HIVADAPTNCT02872805
Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study
A study testing Peer Transition Advocate (PTA) in people with HIV and AIDS, run by University of Maryland, Baltimore at 1 site in Nigeria.
Trial summary
One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- What is being tested?
- Peer Transition Advocate (PTA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Nov 2019to 21 Dec 2023
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected patients between the ages of 16-19 years of age
- Patients who have been in care at the study site facility for a minimum of 1 year
- Patients who plan to transition their HIV care to one of the selected study sites
- Patients who are able to provide informed consent
Who cannot join
- HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
- Patients planning to transition their HIV care outside the selected study facilities
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Institute of Human Virology, Nigeria
Abuja, Federal Capital Territory
About this study
One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. The Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the ART continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.
Read the detailed description
The specific aims of ADAPT are: 1. To inform strategies for transition services in resource-limited settings; 2. To examine the developmental, clinical, and other factors that predict a successful transition; and, 3. To gain fundamental insight on implementation barriers among African adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups including: Adolescent patients, parents and health care providers. To address aim 2, the investigators will conduct a cluster randomized clinical trial. The two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. The investigators will enroll 300 patients (150 patients in each arm). The sites will be assigned to either the intervention arm or a control arm. The primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. Secondary outcomes, as recommended by focus group participants will also be measured. To examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a Generalized Estimating Equation (GEE) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. The finding from this study will guide institution of best practices for transitioning adolescents in Nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.
- Being tested
- PEPFAR Enhanced Standard of Care (PESCA), Peer Transition Advocate (PTA)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPFAR Enhanced Standard of Care (PESCA)Other
Also called Enhanced Standard of Care
Standardized materials will be provided to PEPFAR supported clinical sites to assist clinic teams with supporting patients in the transition from pediatric to adult medical care
Peer Transition Advocate (PTA)Behavioural
The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues.
| Study group | Role | What they receive |
|---|---|---|
| PEPFAR Enhanced Standard of Care (PESCA) | Active comparator | This arm reflects an enhanced standard of care comparison group for PEPFAR supported sites. We will provide standardized materials to be used by current clinical staff to help support whatever the site specific activities are related to transition from pediatric to adult medical care Receives: Other: PEPFAR Enhanced Standard of Care (PESCA) |
| Peer Transition Advocate (PTA) | Experimental | The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues. Receives: Behavioral: Peer Transition Advocate (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful transition
ADAPT focuses on a service primary outcome, successful transition, which is defined as two consecutive kept appointments at the designated adult clinic within 9 months of transition
Measured: 9 months after transition occurs
Viral load suppression
viral load (VL)<400 at 12 months post-transition
Measured: 12 months after transition occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start1 Nov 2019
- Primary completion20 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicki Tepper, University of Maryland, Baltimore
- Investigators
- Vicki J Tepper, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872805
- Sponsor's protocol ID
- HP-00070099
- Acronym
- ADAPT
- Status last verified
- Dec 2023
- First submitted
- 16 Aug 2016
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study
- ClinicalTrials.gov ID
- NCT02872805
- Acronym / sponsor ID
- ADAPT / HP-00070099
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 19 Aug 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.
One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. The Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the ART continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.
Detailed description
The specific aims of ADAPT are: 1. To inform strategies for transition services in resource-limited settings; 2. To examine the developmental, clinical, and other factors that predict a successful transition; and, 3. To gain fundamental insight on implementation barriers among African adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups including: Adolescent patients, parents and health care providers. To address aim 2, the investigators will conduct a cluster randomized clinical trial. The two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. The investigators will enroll 300 patients (150 patients in each arm). The sites will be assigned to either the intervention arm or a control arm. The primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. Secondary outcomes, as recommended by focus group participants will also be measured. To examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a Generalized Estimating Equation (GEE) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. The finding from this study will guide institution of best practices for transitioning adolescents in Nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEPFAR Enhanced Standard of Care (PESCA) | Active comparator | Other: PEPFAR Enhanced Standard of Care (PESCA)This arm reflects an enhanced standard of care comparison group for PEPFAR supported sites. We will provide standardized materials to be used by current clinical staff to help support whatever the site specific activities are related to transition from pediatric to adult medical care |
| Peer Transition Advocate (PTA) | Experimental | Behavioral: Peer Transition Advocate (PTA)The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV infected patients between the ages of 16-19 years of age
- Patients who have been in care at the study site facility for a minimum of 1 year
- Patients who plan to transition their HIV care to one of the selected study sites
- Patients who are able to provide informed consent
Key exclusion criteria (2 listed)
- HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
- Patients planning to transition their HIV care outside the selected study facilities
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 |
|---|---|---|
| PEPFAR Enhanced Standard of Care (PESCA)Also: Enhanced Standard of CareStandardized materials will be provided to PEPFAR supported clinical sites to assist clinic teams with supporting patients in the transition from pediatric to adult medical care | Other | PEPFAR Enhanced Standard of Care (PESCA) |
| Peer Transition Advocate (PTA)The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues. | Behavioural | Peer Transition Advocate (PTA) |
Primary outcome
Successful transition
Time frame: 9 months after transition occurs
ADAPT focuses on a service primary outcome, successful transition, which is defined as two consecutive kept appointments at the designated adult clinic within 9 months of transition
Viral load suppression
Time frame: 12 months after transition occurs
viral load (VL)<400 at 12 months post-transition
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 22 Dec 2023.
- 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.
Vicki J Tepper, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Transition Advocate (PTA) in people with HIV and AIDS, run by University of Maryland, Baltimore at 1 site in Nigeria.
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 22 Dec 2023. 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 Nigeria. 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. 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?
Successful transition (time frame: 9 months after transition occurs). 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?
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 22 Dec 2023.