Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being
|First Received Date ICMJE||September 17, 2013|
|Last Updated Date||June 4, 2014|
|Start Date ICMJE||February 2014|
|Estimated Primary Completion Date||May 2016 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Change in HIV Risk Behavior as measured by the World Aids Foundation (WAF) survey [ Time Frame: Baseline, 0 months post-intervention, 6-months post-intervention, 12 months post-intervention ] [ Designated as safety issue: No ]
The primary outcome is reported HIV risk behaviors, primarily those related to risky sexual behaviors
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT02054780 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Randomized Controlled Trial of Ways to Improve OVC HIV Prevention and Well-being|
|Official Title ICMJE||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 and Trauma-Focused Cognitive Behavioral Therapy, in addressing outcomes of orphans and vulnerable children 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 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: In the first part of this study, the research staff will ask Home Based Care Workers (HBCWs) of the Archdiocese of Lusaka (our partnering organization) to introduce the study to families under their care. This visit can take place during the regularly scheduled home visits conducted by the HBCWs. Research staff will ask the 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. If, however, the adolescent and caretaker indicate to the HBCW that they are interested in hearing more about the study, the HBCW will note their interest and schedule a follow-up appointment in which they will return to the home with one of our study assessors.
Each of the study assessors (interviewers; 4-10) will then go with an HBCW to the families' homes that indicated interest in the study. The assessors will present the consent forms, and if the caregiver and child respond yes to the consent, they 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. Most assessors should be able to complete the screening and assessment procedures for all 3-7 families expected from each HBCW in one week. If a particular HBCW has a high number of families (>=9) under their care who are interested, then an additional week of assessments may be necessary. The HBCW will not be present during the consent or assessment process.
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 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 sequential study number to the adolescent. At this time, the assessor will ask the adolescent and caregiver if they are able to complete the assessment battery at this time, or if they prefer to set up another day/time to complete it. 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. The results will be tabulated and checked at the main office, with the locally based project director allocating group assignments (based on a pre-determined random sequence number order sent by U.S. based PIs), and assigning counselors to families. Both interventions will be available at all study sites. Neither assessor, caretaker, nor adolescent will know which intervention the adolescent will receive.
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.
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 the PIs who retain the confidential master list linking study IDs to interventions based on random assignment (see below). She 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.
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, VCT, Community Sensitization Campaigns, Behavioral Change, livelihood support, TB 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 will 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. If one treatment shows substantially greater efficacy at 6 months it will be offered to those that received the other intervention and the 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:
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||750|
|Estimated Completion Date||May 2016|
|Estimated Primary Completion Date||May 2016 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||13 Years to 17 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Zambia|
|NCT Number ICMJE||NCT02054780|
|Other Study ID Numbers ICMJE||5R01HD070720|
|Has Data Monitoring Committee||No|
|Responsible Party||Johns Hopkins Bloomberg School of Public Health|
|Study Sponsor ICMJE||Johns Hopkins Bloomberg School of Public Health|
|Collaborators ICMJE||Catholic Relief Services, Zambia|
|Information Provided By||Johns Hopkins Bloomberg School of Public Health|
|Verification Date||April 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP