Adolescent BehaviorPHENCT02386878
HIV/AIDS Orphaned and Vulnerable Children Public Health Evaluation
A study testing Interpersonal Psychotherapy for Groups (IPTG) and Vhutshilo 2 in people with Adolescent Behavior and Risk Reduction Behavior, run by Tulane University School of Social Work.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Adolescent Behavior, Risk Reduction Behavior, Stress, Psychological
- What is being tested?
- Interpersonal Psychotherapy for Groups (IPTG) and Vhutshilo 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,302 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.
About this study
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
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.
Read the 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).
- Being tested
- Interpersonal Psychotherapy for Groups (IPTG), Vhutshilo 2
- Keywords
- Orphans and vulnerable children (OVC), Program Evaluation, HIV Prevention, Psychosocial Wellbeing, Adolescents
- Medical subject headings
- Adolescent Behavior, Risk Reduction Behavior, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Groups (IPTG)Behavioural
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.
Vhutshilo 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy for Groups (IPTG) | Experimental | The intervention consists of 16 weekly 60 to 90 minute psychotherapy sessions, implemented once a week by a trained lay facilitator. Receives: Behavioral: Interpersonal Psychotherapy for Groups (IPTG) |
| Vhutshilo 2 | Experimental | The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator. Receives: Behavioral: Vhutshilo 2 |
| IPTG and Vhutshilo | Experimental | Participants receive the IPTG intervention first, followed by Vhutshilo 2. Receives: Behavioral: Interpersonal Psychotherapy for Groups (IPTG); Behavioral: Vhutshilo 2 |
| No Intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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).
Measured: Baseline, 0 months post-intervention, 12 months post intervention
Secondary outcomes (9)
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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).
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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).
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
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.
Measured: Baseline, 0 months post-intervention, 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Social Work
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Tonya Renee Thurman, Tulane University School of Social Work
- Investigators
- Tonya R Thurman, MPH PhD, Principal investigator, Tulane University School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386878
- Sponsor's protocol ID
- PHE# ZA.09.0257
- Acronym
- PHE
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32680417
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02386878
- Acronym / sponsor ID
- PHE / PHE# ZA.09.0257
- Keywords
- Orphans and vulnerable children (OVC), Program Evaluation, HIV Prevention, Psychosocial Wellbeing, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,302 participants (actual)
- Lead sponsor
- Tulane University School of Social WorkUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy for Groups (IPTG) | Experimental | Behavioral: 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. |
| Vhutshilo 2 | Experimental | Behavioral: Vhutshilo 2The intervention consists of 13 group sessions, implemented once a week by a trained lay facilitator. |
| IPTG and Vhutshilo | Experimental | Behavioral: Interpersonal Psychotherapy for Groups (IPTG), Behavioral: Vhutshilo 2Participants receive the IPTG intervention first, followed by Vhutshilo 2. |
| No Intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | IPTG and Vhutshilo, Interpersonal Psychotherapy for Groups (IPTG) |
| Vhutshilo 2The 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. | Behavioural | IPTG and Vhutshilo, Vhutshilo 2 |
Primary outcome
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.
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).
9 secondary outcomes
Change in HIV knowledge
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Condom Knowledge and Attitudes
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Peer Norms
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Self-Efficacy
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Social Support
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Future Expectations
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in Alcohol Use
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in VCT
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Change in STI
Time frame: Baseline, 0 months post-intervention, 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 32680417Thurman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonya R Thurman, MPH PhD principal investigator
Tulane University School of Social Work
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy for Groups (IPTG) and Vhutshilo 2 in people with Adolescent Behavior and Risk Reduction Behavior, run by Tulane University School of Social Work.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Risk Behavior (time frame: Baseline, 0 months post-intervention, 12 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.