HIV/AIDSA4ANCT04432571
ADAPT for Adolescents Adolescents
A study testing SOC-REC/SOC-OIC, SOC-REC/CCT and SOC-REC/IP-NAV in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Kenya.
Trial summary
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines)… Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- SOC-REC/SOC-OIC, SOC-REC/CCT and SOC-REC/IP-NAV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteKenya
- Study dates
- 6 Apr 2021to 31 Dec 2025
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-infection, on or initiating ART,
- 14-24 years of age,
- Living > 6 months in Kisumu County, Kenya in previous year,
- Capable of informed consent (> 18 years) or with a legal caregiver available for consent (14-<18 years),
- Access to a cell phone,
- Ability to read or be read short message service (SMS) messages,
Show all 9Show fewer
- Willingness to be contacted by clinic upon missed appointment,
- For AYA who report phone sharing must have disclosed to the person sharing the phone.
- Additionally, we will include AYA who are aware of their HIV status or whose caregivers agree to assisted disclosure.
Who cannot join
- AYA who participated in ADAPT-R,
- Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization,
- Those who report sharing phones but have not disclosed to the person sharing the phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.
Read the detailed description
While the global response to HIV has reached close to 20 million persons with life-saving antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense barriers to adherence and retention. The investigators will utilize a SMART study design in two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in retention, medication pick up and viral suppression) will be maintained on these low-intensity interventions, whereas those who fail will be re-randomized a second time to one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1) for prevention: lapse in engagement or viral non-suppression following current MOH guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and (3) across six strategies: sustained viral suppression and sustained engagement in care at two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to detect a 15% difference in the primary outcome between intervention groups. The investigators believe this study will yield evidence specific to AYA with HIV, quantify the relative magnitude of different sequenced interventions, capture the costs, and have direct relevance for public health programming to end the AIDS epidemic through engaging adolescents and young adults with HIV.
- Conditions
- HIV/AIDS
- Being tested
- SOC-REC/SOC-OIC, SOC-REC/CCT, SOC-REC/IP-NAV, E-NAV/SOC-OIC, E-NAV/CCT
- Keywords
- Adolescents, Retention, Engagement in Care, Lost to follow-up, Kenya, Adaptive strategies, Sequentially randomized trial, Sequential Multiple Assignment Randomized Trial
- 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.
SOC-REC/SOC-OICBehavioural
Also called Standard of care-routine education and counseling/Outreach and Intensified Counselling
Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
SOC-REC/CCTBehavioural
Also called Standard of care-routine education and counseling/Conditional Cash Transfer
SOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following per current MOH guidelines).
SOC-REC/IP-NAVBehavioural
Also called Standard of care-routine education and counseling/In-Person Peer Navigation
SOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated.
E-NAV/SOC-OICBehavioural
Also called Electronic-Navigation/SOC-Outreach and Intensified Counseling
E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
E-NAV/CCTBehavioural
Also called Electronic-Navigation/Conditional cash transfer
E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following current MOH guidelines).
E-Nav/IP-NAVBehavioural
Also called Electronic-Navigation/In-Person Peer Navigation
E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (MOH guidelines). Trained peer navigators will provide psychosocial support, case management, assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers
| Study group | Role | What they receive |
|---|---|---|
| SOC-REC/SOC-OIC | Active comparator | Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC) Receives: Behavioral: SOC-REC/SOC-OIC |
| SOC-REC/CCT | Experimental | SOC-REC/Conditional Cash Transfer (CCT) Receives: Behavioral: SOC-REC/CCT |
| SOC-REC/IP-NAV | Experimental | SOC-REC/In-Person Peer Navigation (IP-NAV) Receives: Behavioral: SOC-REC/IP-NAV |
| E-NAV/SOC-OIC | Experimental | Electronic Navigation/SOC-OIC Receives: Behavioral: E-NAV/SOC-OIC |
| E-NAV/CCT | Experimental | E-Nav/Conditional cash transfer Receives: Behavioral: E-NAV/CCT |
| E-NAV/IP-NAV | Experimental | E-Nav/In-Person Peer Navigation Receives: Behavioral: E-Nav/IP-NAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care engagement failure
Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.
Measured: 24 months
Re-engagement
Viral suppression (per current MOH guidelines) six months after re-randomization
Measured: 24 months
Sustained viral suppression and engagement in care
Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months
Measured: 24 months
Secondary outcomes (7)
Compare survival between arms
Use log rank test to compare survival curves between arms
Measured: 24 months
Explore alternative outcome definitions: Mean visit adherence
mean number of scheduled clinic visits attended
Measured: 24 months
Explore alternative outcome definitions: Medication possession ratio
Proportion of scheduled pharmacy/medication visits attended
Measured: 24 months
Explore alternative outcome definitions: HIV RNA levels
Viral suppression threshold (following current MOH guidelines)
Measured: 24 months
Composite of time to return and time to viral resuppression
Composite of time to return for the subset of patients failing Stage 1 treatments through missed visits, and time to viral resuppression for those who failed through an elevated viral load
Measured: 24 months
Cost effectiveness
We will compute unit cost for intervention activity and use information on activities for each participant to compute intervention cost per participant for each intervention strategy.
Measured: 24 months
Qualitative evaluation of how interventions work
Qualitative methods will be used to identify major themes to understand how interventions worked (or did not work).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start6 Apr 2021
- Primary completion13 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of California, San Francisco, University of California, Berkeley, Kenya Medical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432571
- Sponsor's protocol ID
- 201910133
- Acronym
- A4A
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2020
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ontuga GM, Mangale DI, Lewis-Kulzer J, Kwena ZA, Akama E, Adhiambo HF, Iguna S, Akinyi OB, Nyandieka E, Omondi E, Ochieng F, Owino OC, Goldin S, Anne BE, Geng E, Beres LK, Abuogi LL. "I feel like a guest on the other side": youth-identified challenges and solutions to transitioning from adolescent to adult HIV services in Western Kenya. AIDS Care. 2026 Jun;38(6):1341-1352. doi: 10.1080/09540121.2025.2591425. Epub 2026 Feb 17.
PubMed 41700479Abuogi LL, Kulzer JL, Akama E, Odeny TA, Eshun-Wilson I, Petersen M, Shade SB, Montoya LM, Beres LK, Iguna S, Adhiambo HF, Osoro J, Opondo I, Sang N, Kwena Z, Bukusi EA, Geng EH. Adapt for Adolescents: Protocol for a sequential multiple assignment randomized trial to improve retention and viral suppression among adolescents and young adults living with HIV in Kenya. Contemp Clin Trials. 2023 Apr;127:107123. doi: 10.1016/j.cct.2023.107123. Epub 2023 Feb 20.
PubMed 36813086
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Strategy for Preventing and Treating Lapses of Retention in HIV Care for Adolescents
- ClinicalTrials.gov ID
- NCT04432571
- Acronym / sponsor ID
- A4A / 201910133
- Conditions
- HIV/AIDS
- Keywords
- Adolescents, Retention, Engagement in Care, Lost to follow-up, Kenya, Adaptive strategies, Sequentially randomized trial, Sequential Multiple Assignment Randomized Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of California, San Francisco, University of California, Berkeley, Kenya Medical Research Institute
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jun 2020 (actual)
- 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.
Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.
Detailed description
While the global response to HIV has reached close to 20 million persons with life-saving antiretroviral therapy (ART) and saved upwards of 60 million life-years, progress has been uneven and adolescents and young adults (AYA) aged 14-24 years represent a key group left behind. Compared to adults, AYA with HIV face more numerous, more diverse and more intense barriers to adherence and retention. The investigators will utilize a SMART study design in two stages among 880 AYA with HIV in Kenya to improve retention and viral suppression per the current MOH guidelines. In stage 1 AYA will be randomized 1:1 to either (1) standard of care education or counseling vs. (2) electronic navigation. Participants who do well (no lapses in retention, medication pick up and viral suppression) will be maintained on these low-intensity interventions, whereas those who fail will be re-randomized a second time to one of three re-engagement interventions (stage 2): (1) standard of care tracing, (2) a conditional cash transfer and (3) in-person peer navigation. The primary outcomes include (1) for prevention: lapse in engagement or viral non-suppression following current MOH guidelines; (2) for re-engagement: viral suppression six months after re-randomization; and (3) across six strategies: sustained viral suppression and sustained engagement in care at two years. The investigators anticipate that enrolling 880 AYA will result in 99% power to detect a 15% difference in the primary outcome between intervention groups. The investigators believe this study will yield evidence specific to AYA with HIV, quantify the relative magnitude of different sequenced interventions, capture the costs, and have direct relevance for public health programming to end the AIDS epidemic through engaging adolescents and young adults with HIV.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SOC-REC/SOC-OIC | Active comparator | Behavioral: SOC-REC/SOC-OICStandard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC) |
