HIVAdaPT-RNCT02338739
An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya
A study testing REC; Outreach if Failure, REC; SMS + Voucher if Failure and REC; Navigator if Failure in people with HIV, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- REC; Outreach if Failure, REC; SMS + Voucher if Failure and REC; Navigator if Failure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,816 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2015to Nov 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infection
- 18 years old
- Planning to remain in the study area (Nyanza region) for the duration of the study, capable of informed consent
- Newly initiating ART (within past 90 days)
- Access to a cell phone
- Ability to read or be read SMS messages
- And willingness to be contacted by clinic upon missed appointment.
Who cannot join
- Plans to move out of Nyanza region or acutely ill and requiring hospitalization.
- Hospitalized patients who later recover will be eligible for enrolment at the first post-hospitalization clinic visit during which eligibility criteria are met.
- No access to a cell phone.
- Involvement in studies with the potential to influence retention behaviors.
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 Adult HIV Care (AdaPT-R)
Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed. Sequential adaptive strategies - a novel class of public health approaches - may offer a solution. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies. the investigators will randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after missed visit (and not verified to have left the area or transferred to another clinic) will also be rerandomized to of one the same three re-engagement interventions. Individuals randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12 months to stop first stage intervention or continue with that same intervention to 24 months. The investigators primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. The investigators primary endpoint is fraction of time retained in care two years after enrolment. In addition, the investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse. This study will also compare outcomes among patients who continue versus discontinue the SMS and voucher interventions, including a small complementarity component utilizing qualitative methods to examine the voucher approach and the effects of discontinuing this approach after success among a subset of participants. At study conclusion the investigators output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.
- Conditions
- HIV
- Being tested
- REC; Outreach if Failure, REC; SMS + Voucher if Failure, REC; Navigator if Failure, SMS; Outreach if Failure, SMS; Outreach if Failure; Stop SMS if Success
- Keywords
- Retention, Lost to follow up, Adaptive strategies, Dynamic regime, Sequentially randomized trial, Sequential multiple assignment randomized trial, Engagement in care, Kenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REC; Outreach if FailureBehavioural
Routine education and counseling (REC) services, delivered per Kenya Ministry of Health Guidelines; followed by standard of care (SOC) outreach to encourage return to clinic for patients 14 days late for a scheduled visit in year 1.
REC; SMS + Voucher if FailureBehavioural
Routine education and counseling services, delivered per Kenya Ministry of Health (MOH) Guidelines; followed by SMS text messages for patients and reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
REC; Navigator if FailureBehavioural
REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
SMS; Outreach if FailureBehavioural
SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
SMS; Outreach if Failure; Stop SMS if SuccessBehavioural
SMS text messages for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
SMS; SMS+Voucher if FailureBehavioural
SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
SMS; SMS+Voucher if Failure; Stop SMS if SuccessBehavioural
SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1, and discontinuation of SMS text messages if never 14 days late
SMS; Navigator if FailureBehavioural
SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
SMS; Navigator if Failure; Stop SMS if SuccessBehavioural
SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
Voucher; Outreach if FailureBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit
Voucher; Outreach if Failure; Stop Voucher if SuccessBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
Voucher; SMS+Voucher if FailureBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit
Voucher; SMS+Voucher if Failure; Stop Voucher if SuccessBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
