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HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation (PHE)

Primary Purpose

Adolescent Behavior, Risk Reduction Behavior, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Groups (IPTG)
Vhutshilo 2
Sponsored by
Tulane University School of Social Work
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Behavior focused on measuring Orphans and vulnerable children (OVC), Program Evaluation, HIV Prevention, Psychosocial Wellbeing, Adolescents

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 14-17 years old as of January 1, 2012;
  • Enrolled in a selected World Vision site;
  • Willing and able to assent to study participation; and
  • Consent given by the parent or guardian for the adolescent to participate in the study.

Exclusion Criteria:

  • Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Interpersonal Psychotherapy for Groups (IPTG)

    Vhutshilo 2

    IPTG and Vhutshilo

    No Intervention

    Arm Description

    The intervention consists of 16 weekly 60 to 90 minute psychotherapy sessions, implemented once a week by a trained lay facilitator.

    The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator.

    Participants receive the IPTG intervention first, followed by Vhutshilo 2.

    No intervention

    Outcomes

    Primary Outcome Measures

    Change in Sexual Risk Behavior
    Adolescent self-report of key sexual behaviors including age at sexual debut; the number of sexual partners; and whether condoms were used consistently in the last 6 months.
    Change in Depressive Symptoms
    Adolescent self-report of the 20-item Center for Epidemiologic Studies Depression Scale for children (CES-DC). The response options used for the CES-DC are on a 4-point scale (not at all; a little; some; a lot).

    Secondary Outcome Measures

    Change in HIV knowledge
    Adolescent self-report of basic HIV knowledge: 9 items were used to measure general HIV transmission, testing and treatment knowledge. Respondents were asked to agree or disagree with each item. They could also respond with 'don't know'. The first item (testing for HIV) came from the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)'s Asking Young People about Sexual And Reproductive Health (HIV testing). Four items, including transmission by mosquitoes, sharing food, witchcraft, and healthy-looking person with HIV, were from the South African Demographic and Health Survey. Two items were pulled from a previous evaluation of Vhutshilo 2 in South Africa (perinatal transmission, sex with a virgin). Two questions were self-generated to gather knowledge of drug treatment availability and exact location of VCT site.
    Change in Condom Knowledge and Attitudes
    Adolescent self-report of three items assessing condom knowledge and three items assessing condom attitudes. Respondents indicated agree, disagree or don't know for each item. The South Africa DHS provided two condom knowledge items, whether the male condom provides protection from HIV and whether condoms can be washed and reused. The third knowledge item, whether condoms can be used with Vaseline, came from the South Africa and Tanzania project (SATZ) questionnaire. The SATZ questionnaire also provided one of the three items to measure attitudes toward condom use, which is particularly useful for its gendered perspective; the question asks whether it is okay for a girl to suggest condom use to a sexual partner. The other two items assessing attitudes, including embarrassment and trust, are from the Stepping Stone Study men's questionnaire.
    Change in Peer Norms
    Adolescent self-report of three self-generated items with the stem "Many friends your age are…" These items were used to assess peer norms regarding sexual activity, condom use and peer expectations. Respondents indicated agree, disagree or don't know for each item.
    Change in Self-Efficacy
    Adolescent self-report of six items adapted from the SATZ Women's Questionnaire. Using a 4-point Likert scale (very low to very high), they ask "what are the chance you would be able…" regarding condom use (3 items) and refusal to have sex (3 items).
    Change in Social Support
    Evidence suggests that social support is a mediator of depression symptom severity. Four items were used to assess social support (friends and people in your life) using the 4-point scale from the CES-DC (not at all; a little, some, a lot). Adolescent self-report of four items adapted from the Interpersonal Support Evaluation List (ISEL).
    Change in Future Expectations
    Adolescent self-report of six items assessing future expectations. Participants were asked "what are the chances that you will…" fulfill each of six items (marriage, children, secondary school, long life, manage difficulties, job) on a 4-point Likert scale (very low to very high). The items were based on two scales; one is a self-generated scale used in a previous study of OVC in South Africa by the authors and the other is an adapted subscale of the Social and Health Assessment (SAHA) previously used among South African adolescents.
    Change in Alcohol Use
    Adolescent self-report of two items. The SA DHS provided an item to assess alcohol use ever, while frequency of alcohol use (last 6 months) was measured using an item from Transitions study.
    Change in VCT
    Adolescent self report of two items measuring whether the participant has received an HIV test (ever and last six months) were adapted from Transitions and self-generated respectively.
    Change in STI
    Adolescent self report on of sores on or abnormal discharge from their penis/vagina. Symptoms of an STI was measured with one question modified from Transitions.

