MAMAS: Mentoring Adolescent Mothers at School
Condition: Human Immunodeficiency Virus; Herpes Simplex Type II; Chlamydia; Gonorrhea; Trichomonas Vaginitis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Herpes Simplex; Gonorrhea; Trichomonas Vaginitis; Vaginitis; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV
      incidence by increasing the number of adolescent mothers who re-enroll and remain in school.
      The objective of the intervention is to have older mentor mothers, who themselves were
      pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide
      ongoing psychosocial support, help navigate re-admission to school, and help facilitate
      access to an existing State-sponsored cash transfer, the child support grant (CSG), in the
      early postpartum period. Our combination social protection program will enhance resilience of
      young adolescent mothers to facilitate their return to school and thereby reduce HIV risk.
      The investigators will evaluate the efficacy of the intervention using a pre-test post-test
      randomized controlled trial design. Participants in the intervention will receive the
      Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care.
      Those in the control arm will receive standard postpartum care. Additionally, for those
      participants randomized to the intervention arm, mentor mothers will use participatory visual
      methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last,
      among those participants randomized to the intervention arm and who return for their 9-month
      assessment, the investigators will conduct 20 in-depth interviews to understand the process
      of resilience development from their perspective.

      Primary outcomes:

      School outcomes (initial outcomes) HYP 1.1: Program participation will increase school
      enrollment HYP 1.2: Program participation will increase school engagement

      HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number
      of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP
      2.3: Program participation will reduce intimate partner violence HYP 2.4: Program
      participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will
      increase retention in care

      Secondary outcomes:

      HYP 5: Program participation will increase peer support HYP 6: Program participation will
      increase familial support HYP 7: Program participation will increase school re-admission HYP
      8: Program participation will increase application to the child support grant HYP 9: Program
      participation will increase receipt of the child support grant
    

Detailed description: 
      All study activities will take place in Umlazi township in eThekwini district. The township
      is served by one regional hospital, Prince Mshiyeni Memorial Hospital, which is the referral
      hospital for 17 primary health care clinics.

      Participants will be involved in the study from delivery to 9 months postpartum. The
      intervention study will be delivered in two cohorts (n=240 per cohort). The first cohort will
      be enrolled beginning in May 2017. The investigators anticipate that 4 adolescent mothers
      will be enrolled per day based on the monthly number of adolescent deliveries at Prince
      Mshiyieni hospital and our own capacity. Therefore, investigators will be finished enrolling
      the first cohort by July 2017. The first cohort will complete the end line assessment between
      December 2017-February 2018.

      The investigators will begin enrolling the second cohort in September 2017 and will complete
      enrollment by November 2017. The second cohort will complete the end line assessment between
      June-August, 2018. Primary outcome analysis will be complete by October, 2018.

      MAMAS Intervention The investigators will roll out the program with two cohorts of adolescent
      mothers (n=240 per cohort); each mentor mother will work with 10 adolescent mothers per
      cohort. Within each cohort, there will be an intervention arm and control arm (N=240 per arm
      for the both cohorts). The participants of the program arm will have 15 group sessions with
      mentor and up to 2 home visits from 3 weeks-6 months postpartum. Investigators will use
      participatory visual methods (e.g., photovoice, journaling, and drawing) throughout program
      implementation with adolescent mothers to understand and further facilitate their process of
      resilience development. As one example, as part of the mentoring process, adolescent mothers
      may be asked to engage in reflexive journaling. Mentor mothers will ask adolescent mothers
      who are comfortable doing so to share excerpts from their journals in a particular group
      session. Through the group session, the adolescent mothers themselves will identify common
      barriers they are facing and will work together to overcome them. Mentor mothers will keep
      weekly logs documenting what was covered in the sessions; these will be abstracted as part of
      ongoing monitoring and evaluation.