Voucher; Navigator if FailureBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
Voucher; Navigator if Failure; Stop Voucher if SuccessBehavioural
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
| Study group | Role | What they receive |
|---|---|---|
| REC; Outreach if Failure | Active comparator | Not described Receives: Behavioral: REC; Outreach if Failure |
| REC; SMS + Voucher if Failure | Active comparator | Not described Receives: Behavioral: REC; SMS + Voucher if Failure |
| REC; Navigator if Failure | Active comparator | Not described Receives: Behavioral: REC; Navigator if Failure |
| SMS; Outreach if Failure | Active comparator | Not described Receives: Behavioral: SMS; Outreach if Failure |
| SMS; Outreach if Failure; Stop SMS if Success | Active comparator | Not described Receives: Behavioral: SMS; Outreach if Failure; Stop SMS if Success |
| SMS; SMS+Voucher if Failure | Active comparator | Not described Receives: Behavioral: SMS; SMS+Voucher if Failure |
| SMS; SMS+Voucher if Failure; Stop SMS if Success | Active comparator | Not described Receives: Behavioral: SMS; SMS+Voucher if Failure; Stop SMS if Success |
| SMS; Navigator if Failure | Active comparator | Not described Receives: Behavioral: SMS; Navigator if Failure |
| SMS; Navigator if Failure; Stop SMS if Success | Active comparator | Not described Receives: Behavioral: SMS; Navigator if Failure; Stop SMS if Success |
| Voucher; Outreach if Failure | Active comparator | Not described Receives: Behavioral: Voucher; Outreach if Failure |
| Voucher; Outreach if Failure; Stop Voucher if Success | Active comparator | Not described Receives: Behavioral: Voucher; Outreach if Failure; Stop Voucher if Success |
| Voucher; SMS+Voucher if Failure | Active comparator | Not described Receives: Behavioral: Voucher; SMS+Voucher if Failure |
| Voucher; SMS+Voucher if Failure; Stop Voucher if Success | Active comparator | Not described Receives: Behavioral: Voucher; SMS+Voucher if Failure; Stop Voucher if Success |
| Voucher; Navigator if Failure | Active comparator | Not described Receives: Behavioral: Voucher; Navigator if Failure |
| Voucher; Navigator if Failure; Stop Voucher if Success | Active comparator | Not described Receives: Behavioral: Voucher; Navigator if Failure; Stop Voucher if Success |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Fraction of time in care
Measured: Up to two years after enrollment
Secondary outcomes (7)
Alive with suppressed HIV RNA level (<400 copies/ml)
Number of subjects alive with suppressed HIV RNA levels (<400 copies/ml)
Measured: Two years after study enrollment
Time from second randomization to return to clinic after initial retention lapse
Time from second randomization to re-engagement; re-engagement is defined as first visit back to clinic
Measured: Up to two years after enrollment
Mean visit adherence (% visits made)
Proportion of kept scheduled appointments (range=0-100%), with kept visits being those attended by the patient and with the denominator excluding canceled visits
Measured: Two years after study enrollment
Retention
Fraction of time in care
Measured: Two years after enrollment
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Proportion of prescriptions filled and picked up by participants to prescriptions written
Measured: Two years after enrollment
Cost effectiveness
Cost per failure (virological failure (HIV RNA>=400 copies/ml) or death averted
Measured: After two years of enrollment
Patient-reported barriers to engagement
Self-reported by questionnaire
Measured: At years one and two after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2020
- Study completionNov 2020
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 HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 1,816 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Kenya Medical Research Institute, University of Washington, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elvin Geng, MD, Principal investigator, University of California, San FranciscoMaya Petersen, MD, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338739
- Sponsor's protocol ID
- 1R01MH104123-01
- Other IDs
- 1R01MH104123-01
- Acronym
- AdaPT-R
- Status last verified
- Mar 2021
- First submitted
- 11 Dec 2014
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Geng EH, Odeny TA, Montoya LM, Iguna S, Kulzer JL, Adhiambo HF, Eshun-Wilson I, Akama E, Nyandieka E, Guze MA, Shade S, Packel L, Fox B, Camlin C, Thirumurthy H, Lyons C, Bukusi EA, Petersen ML. Adaptive Strategies for Retention in Care among Persons Living with HIV. NEJM Evid. 2023 Apr;2(4):10.1056/evidoa2200076. doi: 10.1056/evidoa2200076. Epub 2023 Mar 28.
PubMed 38143482
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. 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 Adult HIV Care (AdaPT-R)
- ClinicalTrials.gov ID
- NCT02338739
- Acronym / sponsor ID
- AdaPT-R / 1R01MH104123-01
- Conditions
- HIV
- Keywords
- Retention, Lost to follow up, Adaptive strategies, Dynamic regime, Sequentially randomized trial, Sequential multiple assignment randomized trial, Engagement in care, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,816 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Kenya Medical Research Institute, University of Washington, National Institute of Mental Health (NIMH)
- Study start
- Mar 2015
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 14 Jan 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.
Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes. A strategy to optimize retention within resource constraints is urgently needed. Sequential adaptive strategies - a novel class of public health approaches - may offer a solution. A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention. This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies. the investigators will randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC), (2) SMS text messages, or (3) transport vouchers. Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator. Patients not successfully contacted by 28 days after missed visit (and not verified to have left the area or transferred to another clinic) will also be rerandomized to of one the same three re-engagement interventions. Individuals randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12 months to stop first stage intervention or continue with that same intervention to 24 months. The investigators primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur. The investigators primary endpoint is fraction of time retained in care two years after enrolment. In addition, the investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse. This study will also compare outcomes among patients who continue versus discontinue the SMS and voucher interventions, including a small complementarity component utilizing qualitative methods to examine the voucher approach and the effects of discontinuing this approach after success among a subset of participants. At study conclusion the investigators output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| REC; Outreach if Failure | Active comparator | Behavioral: REC; Outreach if Failure |
| REC; SMS + Voucher if Failure | Active comparator | Behavioral: REC; SMS + Voucher if Failure |
| REC; Navigator if Failure | Active comparator | Behavioral: REC; Navigator if Failure |
| SMS; Outreach if Failure | Active comparator | Behavioral: SMS; Outreach if Failure |
| SMS; Outreach if Failure; Stop SMS if Success | Active comparator | Behavioral: SMS; Outreach if Failure; Stop SMS if Success |
| SMS; SMS+Voucher if Failure | Active comparator | Behavioral: SMS; SMS+Voucher if Failure |
| SMS; SMS+Voucher if Failure; Stop SMS if Success | Active comparator | Behavioral: SMS; SMS+Voucher if Failure; Stop SMS if Success |
| SMS; Navigator if Failure | Active comparator | Behavioral: SMS; Navigator if Failure |
| SMS; Navigator if Failure; Stop SMS if Success | Active comparator | Behavioral: SMS; Navigator if Failure; Stop SMS if Success |
| Voucher; Outreach if Failure | Active comparator | Behavioral: Voucher; Outreach if Failure |
| Voucher; Outreach if Failure; Stop Voucher if Success | Active comparator | Behavioral: Voucher; Outreach if Failure; Stop Voucher if Success |
| Voucher; SMS+Voucher if Failure | Active comparator | Behavioral: Voucher; SMS+Voucher if Failure |
| Voucher; SMS+Voucher if Failure; Stop Voucher if Success | Active comparator | Behavioral: Voucher; SMS+Voucher if Failure; Stop Voucher if Success |
| Voucher; Navigator if Failure | Active comparator | Behavioral: Voucher; Navigator if Failure |
| Voucher; Navigator if Failure; Stop Voucher if Success | Active comparator | Behavioral: Voucher; Navigator if Failure; Stop Voucher if Success |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-infection
- 18 years old
- Planning to remain in the study area (Nyanza region) for the duration of the study, capable of informed consent
- Newly initiating ART (within past 90 days)
- Access to a cell phone
Key exclusion criteria (4 listed)
- Plans to move out of Nyanza region or acutely ill and requiring hospitalization.
- Hospitalized patients who later recover will be eligible for enrolment at the first post-hospitalization clinic visit during which eligibility criteria are met.
- No access to a cell phone.
- Involvement in studies with the potential to influence retention behaviors.