| SOC-REC/CCT | Experimental | Behavioral: SOC-REC/CCTSOC-REC/Conditional Cash Transfer (CCT) |
| SOC-REC/IP-NAV | Experimental | Behavioral: SOC-REC/IP-NAVSOC-REC/In-Person Peer Navigation (IP-NAV) |
| E-NAV/SOC-OIC | Experimental | Behavioral: E-NAV/SOC-OICElectronic Navigation/SOC-OIC |
| E-NAV/CCT | Experimental | Behavioral: E-NAV/CCTE-Nav/Conditional cash transfer |
| E-NAV/IP-NAV | Experimental | Behavioral: E-Nav/IP-NAVE-Nav/In-Person Peer Navigation |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- HIV-infection, on or initiating ART,
- 14-24 years of age,
- Living > 6 months in Kisumu County, Kenya in previous year,
- Capable of informed consent (> 18 years) or with a legal caregiver available for consent (14-<18 years),
- Access to a cell phone,
Key exclusion criteria (3 listed)
- AYA who participated in ADAPT-R,
- Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization,
- Those who report sharing phones but have not disclosed to the person sharing the phone
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 |
|---|---|---|
| SOC-REC/SOC-OICAlso: Standard of care-routine education and counseling/Outreach and Intensified CounsellingStandard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic. | Behavioural | SOC-REC/SOC-OIC |
| SOC-REC/CCTAlso: Standard of care-routine education and counseling/Conditional Cash TransferSOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following per current MOH guidelines). | Behavioural | SOC-REC/CCT |
| SOC-REC/IP-NAVAlso: Standard of care-routine education and counseling/In-Person Peer NavigationSOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated. | Behavioural | SOC-REC/IP-NAV |
| E-NAV/SOC-OICAlso: Electronic-Navigation/SOC-Outreach and Intensified CounselingE-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic. | Behavioural | E-NAV/SOC-OIC |
| E-NAV/CCTAlso: Electronic-Navigation/Conditional cash transferE-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) who have unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (following current MOH guidelines). | Behavioural | E-NAV/CCT |
| E-Nav/IP-NAVAlso: Electronic-Navigation/In-Person Peer NavigationE-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has unsuppressed HIV RNA as per current MOH viral load threshold or (3) clinically documented non-adherence after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (MOH guidelines). Trained peer navigators will provide psychosocial support, case management, assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers | Behavioural | E-NAV/IP-NAV |
Primary outcome
Care engagement failure
Time frame: 24 months
Experiencing any of the following three events within the first year of follow-up: lapse in retention (defined as 14 days late for a scheduled visit) or unsuppressed HIV RNA following current MOH guidelines during routine monitoring, or death.
Re-engagement
Time frame: 24 months
Viral suppression (per current MOH guidelines) six months after re-randomization
Sustained viral suppression and engagement in care
Time frame: 24 months
Sustained viral suppression (per current MOH guidelines) and sustained engagement in care at 24 months
7 secondary outcomes
Compare survival between arms
Time frame: 24 months
Explore alternative outcome definitions: Mean visit adherence
Time frame: 24 months
Explore alternative outcome definitions: Medication possession ratio
Time frame: 24 months
Explore alternative outcome definitions: HIV RNA levels
Time frame: 24 months
Composite of time to return and time to viral resuppression
Time frame: 24 months
Cost effectiveness
Time frame: 24 months
Qualitative evaluation of how interventions work
Time frame: 24 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 30 Jun 2026.
- Derived from this study: PubMed 41700479Ontuga GM, Mangale DI, Lewis-Kulzer J, Kwena ZA, Akama E, Adhiambo HF, Iguna S, Akinyi OB, Nyandieka E, Omondi E, Ochieng F, Owino OC, Goldin S, Anne BE, Geng E, Beres LK, Abuogi LL. "I feel like a guest on the other side": youth-identified challenges and solutions to transitioning from adolescent to adult HIV services in Western Kenya. AIDS Care. 2026 Jun;38(6):1341-1352. doi: 10.1080/09540121.2025.2591425. Epub 2026 Feb 17.
- Derived from this study: PubMed 36813086Abuogi LL, Kulzer JL, Akama E, Odeny TA, Eshun-Wilson I, Petersen M, Shade SB, Montoya LM, Beres LK, Iguna S, Adhiambo HF, Osoro J, Opondo I, Sang N, Kwena Z, Bukusi EA, Geng EH. Adapt for Adolescents: Protocol for a sequential multiple assignment randomized trial to improve retention and viral suppression among adolescents and young adults living with HIV in Kenya. Contemp Clin Trials. 2023 Apr;127:107123. doi: 10.1016/j.cct.2023.107123. Epub 2023 Feb 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOC-REC/SOC-OIC, SOC-REC/CCT and SOC-REC/IP-NAV in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Kenya.
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 9 inclusion and 3 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 30 Jun 2026. 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 Kenya. 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?
Care engagement failure (time frame: 24 months). The study lists 3 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 NCT04432571, which also lists 2 linked publications.
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 30 Jun 2026.