Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being
Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being
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.
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.
Inclusion Criteria:

 -  13-17 year olds

 -  Live in one of the 16 compounds that serve as our study sites (i.e., not staying
 temporarily)

 -  Both OVC and caretaker speak English, Nyanja, or Bemba.

 -  Responses to the screening measure suggest the presence of behaviors that increase
 risk of HIV.

 -  Responds "yes" to one of the study criteria for an orphaned or vulnerable child

 -  Adolescent assents to participate and caregiver provides permission for the adolescent
 to participate as well as consents to his/her own participation in project

 -  This study will also enroll adolescents who do not have a primary caretaker or who
 live in child headed households. In these situations the person that is the caretaker
 has to declare that he/she is the principal caregiver or they have been charged with
 the responsibility of making sure the adolescent receives care. For any child headed
 households or street youth, the ministry of community and social welfare should be
 contacted. In these cases the ministry usually has the adolescent themselves consent
 before they could be involved.

 Exclusion Criteria:

 -  Currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2
 months)

 -  Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past
 month.

 -  A current psychotic disorder (identified by OVC STEPS programming or other sources).

 -  Serious developmental disorder (e.g., mental retardation, autism) that would preclude
 participation in cognitive-behavioral oriented skills intervention