Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being

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.