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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02386878
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Tonya Renee Thurman, Tulane University School of Social Work

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.

Condition or disease Intervention/treatment Phase
Adolescent Behavior Risk Reduction Behavior Stress, Psychological Behavioral: Interpersonal Psychotherapy for Groups (IPTG) Behavioral: Vhutshilo 2 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2302 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Interpersonal Psychotherapy for Groups (IPTG)
The intervention consists of 16 weekly 60 to 90 minute psychotherapy sessions, implemented once a week by a trained lay facilitator.
Behavioral: Interpersonal Psychotherapy for Groups (IPTG)
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.

Experimental: Vhutshilo 2
The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator.
Behavioral: Vhutshilo 2
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.

Experimental: IPTG and Vhutshilo
Participants receive the IPTG intervention first, followed by Vhutshilo 2.
Behavioral: Interpersonal Psychotherapy for Groups (IPTG)
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.

Behavioral: Vhutshilo 2
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.

No Intervention: No Intervention
No intervention



Primary Outcome Measures :
  1. Change in Sexual Risk Behavior [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  2. Change in Depressive Symptoms [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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 :
  1. Change in HIV knowledge [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  2. Change in Condom Knowledge and Attitudes [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  3. Change in Peer Norms [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  4. Change in Self-Efficacy [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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).

  5. Change in Social Support [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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).

  6. Change in Future Expectations [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  7. Change in Alcohol Use [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  8. Change in VCT [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  9. Change in STI [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.


Other Outcome Measures:
  1. Demographic Information [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    Adolescent self-report of age. Caregiver report of age, marriage status, education level, and relationship to adolescent. Interviewer observation of race and gender

  2. Adolescent Education [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    Current attendance and grade level were measured using items modified from the SA DHS. A self-generated question was used to measure school absenteeism.

  3. Adolescent Health [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  4. Traumatic Events [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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)

  5. Caregiver Health [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    Self-rated health and a modified AIDS-specific verbal autopsy

  6. Caregiver Psychological Health [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    Caregiver self-report of depressive symptomology using the the Center for Epidemiological Studies Depression 10 item scale (CESD-10)

  7. Caregiver Social Relationships [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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.

  8. Caregiver HIV Knowledge, Attitudes and Communication [ Time Frame: Baseline, 0 months post-intervention, 12 months post intervention ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02386878


Sponsors and Collaborators
Tulane University School of Social Work
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Tonya R Thurman, MPH PhD Tulane University School of Social Work
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tonya Renee Thurman, Principle Investigator, Tulane University School of Social Work
ClinicalTrials.gov Identifier: NCT02386878    
Other Study ID Numbers: PHE# ZA.09.0257
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Tonya Renee Thurman, Tulane University School of Social Work:
Orphans and vulnerable children (OVC)
Program Evaluation
HIV Prevention
Psychosocial Wellbeing
Adolescents
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms