Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being
Condition: Risk Behavior; Mental Health Impairment
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two types of counseling,
      Psychosocial Counseling (PC) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), in
      addressing outcomes of orphans and vulnerable children (OVC) including mental and behavioral
      health, well-being, social support, and HIV risk behaviors. The study will be conducted in
      Lusaka, Zambia.
    

Detailed description: 
      This is a randomized controlled trial to evaluate the effectiveness of TF-CBT compared to PC
      in improving a range of OVC outcomes including HIV risk behaviors but also mediating factors
      which constitute important outcomes - well-being, mental health, functioning, and caregiver
      health and support. The study design also includes measurement of the impact of factors that
      may moderate effects - age, gender, religion, ethnicity, HIV knowledge and attitudes,
      education, and physical health. This is an effectiveness trial in that the interventions will
      be provided by Ministry of Health (MoH) and organizations already providing services to OVC.

      Assessments: Study instruments will be administered using an Audio Computer Assisted
      Self-Interviewing (ACASI) system developed by Tufts University. The Tufts ACASI system allows
      the responder control to navigate and answer sensitive questions privately and discreetly. It
      was developed using Macromedia Authorware (v7.0) and can be programmed in any language by
      having a native speaker record the screen text. The Tufts ACASI system offers both live
      interview and data entry modes and can deliver a variety of question types, including yes/no,
      single-answer multiple choice (select one answer), and multiple-answer multiple choice
      (select all that apply) questions which allow numeric keypad entry, as well as scale
      questions which allow the user to click on a point along a scale, and text entry for
      interviewer-administered, open-ended questions

      Procedure: Study participants will be recruited via several methods. The first method of
      recruitment is from urban communities through outreach by existing Home Based Care Workers
      (HBCWs) and other peer educators under the Archdiocese of Lusaka, local churches, and other
      local organizations that have outreach activities in the community. The HBCWs and peer
      educators will introduce the study to families in the community who they believe may be
      eligible for the study. Investigators will also ask these peer educators and HBCWs to use a
      recruitment script to introduce the study to both the adolescent and his/her caretaker. If
      the adolescent and/or caretaker are not interested in hearing more about the study, their
      information will not be passed on to study staff and we will have no contact with that
      family. The HBCW will make follow-up appointments with families who are interested in hearing
      more about the study and arrange a time for them to go to a local parish. At these follow-up
      appointments one of the study assessors will discuss the study in detail with the potential
      participants (adolescent and caretaker). This is preferable to clinic-based recruitment
      because, 1) many OVC do not come to clinics for reasons such as stigma, fear, mental health
      problems or transport problems 2) HBCWs will assist with retention, and 3) study staff will
      have no contact with any families who have not already indicated to their HBCW that they
      would like to hear more about the study

      As a second recruitment strategy, investigators will also hold general community meetings in
      each of the study sites in which all members of the community will be invited. Investigators
      will explain the general purpose of the study at these meetings and answer any questions.
      Investigators will invite families to contact us directly if they are interested in hearing
      more about the study from one of our study assessors or to talk with their HBCW who can put
      the family in touch with our research staff. The community will also be given specific dates
      when the study team will be at a central parish where they may come to be assessed and/or ask
      additional questions.

      Third, we may use a school-based recruitment. For this strategy investigators will first hold
      meetings with school officials (e.g., Principals, head teachers) in schools within our
      catchment area in Lusaka. Investigators will also gain approval from the Ministry of
      Education of Zambia if needed. Investigators will also hold general meetings at the school
      open to all staff, students, and parents to let them know about the study. If the school
      officials agree to have recruitment in the school, investigators will ask that they introduce
      guidance counselors. Investigators will train the guidance counselors in the school, who have
      knowledge of which students in the school might be eligible for the study, on the purpose of
      the study and how to introduce the study to families that they believe would be eligible.
      Meet with head teacher, explain study. Also talks to other staff members. Guidance counselor
      would meet with the parents and child to see if they are interested. Additionally, we will
      provide our study contact information at the general school meeting so that interested
      families may contact us directly. Investigators will have study staff on-site on selected
      days to meet privately with interested families for explaining the study in full, obtaining
      informed consent, and proceeding with study activities.

      Fourth, investigators will use a snowball sampling strategy. A large number of adolescents
      and caregivers enrolled in the study have informed us that they know other families in their
      communities they think would benefit from mental health and psychosocial services.
      Investigators plan to have counselors ask current study participants if they know of specific
      families who they think would be interested in hearing more about the study. If participants
      know other families who they think would be interested, investigators will ask the
      participants to bring those families to meet with the counselor. The counselor will then give
      a brief introduction to the study. The counselor will then refer families who are still
      interested to the research team and a day/time will be setup for the family to privately meet
      with an assessor for consenting and screening as per the original study protocol.

