HIV InfectionNCT02921516
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
A study testing N'ap Grandi, N'ap Grandi - A and Health Promotion - A in people with HIV Infection, run by Florida International University at 1 site in Haiti.
Trial summary
Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle income countries, both have risen among youth. In addition, HIV-infected youth achieve inferior treatment outcomes compared to their adult counterparts in both high- and low-income countries, and these poorer outcomes are… Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- N'ap Grandi, N'ap Grandi - A and Health Promotion - A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteHaiti
- Study dates
- Sep 2016to May 2018
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- youth aged 15-19 years receiving 1st-line ART for at least 3 months;
- exhibiting risk factors of detectable Viral Load and/or unprotected vaginal/anal intercourse in the previous 6 months;
- fluent in spoken Haitian Creole which is required to complete assessments and to participate in the intervention groups;
- willing to a) assent to study participation if under 18, and b) having a parent or caregiver aged >18 years provide informed consent and participate in the caregiver workshops.
Who cannot join
- cognitively impaired, as determined by the Test of Nonverbal Intelligence (TONI), since such impairment may compromise the ability to comprehend and participate in the assessment and intervention;
- exhibits bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle income countries, both have risen among youth. In addition, HIV-infected youth achieve inferior treatment outcomes compared to their adult counterparts in both high- and low-income countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus, there is a critical need for the development of adherence and risk reduction interventions for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is one such intervention.
Read the detailed description
As pediatric HIV infection has shifted from being a fatal disease to a chronic illness, a growing cohort of young people are moving through adolescence with all the challenges of the adult HIV-infected population but largely without comparable treatment outcomes or an evidence base to improve adherence to antiretroviral treatment (ART) and preventive behavior. Despite overall declines in HIV incidence and mortality since the ART scale-up, both have risen among youth. The goal of the proposed 3-year R34 developmental study is to respond to this need for tailored research, in particular among HIV+ older adolescents, and contribute to understanding the added value in resource-limited settings of including caregivers in an adherence and risk reduction program. Although caregiver involvement is a recognized correlate of outcomes in HIV+ youth, there are no rigorous studies of the role of caregivers in outcomes among HIV+ older adolescents.This project will integrate caregiver involvement and cognitive behavioral intervention (CBI) elements to improve ART adherence and HIV risk reduction for HIV+ older adolescents treated in resource-poor clinical settings.Our proposed study population will include caregivers and 15 to 19 year-old HIV+ youth who know their status and are receiving ART in Port-au-Prince, Haiti. Guided by the theoretical framework of the developmentally sensitive Information-Motivation-Behavioral Skills for Pediatric Adherence (IMB-PED), we will develop Growing Up (N'ap Grandi, in Haitian Creole) as a collaborative model of caregiver-adolescent engagement in the key informational, motivational, and behavioral skills antecedents of ART adherence and risk reduction. The study will utilize qualitative and quantitative methods to: identify barriers and facilitators to adherence and risk reduction (Aim 1); develop and pretest N'ap Grandi, including developmentally-appropriate manuals, training materials, procedures, and psychometric adequacy of measures (Aim 2); and assess feasibility and preliminary efficacy in a 3-arm randomized controlled trial (RCT), in which 120 youth will be assigned to three groups: the experimental caregiver-adolescent N'ap Grandi, an adolescent-only version (N'ap Grandi-A) and an adolescent-only health promotion group (HP-A), examining ART adherence and virologic response, HIV risk behaviors, positive communication and monitoring, stress and mood, and costs from the health center perspective (Aim 3).
- Conditions
- HIV Infection
- Being tested
- N'ap Grandi, N'ap Grandi - A, Health Promotion - A
- Keywords
- Adolescence, Adherence
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N'ap GrandiBehavioural
Eight 90-minute adolescent cognitive behavioral modules and four 90-minute caregiver cognitive behavioral modules, delivered in weekend workshops over a 1 month period, with the last two modules for joint participation of adolescents and caregivers.
N'ap Grandi - ABehavioural
Eight 90-minute adolescent cognitive behavioral modules delivered in weekend workshops over a 1 month period.
Health Promotion - ABehavioural
Eight 90-minute adolescent health promotion modules delivered in weekend workshops over a 1 month period.
| Study group | Role | What they receive |
|---|---|---|
| N'ap Grandi | Experimental | Both Adolescent and Caregiver participate in assessment and intervention groups. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. Receives: Behavioral: N'ap Grandi |
| N'ap Grandi - A | Active comparator | Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. Receives: Behavioral: N'ap Grandi - A |
| Health Promotion - A | Placebo comparator | Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. Receives: Behavioral: Health Promotion - A |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART Adherence and response
Data from self report questionnaire (percent medications taken), medication possession ratio (percent completed), and virologic suppression (percent improvement) will be aggregated into a composite measure of adherence.