      All 480 participants will complete a baseline behavioral and biological assessment (HIV and
      HSV-2 testing) at 2 weeks postpartum and an additional baseline biological assessment
      (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia trachomatis testing) at 6 weeks
      postpartum. Further, all participants will receive regular postpartum and well-baby visits at
      6 weeks, 10 weeks, 14 weeks and 6 months with an adolescent-friendly study nurse. During the
      visits, participants will complete routine assessments. At 9-months postpartum, participants
      will complete end line behavioral and biological assessment (HIV, HSV-2 Trichomonas
      vaginalis, Neisseria gonorrhea and Chlamydia trachomatis testing).

      Provision to Privacy All participants will receive adolescent-friendly clinical services with
      our study nurse during the postnatal period. The study nurse will provide standard of care
      clinical services, and will have gone through training to ensure she is providing
      youth-friendly care. In addition, a trained research assistant will administer all behavioral
      assessments and be available for any queries that participants have as they complete the
      survey. The research assistant will complete training on multicultural sensitivity,
      gender-based violence, and ethical guidelines as recommended by the WHO Violence Against
      Women (VAW) study to engage with participants in a supportive and non-judgmental manner, deal
      with sensitive issues, and respond to distressed participants.

      Additionally, the following systems are in place to maintain cohort retention and follow up
      while protecting the privacy interests of subjects: At enrollment, study participants will be
      asked if they are willing to share their telephone number, their physical home address and a
      postal address. Women will be told that providing this information is entirely voluntary, and
      will only be used to follow up with the women to remind them of their appointments. Study
      participants in the intervention trial will be contacted by text message prior to a study
      visit to remind them of their visit. Study participants who miss their scheduled appointment
      are contacted within 24 hours. The first line of contact is an SMS. The second is a reminder
      telephone call to the participant directly or to a close contact that is identified by the
      client, while maintaining confidentiality. If the study staff cannot reach the participant,
      she will call once per day over the next three days. If the tracer still cannot reach the
      participant by the end of the third day, the tracer will do a home visit if home location was
      provided by the participant. Home visits are done by tracers familiar with the residential
      areas. For the proposed study, the investigators will employ two full-time tracers. If the
      participant has changed her address maximum information is gathered (while maintaining
      confidentiality of the participant) from neighbors and relatives that form the basis of
      further contact. A participant will be considered lost to follow-up after 3 unsuccessful
      attempts of phone contact and 2 unsuccessful home visits. A SMS and phone script that will be
      used to contact women and remind them of their appointments.

      A similar system for tracing study participants was used in the previous clinical trials
      implemented and has resulted in retention rates of higher than 75%, with no adverse events
      associated with tracing reported.

      Data Management and Analysis Data will be primarily managed on-site by a data entry and
      management team. All risks will be minimized through staff ethics training, layered data
      security and by restricting access of sensitive information to staff members who have a
      specific need for the information. Furthermore, as part of the training that investigators
      conduct for all staff members, investigators will include a training module on the
      confidential nature of the data. Investigators have conducted similar training modules for
      research staff in other studies. Following the training, all staff will sign an Oath of
      Confidentiality.

      Data Security for all Data All participants will be assigned a participant identifier (PID)
      after randomization. Thereafter, all biological and non-biological samples/data will only be
      identifiable vis-a-vis the PID. Participant's names will never appear on the samples/data.
      Further, consent forms and any other forms with personal identifiers will be kept separate
      from data files in key-locked filing cabinets. A computerized follow-up system which links
      identification numbers and personal information will be kept on a computer with password
      protection. Only the site PI, Dr. Daya Moodley and authorized study staff who have completed
      all required ethics training will have access to the computer. Protection against loss of
      data is provided through scheduled backup of data files.

      Non-biological Data Data will be collected using Samsung Galaxy or equivalent Tablets running
      customized version of Android operating system. The investigators have multiple levels of
      security measures to ensure the safety of data on the tablets. With the customized version of
      operating system, the interviewers are allowed access to only certain apps and settings on
      the tablets. A password is required to activate the tablet and a second password must be
      entered to access the data capture software. There are also separate levels of access for
      interviewers, field supervisors, and system administrators. Only users with administrator
      level access will can delete data that had been previously captured. Further, the data
      captured on the device will be in a machine-readable (xml) format and is not easy to
      interpret without using a computer program. To add another layer of security, once the data
      has been transferred to the project server, it will be removed from the device. As an
      additional security measure, lost or stolen tablets can be tracked and have their data erased
      remotely by the data team when the lost or stolen tablet is connected to a Wi-Fi or cellular
      network.

      All data captured by the tablets will be transmitted to the project server using HTTPS, which
      is a widely-used communications protocol for secure communication over a computer network.
      HTTPS provides authentication of the web app and associated web server that one is
      communicating with, which protects against malicious attacks. Additionally, it provides
      bidirectional encryption of communications between a client and server, which protects
      against eavesdropping and tampering with and/or forging the contents of the communication.

      Once the data is on project server, it allows real time monitoring of progress in the field,
      reported via automated Benchmark reporting tables on a password protected website, and
      facilitates monitoring of the status of data collection, and helps make rapid corrections to
      assure timely adherence to the timeline. In addition, the data will be processed to create
      incremental Stata datasets every week and will be sent through email in an encrypted format
      to Project coordinator, who in turn will run weekly QC activities and return any queries to
      field staff.

      Data Collection, Storage and Sharing for Biological Data Biological specimens will be stored
      at the CAPRISA repository in -70 refrigerators. The samples will be stored in temperature
      controlled and monitored environment. Specimens will be stored until all assays are complete
      which is dependent on the receipt of funds for the relevant assays proposed. Repository staff
      who maintain the samples daily will have access to the samples.

      Statistical Analysis The investigators will use appropriate bivariate and multivariate
      analysis to test whether adolescent mothers who received the intervention have lower levels
      of STIs and HIV risk than those in the control arm. Multivariate analysis will be used to
      measure the association between treatment arm and school reenrollment. For HIV-positive
      participants, investigators will assess whether receiving the intervention increases
      retention in care. Analyses will be completed using SAS statistical programs.

      Power Analysis Investigators used data from a previous trial in the same setting to help
      estimate the appropriate sample size for our RCT [1]. Specifically, in the previous study,
      investigators had a 26.5% prevalence of consistent condom use and a 21.6% prevalence of any
      STI in the control group at the postpartum assessment.

      Outcome 1: STI. Investigators estimate that the total sample size needed at follow-up to
      detect a standardized effect (d) of .20 (OR=.69) of our intervention on STI with 80% power
      (2-sided, alpha=.05) is 350 (total across both arms). The investigators inflated this sample
      size assuming an attrition rate from baseline to follow-up of 25% (350/.70=467).

      Outcome 2: Inconsistent condom use. The investigators estimate that the total sample size
      needed at follow-up to detect a standardized effect (d) of .20 (OR=.69) of our intervention
      on inconsistent condom use with 80% power (2-sided, alpha=.05) is 314 (total across both
      arms). Investigators inflated this sample size assuming an attrition rate from baseline to
      follow-up of 25% (314/.70=419).

      While investigators estimated that 467 participants would provide sufficient power to detect
      an effect on STI outcomes, investigators increased our sample size to 480 participants so
      that each of the 12 mentor mothers would be delivering the intervention to an equal number of
      participants (n=10) in each cohort.
    

Intervention name(s): Mentoring Adolescent Mothers at School (MAMAS)
Intervention type(s): Behavioral
Intervention description(s): Through the MAMAS program, 12 older mentor mothers, who themselves were pregnant adolescents, will mentor 240 younger adolescent mothers to provide ongoing psychosocial support, navigate re-admission to school, and facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Immunodeficiency Virus; resilience; adolescent mothers; Sub-Saharan Africa; intimate partner violence; postpartum period