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 |
|---|---|---|
| REC; Outreach if FailureRoutine education and counseling (REC) services, delivered per Kenya Ministry of Health Guidelines; followed by standard of care (SOC) outreach to encourage return to clinic for patients 14 days late for a scheduled visit in year 1. | Behavioural | REC; Outreach if Failure |
| REC; SMS + Voucher if FailureRoutine education and counseling services, delivered per Kenya Ministry of Health (MOH) Guidelines; followed by SMS text messages for patients and reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1. | Behavioural | REC; SMS + Voucher if Failure |
| REC; Navigator if FailureREC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit | Behavioural | REC; Navigator if Failure |
| SMS; Outreach if FailureSMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit | Behavioural | SMS; Outreach if Failure |
| SMS; Outreach if Failure; Stop SMS if SuccessSMS text messages for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late | Behavioural | SMS; Outreach if Failure; Stop SMS if Success |
| SMS; SMS+Voucher if FailureSMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1. | Behavioural | SMS; SMS+Voucher if Failure |
| SMS; SMS+Voucher if Failure; Stop SMS if SuccessSMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1, and discontinuation of SMS text messages if never 14 days late | Behavioural | SMS; SMS+Voucher if Failure; Stop SMS if Success |
| SMS; Navigator if FailureSMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit | Behavioural | SMS; Navigator if Failure |
| SMS; Navigator if Failure; Stop SMS if SuccessSMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late | Behavioural | SMS; Navigator if Failure; Stop SMS if Success |
| Voucher; Outreach if FailureReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit | Behavioural | Voucher; Outreach if Failure |
| Voucher; Outreach if Failure; Stop Voucher if SuccessReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late | Behavioural | Voucher; Outreach if Failure; Stop Voucher if Success |
| Voucher; SMS+Voucher if FailureReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit | Behavioural | Voucher; SMS+Voucher if Failure |
| Voucher; SMS+Voucher if Failure; Stop Voucher if SuccessReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late | Behavioural | Voucher; SMS+Voucher if Failure; Stop Voucher if Success |
| Voucher; Navigator if FailureReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit | Behavioural | Voucher; Navigator if Failure |
| Voucher; Navigator if Failure; Stop Voucher if SuccessReimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late | Behavioural | Voucher; Navigator if Failure; Stop Voucher if Success |
Primary outcome
Retention
Time frame: Up to two years after enrollment
Fraction of time in care
7 secondary outcomes
Alive with suppressed HIV RNA level (<400 copies/ml)
Time frame: Two years after study enrollment
Time from second randomization to return to clinic after initial retention lapse
Time frame: Up to two years after enrollment
Mean visit adherence (% visits made)
Time frame: Two years after study enrollment
Retention
Time frame: Two years after enrollment
Fraction on-time pharmacy pick-ups for antiretroviral drugs
Time frame: Two years after enrollment
Cost effectiveness
Time frame: After two years of enrollment
Patient-reported barriers to engagement
Time frame: At years one and two after study enrollment
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 16 Mar 2021.
- Derived from this study: PubMed 38143482Geng EH, Odeny TA, Montoya LM, Iguna S, Kulzer JL, Adhiambo HF, Eshun-Wilson I, Akama E, Nyandieka E, Guze MA, Shade S, Packel L, Fox B, Camlin C, Thirumurthy H, Lyons C, Bukusi EA, Petersen ML. Adaptive Strategies for Retention in Care among Persons Living with HIV. NEJM Evid. 2023 Apr;2(4):10.1056/evidoa2200076. doi: 10.1056/evidoa2200076. Epub 2023 Mar 28.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Elvin Geng, MD principal investigator
University of California, San Francisco
Maya Petersen, MD, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REC; Outreach if Failure, REC; SMS + Voucher if Failure and REC; Navigator if Failure in people with HIV, run by University of California, San Francisco 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 7 inclusion and 4 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 16 Mar 2021. 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?
Retention (time frame: Up to two years after enrollment). 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 NCT02338739, 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 16 Mar 2021.