Measured: 6 months
Secondary outcomes (4)
HIV sexual transmission risk reduction
Increase in self-reported safer sex behavior via questionnaire
Measured: 6 months
Caregiver supportive communication
Increase in self-reported positive caregiver-adolescent communication and monitoring via questionnaire
Measured: 6 months
Psychosocial health
Improvement in self-reported stress and mood via questionnaire
Measured: 6 months
Cost of intervention from the health center perspective
Provide data on the economic feasibility of broader scale up of these interventions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jessy g devieux, Florida International University
- Investigators
- Jessy G. Dévieux, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921516
- Sponsor's protocol ID
- NIMH R34MH107335
- Status last verified
- Jul 2018
- First submitted
- 24 Sep 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
- ClinicalTrials.gov ID
- NCT02921516
- Acronym / sponsor ID
- NIMH R34MH107335
- Conditions
- HIV Infection
- Keywords
- Adolescence, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Oct 2016 (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.
Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle income countries, both have risen among youth. In addition, HIV-infected youth achieve inferior treatment outcomes compared to their adult counterparts in both high- and low-income countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus, there is a critical need for the development of adherence and risk reduction interventions for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is one such intervention.
Detailed description
As pediatric HIV infection has shifted from being a fatal disease to a chronic illness, a growing cohort of young people are moving through adolescence with all the challenges of the adult HIV-infected population but largely without comparable treatment outcomes or an evidence base to improve adherence to antiretroviral treatment (ART) and preventive behavior. Despite overall declines in HIV incidence and mortality since the ART scale-up, both have risen among youth. The goal of the proposed 3-year R34 developmental study is to respond to this need for tailored research, in particular among HIV+ older adolescents, and contribute to understanding the added value in resource-limited settings of including caregivers in an adherence and risk reduction program. Although caregiver involvement is a recognized correlate of outcomes in HIV+ youth, there are no rigorous studies of the role of caregivers in outcomes among HIV+ older adolescents.This project will integrate caregiver involvement and cognitive behavioral intervention (CBI) elements to improve ART adherence and HIV risk reduction for HIV+ older adolescents treated in resource-poor clinical settings.Our proposed study population will include caregivers and 15 to 19 year-old HIV+ youth who know their status and are receiving ART in Port-au-Prince, Haiti. Guided by the theoretical framework of the developmentally sensitive Information-Motivation-Behavioral Skills for Pediatric Adherence (IMB-PED), we will develop Growing Up (N'ap Grandi, in Haitian Creole) as a collaborative model of caregiver-adolescent engagement in the key informational, motivational, and behavioral skills antecedents of ART adherence and risk reduction. The study will utilize qualitative and quantitative methods to: identify barriers and facilitators to adherence and risk reduction (Aim 1); develop and pretest N'ap Grandi, including developmentally-appropriate manuals, training materials, procedures, and psychometric adequacy of measures (Aim 2); and assess feasibility and preliminary efficacy in a 3-arm randomized controlled trial (RCT), in which 120 youth will be assigned to three groups: the experimental caregiver-adolescent N'ap Grandi, an adolescent-only version (N'ap Grandi-A) and an adolescent-only health promotion group (HP-A), examining ART adherence and virologic response, HIV risk behaviors, positive communication and monitoring, stress and mood, and costs from the health center perspective (Aim 3).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N'ap Grandi | Experimental | Behavioral: N'ap GrandiBoth Adolescent and Caregiver participate in assessment and intervention groups. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. |
| N'ap Grandi - A | Active comparator | Behavioral: N'ap Grandi - AAdolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. |
| Health Promotion - A | Placebo comparator | Behavioral: Health Promotion - AAdolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- youth aged 15-19 years receiving 1st-line ART for at least 3 months;
- exhibiting risk factors of detectable Viral Load and/or unprotected vaginal/anal intercourse in the previous 6 months;
- fluent in spoken Haitian Creole which is required to complete assessments and to participate in the intervention groups;
- willing to a) assent to study participation if under 18, and b) having a parent or caregiver aged >18 years provide informed consent and participate in the caregiver workshops.
Key exclusion criteria (2 listed)
- cognitively impaired, as determined by the Test of Nonverbal Intelligence (TONI), since such impairment may compromise the ability to comprehend and participate in the assessment and intervention;
- exhibits bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization.
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 |
|---|---|---|
| N'ap GrandiEight 90-minute adolescent cognitive behavioral modules and four 90-minute caregiver cognitive behavioral modules, delivered in weekend workshops over a 1 month period, with the last two modules for joint participation of adolescents and caregivers. | Behavioural | N'ap Grandi |
| N'ap Grandi - AEight 90-minute adolescent cognitive behavioral modules delivered in weekend workshops over a 1 month period. | Behavioural | N'ap Grandi - A |
| Health Promotion - AEight 90-minute adolescent health promotion modules delivered in weekend workshops over a 1 month period. | Behavioural | Health Promotion - A |
Primary outcome
ART Adherence and response
Time frame: 6 months
Data from self report questionnaire (percent medications taken), medication possession ratio (percent completed), and virologic suppression (percent improvement) will be aggregated into a composite measure of adherence.
4 secondary outcomes
HIV sexual transmission risk reduction
Time frame: 6 months
Caregiver supportive communication
Time frame: 6 months
Psychosocial health
Time frame: 6 months
Cost of intervention from the health center perspective
Time frame: 6 months
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 11 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Jessy G. Dévieux, Ph.D. principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N'ap Grandi, N'ap Grandi - A and Health Promotion - A in people with HIV Infection, run by Florida International University at 1 site in Haiti.
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 2 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
ART Adherence and response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2018.