with <90% PrEP adherence or discontinuation (Predictors of non-adherence)
time frame: 6-months postpartum
description: Factors associated with poor adherence (outcomes of <90% adherent on PrEP or discontinuation) will include demographics, relationship/partner characteristics, psychosocial factors, socioeconomic status, low health/HIV literacy, fear of disclosure
measure: Incidence of STI diagnoses
time frame: 6-months postpartum
description: Frequency of STI (syphilis, gonorrhea, chlamydia) detection at follow-up visits will be compared between randomization arms
measure: Incidence of HIV acquisition
time frame: 6-months postpartum
description: Frequency of HIV diagnosis at follow-up visits will be compared between randomization arms
measure: % of participants who experience preterm birth, neonatal death, and infant growth faltering
time frame: 6-months postpartum
description: Frequency of preterm birth, neonatal death, and infant growth faltering outcomes will be compared between randomization arms
measure: % of participants who offer male partners expedited partner therapy (EPT)
time frame: 6-months postpartum
description: Among women with STI diagnoses, frequency of offering male partners EPT will be compared between randomization arm
arm group label: mWACh-PrEP
arm group type: Experimental
arm group label: Standard of Care
arm group type: Other
intervention type: Behavioral
intervention name: mWACh-PrEP
description: Participants randomized to mWACh-PrEP will be registered into the system, in addition to receipt of SOC services. Women registered into the mWACh-PrEP platform will indicate their preferences for message delivery including a preferred name for messaging, language (English or Kiswahili or Dholuo), and day of the week and time for SMS delivery. Once registered, women will receive weekly automated push messages on the day/time of their choice from enrollment through 6-months postpartum. All automated push messages will include participant nickname, clinic and nurse name, an educational message or actionable advice targeting PrEP adherence and continuation and/or maternal and child health (MCH) topics, and a question related to the content. SMS topics will include adherence encouragement, PrEP efficacy and safety, self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications) and visit reminders.
arm group label: mWACh-PrEP
intervention type: Other
intervention name: Standard of Care
description: All participants will receive SOC services for MCH and PrEP that will include health education, clinical assessments, laboratory safety monitoring, STI (syphilis, gonorrhea, and chlamydia) screening and treatment (including expedited partner treatment for
arm group label: Standard of Care
arm group label: mWACh-PrEP
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jillian Pintye, RN, MPH, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Jillian Pintye, RN, MPH, PhD
phone: (206) 543-8736
email: jpintye@uw.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Jillian Pintye
investigator title: Assistant Professor
mesh term: HIV Infections