    Full Information

    First Posted
    March 6, 2015
    Last Updated
    March 10, 2017
    Sponsor
    Tulane University School of Social Work
    Collaborators
    United States Agency for International Development (USAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02386878
    Brief Title
    HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation
    Acronym
    PHE
    Official Title
    The Effectiveness of Two Promising Interventions for Reducing HIV Risk and Improving the Wellbeing of Orphaned and Vulnerable Adolescents in the Eastern Cape of South Africa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tulane University School of Social Work
    Collaborators
    United States Agency for International Development (USAID)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The PHE study is a two-year longitudinal study evaluating two interventions for reducing depression and HIV risk behaviors among highly vulnerable adolescents in the Eastern Cape of South Africa. Research suggests that children affected by AIDS are at heightened risk of HIV infection relative to their peers; however, evidence on how best to address HIV prevention and psychological health among this population is lacking. This study examines the efficacy of both a psychological and behavioral intervention, alone and in combination, on related outcomes among vulnerable youth age 14-17. A mixed methods approach is applied, including a community-randomized controlled trial with a factorial design, a cost-effectiveness analysis, and a qualitative component. At baseline data collection in January 2012, more than 1000 adolescents and their caregivers were interviewed; these participants were invited to take part in two more survey rounds designed to examine both the immediate and long term effects of the interventions. Support for this research was provided by USAID under Grant No. GHH-I-00-007-00069-00.
    Detailed Description
    The study will apply a mixed-methods approach involving two primary components: 1) an impact evaluation using a community-randomized controlled trial (CRCT); and 2) a detailed analysis of intervention costs, linked to the impact evaluation to determine the cost-effectiveness of these interventions. For the CRCT, sixty World Vision drop-in centers which deliver standard care were randomly assigned to one of four study conditions: IPTG, Vhutshilo, IPTG+Vhutshilo, and control. Approximately 1600 adolescent OVC aged 14-17 years (current beneficiaries at the drop-in centers) and their caregivers were eligible to participate in the study at baseline. Participants were visited three times including the baseline survey. Follow-up data collection was conducted in two rounds. The first round took place 8 months after the baseline survey and immediately following intervention exposure. A second follow-up round took place a year later, allowing assessment of both the immediate and longer-term impact of the interventions. Participants were interviewed at home in Xhosa or Sesotho. Caregivers in the sample completed face-to-face interviews with trained interviewers, while adolescents complete surveys used a mix of face-to-face interviewing and audio computer-assisted self-interview technology (ACASI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Behavior, Risk Reduction Behavior, Stress, Psychological
    Keywords
    Orphans and vulnerable children (OVC), Program Evaluation, HIV Prevention, Psychosocial Wellbeing, Adolescents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    2302 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Interpersonal Psychotherapy for Groups (IPTG)
    Arm Type
    Experimental
    Arm Description
    The intervention consists of 16 weekly 60 to 90 minute psychotherapy sessions, implemented once a week by a trained lay facilitator.
    Arm Title
    Vhutshilo 2
    Arm Type
    Experimental
    Arm Description
    The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator.
    Arm Title
    IPTG and Vhutshilo
    Arm Type
    Experimental
    Arm Description
    Participants receive the IPTG intervention first, followed by Vhutshilo 2.
    Arm Title
    No Intervention
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Interpersonal Psychotherapy for Groups (IPTG)
    Intervention Description
    Interpersonal psychotherapy is a theory- and evidence-based treatment approach for depression developed by clinicians. World Vision has helped to pioneer the use of this model in sub-Saharan Africa including adapting the model for use with OVC within South Africa. Sessions are designed to provide participants with opportunities to learn and practice interpersonal skills for solving problems that bring about depression, and to facilitate the provision of emotional support between members of the group. Groups are implemented by a trained adult facilitator from the community who helps participants to identify people who are important in their lives, understand links between their psychological state and current problems, and practice new ways of problem-solving.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vhutshilo 2
    Intervention Description
    The Vhutshilo 2 model was developed in 2008 by the Centre for the Support of Peer Education (CSPE), a branch of the South African non-profit organization Health and Education Training and Technical Assistance Services. The Vhutshilo program was designed specifically for adolescent OVC in South Africa, and attends to risk factors and pathways considered particularly relevant for this population. Topics include finding and giving emotional support; dealing with grief and loss; alcohol and substance abuse; crime and sexual violence; HIV/AIDS; healthy and safe sexual relationships; and transactional sex. In addition to its knowledge component, the program places heavy emphasis on building relevant skills and efficacy.
    Primary Outcome Measure Information:
    Title
    Change in Sexual Risk Behavior
    Description
    Adolescent self-report of key sexual behaviors including age at sexual debut; the number of sexual partners; and whether condoms were used consistently in the last 6 months.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Depressive Symptoms
    Description
    Adolescent self-report of the 20-item Center for Epidemiologic Studies Depression Scale for children (CES-DC). The response options used for the CES-DC are on a 4-point scale (not at all; a little; some; a lot).
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Secondary Outcome Measure Information:
    Title
    Change in HIV knowledge
    Description
    Adolescent self-report of basic HIV knowledge: 9 items were used to measure general HIV transmission, testing and treatment knowledge. Respondents were asked to agree or disagree with each item. They could also respond with 'don't know'. The first item (testing for HIV) came from the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)'s Asking Young People about Sexual And Reproductive Health (HIV testing). Four items, including transmission by mosquitoes, sharing food, witchcraft, and healthy-looking person with HIV, were from the South African Demographic and Health Survey. Two items were pulled from a previous evaluation of Vhutshilo 2 in South Africa (perinatal transmission, sex with a virgin). Two questions were self-generated to gather knowledge of drug treatment availability and exact location of VCT site.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Condom Knowledge and Attitudes
    Description
    Adolescent self-report of three items assessing condom knowledge and three items assessing condom attitudes. Respondents indicated agree, disagree or don't know for each item. The South Africa DHS provided two condom knowledge items, whether the male condom provides protection from HIV and whether condoms can be washed and reused. The third knowledge item, whether condoms can be used with Vaseline, came from the South Africa and Tanzania project (SATZ) questionnaire. The SATZ questionnaire also provided one of the three items to measure attitudes toward condom use, which is particularly useful for its gendered perspective; the question asks whether it is okay for a girl to suggest condom use to a sexual partner. The other two items assessing attitudes, including embarrassment and trust, are from the Stepping Stone Study men's questionnaire.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Peer Norms
    Description
    Adolescent self-report of three self-generated items with the stem "Many friends your age are…" These items were used to assess peer norms regarding sexual activity, condom use and peer expectations. Respondents indicated agree, disagree or don't know for each item.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Self-Efficacy
    Description
    Adolescent self-report of six items adapted from the SATZ Women's Questionnaire. Using a 4-point Likert scale (very low to very high), they ask "what are the chance you would be able…" regarding condom use (3 items) and refusal to have sex (3 items).
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Social Support
    Description
    Evidence suggests that social support is a mediator of depression symptom severity. Four items were used to assess social support (friends and people in your life) using the 4-point scale from the CES-DC (not at all; a little, some, a lot). Adolescent self-report of four items adapted from the Interpersonal Support Evaluation List (ISEL).
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Future Expectations
    Description
    Adolescent self-report of six items assessing future expectations. Participants were asked "what are the chances that you will…" fulfill each of six items (marriage, children, secondary school, long life, manage difficulties, job) on a 4-point Likert scale (very low to very high). The items were based on two scales; one is a self-generated scale used in a previous study of OVC in South Africa by the authors and the other is an adapted subscale of the Social and Health Assessment (SAHA) previously used among South African adolescents.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in Alcohol Use
    Description
    Adolescent self-report of two items. The SA DHS provided an item to assess alcohol use ever, while frequency of alcohol use (last 6 months) was measured using an item from Transitions study.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in VCT
    Description
    Adolescent self report of two items measuring whether the participant has received an HIV test (ever and last six months) were adapted from Transitions and self-generated respectively.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Change in STI
    Description
    Adolescent self report on of sores on or abnormal discharge from their penis/vagina. Symptoms of an STI was measured with one question modified from Transitions.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Other Pre-specified Outcome Measures:
    Title
    Demographic Information
    Description
    Adolescent self-report of age. Caregiver report of age, marriage status, education level, and relationship to adolescent. Interviewer observation of race and gender
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Adolescent Education
    Description
    Current attendance and grade level were measured using items modified from the SA DHS. A self-generated question was used to measure school absenteeism.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Adolescent Health
    Description
    Adolescent self-report of five items measuring health. Self-rated health was measured using question G1.2 of the World Health Organization's Quality of Life-100 instrument (WHOQOL-100). Morbidity, including illnesses common to South Africa was measured using an abbreviated scale from The Young Carers Project South Africa survey.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Traumatic Events
    Description
    Adolescent self-report of personal experience with HIV (experience and relationship to someone infected with or deceased from HIV/AIDS); emotional maltreatment in the home; and bullying/social isolation (how often other kids make fun of the youth). Caregiver report of adolescent's contact with parents; parental illness and death (including AIDS-specific verbal autopsy); and household illness and deaths burden in last year (including economic impact)
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Caregiver Health
    Description
    Self-rated health and a modified AIDS-specific verbal autopsy
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Caregiver Psychological Health
    Description
    Caregiver self-report of depressive symptomology using the the Center for Epidemiological Studies Depression 10 item scale (CESD-10)
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Caregiver Social Relationships
    Description
    Caregiver self-report of items measuring Social support; Caregiving burden for orphans and for ill household members; Perceived community stigma; and monitoring of adolescent behavior.
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention
    Title
    Caregiver HIV Knowledge, Attitudes and Communication
    Description
    Caregiver self-report of items measuring HIV transmission methods; Rejection of major HIV misconceptions; Attitudes towards sex and reproductive health education; and communication with adolescent pertaining to sexuality and HIv
    Time Frame
    Baseline, 0 months post-intervention, 12 months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 14-17 years old as of January 1, 2012; Enrolled in a selected World Vision site; Willing and able to assent to study participation; and Consent given by the parent or guardian for the adolescent to participate in the study. Exclusion Criteria: Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tonya R Thurman, MPH PhD
    Organizational Affiliation
    Tulane University School of Social Work
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32680417
    Citation
    Thurman TR, Nice J, Taylor TM, Luckett B. Mitigating depression among orphaned and vulnerable adolescents: a randomized controlled trial of interpersonal psychotherapy for groups in South Africa. Child Adolesc Ment Health. 2017 Nov;22(4):224-231. doi: 10.1111/camh.12241. Epub 2017 Sep 26.
    Results Reference
    derived

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    HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation

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