Theory-based HIV Disclosure Intervention for Parents (ICOPE)
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|ClinicalTrials.gov Identifier: NCT04051177|
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Disclosure||Behavioral: Interactive Communication with Openness, Passion, and Empowerment "ICOPE" Behavioral: Nutrition Curriculum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||791 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Theory-based HIV Disclosure Intervention for Parents|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||December 2018|
Experimental: parents living with HIV intervention group
Parents living with HIV in this group received five two-hour parent HIV disclosure intervention, delivered one session per week for five weeks in the clinics where the parents are recruited. The intervention curriculum is modeled after the TRACK program with supplemental materials from TALC.
Behavioral: Interactive Communication with Openness, Passion, and Empowerment "ICOPE"
The parent curriculum consists of five interactive training sessions (120 minutes each session for 10 hours total) with three specific focuses: understanding the stages of childhood cognitive development in the context of parental illness (Session #1 "Child's readiness for disclosure"); improving the parents' cognitive and behavioral skills related to parental HIV disclosure (Session #2 "Benefits and risks of disclosure", Session #3 "How to tell and what to tell", and Session #4 "Disclosure is an ongoing process"); and improving parental psychosocial well-being in adapting to living with HIV/AIDS (Session #5 "Cope with my infection/illness"). The curriculum addresses the issues of child and family strengths and community support across sessions.
Parents living with HIV control group
Parents living with HIV in this group received five two-hour nutrition education curriculum in same delivery way. The nutrition curriculum is modeled after the "Simply Good Eating: curriculum developed at University of Minnesota.
Behavioral: Nutrition Curriculum
The modified curriculum consists of five 2-hour interactive training sessions with aims to increase parents' knowledge of nutrition (Session #1: Food variety; Session #2: Food for growing child), healthy diets and cooking practice (Session 3: Fat, salt and sugar; Session 4: Fruits, vegetables and minerals), and food safety (Session #5 "Food safety")
- number of participants who have disclosed their HIV serostatus to their children assessed by one question in the survey [ Time Frame: from baseline to 36 month follow-up ]question in questionnaire "have you disclosed your HIV serostatus to your children"?
- participants' stage status regarding parental disclosure assessed by one question in the survey with 6 stages (see description) [ Time Frame: from baseline to 36 month follow-up ]question in questionnaire "what stage status are you in now regarding disclosing your status to your children" 1 = "having not started disclosure in the past 6 months and no intention to start", 2 = "having not started disclosure in the past 6 months but is intending to start", 3 = "having not started disclosure in the past 6 months but already made a plan", 4 = "started disclosing but not mentioning HIV", 5 = "started disclosing with the word HIV", and 6 = "started disclosing with the word HIV and how I got infected".
- depression [ Time Frame: from baseline to 36 month follow-up ]The Center for Epidemiologic Studies Depression Scale. Depression is measured using the Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) with a 4-point ordinal response: 0 = rarely or none of the time (less than 1 day); 1 = some or a little of the time (1-2 days); 2 = occasionally or a moderate amount of the time (3-4 days); 3 = most or all of the time (5-7 days). A summary score of all 10 items is calculated with higher scores indicating higher levels of depression. The summary score ranges between 0 to 30, and a score of 10 or greater is considered depressed.
- stress [ Time Frame: from baseline to 36 month follow-up ]Perceived Stress Scale. Perceived stress is assessed using 14 items from the perceived stress scales (PSS) with a 5-point responses option (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). A composite score was calculated by summing all 14 item responses. The composite score ranges between 0 to 56, and Higher scores indicating a higher level of perceived stress.
- tobacco use [ Time Frame: from baseline to 36 month follow-up ]tobacco use
- alcohol use [ Time Frame: from baseline to 36 month follow-up ]alcohol use
- drug use [ Time Frame: from baseline to 36 month follow-up ]drug use
- condom use in sexual intercourse [ Time Frame: from baseline to 36 month follow-up ]condom use
- quality of life of people living with HIV [ Time Frame: from baseline to 36 month follow-up ]The Medical Outcomes Study HIV Health Survey is composed of 35 items with 3, 5, and 6-point likert-type scale and dichotomous yes/no. 11 of the 35 items in the survey require recoding. Item scores are linearly transformed to a 0-100 scale with higher score indicating a higher level of quality of life.
- most recent CD4 count [ Time Frame: from baseline to 36 month follow-up ]most recent CD4 count
- most recent viral load [ Time Frame: from baseline to 36 month follow-up ]most recent viral load
- disease progression [ Time Frame: from baseline to 36 month follow-up ]disease progression using the HIV staging system by WHO
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051177
|United States, South Carolina|
|University of South Carolina|
|Columbia, South Carolina, United States, 29208|