      The assessors will be at the parish locations, or if needed would go with an HBCW (if an HBCW
      was involved in the recruitment) to the families' homes that indicated interest in the study.
      The assessor will conduct the adult consent and caretaker permission process with the
      caretaker first. Consent and permission will be obtained at this time for all parts of the
      study-- screening, interview using ACASI, and intervention. In all cases, the caretaker will
      have to provide consent to participate in the interview and intervention for him/herself and
      will also have to provide permission for the adolescent to participate in the screening,
      interview, and intervention. For these cases, in the response section the assessor will
      indicate if the caretaker consents to participate in each of the sections
      (screening/interview and intervention) separately and gives permission for their adolescent
      to participate in each of the 3 sections (screener, interview and intervention) separately.

      If the caregiver and child respond yes to the consent and the caretaker provides permission
      for the adolescent, the assessor will administer the screener. This screener will be scored
      immediately and if the child is determined eligible for the study, the assessor will ask if
      they are able to complete the full assessment battery at this time (approximately 2 hours) or
      if they would like to schedule a separate time to complete this. If a separate time/date is
      preferred, the assessor will schedule that with the family. The HBCW will not be present
      during the consent or assessment process.

      If the adolescent is found to be eligible after the screening interview (through the results
      of either the adolescent screening, caretaker screening, or both), then the assessor will
      allocate a study ID number to the adolescent. When the baseline is designated to be
      completed, the assessor will set up two notebook computers for the baseline interview: one
      for the adolescent and one for the caretaker. The adolescent and caretaker will complete the
      interview simultaneously but separately (in separate rooms), with the assessor not present
      but close by in case of problems or questions. On completion of the baseline interview the
      assessor will let the family know that someone from their nearest MoH clinic will contact
      them.

      At the end of each day all assessors will report the allocated study IDs to the on-site Study
      Director, who will send them to a Johns Hopkins-based research staff who will retain the
      confidential master list linking study IDs to interventions based on random assignment. The
      Johns Hopkins researcher will respond with the allocations for those study IDs. These data
      will be used to inform the clinics which intervention each new participant will receive prior
      to their first visit. Both interventions will be available at all study sites. Neither
      assessor, caretaker, nor adolescent will know which intervention the adolescent will receive.

      Whether or not an adolescent agrees to join the study s/he will have access to other services
      under the Archdiocese of Lusaka. These services include Psychosocial Counseling, Home Based
      Care services, medical and education support, voluntary counseling and testing (VCT),
      Community Sensitization Campaigns, Behavioral Change, livelihood support, tuberculosis care,
      awareness programs on communicable diseases. The adolescent will also have access to the HIV
      prevention strategies available at the MoH clinics including, VCT, counseling, safe sex
      interventions and primary care services. For those in the study, we will monitor utilization
      of these services and include that information as a variable in the analysis, to determine
      their effects as potential moderators of treatment effects.

      The adolescent will either go to a MoH clinic or a different, pre-identified community center
      for their first appointment with their counselor to receive either TF-CBT or PC. Later
      sessions will either be at the clinic or at another location that the counselor and family
      agree on, and locations can vary from week to week if necessary and feasible. The caretaker
      may also participate in these sessions (if they have consented to participate in the study
      along with the adolescent). Because the Archdiocese of Lusaka sites are deeply embedded into
      the community, other neighborhood structures-such as churches-may be used as meeting points.

      Follow-up Assessments with both adolescent and caretaker will be done at 0 and 6 months after
      completion of the interventions. The 6 month time point is considered the primary time point
      of interest. If one treatment shows substantially greater efficacy at 6 months it will be
      offered to those that received the other intervention and a 12 month assessment will be done
      only with the group originally allocated to the more effective intervention.

      We expect to have 3-4 study contacts with research participants and their caregivers:

        1. Baseline interview

        2. Follow-up at 0 months

        3. Follow-up interview at 6 months

        4. Follow-up interview at 12 months.

      The outcomes for Specific Aim 1 are indicators of HIV risk behaviors. This includes questions
      about social circles engaging in risky sexual behaviors such as multiple sexual partners,
      having sex without a condom, sexually transmitted infections (STIs) and substance use (HIV
      risk assessment screening tool). The WAF instrument will also assess broader HIV risk
      indicators such as knowledge, attitudes, self-efficacy and sexual practices. The outcomes for
      Specific Aim 2 are the scores on various mental health and well-being tests, including Child
      PTSD Symptom Scale (CPSS), Child Behavior Checklist (CBCL), self-perception, Achenbach Youth
      Self Report, ASSIST (substance use), and functionality.

      All primary analyses will be based on an intent-to-treat approach. For all continuous
      outcomes, linear mixed models will model each outcome over time by incorporating a random
      intercept term and possibly a random slope term to account for within subject correlation on
      repeated measures. The test scores at completion of intervention and at 6 and 12 months after
      completion will be modeled separately using treatment arm, baseline symptom score, time, and
      an interaction between each treatment arm and time as fixed covariates in each model. This
      analysis will allow estimation of the mean difference in each symptomatology score between
      the two treatment arms at each time, adjusting for baseline score if needed. Mean differences
      and 95% confidence intervals will be calculated and presented. For dichotomous variables, a
      generalized linear mixed effects models will be used. A risk ratio and 95% confidence
      interval comparing each binary outcome between the two arms at each time will be reported.
      Potential modifiers and mediators will be handled as described below.

      Moderator and mediator analyses: The study will evaluate the impact of hypothesized
      moderators (child age, gender, religion, ethnicity, HIV knowledge and attitudes, family
      formation, education, physical health) on treatment response. We have also hypothesized that
      changes in the course of therapy in caregiver levels of distress and support and changes in
      the child's mental health and self-perception will mediate the impact of treatment on
      children's outcomes.

      All of the significant moderating and mediating variables then will be simultaneously entered
      into multiple regression analyses with respect to the individual outcome measures to
      ascertain which variables contribute unique variance to estimating the outcome variables.
      Significant moderators and mediators will then be tested for specific treatment effects using
      multiple linear-regression analyses. Multiple regression techniques will examine the pattern
      of relationships between treatment, hypothesized mediating influences and outcomes. Using the
      steps suggested by Baron and Kenny, we will examine whether a) each treatment arm
      significantly predicts mediator; b) mediator significantly predicts symptom outcome; and c)
      whether the significant relationship between each treatment condition and symptom outcome
      decreases significantly when the change in mediator is entered into the regression model.

      In addition to primary analyses on the clinical effectiveness of the interventions, we will
      also analyze cost effectiveness and implementation challenges.

      Service use, employment-related and caregiver data will be collected for a retrospective
      period of 3 months at baseline, and at 1 month, 6 months and 12 months post-treatment using a
      version of the Client Service Receipt Inventory adapted for OVC. Service use and carer inputs
      will be turned into cost measures by applying local and national unit cost values.

      We will also monitor and evaluate system implementation factors, including acceptability,
      adoption, appropriateness, feasibility, fidelity, penetration and sustainability from the
      perspective of multiple stakeholders including, providers, organizations and policy leaders.
      Semi-structured interviews will be conducted with these stakeholders to examine perspectives
      on the barriers and facilitators of implementation.
    

Intervention name(s): Trauma-Focused Cognitive Behavioral Therapy; Psychosocial Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We propose using TF-CBT to address stress related problems (SRP) and reduce HIV risk behaviors. OVC lack behavioral and cognitive skills and intention necessary to use the available information and resources to prevent HIV. For example, internalizing problems are related to HIV risk through low self-efficacy, poor assertiveness skills, and reduced ability to negotiate safe sex. Given evidence on the link between abuse/trauma and elevated HIV risk, researchers have called for overlap between evidence-based mental health treatments like TF-CBT and HIV prevention programs. Some studies have found that skills-oriented interventions reduced HIV-risk behaviors among minority and troubled youths. An intervention study using CBT increased condom use and decreased high-risk sexual behaviors among runaway youths in a short-term follow-up evaluation. However, these studies were done in Western countries; their relevance to OVC in Africa is unproven.; The curriculum "Psychosocial Care and Counseling" was developed for HIV Infected Children and Adolescents. The goal is to enable health care providers to provide safe supportive counseling and support services to HIV infected youth and their families. The course materials are designed to be adapted to different cultures and needs. The 14 modules cover child development, family systems, communicating with children, disclosure and adherence and legal/ethical issues. The course teaches basic counseling skills with children such as listening and play. It explores and challenges barriers to care such as caregivers' fear and reluctance to disclose an HIV positive diagnosis to a child, discussing adolescent sexuality, and practical issues such as inadequate legislation governing child rights. The curriculum was adapted for Zambia and endorsed by the MoH.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment